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Research issues in complementary therapies
Research issues in complementary therapies Carole Archer Complementary medicine views health as a balance of forces to achieve optimum wellbeing of body, mind and spirit, whilst conventional healthcare focuses on the prevention, diagnosis and treatment of disease. The World Health Organisation estimates that globally 80% of primary consultations occur within holistic therapies (Lewith 1995). Numerous reasons explain this, e.g. dissatisfaction with technological medicine, increasing individual responsibility for health, and more client involvement in treatment. The increased use of complementary therapies in the U K has stimulated debate about health, illness and care which poses issues for the overall delivery of contemporary healthcare. Rising standards of accountability create expectations that research is available which informs safe and effective practice.This article reflects on the particular issue of research methodology into the effectiveness of healthcare.
WHY RESEARCH INTO EFFECTIVENESS OF HOLISTIC T H E R A P I E S IS I M P O R T A N T
Carole A r c h e r
BSc (Hons), Project Worker, REACHOUT, The Weald of Kent Mental Health Outreach Project, Tunbridge Wells Mental Health Resource Ltd, UK (Requests for offprints to: Carole Archer, 22 Bickmore Way, Tonbridge, Kent TN9 IND, UK)
Many complementary therapies are of unproven efficacy. Research has hitherto been lacking, and results controversial and contradictory. Difficulties abound in determining efficacy due to the variety of methods used to compare different therapies and the lack of comprehension of the model of holistic medicine (Chabot 1990). To illustrate Ter Riet et al. (1990) claim the effectiveness of acupuncture for chronic pain has not been definitely demonstrated (Ernst 1997). However, Pantanowitz (1994) claims evidence of acupuncture efficacy stating biochemical measurements show naturally produced pain killers, endorphins, are elevated by acupuncture. Added to this Reilly et al. (1993) claim evidence for the effectiveness of homoeopathy for hay fever, but Buckman (Buckman & Lewith 1994) disputes this, claiming results have not been successfully repeated to show objective conclusions. These apparent inconsistencies may be explained by the individual nature of complementary therapies. For example, homoeopathy cannot be defined by the molecules of conventional pharmacology (Fisher 1995). Such diversity indicates that differing research
methodologies may be required to establish effectiveness. It appears that the emphasis with many complementary therapies is more care than cure, such as the use of reflexology and aromatherapy in nursing and midwifery, but safety, ethics and a moral duty still require evaluation of effectiveness, perhaps by qualitative outcomes, e.g. wellbeing, or therapist/patient interaction. Less acknowledged complementary therapies do claim successful research into efficacy. Benor (1995) refers to controlled studies into spiritual healing substantiating effectiveness, although conventional practitioners may dispute this. Dr Reilly, consultant at the Glasgow Homoeopathic Hospital, has suggested that most conventional practitioners believe self-healing is due to the placebo effect, i.e. the client improves because he believes he is receiving treatment (Vickers 1994). Lewith (1994) suggests that the placebo effect is poorly understood and probably reflects doctors' attitudes to the client, the natural resolution of the illness, the effects of receiving treatment, and the belief system of the client and practitioner. Such a lack of explanatory mechanisms and the body's capacity for self-healing require further research. In 1995 Coulson found that 65% of general practitioners (GPs) believe that complementary
Complementary Therapiesin Nursing & Midwifery (1999)5,108-114 9 1999Harcourt PublishersLtd
Research issues in complementary therapies
therapies are relevant to contemporary healthcare, but are concerned about the lack of research into their efficacy and safety. Autonomy requires GPs to respect patients' decisions. Thus, the increase in demand for complementary therapies can be problematic. A GP may have to decide whether to advocate, or advise against, a complementary therapy which is not conventionally validated. However, much contemporary healthcare has not been tested. Lewith (Buckman & Lewith 1994) states most trials of non-steroidal anti-inflammatory agents examine the short term, but are prescribed long term for arthritis and pain. Perhaps those in conventional medicine who demand thorough testing of complementary therapies should address such inconsistencies. The above illustrates the controversies surrounding complementary therapy research. Ernst (1996) claims that ethically, unproven remedies must be substantiated by scientific research. Thus, for a more integrated healthcare system agreement must be reached regarding appropriate methods of researching the efficacy and safety of complementary therapies. The continuation of two disparate systems of medicine could be detrimental to the consumer and provider, denying a wider choice of therapies. However, it must be debatable whether effectiveness is ever conclusive, for research rarely provides unequivocal answers and indeed often raises further questions.
DIFFERENT C U L T U R A L PERSPECTIVES T O RESEARCH
Complementary and contemporary healthcare result from differing ideologies...
Personal and social beliefs about the body and illness are constructed by cultures, and vary considerably. Complementary and contemporary healthcare result from differing ideologies and draw on their traditional culture for validity and efficacy (Hopwood 1997). Thus, cultural diversity has implications for researching the social and cultural context of illness. From an anthropological perspective, science is not an objective research tool for evaluation or effectiveness (Ryan 1995). The biomedical paradigm of conventional healthcare would dispute this, assuming that the social setting is real, with observable and measurable facts about bodies and disease. Biomedicine claims to be scientific, and thus valid and unaffected by culture (Byrne 1992). However, as a social construct it is one approach amongst many. Of course other issues, such as safety and ethics, are relevant. It would be irresponsible not to explore efficacy, but it is debatable whether any health practice should be rejected, or its research methods used to appraise other health systems.
