Wednesday 22 March

Simon Mills' Clinic

On arrival at Exeter the Committee visited the clinic where Simon Mills practises. The purpose of this visit was to get a feel of a working Complementary Medicine Clinic and to meet some practising CAM therapists. The Committee were given a brief tour of the practice which consisted of: a waiting room; a small herbal medicine pharmacy where Simon Mills took questions; a treatment room where Chris Bury the clinic's osteopath demonstrated; another treatment room where Tricia Hemmingway the clinic's Alexander Technique teacher and Roger Wells a GP/psychotherapist were based; and finally the ESCOP secretariat and library.

Dinner at Crossmead Conference Centre

The Committee were welcomed by Sir Geoffrey Holland KCB, Vice Chancellor of Exeter University. Other guests at the dinner were:

Dame Margaret Turner-Warwick - Past president of the Royal College of Physicians

Professor Ruth Hawker - Chair of the local NHS trust and member of Exeter University Council

Maurice Newbound - President of the British Complementary Medicine Association

Professor Edzard Ernst - Director of the Department of Complementary Medicine and the holder of the only UK Chair in Complementary Medicine

Professor Brian Kirby - Acting Head of the Post-graduate Medical School at Exeter University

David Rogers - Head of Communications and External Relations at Exeter University

Simon Mills - Director of the Centre for Complementary Health Studies, University of Exeter

Sir Geoffrey Holland talked about Exeter University's bid to develop a new undergraduate medical school in conjunction with the University of Plymouth. The proposed curriculum for the new undergraduate medical course would include aspects of CAM. A course which promoted the awareness of other medical philosophies would be a compulsory part of the curriculum, and optional courses which explored different aspects of CAM would also be available.

Thursday 23 March

The Committee were welcomed to Senate House at the University of Exeter by Professor Brian Kirby. Professor Kirby discussed how the relationship between CAM and orthodox medicine had grown closer since he graduated 40 years ago. He also discussed how the two Exeter Departments look at both sides of complementary therapies and he highlighted the growing popularity of CAM.

Presentations by the Department for Complementary Medicine, University of Exeter

Professor Edzard Ernst

The aim of this presentation was to familiarise the Committee with the Department's work. The Department use a specific definition of CAM:

"Complementary medicine is diagnosis, treatment and/or prevention which complements mainstream medicine by contributing to a common whole, by satisfying a demand not met by orthodoxy or by diversifying the conceptual frameworks of medicine."

Ernst et al British General Practitioner 1995; 45:506

1. Background

The Department of Complementary Medicine was established in 1992 through a donation from the Laing Foundation, to the Centre for Complementary Health Studies (CCHS). This donation has provided a solid foundation of funding which helped establish a good infrastructure for research. In 1993 Professor Ernst was appointed Professor of Complementary Medicine and director of CCHS. In 1996 the Department of Complementary Medicine was established within the School of Postgraduate Medicine and the Directorship of CCHS was returned to Simon Mills.

The Department chose to concentrate its research on the CAM therapies that are most prevalent in the UK i.e. acupuncture, healing, herbalism, homeopathy and spinal manipulation. It also includes placebo studies. Their research aims to answer the questions: is it effective? is it safe? does it save money? The main investigative tools the Department uses are systematic reviews of published RCTs, clinical trials, surveys and other experimental studies. As well as research the Department participates in several other activities; these include the publication of FACT, holding an annual scientific meeting, occasional conferences, lectures, courses and advice.

Professor Ernst listed the strengths of the Department as: relatively strong funding, a clear focus on research, having no 'axe to grind', a staff of trained scientists, a multi-professional team, staff with 'hands on' experience with CAM treatments and numerous international collaborations, which included links with universities in the USA, Austria, Switzerland, Turkey and Germany.

