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RESEARCH

I attained a Masters degree in 2000 in Health Education and Health Promotion, and have been interested in research ever since then and regularly attended research meetings at the Complementary Medicine Research Unit at the University of Southampton.

In November 2004 I was employed by The University of Southampton with a Department of Health funded research fellowship to do a PhD exploring the homeopathic consultation.

A qualitative study of homeopathic consultations

This study is part of a larger project that seeks to identify important aspects of complementary therapy consultations to benefit patients. My aim is to identify and explore factors that homeopathic practitioners perceive to be important in promoting a satisfying and therapeutically effective consultation with their patients.

This is a qualitative study and is concerned with the experiences and perceptions of the practitioners. This is a two phase study. In phase one I will be using interviews to gather my data and during the interview I will ask the research participants to describe the process of a “typical consultation”, and also to tell me about their experiences of the homeopathic consultation in some depth, focusing on things that have gone well and those that they feel did not go so well.

I would expect the interview to last approximately one hour. I will then listen to, transcribe and systematically analyse the interview using a qualitative methodology called grounded theory. As part of this process I will also compare their interview with other interviews I have conducted so I can identify common codes and categories that capture commonalities and differences among homeopathic consultations.

Following the analysis of the interview an emerging theory of the homeopathic consultation will be developed and tested in phase two. In phase two of the study in order to test out the emerging theory I will be observing homeopathic consultations and asking practitioners to complete a reflective diary focussing on challenging consultations. A theory and model of the homeopathic consultation will be developed from phase one and phase two.

If you are a homeopathic practitioner and would like to take part in this study, require further information or a copy of the practitioner's information sheet please contact me at the University of Southampton:

Caroline Eyles RS Hom, M.A.
Complementary Medicine Research Unit
Primary Medical Care
School of Medicine
University of Southampton
Aldermoor Health Center
Aldermoor Close
Southampton
Hampshire
SO16 5ST
United Kingdom

Telephone: +44(0)23 8024 1072
Fax: +44(0)23 8070 1125
Email: C.G.Eyles@soton.ac.uk.

The present state of homeopathy research

Homeopathy is a complex intervention meaning that there are multiple components in the treatment package e.g. the relationship between the patient and homeopath, the role of the practitioner which may each affect outcomes, the remedy and the philosophy behind homeopathy. Additionally there is huge paradigm difference between homeopathy and conventional medicine, homeopathy has its roots in a vitalistic tradition and has a holistic approach, and together these imply that there may be fundamental differences in the approach to the consultation style and the relationship between the patient and practitioner.

These issues have implications for how homeopathy has been researched and for the future approach to homeopathy research. Until recently research into homeopathy has focussed on the question, does homeopathy work? The evidence for the effectiveness of homeopathy has included two areas of research:

   1) Studies looking for biological effects from potencies especially ultra-high dilutions. Recently a rigorous laboratory study on high dilutions of histamine found that they exerted an effect on basophil activity [1].

   2) Studies of the efficacy of homeopathic remedies for particular clinical conditions. Many randomised placebo controlled trials (RCTs) have assessed the efficacy of homeopathy in single medical conditions. When high quality studies have been selected for analysis (such as those with adequate randomisation, blinding, sample size and other methodological criteria that limit bias) a number show positive results [2;3]. Moreover in a prospective observation study to evaluate the usefulness of homeopathy in the real world clinical setting of primary care, homeopathy was found to be at least as effective as conventional medicine [4].

However, the strengths and limitations of the use of RCT's to assess the efficacy of CAM have been widely debated. The limitations of RCT's can be categorised as either practical or methodological in nature.

Contemporary problems in CAM research

The practical challenges facing RCT CAM research include inadequate research infrastructure and inadequate funding for research. One of the main practical challenges has been that clinically orientated CAM research does not always research CAM as practiced in the field, but rather is research into some of the "tools of the trade" of CAM practitioners. For example the efficacy of a remedy may be tested rather than the whole treatment effect in a natural setting [5]. Criticism of the use of RCTs for research into homeopathy was discussed by Weatherley-Jones et al [6] who suggested that follow up consultations of patients taking part in a RCT may be hampered by the use of placebo, as the homeopaths do not know if change or lack of it may be due to the patient receiving placebo or being on a remedy that is not working . Data from Bell et al's paper which investigated individualised homeopathic remedies versus placebo in fibromyalgia patients supports this. The number of remedies recommended by the homeopaths was significantly higher in the placebo group than in the active treatment group [7]. More studies are needed to confirm or refute this proposal.

There are many methodological challenges facing RCT CAM research. One of the main issues that underlies many other methodological challenges is concerned with the differences in philosophy and paradigm between many CAM therapies such as homeopathy and conventional medicine [8]. There is unease amongst many CAM researchers and practitioners on the use of RCT's to investigate CAM, because the RCT method can be seen as deriving from a reductionist approach to the world whereas CAM embraces a highly individualised holistic approach to the treatment of [9]. Another challenge facing RCT CAM researchers is the criticism that it is not meaningful to examine the specific effects of a therapy (the remedy) as separate to the non specific effects of a therapy (the effects from the practitioner patient relationship etc), as a such pragmatic trials are more appropriate. For example, it has been proposed in homeopathy that the specific and non specific effects may interact rather than just being an additive of the homeopathic intervention [6]. This view is reiterated in Paterson & Dieppe's [10] observations on acupuncture research. Additionally RCT's only address whether an intervention works but does not address the process of how it works and the context in which it works best [11].