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Complementary therapies claim that biological science, and by inference conventional medicine, is based on the Cartesian or reductionalist philosophy, attempting explanation by biological means. Such a perspective may not apply to complementary therapies which involve understanding of the world (ontology), so different methods (epistemology) of research are required. Many complementary practitioners, e.g. non-medically qualified homoeopaths, claim that a scientific theory for complementary therapies would align them to the scientific paradigm (Cant & Sharma 1996b), removing their social constructs and threatening their ideology and individuality. Is it, therefore, right for conventional medicine to assume that its validating methods are the best available and most appropriate for determining complementary therapy efficacy? Perhaps this is narrow minded and blinkered. Examining the philosophies of complementary therapies may expand contemporary medicine conceptually and therapeutically, offering better overall healthcare, for which we all strive. However, conventional medicine may not address such holistic therapies because they challenge the biomedical model, leading to some worthwhile approaches being rejected. Similarly, orthodox medicine may denounce complementary therapy research out of context, stereotyping holistic therapies as 'quackery' (Berman & Anderson 1994). Such refusal to address differing concepts of complementary medicine threatens objective investigation. Consumers of conventional healthcare with such views on holistic therapies may be denied the option of accessing complementary therapies. However, probably due to client demand, contemporary healthcare does now appear to view holistic therapies more favourably, but still remains suspicious of researching them from differing perspectives. Yet such issues as the placebo effect, hypnosis, psychoneuroimmunology, and spontaneous remission may force conventional research to a new paradigm. The holistic and humanistic view values all subjective data, recognizing individual uniqueness. This perspective does not seek to control or manipulate, and includes social and personal dimensions and life situations (Vickers 1996). Thus the assessment of complementary medicine effectiveness may require an ideological shift in understanding health, illness and treatment. It remains questionable whether conventional practitioners will ever accept a different paradigm. Rather than compromising complementary therapies to science, conventional medicine is challenged to include new research methods (Berman & Anderson 1994). Evaluating holistic therapies, especially spiritual and emotional aspects, indicates different research paradigms,
I10
... the randomized controlled trial represents only one type of research design
Generally speaking, the concept of
knowledge develops not from experiment but from insight and intuition.
ComplementaryTherapiesin Nursing & Midwifery
e.g. qualitative (subjective) appraisal. These could provide innovative directions and greater understanding, not just of treatments for illness, but of wellbeing.
IS PRESENT SCIENTIFIC M E T H O D O L O G Y SUITABLE FOR COMPLEMENTARY THERAPY RESEARCH? The increasing use of holistic therapies, heightens the need to clarify which research designs appropriately assess effectiveness. Hobbs and Davies (1998) suggest scientific methodology is moving towards non-linear thought processes of the biopsychological models. However, many scientists still prefer the measurable results of quantitative research. Ernst (1997) and Vickers et al. (1997) from this conventional viewpoint, advocate empirical research for efficacy, mainly randomized controlled trials. These allocate participants randomly, assessing an active treatment, against a control (Fitter & Thomas 1997). Yet randomized controlled trials involve features such as double blinding (neither subject nor researcher know which treatment is given to whom), which raise ethical and practical issues for holistic therapy research. Further problems occur with randomization, and generalization of findings as complementary treatments are frequently individual, and their application may not be transferable between clients, e.g. individual specific homoeopathic prescriptions. Despite the extensive use of randomized controlled trials many improvements in clinical medicine have arisen from trial and error, intuition and systematic observation and study (Pietroni 1991). This does not reduce the importance of researching efficacy, but illustrates that too much significance may be placed on the randomized controlled trial as if nothing could replace its viability. Indeed the randomized controlled trial is a fairly recent development, the first double blind, placebo controlled, randomized clinical trial of any therapy was the Medical Research Council's 1948 trial of Streptomycin for tuberculosis (Fisher 1995a). Furthermore, the randomized controlled trial represents only one type of research design and as such must only be suitable for certain types of research question. With complementary medicine other types of questions are being asked suggesting that a wider range of research methods should be considered and may be more applicable when deciding the efficacy of many complementary therapies. Generally speaking, the concept of knowledge develops not from experiment but from insight and intuition. Scientists like Newton and Einstein were directed by a conviction rather
than previous research findings. Kuhn (1970) states that the failure of existing rules introduces a search for improvement, so that what evolves is not a right or a wrong way but a new way, and that the scientist with a new paradigm must see through different eyes (Hobbs & Davies 1998). Perhaps this is an answer to the recent Guest Editorial in Complementary Therapies in Nursing & Midwifery (Rayner 1998) which states that acupuncture only makes sense now that we understand endorphins, but that reflexology is not valid because we do not yet comprehend its mechanisms of action. Sadly, this perspective illustrates the need of conventional medicine to relate every new therapy to its own validating terms instead of seeing 'with different eyes' for some appear to be blind to new ideas. It is not conducive to better integration of complementary and conventional health care to postulate, as Rayner (1998) does, that reflexology is nonsense merely because in contemporary, conventional terms we do not 'know'. However, the problem is further compounded by dissension within complementary medicine as to which methodologies research is efficacious. The Society of Homoeopaths uses randomized controlled trials (Cant & Sharma 1996a), but the College of Homoeopathy (1993) claims that this scientific basis is simply experimental biology, a conflict which further distances complementary medicine from orthodox healthcare. St George (1993) believes that the medicalization of holistic therapies into the contemporary healthcare system reduces all treatments to investigation through the randomized controlled trial. Yet this only relates to those holistic therapies which easily integrate into conventional healthcare, without considering those which do not, thereby potentially losing much of the therapeutic value, and reducing treatment choices for practitioner and client. Vickers et al. (1997) state that research is always feasible regardless of the therapy, but until the development of research methods acceptable to conventional healthcare, many valuable treatments may be shortsightedly dismissed. The Research Council for Complementary Medicine (RCCM 1993) state that the lack of a theoretical model should not result in the rejection of the unorthodox, nor prohibit demonstration of efficacy. As well as the randomized controlled trial, an RCCM (1993a) Research Policy Committee advocated a range of approaches for evaluating complementary therapies including non-randomizing comparisons which recognize the behavioural aspects of using complementary therapies (Ersser 1995). This could embrace historical controls, phenomenological description, illustrative case studies, conceptual and theoretical research, and literature research and review.
Research issues in complementary therapies
However, enhancing research methods requires training and time, funding in particular is another area of dissent. Lewith (1994) stresses that methodological design needs understanding of science, orthodox research, and holistic therapy philosophy (Monckton 1994), and that conventional studies may research the therapy, rather than the holistic approach. Maybe the method of research should be questioned for not assessing effectiveness, rather than rejecting the holistic therapy.
HOLISTIC T H E R A P Y RESEARCH Recent developments
The Cochrane Collaboration ...includes complementary medicine research, and is not restricted to randomized controlled trials.
