The Research Unit: Introduction

One in ten of the UK population use complementary medicine each year and approximately 50% are lifetime users. The House of Lords' Report has clearly defined a public need for further research into both safety and efficacy. The Department of Health research capacity building initiative was one of the first main responses to the Select Committee's recommendations. We have developed a complementary medical research unit within the University of Southampton with cooperation from colleagues, both within Southampton Medical School and in other Schools and Faculties at Southampton. As a consequence of our academic success and team based approach we have been able to draw in major funding along with a growing body of high quality peer review publications.

Our unit was established by George Lewith in 1995; he is now Professor of Health Research within the Department of Primary Care where the unit is located. We have been provided with core funding by the Rufford Maurice Laing Foundation and have also been able to generate substantial amounts of soft money funding for a number of minor and major projects from charitable (including the Wellcome Trust) sources as well as MRC and NHS R&D funding. Laing funding continues to generously provide our unit with an administrative core. Dr Lewith has been appointed as a Visiting Professor to the School of Integrated Health at the University of Westminster.

The Department of Health includes Complementary and Alternative Medicine (CAM) within its fellowship funding and we have been successful in obtaining DH support for two post-doctoral fellows (Peter White and Sarah Brien) and two PhD students. Wellcome is currently funding 37% of the applications it puts out for review in the field of CAM and the MRC has publicly stated that it welcomes quality applications in this area: our initial asthma and homeopathy randomised controlled trials was MRC alpha rated, the Alexander Technique study was alpha-alpha rated and funded by the MRC and involves a randomised controlled trial, economic analysis and nested qualitative study. There are opportunities for substantial growth in this area for rigorous research and the track record that we have developed in Southampton makes us well placed to capitalise on this opportunity We are using mixed qualitative and quantitative methods to investigate whole systems so that we can define the specific and non-specific elements of these therapeutic interventions. This understanding will substantially increase our evidence base for CAM while taking into account the effects of therapeutic context and meaning as well as the health economic impact of specific interventions.

Over the last 10 years we have created a unique multidisciplinary team (non-clinical post-docs, doctors, nurses, Cam practitioners, physiotherapists, pharmacists and health psychologists) in Southampton which has developed considerable skill in mixed method approaches and whole systems research. These studies have been directed at asking not only where complementary therapies may be most applicable, but whether and how they work using techniques such and functional magnetic resonance imaging (fMRI). Furthermore, our research has led us to understand that the nature, content and context of the therapeutic relationship and the potential value of a patient-centred therapeutic consultation within CAM. We are in the process of developing rigorous clinical trial methodology that will allow us to look at the consultation independently from a particular therapeutic intervention, currently focusing on the non-specific and specific clinical effects of homeopathy and acupuncture in chronic illness. It is not always possible to design controlled trials within CAM that involve real and credible placebos which can be delivered with equipoise. We are therefore developing techniques that will allow us to investigate these interventions pragmatically within a health services research framework. As well as phase III clinical trials we have also become involved in phase II dose ranging studies for herbal medicine and a number of pilot and feasibility studies for a range of different CAM techniques. We are developing approaches to define best practice including Delphi and also have expertise in questionnaire design and development and qualitative research methods including grounded theory, IPA framework and thematic analysis. Quality of life if an essential outcome measure if we are to understand the patient-centred approach to CAM. We are using this with questionnaire design as these 2 approaches form an important part of our 'clinical outcomes' development. Our statistical support is excellent and allows us to use both multi-variate analysis and structure equation modelling within our research.

We have been able to develop a unique research environment that we hope combines the best of CAM and conventional medicine.