2. Research into homeopathy

This part of the talk summarised some of the research that the Department has conducted into homeopathy. Several papers were discussed. The first of these was a meta-analysis (by other authors) that had looked at 89 trials of homeopathy and had concluded that the clinical effects of homeopathy were not entirely due to placebo effects. This paper had attracted a lot of attention from various medical journals. However it had also been criticised, primarily because it had examined a range of different homeopathic treatments for a range of conditions and was therefore very non-specific. In response to these criticisms a lot of further research including new analysis by Department staff has been undertaken which has looked at the effects of specific homeopathic remedies for specific complaints. These more specific studies had found no direct effect for any particular homeopathic remedy on a range of clinical problems. Research in this area at the Department is continuing.

3. General CAM Research

This part of the presentation discussed several research papers the Department has published on the perception of CAM in the UK. Professor Ernst believes that non-specific (placebo) effects are a fascinating and under-researched area which he thinks may provide a link between CAM and orthodox medicine.

One study that he described had used a questionnaire to examine levels of patient satisfaction with CAM and orthodox medicine amongst arthritis suffers who had experienced treatments by both types of practitioners. This research had found that CAM therapists were perceived as much more friendly, as having much more time to spend on the patient and the treatment, as giving more information on the treatment and on the disease, and even as giving slightly more efficacious treatments. Another study that he discussed looked at cross-referral rates between CAM and orthodox medicine and found that they were very low.

The third research area discussed was publication bias. One survey the Department had conducted had shown that CAM journals have a strong bias in favour of publishing papers which had positive results for CAM as opposed to negative or neutral results for CAM. However Professor Ernst also discussed other research which had involved submitting almost identical papers to CAM and orthodox medicine journals. The two papers both reported fictional results of an RCT that showed positive results for either a CAM therapy or an orthodox medicine therapy. They found that the paper based on an orthodox medicine treatment was more likely to be accepted for publication by an orthodox medicine journal than the identical paper which provided the same results for a CAM treatment.

Professor Ernst talked about research into the safety of CAM. He noted that the CAM community have felt that safety research is unnecessary as they feel CAM is inherently safe. He said that he felt responsible as the only UK Professor of CAM to look at safety. He discussed a survey of CAM users that had found that users could remember side effects of homeopathy, herbalism, spinal manipulation and acupuncture. However a similar survey of GPs found they could only recall having seen side effects of spinal manipulation. Later in his presentation Professor Ernst was asked whether his Department's emphasis on safety gave it a negative image in the CAM world. He answered by saying that safety is the logical first line to examine and as much of the Department's work has found in favour of the safety of CAM it should be welcomed by the CAM world. He also responded to a comment that CAM is relatively safe when compared to the levels of iatrogenic disease caused by orthodox medicine by saying that one must always keep in mind the risk/benefit balance.

The last part of this talk discussed CAM research funding which Professor Ernst described as the biggest obstacle to CAM research in the UK. A survey by the Department showed that in 1996 only 0.08% of the NHS research budget and only 0.05% of the medical charities' research budget was spent on CAM. Prof. Ernst described the CAM research funding situation in the UK as 'dismal' and compared it to the situations in Germany, the USA and Switzerland where public money is ring-fenced for CAM research. He believes that if ring fencing is done well it does not necessarily reduce the quality of research and he sees it as the only way forward. Professor Ernst also discussed what he calls the 'Catch 22' situation whereby the MRC, Wellcome Trust etc. say they would fund more CAM research if there were better research applications. He suggested that his Department's experience of rejections of grant applications has shown that the people on the research application review panels often do not understand CAM.

4. Vision of Department's future.

The final part of this presentation described how the Department would like to develop in the future. Professor Ernst described a Department which had an overall head of operations who was supported by a research unit, a publication unit, an education unit, an information programme and a clinical programme. The education programme would include undergraduate teaching and teaching of CAM to orthodox medicine professionals to increase communication between the two fields. The information programme would have links with journals, the media and the public and would work to counteract the misinformation present in newspapers; it would possibly be linked to NHS Direct. The clinical service would ensure that those in the unit were still seeing patients and therefore did not lose contact with those that CAM is meant to benefit, thus developing the 'ivory tower syndrome'.