Despite controversy regarding methodology there is progress in holistic therapy research. The US Congress has appropriated $2 million to study complementary medicine validity (Seaward 1994), and since 1991 the Division of Complementary Medicine (US) has been actively conducting research using varying methodologies (Berman 1997a). In the U K the Medical Research Council (MRC) claims to support research into complementary medicine, presumably from a biomedical perspective. The Centralised Information Service for Complementary Medicine (CISCOM), a database established by the RCCM, specializes in collating clinical trails. The Centre for the Study of Complementary Medicine promotes research, e.g. studying subtle energies which may explain many holistic therapies (Rees 1995). The Cochrane Collaboration, a world network of systematic reviews includes complementary medicine research, and is not restricted to randomized controlled trials. Haynes et al. (1996) describes how the Collaboration supports evidence-based practice which strives to incorporate scientifically proven procedures into clinical practice more quickly and more widely than in the past. This integrates clinical experience with external evidence protecting the interests of the patient (Ernst 1997). The aim is improved care, integrating conventional and holistic therapies. However, Vickers et al. (1997) claim that to practise evidence-based healthcare the means by which healthcare is based on evidence must be understood, and that currently controversies regarding holistic therapy research question this understanding. Thus much is underway to assess complementary therapy effectiveness along with some joint efforts with conventional medicine. However, more pilot trials, research in general practice and hospitals is required (Fisher 1995). Longitudinal studies would also appraise efficacy as the nature of holistic therapies often dictates longer treat-
III
ment than conventional healthcare, e.g. aromatherapy for anxiety.
Implications for consumers Holistic therapies provide time and attention for the individual, considering attitudes, behaviour, age, culture and gender. Such considerations may be lacking in. conventional healthcare due to less time, problems of terminology, funding and staff. Further lack of client confidence in conventional healthcare may increase this divide. However, availability and choice of complementary healthcare could confuse the consumer. Advice may not be forthcoming from GPs who may lack knowledge and belief in holistic therapies. Many consumers seek therapists on personal recommendation, but can be misled by complementary therapy qualifications which are not unified, or recognizable. No treatment, contemporary or holistic, is completely safe. Many have risks, e.g. radiography is carcinogenic and some aromatherapy oils are harmful in pregnancy, yet consumers assume, without supporting research, that complementary therapies are safe. Added to this several complementary medicines are selfadministered, available 'over the counter' and used following recommendations from laypersons, although many conventional treatments are utilized similarly. Even if contemporary healthcare and holistic therapies agreed suitable research methodology to prove effectiveness the way in which consumers see the efficacy of holistic therapies, or what determines their perceptions, would not be revealed; yet this dictates usage. Further research into why consumers use holistic therapies would indicate awareness of the risks. Social research is an important and expanding area which informs the psychological and social dimension of health and illness behaviour. For example, survey work has been conducted giving information on the public impact of complementary therapies (e.g. The British Sociological Association 1993). However, such studies are problematic due to the diversity and number of different holistic therapies. Rationing healthcare requires investigation of cost, but research in complementary therapy economics is inconclusive. Meade et al. (1995), researching the costs of chiropractic compared to primary care for low back pain, suggests complementary treatments save expense. However, Carey et al. (1995) investigating the same issue implied that complementary therapy costs more than conventional treatment for the same condition. It is not known if the researchers had a biomedical or holistic bias which may have affected outcome and further research may clarify the position. Nevertheless, the consumer
112 ComplementaryTherapiesin Nursing & Midwifery
Complementary therapists are hindered by lack of research efficacy, but are apprehensive that conventional research could threaten their practice
of holistic therapies may face high costs as most complementary therapies are not available on the National Health Service (NHS) leading to possible elitism if no provision is made within contemporary healthcare. Many complementary therapy benefits would be lost, together with the opportunity to develop wide treatment options for all, a fundamental concept of the original NHS. Until a more unified healthcare system develops, a susceptible, vulnerable, ill client may experience further distress attempting to understand the existing controversies between holistic and contemporary healthcare. The consumer must be able to benefit from multidisciplinary research, leading to broader treatment choice, additional to conventional healthcare.
Implications for practitioners Both complementary and contemporary therapies aim to be holistic, but NHS resources restrict conventional practitioners (Caiman 1994). Complementary therapists are hindered by lack of research efficacy, but are apprehensive that conventional research could threaten their practice, e.g. homoeopaths fear losing holism and autonomy (Wilkinson 1997). The Department of Health is funding pilot studies assessing how osteopathy and chiropractic could be available on the NHS. This gradualist policy may become more interventionist with questions of cost effectiveness and efficacy (Chevallier 1996). But such decisions are politically influenced and an increase in the internal market approach to health may negate intervention. Many holistic therapies wish to receive NHS referrals and Dickinson (1995) suggests that an integrated system, with GP as gatekeeper, could ease safety concerns. However, this raises issues of provision, financing, accountability and subjectivity. Despite radical differences between practitioners some conventional and holistic therapists have integrated to the benefit of the client. Dr Brown, GP President of the National Federation of Spiritual Healers, employs a healer and has found that research into clients with depression and back pain referred to healers, led to an increase in quality of life (Ameghino 1998). The British Medical Association (BMA 1986) review of complementary medicine (in Chevallier 1996) maintained that there were many unscientific, unsubstantiated claims for alternative therapies. This led to the formation of the Council for Complementary and Alternative Medicine (CCAM) to develop relationships with conventional medicine whilst upholding autonomous practice (Cant & Sharma 1996b). The rise in use and interest of complementary therapies resulted in the BMA's (1993) report which
advocated that holistic therapies should be complementary, rather than alternative, to orthodox medicine. Although there is still a bias towards randomized controlled trials (Ersser 1995), it is discouraging t h a t experimental research design of complementary therapies is not more emphasized.
THE FUTURE Whether conventional healthcare is prepared to accept complementary medicine or vice versa is debatable as one challenges the autonomy of the other. Many in contemporary medicine, such as Ernst (1997), are only prepared to incorporate elements of complementary therapies deemed to be appropriate to biomedicine. Issues mentioned, particularly safety, are relevant and account for such reservations, but the apparent short sightedness may preclude much that is of holistic benefit to the client, the interests of whom should be at the forefront of all who debate these issues. An interdisciplinary programme with integrated clinical, educational, and research objectives would improve client opportunities (Berman & Anderson 1994). This would emphasize holism, the person not the disease, their emotional experience of illness, including fear, helplessness and anger. There are examples of recognition of the conflicts discussed and initiatives to address them. The RCCM (1993) is pursuing research finding from the Government. In 1994 the European Parliament Committee on the Environment, Public Health and Consumer Protection adopted a report on the status of complementary medicine in Europe. This report, by MEP Paul Lannoye, recommended appropriate research and expert representation at European level, and that finances for research be forthcoming for each area of complementary medicine. Lannoye is currently seeking money to initiate these recommendations (Trevelyan 1998).
