Complementary Medicine Research Unit

One in ten of the UK population use complementary medicine each year and 50% are lifetime users. The recent 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 is one of the first main responses to the Select Committee’s recommendations. We know that within this emerging field we have developed a unit with cooperative ventures within the university, both intra-faculty and inter-faculty. As a consequence, we have been able to draw in major funding along with a growing body of academic publications. Our unit was established by George Lewith in 1995 with his appointment as Honorary Visiting Senior Lecturer. He now has a University contract as a Reader within the Department of Primary Care where the unit is located. The unit was initially provided with core funding by the Maurice Laing Foundation and has been able to generate substantial amounts of soft money funding for a number of minor and major projects from charitable (including Wellcome) sources as well as National Health Service Research and Development (NHS R&D) funding. Laing funding continues to 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 is now providing funds for research capacity building within complementary medicine and we have been successful in obtaining Department of Health support for two post-doctoral fellows (Peter White and Sarah Brien) and two PhD students during the first 2 years of the awards. The Department of Health is also funding complementary and alternative medicine (CAM) projects within palliative cancer care (£300 000) and we have successfully applied for this funding, in conjunction with Jessica Corner as the primary investigator. Wellcome is currently funding 37% of the applications it puts out for review in the field of CAM and is considering further initiatives in the light of the Department of Health proposals. The Medical Research Council has publicly stated that it welcomes quality applications in this area: our initial asthma and homeopathy study was alpha rated, the Alexander Technique study was alpha– alpha rated and funded. There is clearly now an opportunity for substantial growth in this area of research and the track record that we have developed in Southampton makes us well placed to capitalize on these initiatives. Over the last 8 years we have created a unique multidisciplinary team (non-clinical post-docs, doctors, nurses, physiotherapists, pharmacists and health psychologists) in Southampton, which has developed considerable skill in primary clinical research within CAM. These studies have been directed at asking not only where complementary therapies may be most applicable but also whether and how they work. Furthermore, our research has led us to understand that the nature and content of the therapeutic relationship within complementary medicine is of paramount importance, and therefore we are in the process of developing clinical trial methodology that will allow us to look at the consultation independently from a particular therapeutic intervention, focusing particularly on the non-specific effects of homeopathy and acupuncture in chronic disease. The major studies in which our unit has been involved to date are as follows:

One in ten of the UK population use complementary medicine each year and 50% are lifetime users. The recent 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 is one of the first main responses to the Select Committee's recommendations. We know that within this emerging field we have developed a unit with cooperative ventures within the university, both intra-faculty and inter-faculty. As a consequence, we have been able to draw in major funding along with a growing body of academic publications.
Our unit was established by George Lewith in 1995 with his appointment as Honorary Visiting Senior Lecturer. He now has a University contract as a Reader within the Department of Primary Care where the unit is located. The unit was initially provided with core funding by the Maurice Laing Foundation and has been able to generate substantial amounts of soft money funding for a number of minor and major projects from charitable (including Wellcome) sources as well as National Health Service Research and Development (NHS R&D) funding. Laing funding continues to 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 is now providing funds for research capacity building within complementary medicine and we have been successful in obtaining Department of Health support for two post-doctoral fellows (Peter White and Sarah Brien) and two PhD students during the first 2 years of the awards. The Department of Health is also funding complementary and alternative medicine (CAM) projects within palliative cancer care (£300 000) and we have successfully applied for this funding, in conjunction with Jessica Corner as the primary investigator. Wellcome is currently funding 37% of the applications it puts out for review in the field of CAM and is considering further initiatives in the light of the Department of Health proposals. The Medical Research Council has publicly stated that it welcomes quality applications in this area: our initial asthma and homeopathy study was alpha rated, the Alexander Technique study was alphaalpha rated and funded. There is clearly now an opportunity for substantial growth in this area of research and the track record that we have developed in Southampton makes us well placed to capitalize on these initiatives.
Over the last 8 years we have created a unique multidisciplinary team (non-clinical post-docs, doctors, nurses, physiotherapists, pharmacists and health psychologists) in Southampton, which has developed considerable skill in primary clinical research within CAM. These studies have been directed at asking not only where complementary therapies may be most applicable but also whether and how they work. Furthermore, our research has led us to understand that the nature and content of the therapeutic relationship within complementary medicine is of paramount importance, and therefore we are in the process of developing clinical trial methodology that will allow us to look at the consultation independently from a particular therapeutic intervention, focusing particularly on the non-specific effects of homeopathy and acupuncture in chronic disease. The major studies in which our unit has been involved to date are as follows: Acupuncture for stroke (study completed, two papers published and three in preparation; Val Hopwood). Enzyme potentiated desensitization for seasonal rhinitis-in conjunction with Michael Radcliffe (study completed, one paper published and one in preparation; George Lewith). Homeopathic proving: this study looks at some of the basic assumptions within the whole development of homeopathy (pilot study published, definitive study published with three additional publications in press or published; Sarah Brien). Gene expression in chronic fatigue syndrome in conjunction with Rob Powell and Wendy Barclay, University of Reading (pilot study completed and published; George Lewith). Does the patient's perception of the impact of Chronic Fatigue Syndrome (CFS) affect outcome? (study completed and paper in submission with Michael Hyland; George Lewith). The Alexander Technique in low back pain (led by Paul Little) (study in progress; George Lewith). The placebo effects of acupuncture (pilot study completed and paper in press; Peter White/George Lewith). Acupuncture in disabling breathlessness (pilot completed and published, definitive study completed and paper published; Clare Hill/George Lewith). The development of a validated questionnaire, which evaluates attitudes to CAM and health beliefs, important potential covariates in evaluating outcome in clinical trials-in conjunction with Michael Hyland) (George Lewith). The development of theoretical models (in conjunction with Michael Hyland) based on complexity theory that may underpin the basic mechanisms that underlie the clinical effects of CAM (paper published and further submission in progress; George Lewith). Absent healing (study in progress in conjunction with the University of Freiburg, Germany and the University of Reykjavik, Iceland; George Lewith). Why patients (re)turn to complementary medicine (a series of ethnographic and questionnaire based studies (5) in progress; Lucy Yardley/Felicity Bishop/George Lewith). A study of the effects of a daily supplement of Siberian ginseng extract on well-being of young women with persistent fatigue of <6 months' duration-in cooperation with Ann Walker (study in progress; George Lewith). A randomized controlled trial of Biobran for chronic fatigue patients (funded by Daiwa, study in progress; George Lewith/Selwyn Richards/Clare McDermott). An investigation of the 'Candida syndrome' using an explanatory Randomised Controlled Trial (RCT) in conjunction with laboratory investigations (protocol in submission with Michael Radcliffe) (George Lewith). Bromelain, a herbal remedy for the treatment of osteoarthritis. A placebo controlled, randomized trial (study completed, publication and review paper in submission; Sarah Brien). The specific and non-specific effects of acupuncture in chronic pain: a combined RCT and qualitative study (Clare Hill and Peter White, Department of Health Fellowship). The placebo/Streitberger needle. A series of clinical trials and imaging experiments (PET) to evaluate its validity and the underlying mechanism of acupuncture (Peter White in conjunction with the Wellcome Imaging Unit, University College, London). Research into the role of CAM in the care of patients with cancer (successful submission to the Department of Health, study in progress with Jessica Corner) (George Lewith). Applied kinesiology; is it an effective treatment for back pain? (study in progress; Sue Hall). Homeopathic remedies as a treatment for rheumatoid arthritis: is it the medication or the homeopathic process that benefits patients? (protocol completed, initial funding obtained, one publication published; Sarah Brien/ Laurie Lachance). The development of a practitioner scale to evaluate consultation content (in development; Sarah Brien/Laurie Lachance). A qualitative study of the effects of acupuncture in chronic pelvic pain (in development; Will Stones, Clare Hill and Peter White). Devil's Claw and osteoarthritis of the knee. A Phase II RCT (protocol completed and funding obtained, data collection July 2004, one publication in submission; Sarah Brien). A Cochrane systematic review of micronutrient supplementation for glycemic control in type II diabetes (in progress; Damian Smith). Predictors of CAM use in asthma. Proposal in submission to Wellcome (Primary Investigator; George Lewith). An investigation into how local ethics committees manage CAM submissions (in submission, The Nuffield Foundation; Gay Walker, George Lewith, Jane Maher). The patient perceived value of a Traditional Chinese diagnosis in chronic pelvic pain (Clare Hill/George Lewith). Endometriosis. We would like to look at how endometriosis is treated by CAM practitioners, evaluate how patients perceive CAM in the context of their endometriosis treatment and based on these more general investigations, develop clinical trial methodology to evaluate the use of Chinese herbal medicines and acupuncture as treatments, in both short-term and long-term, for endometriosis

Teaching
We run a Special Study Unit on CAM familiarization for the third year medical students, chiropractic students and student nurses to give them a brief introduction to complementary and alternative therapies. This course includes placements with CAM practitioners. Lectures on acupuncture and pain are given for the School of Medicine Foundation Course and Term 4 teaching, and the fourth year projects on CAM supervised.
We also run an annual research strategy conference in conjunction with the Research Council for Complementary Medicine and regular critical appraisal courses for CAM practitioners.

Cooperation with Professional Organizations
The government is anxious to ensure that the provision of complementary medicine is evidence-based and safe. We have cooperated with a number of professional organizations in order to try and achieve this. These include the Society of Teachers of the Alexander Technique, the Acupuncture Association of Chartered Physiotherapists, the British Acupuncture Council, the Acupuncture Research Centre, the National Institute of Medical Herbalists and the Anglo-European College of Chiropractic. These initiatives have involved both regulation and specific research projects. Furthermore, George Lewith and Stephen Holgate have been involved in establishing a Royal College of Physicians sub-committee on complementary medicine. Our unit has played an active part in the House of Lords' Select Committee Report on Complementary Medicine (2000) and three pages of this report are dedicated to the activities within Southampton. Southampton Medical School has also played an important role in the development of the Foundation for Integrated Health, particularly with respect to its research and development agenda. George Lewith is President Elect of the International Society for CAM Research and through that we are initiating a number of projects that include whole systems research workshops and regular annual international conferences. He is also a Director of the Marylebone Trust and Member of DH National Capacity Building Award Committee. Publications 2001-04