The increasing popularity of CAM amongst patients has produced an assortment of alternative research questions which are concerned with the outcomes and process and structure of these therapies. These and other challenges can be addressed by thoughtful design in the application of RCT method to investigate CAM, for example, using pragmatic approaches [12] and by combining RCT's with qualitative methods [11]. In order to fully understand a CAM intervention research must address the separate components of it whilst allowing the system to remain intact because of synergy between the different components [11]. CAM whole systems research (WSR) is an emerging research framework specifically designed for the investigation of the effectiveness complex interventions which have many varied components. The definition of WSR is research that:

   - Encompasses the investigation of both the processes and the outcomes of complex interventions
   - Includes all aspects of any internally consistent approach to treatment (philosophical basis, patients. Practitioners, setting of practice, methods and materials)
   - Acknowledges unique patient, family, community and environmental characteristics and perspectives [13].

The aim therefore is to employ appropriate research designs and methods so that the all the components of the therapy can be assessed within the framework [14]. This WSR frameworks differs from The Medical Research Council's [15] sequential framework for evaluating complex interventions which does not address the philosophical issues, individualised treatment packages or allow for the evaluation of the context of an intervention.

Although homeopathy has many differences to medicine it has been researched within a biomedical paradigm so that research has focussed on the question of whether homeopathy works but has largely ignored the question of how homeopathy works. Additionally the use of RCTs to research CAM has had many methodological challenges, mainly because in CAM interventions such as homeopathy the process and context are fundamental to effective treatment and positive outcomes and the practitioner is central to this process [11]. This focus on the therapy rather than the therapist means that the therapist's contribution to answering both questions of whether homeopathy works and how it works is poorly understood. The process and context of a therapy refer to components such as the relationship between the patient and practitioner, expectations and how an intervention is delivered. The therapists' contribution to these components can only be understood by exploring the consultation in depth from the practitioners' perspectives.

Reference List

(1) Belon P, Cumps J, Ennis M, Mannaioni PF, Roberfroid M, Sainte-Laudy J et al. Histamine dilutions modulate basophil activation. Inflamm Res 2004; 53(5):181-188.
(2) Kleijnen J, Knipschild P, ter Riet G. Clinical Trials of Homeopathy. BMJ 1991; 302:316-323.
(3) Linde K, Clausius N, Ramirez G, Melchart D, Eltel F, Hedges LV et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350(9081):834-843.
(4) Riley D, Fischer M, Singh B, Haidvogl M, Heger M. Homeopathy and Conventional Medicine: An Outcomes Study Comparing Effectiveness in a Primary Care Setting. The Journal of Alternative and Complementary Medicine 2001; 7(2):149-159.
(5) Cohen M. Evidence and CAM Research. In: Adams J, editor. Researching Complementary and Alternative Medicine. London: Routlledge; 2007. 89-104.
(6) Weatherley-Jones E, Thompson EA, Thomas KJ. The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment. Homeopathy 2004; 93(4):186-189.
(7) Bell IR, Lewis DA, II, Brooks AJ, Schwartz GE, Lewis SE, Walsh BT et al. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology 2004; 43(5):577-582.
(8) Mason S, Tovey P, Long AF. Evaluating complementary medicine: methodological challenges of randomised controlled trials. BMJ 2002; 325(7368):832-834.
(9) Thompson T. Can the caged bird sing? Reflections on the application of qualitative research methods to case study design in homeopathic medicine. BMC Medical Research Methodology 2004; 4(1):4.
(10) Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330(7501):1202-1205.
(11) Verhoef MJ, Vanderheyden LC. Combining qualitative methods and RCTs in Cam intervention research. In: Adams J, editor. Researching Complemantary and Alternative Medicine. London: Routledge; 2007. 72-86.
(12) Pirotta M. Towards the Application of RCTs for CAM. In: Adams J, editor. Researching Complementary and Alternative Medicine. London: Routlledge; 2007. 52-71.
(13) Verhoef MJ, Lewith GT, Ritenbaugh C, Thomas K, Boon H, Fonnebo V. Whole Systems Research: moving forward. Focus on Alternative and Complementary Therapies 2004; 9(2):87-90.
(14) Verhoef MJ, Lewith G, Ritenbaugh C, Boon H, Fleishman S, Leis A. Complementary and alternative medicine whole systems research: Beyond identification of inadequacies of the RCT. Complementary Therapies in Medicine 2005; 13(3):206-212.
(15) Medical Research Council. MRC Health Services and Public Health Research Board. A Gramework for development and evaluation of RCTs for complex interventions to improve health. 2000. Medical Research Council (MRC). Ref Type: Report