Integrated Medicine. The Way Forwardfor the Next 5 Years (Foundation for Integrated Medicine 1997) proposed an examination of the research issues of efficacy, safety, biological plausibility, methodology, and funding. The report recommends that the public, practitioners and purchasers need to be shown the importance of research and should also be consulted about what they believe is required. Special research centres could be created to undertake or coordinate research, perhaps linked with higher education institutes, and funded through complementary medicine charities. Dissemination of results could be improved, e.g. by strengthening existing resources such as networking all complementary medicine databases and using the Internet. The Foundation proposes the creation
Research issues in complementary therapies
In brief good research means better patient care.
o f an integrated health care service. Complementary and conventional healthcare would be available together, provided by well trained, well regulated practitioners. G o o d quality research would support the therapeutic benefits (Trevelyan 1998a).
CONCLUSION
. . . the client, who is the ultimate loser if the issues discussed are not resolved.
Complementary therapies must expand with accountability or recede, sustaining investigation into efficacy and safety (Mills 1995). M u c h time, effort, patience and reflection is necessary to evaluate effectiveness, safety and cost o f therapies in relation to c o n t e m p o r a r y healthcare. The specific effects o f the therapies, how they should be used and delivered to o p t i m u m benefit, need to be established. It is unlikely that effective, high quality therapy will be available unless these questions are answered by appropriate research. In brief good research means better patient care. There must be access to resources, expertise, a balanced evaluation o f the literature and a research p r o g r a m m e o f outcome studies, surveys a n d clinical trials. Research should be collaborative between orthodox and complementary practitioners, purchasers and providers, N H S trust managers and academics, acknowledging cultural perspectives and differing methodologies. However, it m a y not be time for methodological breakthroughs assessing holistic therapy efficacy. A t present, dialogue, shared work (clinical and academic) and evaluation m a y be all that is achievable (Berman 1997b). Nonetheless, healthcare needs are growing and resources shrinking. Rising standards o f accountability, and the Patient's charter (Department o f Health 1989, 1991), create expectations that research is available which informs on safe and effective practice (Department of Health 1994). There is also growing awareness o f the need to p r o m o t e closer collaboration between practitioners and researchers, and to help clinical staff use research findings more effectively (Ersser 1995). The contribution o f initiatives other than research to raising standards o f practice require consideration. A u d i t measures, such as examining patient anxiety, pain and rest (Lewith & Aldridge 1991) are an example. Clinical observation o f the effects o f therapies must be meticulously recorded and communicated to others (Ersser 1995). The integration and p r o m o t i o n o f all available healing practices, both conventional and complementary, is positive. Broadening healthcare to holism, prevention, wellness with less emphasis on illness must offer greater informed choice to the practitioner and, most importantly, the client, who is the ultimate loser if the issues discussed are not resolved.
113 REFERENCES
Ameghino J 1998 Have faith. The Guardian 7/4/98:13 Benor D J 1995 Literature review. Spiritual healing: a unifying experience in complementary therapies. Complementary Therapies in Medicine 3(4): 234-238 Berman B M 1997a The National Institutes on Health Funded Centers for Alternative Medicine Research and The Center for Alternative Medicine Pain Research and Evaluation at the University of Maryland at Baltimore. Complementary Therapies in Medicine 5:1-2 Berman B M 1997b The Cochrane Collaboration and evidence based complementary medicine. The Journal of Alternative and Complementary Medicine. 3(2): 191-194 Berman B M, Anderson R W 1994 Improving health care through the evaluation and integration of complementary medicine. Complementary Therapies in Medicine 2:217-220 British Medical Association. BMA 1993 Complementary medicine: New approaches to good practice. Oxford: OUP British Sociological Association 1993 Network newsletter of the BSA (Oct) Buckman R, Lewith G 1994 What does homoeopathy do and how? British Medical Journal 309:103-106 Byrne C 1992 Research methods in complementary therapies. Nursing Standard 6(50): 54-56 Caiman K 1994 The profession of medicine. British Medical Journal. 309:114(~1143 Cant S, Sharma U 1996a Demarcation and transformation within homeopathic knowledge. A strategy of professionalization. Social Science & Medicine 42(4): 579-588 Cant S, Sharma U 1996b Professionalization of complementary medicine in the United Kingdom. Complementary Therapies in Medicine 4:157-162 Carey T H S, Garrett J, Jackman A, McLaughlin C, Fryer J, Smucker D R 1995 The outcome and costs of care for acute low back pain among patients seen by primary care practitioners, chiropractors, and orthopaedic surgeons. New England Journal of Medicine 333:913-917 Chabot P 1990 The evaluation of holistic care. International Review of Community Development (Revue-international-d'action-communautaire) 24(64): 109-114 Chevallier A 1996 The Council for Complementary and Alternative Medicine. Complementary Therapies in Medicine 4:271-273 College of Homeopathy (Editorial, Author not supplied). 1993 Homeopathy: Medicine or myth? Nursing Standard 7(32): 62 Coulson J 1995 Doctors need evidence on complementary therapy. BMA News Review (July): 16 Department of Health 1989 Working for patients. HMSO, London Department of Health 1991 The patient's charter. HMSO, London Department of Health 1994 The challenge for nursing and midwifery in the 21 st century. The Heathrow debate. HMSO, London Dickinson D P S 1995 Complementary therapies in medicine: The patient's perspective. Complementary Therapies in Medicine 3:9 12 Ernst E 1996 The ethics of complementary medicine. Journal of Medical Ethics 22:197-198 Ernst E 1997 Evidence based complementary medicine. Complementary Therapies in Nursing & Midwifery 3:42-45 -
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Ersser S J 1995 Complementary therapies and nursing research: issues and practicalities. Complementary Therapies in Nursing & Midwifery 1:44-50 Fisher F 1995 The issues: complementary medicine: new approaches to good practice. Complementary Therapies in Medicine 3:5 Fisher F 1995a The development of research methodology in homoeopathy. Complementary Therapies in Nursing & Midwifery 1:168-174 Fitter M J, Thomas K J 1997 Evaluating complementary therapies for use in the National Health Service: 'Horses for courses'. Part 1: The design challenge. Complementary Therapies in Medicine 5:9(~93 Foundation for Integrated Medicine 1997 Integrated healthcare. A way forward for the next five years. The Foundation for Integrated Medicine Haynes R, Saekett D, Gray F, Cook D, Guyatt G 1996 Transferring evidence from research into practice: 1. The role of clinical decisions. Evidence Based Medicine 1:196-198 Hobbs S, Davies P D 1998 Critical review of how nurses research massage therapy: are they using the best methods? Complementary Therapies in Nursing & Midwifery 4:35-40 Hopwood A L 1997 The social construction of illness and its implications for complementary and alternative medicine. Complementary Therapies in Medicine 5:152-155 Kuhn T 1970 (2nd edn) The structure of scientific revolutions. The University of Chicago Press, Chicago Lewith G T 1995 Competence: the issue addressed. Complementary Therapies in Medicine 3: 1-2. Lewith G, Albridge D 1991 Complementary medicine and the European community. C W Daniel, Saffron Waldron Meade T W, Dyer S, Browne W, Frank A O 1995 Randomised comparisons of chiropractic and hospital outpatient management for low back pain: Results from extended follow up. British Medical Journal 311:349-351 Mills S 1995 What are complementary practitioners competent to do? Complementary Therapies in Medicine 3:3-4 Monckton J 1994 Research: from concept to publication. Complementary Therapies in Medicine 2 : 1 7 ~ 1 7 5
Pantanowitz D 1994 Alternative medicine: A doctor's perspective. Southern Book Publishers Pietroni P 1991 The greening of medicine. Victor Gollancz, London Rayner C 1998 Medicine: magic or myth? Complementary Therapies in Nursing & Midwifery 4:33-34 Rees R W 1995 CISCOM. the Centralised Information Service for Complementary Medicine. Complementary Therapies in Medicine 3:183-186 Reilly D T, Taylor M A, Campbell J, Beatie N, McSharry C, Aitchison T 1993 Is homoeopathy a placebo response? A controlled trial of homoeopathic immunotherapy (HIT) in atopic asthma. Complementary Therapies in Medicine 1 (suppl 1): 24-25 Research Council for Complementary Medicine (RCCM) 1993 Recommendations and conclusions. Royal College of Complementary Medicine. Research Fellowship in Complementary Medicine. University of Glasgow, 1987-90. Complementary Therapies in Medicine 1 (suppl. 1): 37-39 Research Council for Complementary Medicine (RCCM) 1993a Research Council for Complementary Medicine 10th anniversary report 1983-1993. RCCM, London Ryan M 1995 Bodies and nature in alternative therapy. Complementary Therapies in Medicine 3:111-112 Seaward B L 1994 Alternative medicine complements standard. Health Progress 75(7): 5~57 St George D 1993 Orthodox medicine isn't fallible. (letter). British Medical Journal 307:624 Trevelyan J 1998 Future of complementary medicine: training, status and the European perspective (Part 2). Complementary Therapies in Nursing & Midwifery 4:108-110 Trevelyan J 1998a Complementary therapies on the NHS: current practice, future developments (Part I). Complementary Therapies in Nursing & Midwifery 4:82-84 Vickers A J 1994 Complementary medicine, intermediate medicine and the degree of intervention. Complementary Therapies in Medicine 2:123-127 Vickers A 1996 Old myths given new voice. The Nuffield Report: Researching and Evaluating Complementary Therapies: The State of the Debate. Complementary Therapies in Medicine 4:198-201
WHY RESEARCH INTO EFFECTIVENESS OF HOLISTIC T H E R A P I E S IS I M P O R T A N T
Carole A r c h e r
BSc (Hons), Project Worker, REACHOUT, The Weald of Kent Mental Health Outreach Project, Tunbridge Wells Mental Health Resource Ltd, UK (Requests for offprints to: Carole Archer, 22 Bickmore Way, Tonbridge, Kent TN9 IND, UK)
Many complementary therapies are of unproven efficacy. Research has hitherto been lacking, and results controversial and contradictory. Difficulties abound in determining efficacy due to the variety of methods used to compare different therapies and the lack of comprehension of the model of holistic medicine (Chabot 1990). To illustrate Ter Riet et al. (1990) claim the effectiveness of acupuncture for chronic pain has not been definitely demonstrated (Ernst 1997). However, Pantanowitz (1994) claims evidence of acupuncture efficacy stating biochemical measurements show naturally produced pain killers, endorphins, are elevated by acupuncture. Added to this Reilly et al. (1993) claim evidence for the effectiveness of homoeopathy for hay fever, but Buckman (Buckman & Lewith 1994) disputes this, claiming results have not been successfully repeated to show objective conclusions. These apparent inconsistencies may be explained by the individual nature of complementary therapies. For example, homoeopathy cannot be defined by the molecules of conventional pharmacology (Fisher 1995). Such diversity indicates that differing research
methodologies may be required to establish effectiveness. It appears that the emphasis with many complementary therapies is more care than cure, such as the use of reflexology and aromatherapy in nursing and midwifery, but safety, ethics and a moral duty still require evaluation of effectiveness, perhaps by qualitative outcomes, e.g. wellbeing, or therapist/patient interaction. Less acknowledged complementary therapies do claim successful research into efficacy. Benor (1995) refers to controlled studies into spiritual healing substantiating effectiveness, although conventional practitioners may dispute this. Dr Reilly, consultant at the Glasgow Homoeopathic Hospital, has suggested that most conventional practitioners believe self-healing is due to the placebo effect, i.e. the client improves because he believes he is receiving treatment (Vickers 1994). Lewith (1994) suggests that the placebo effect is poorly understood and probably reflects doctors' attitudes to the client, the natural resolution of the illness, the effects of receiving treatment, and the belief system of the client and practitioner. Such a lack of explanatory mechanisms and the body's capacity for self-healing require further research. In 1995 Coulson found that 65% of general practitioners (GPs) believe that complementary
Complementary Therapiesin Nursing & Midwifery (1999)5,108-114 9 1999Harcourt PublishersLtd
Research issues in complementary therapies
therapies are relevant to contemporary healthcare, but are concerned about the lack of research into their efficacy and safety. Autonomy requires GPs to respect patients' decisions. Thus, the increase in demand for complementary therapies can be problematic. A GP may have to decide whether to advocate, or advise against, a complementary therapy which is not conventionally validated. However, much contemporary healthcare has not been tested. Lewith (Buckman & Lewith 1994) states most trials of non-steroidal anti-inflammatory agents examine the short term, but are prescribed long term for arthritis and pain. Perhaps those in conventional medicine who demand thorough testing of complementary therapies should address such inconsistencies. The above illustrates the controversies surrounding complementary therapy research. Ernst (1996) claims that ethically, unproven remedies must be substantiated by scientific research. Thus, for a more integrated healthcare system agreement must be reached regarding appropriate methods of researching the efficacy and safety of complementary therapies. The continuation of two disparate systems of medicine could be detrimental to the consumer and provider, denying a wider choice of therapies. However, it must be debatable whether effectiveness is ever conclusive, for research rarely provides unequivocal answers and indeed often raises further questions.
DIFFERENT C U L T U R A L PERSPECTIVES T O RESEARCH
Complementary and contemporary healthcare result from differing ideologies...
Personal and social beliefs about the body and illness are constructed by cultures, and vary considerably. Complementary and contemporary healthcare result from differing ideologies and draw on their traditional culture for validity and efficacy (Hopwood 1997). Thus, cultural diversity has implications for researching the social and cultural context of illness. From an anthropological perspective, science is not an objective research tool for evaluation or effectiveness (Ryan 1995). The biomedical paradigm of conventional healthcare would dispute this, assuming that the social setting is real, with observable and measurable facts about bodies and disease. Biomedicine claims to be scientific, and thus valid and unaffected by culture (Byrne 1992). However, as a social construct it is one approach amongst many. Of course other issues, such as safety and ethics, are relevant. It would be irresponsible not to explore efficacy, but it is debatable whether any health practice should be rejected, or its research methods used to appraise other health systems.
109
Complementary therapies claim that biological science, and by inference conventional medicine, is based on the Cartesian or reductionalist philosophy, attempting explanation by biological means. Such a perspective may not apply to complementary therapies which involve understanding of the world (ontology), so different methods (epistemology) of research are required. Many complementary practitioners, e.g. non-medically qualified homoeopaths, claim that a scientific theory for complementary therapies would align them to the scientific paradigm (Cant & Sharma 1996b), removing their social constructs and threatening their ideology and individuality. Is it, therefore, right for conventional medicine to assume that its validating methods are the best available and most appropriate for determining complementary therapy efficacy? Perhaps this is narrow minded and blinkered. Examining the philosophies of complementary therapies may expand contemporary medicine conceptually and therapeutically, offering better overall healthcare, for which we all strive. However, conventional medicine may not address such holistic therapies because they challenge the biomedical model, leading to some worthwhile approaches being rejected. Similarly, orthodox medicine may denounce complementary therapy research out of context, stereotyping holistic therapies as 'quackery' (Berman & Anderson 1994). Such refusal to address differing concepts of complementary medicine threatens objective investigation. Consumers of conventional healthcare with such views on holistic therapies may be denied the option of accessing complementary therapies. However, probably due to client demand, contemporary healthcare does now appear to view holistic therapies more favourably, but still remains suspicious of researching them from differing perspectives. Yet such issues as the placebo effect, hypnosis, psychoneuroimmunology, and spontaneous remission may force conventional research to a new paradigm. The holistic and humanistic view values all subjective data, recognizing individual uniqueness. This perspective does not seek to control or manipulate, and includes social and personal dimensions and life situations (Vickers 1996). Thus the assessment of complementary medicine effectiveness may require an ideological shift in understanding health, illness and treatment. It remains questionable whether conventional practitioners will ever accept a different paradigm. Rather than compromising complementary therapies to science, conventional medicine is challenged to include new research methods (Berman & Anderson 1994). Evaluating holistic therapies, especially spiritual and emotional aspects, indicates different research paradigms,
I10
... the randomized controlled trial represents only one type of research design
Generally speaking, the concept of
knowledge develops not from experiment but from insight and intuition.
ComplementaryTherapiesin Nursing & Midwifery
e.g. qualitative (subjective) appraisal. These could provide innovative directions and greater understanding, not just of treatments for illness, but of wellbeing.
IS PRESENT SCIENTIFIC M E T H O D O L O G Y SUITABLE FOR COMPLEMENTARY THERAPY RESEARCH? The increasing use of holistic therapies, heightens the need to clarify which research designs appropriately assess effectiveness. Hobbs and Davies (1998) suggest scientific methodology is moving towards non-linear thought processes of the biopsychological models. However, many scientists still prefer the measurable results of quantitative research. Ernst (1997) and Vickers et al. (1997) from this conventional viewpoint, advocate empirical research for efficacy, mainly randomized controlled trials. These allocate participants randomly, assessing an active treatment, against a control (Fitter & Thomas 1997). Yet randomized controlled trials involve features such as double blinding (neither subject nor researcher know which treatment is given to whom), which raise ethical and practical issues for holistic therapy research. Further problems occur with randomization, and generalization of findings as complementary treatments are frequently individual, and their application may not be transferable between clients, e.g. individual specific homoeopathic prescriptions. Despite the extensive use of randomized controlled trials many improvements in clinical medicine have arisen from trial and error, intuition and systematic observation and study (Pietroni 1991). This does not reduce the importance of researching efficacy, but illustrates that too much significance may be placed on the randomized controlled trial as if nothing could replace its viability. Indeed the randomized controlled trial is a fairly recent development, the first double blind, placebo controlled, randomized clinical trial of any therapy was the Medical Research Council's 1948 trial of Streptomycin for tuberculosis (Fisher 1995a). Furthermore, the randomized controlled trial represents only one type of research design and as such must only be suitable for certain types of research question. With complementary medicine other types of questions are being asked suggesting that a wider range of research methods should be considered and may be more applicable when deciding the efficacy of many complementary therapies. Generally speaking, the concept of knowledge develops not from experiment but from insight and intuition. Scientists like Newton and Einstein were directed by a conviction rather
than previous research findings. Kuhn (1970) states that the failure of existing rules introduces a search for improvement, so that what evolves is not a right or a wrong way but a new way, and that the scientist with a new paradigm must see through different eyes (Hobbs & Davies 1998). Perhaps this is an answer to the recent Guest Editorial in Complementary Therapies in Nursing & Midwifery (Rayner 1998) which states that acupuncture only makes sense now that we understand endorphins, but that reflexology is not valid because we do not yet comprehend its mechanisms of action. Sadly, this perspective illustrates the need of conventional medicine to relate every new therapy to its own validating terms instead of seeing 'with different eyes' for some appear to be blind to new ideas. It is not conducive to better integration of complementary and conventional health care to postulate, as Rayner (1998) does, that reflexology is nonsense merely because in contemporary, conventional terms we do not 'know'. However, the problem is further compounded by dissension within complementary medicine as to which methodologies research is efficacious. The Society of Homoeopaths uses randomized controlled trials (Cant & Sharma 1996a), but the College of Homoeopathy (1993) claims that this scientific basis is simply experimental biology, a conflict which further distances complementary medicine from orthodox healthcare. St George (1993) believes that the medicalization of holistic therapies into the contemporary healthcare system reduces all treatments to investigation through the randomized controlled trial. Yet this only relates to those holistic therapies which easily integrate into conventional healthcare, without considering those which do not, thereby potentially losing much of the therapeutic value, and reducing treatment choices for practitioner and client. Vickers et al. (1997) state that research is always feasible regardless of the therapy, but until the development of research methods acceptable to conventional healthcare, many valuable treatments may be shortsightedly dismissed. The Research Council for Complementary Medicine (RCCM 1993) state that the lack of a theoretical model should not result in the rejection of the unorthodox, nor prohibit demonstration of efficacy. As well as the randomized controlled trial, an RCCM (1993a) Research Policy Committee advocated a range of approaches for evaluating complementary therapies including non-randomizing comparisons which recognize the behavioural aspects of using complementary therapies (Ersser 1995). This could embrace historical controls, phenomenological description, illustrative case studies, conceptual and theoretical research, and literature research and review.
Research issues in complementary therapies
However, enhancing research methods requires training and time, funding in particular is another area of dissent. Lewith (1994) stresses that methodological design needs understanding of science, orthodox research, and holistic therapy philosophy (Monckton 1994), and that conventional studies may research the therapy, rather than the holistic approach. Maybe the method of research should be questioned for not assessing effectiveness, rather than rejecting the holistic therapy.
HOLISTIC T H E R A P Y RESEARCH Recent developments
The Cochrane Collaboration ...includes complementary medicine research, and is not restricted to randomized controlled trials.
Despite controversy regarding methodology there is progress in holistic therapy research. The US Congress has appropriated $2 million to study complementary medicine validity (Seaward 1994), and since 1991 the Division of Complementary Medicine (US) has been actively conducting research using varying methodologies (Berman 1997a). In the U K the Medical Research Council (MRC) claims to support research into complementary medicine, presumably from a biomedical perspective. The Centralised Information Service for Complementary Medicine (CISCOM), a database established by the RCCM, specializes in collating clinical trails. The Centre for the Study of Complementary Medicine promotes research, e.g. studying subtle energies which may explain many holistic therapies (Rees 1995). The Cochrane Collaboration, a world network of systematic reviews includes complementary medicine research, and is not restricted to randomized controlled trials. Haynes et al. (1996) describes how the Collaboration supports evidence-based practice which strives to incorporate scientifically proven procedures into clinical practice more quickly and more widely than in the past. This integrates clinical experience with external evidence protecting the interests of the patient (Ernst 1997). The aim is improved care, integrating conventional and holistic therapies. However, Vickers et al. (1997) claim that to practise evidence-based healthcare the means by which healthcare is based on evidence must be understood, and that currently controversies regarding holistic therapy research question this understanding. Thus much is underway to assess complementary therapy effectiveness along with some joint efforts with conventional medicine. However, more pilot trials, research in general practice and hospitals is required (Fisher 1995). Longitudinal studies would also appraise efficacy as the nature of holistic therapies often dictates longer treat-
III
ment than conventional healthcare, e.g. aromatherapy for anxiety.
Implications for consumers Holistic therapies provide time and attention for the individual, considering attitudes, behaviour, age, culture and gender. Such considerations may be lacking in. conventional healthcare due to less time, problems of terminology, funding and staff. Further lack of client confidence in conventional healthcare may increase this divide. However, availability and choice of complementary healthcare could confuse the consumer. Advice may not be forthcoming from GPs who may lack knowledge and belief in holistic therapies. Many consumers seek therapists on personal recommendation, but can be misled by complementary therapy qualifications which are not unified, or recognizable. No treatment, contemporary or holistic, is completely safe. Many have risks, e.g. radiography is carcinogenic and some aromatherapy oils are harmful in pregnancy, yet consumers assume, without supporting research, that complementary therapies are safe. Added to this several complementary medicines are selfadministered, available 'over the counter' and used following recommendations from laypersons, although many conventional treatments are utilized similarly. Even if contemporary healthcare and holistic therapies agreed suitable research methodology to prove effectiveness the way in which consumers see the efficacy of holistic therapies, or what determines their perceptions, would not be revealed; yet this dictates usage. Further research into why consumers use holistic therapies would indicate awareness of the risks. Social research is an important and expanding area which informs the psychological and social dimension of health and illness behaviour. For example, survey work has been conducted giving information on the public impact of complementary therapies (e.g. The British Sociological Association 1993). However, such studies are problematic due to the diversity and number of different holistic therapies. Rationing healthcare requires investigation of cost, but research in complementary therapy economics is inconclusive. Meade et al. (1995), researching the costs of chiropractic compared to primary care for low back pain, suggests complementary treatments save expense. However, Carey et al. (1995) investigating the same issue implied that complementary therapy costs more than conventional treatment for the same condition. It is not known if the researchers had a biomedical or holistic bias which may have affected outcome and further research may clarify the position. Nevertheless, the consumer
112 ComplementaryTherapiesin Nursing & Midwifery
Complementary therapists are hindered by lack of research efficacy, but are apprehensive that conventional research could threaten their practice
of holistic therapies may face high costs as most complementary therapies are not available on the National Health Service (NHS) leading to possible elitism if no provision is made within contemporary healthcare. Many complementary therapy benefits would be lost, together with the opportunity to develop wide treatment options for all, a fundamental concept of the original NHS. Until a more unified healthcare system develops, a susceptible, vulnerable, ill client may experience further distress attempting to understand the existing controversies between holistic and contemporary healthcare. The consumer must be able to benefit from multidisciplinary research, leading to broader treatment choice, additional to conventional healthcare.
Implications for practitioners Both complementary and contemporary therapies aim to be holistic, but NHS resources restrict conventional practitioners (Caiman 1994). Complementary therapists are hindered by lack of research efficacy, but are apprehensive that conventional research could threaten their practice, e.g. homoeopaths fear losing holism and autonomy (Wilkinson 1997). The Department of Health is funding pilot studies assessing how osteopathy and chiropractic could be available on the NHS. This gradualist policy may become more interventionist with questions of cost effectiveness and efficacy (Chevallier 1996). But such decisions are politically influenced and an increase in the internal market approach to health may negate intervention. Many holistic therapies wish to receive NHS referrals and Dickinson (1995) suggests that an integrated system, with GP as gatekeeper, could ease safety concerns. However, this raises issues of provision, financing, accountability and subjectivity. Despite radical differences between practitioners some conventional and holistic therapists have integrated to the benefit of the client. Dr Brown, GP President of the National Federation of Spiritual Healers, employs a healer and has found that research into clients with depression and back pain referred to healers, led to an increase in quality of life (Ameghino 1998). The British Medical Association (BMA 1986) review of complementary medicine (in Chevallier 1996) maintained that there were many unscientific, unsubstantiated claims for alternative therapies. This led to the formation of the Council for Complementary and Alternative Medicine (CCAM) to develop relationships with conventional medicine whilst upholding autonomous practice (Cant & Sharma 1996b). The rise in use and interest of complementary therapies resulted in the BMA's (1993) report which
advocated that holistic therapies should be complementary, rather than alternative, to orthodox medicine. Although there is still a bias towards randomized controlled trials (Ersser 1995), it is discouraging t h a t experimental research design of complementary therapies is not more emphasized.
THE FUTURE Whether conventional healthcare is prepared to accept complementary medicine or vice versa is debatable as one challenges the autonomy of the other. Many in contemporary medicine, such as Ernst (1997), are only prepared to incorporate elements of complementary therapies deemed to be appropriate to biomedicine. Issues mentioned, particularly safety, are relevant and account for such reservations, but the apparent short sightedness may preclude much that is of holistic benefit to the client, the interests of whom should be at the forefront of all who debate these issues. An interdisciplinary programme with integrated clinical, educational, and research objectives would improve client opportunities (Berman & Anderson 1994). This would emphasize holism, the person not the disease, their emotional experience of illness, including fear, helplessness and anger. There are examples of recognition of the conflicts discussed and initiatives to address them. The RCCM (1993) is pursuing research finding from the Government. In 1994 the European Parliament Committee on the Environment, Public Health and Consumer Protection adopted a report on the status of complementary medicine in Europe. This report, by MEP Paul Lannoye, recommended appropriate research and expert representation at European level, and that finances for research be forthcoming for each area of complementary medicine. Lannoye is currently seeking money to initiate these recommendations (Trevelyan 1998).
Integrated Medicine. The Way Forwardfor the Next 5 Years (Foundation for Integrated Medicine 1997) proposed an examination of the research issues of efficacy, safety, biological plausibility, methodology, and funding. The report recommends that the public, practitioners and purchasers need to be shown the importance of research and should also be consulted about what they believe is required. Special research centres could be created to undertake or coordinate research, perhaps linked with higher education institutes, and funded through complementary medicine charities. Dissemination of results could be improved, e.g. by strengthening existing resources such as networking all complementary medicine databases and using the Internet. The Foundation proposes the creation
Research issues in complementary therapies
In brief good research means better patient care.
o f an integrated health care service. Complementary and conventional healthcare would be available together, provided by well trained, well regulated practitioners. G o o d quality research would support the therapeutic benefits (Trevelyan 1998a).
CONCLUSION
. . . the client, who is the ultimate loser if the issues discussed are not resolved.
Complementary therapies must expand with accountability or recede, sustaining investigation into efficacy and safety (Mills 1995). M u c h time, effort, patience and reflection is necessary to evaluate effectiveness, safety and cost o f therapies in relation to c o n t e m p o r a r y healthcare. The specific effects o f the therapies, how they should be used and delivered to o p t i m u m benefit, need to be established. It is unlikely that effective, high quality therapy will be available unless these questions are answered by appropriate research. In brief good research means better patient care. There must be access to resources, expertise, a balanced evaluation o f the literature and a research p r o g r a m m e o f outcome studies, surveys a n d clinical trials. Research should be collaborative between orthodox and complementary practitioners, purchasers and providers, N H S trust managers and academics, acknowledging cultural perspectives and differing methodologies. However, it m a y not be time for methodological breakthroughs assessing holistic therapy efficacy. A t present, dialogue, shared work (clinical and academic) and evaluation m a y be all that is achievable (Berman 1997b). Nonetheless, healthcare needs are growing and resources shrinking. Rising standards o f accountability, and the Patient's charter (Department o f Health 1989, 1991), create expectations that research is available which informs on safe and effective practice (Department of Health 1994). There is also growing awareness o f the need to p r o m o t e closer collaboration between practitioners and researchers, and to help clinical staff use research findings more effectively (Ersser 1995). The contribution o f initiatives other than research to raising standards o f practice require consideration. A u d i t measures, such as examining patient anxiety, pain and rest (Lewith & Aldridge 1991) are an example. Clinical observation o f the effects o f therapies must be meticulously recorded and communicated to others (Ersser 1995). The integration and p r o m o t i o n o f all available healing practices, both conventional and complementary, is positive. Broadening healthcare to holism, prevention, wellness with less emphasis on illness must offer greater informed choice to the practitioner and, most importantly, the client, who is the ultimate loser if the issues discussed are not resolved.
113 REFERENCES
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