Mr M. Pittler: Research into Herbal Medicinal Products

Mr Pittler started his presentation by making the point that much of CAM research is in languages other than English. He believes that one of the strengths of the Department is that they are multi-lingual and so can examine of a lot of evidence that would otherwise be inaccessible to them.

Mr Pittler discussed the prevalence of CAM in the UK. One telephone survey estimated that 20% of Britons had used CAM in the last 12 months and herbal medicine was the most likely CAM to have been used, with 34% of the share. He then discussed the top selling herbs, referring to a US survey, the results of which he suspected would be mirrored over here. This survey found that the top selling herbs were: Ginkgo, St John's Wort, Ginseng, Garlic, Echinacea, Saw Palmetto and Kava Kava (the use of which is growing very rapidly).

Research into herbal medicine can examine particular plant extracts as treatments for specific ailments so rigorous research methods can be applied. Mr. Pittler reviewed a hierarchy of evidence with systematic reviews of RCTs at the top, followed by single RCTs, controlled clinical trials and lastly uncontrolled data such as case reports which can be seen as useful in generating hypotheses. He suggested that clinical replication is important and thus he tries to concentrate on systematic reviews of RCTs which minimise selection bias, minimise random bias and can look at a range of studies and thus increase validity. However he acknowledged that such systematic reviews also have potential weaknesses in that they may include trials of poor methodological quality, they may compare non-heterogeneous data and they may reflect any existing publication bias.

The last part of this presentation reviewed specific trials the Department has carried out for specific herbs and conditions. The results of these trials showed that some herbs can be proven to be effective for certain conditions; however other herbs have, despite their popularity, produced results which are inconclusive.

Dr A. White: Research into Acupuncture

Dr White started his presentation by briefly reviewing his own background. When working as a GP in the late seventies he saw patients who were benefiting from acupuncture. At the same time the discovery of endorphins made him think that the results of acupuncture might have a rational explanation. These two events led him to train as an acupuncturist himself and when he did so he found that there was so little good quality research into acupuncture that he became a research fellow. He discussed the fact that the change from being a clinician who wanted to prove acupuncture worked, to being a researcher who had to find out whether it works or not, was a huge leap in attitude.

The rest of this presentation reviewed specific studies into the efficacy of acupuncture. None of the papers that had investigated acupuncture's efficacy had yielded conclusive or particularly positive results. He is currently involved in a study into the adverse effects of acupuncture that seems to be showing that acupuncture is relatively safe. He has also been trying to attract funding to do a study into the cost consequences of introducing CAM into primary care but has been unable to attract funding as it would be quite an expensive trial which would involve paying GPs.

Presentations by the Centre for Complementary Health Studies

Roger Hill: Introduction

Roger Hill is the programme co-ordinator and co-founder of CCHS. He provided an overview of the main features of the centre:

The purpose of CCHS is to investigate and teach complementary health measures to practitioners. The teaching is carried out by CAM therapists.

CCHS provides a taught MA course which covers a range of disciplines, as well as research MPhil and PhD degrees. They do not offer practical training.

All CCHS post graduate courses emphasise research methodology which creates a tone of "mild scepticism" in all their taught modules. These modules include the therapeutic relationship, the cultural context of CAM and the holistic care of terminally ill patients.

They welcome those who practise orthodox medicine disciplines as well as CAM ones as they acknowledge there is much to learn from orthodox medicine although they object to medical imperialism.

CCHS has links with Bristol Cancer Help Centre and the Thomas Jefferson University in the USA.

CCHS will soon become part of the Department of Lifelong Learning at Exeter University.

Roger Hill aired some concern about the growth of generic undergraduate courses in complementary health studies which offer a smattering of knowledge about a range of disciplines. He suggested these should not be seen to qualify graduates to practise and that the organisations (often umbrella bodies) who support such courses are of variable reliability.

Sarah Budd: Department of Health Scoping Study

In 1999 the Department of Health commissioned CCHS to produce an information pack reviewing the process of regulation, to pilot a standards validation mechanism and to update the 1997 study which surveyed all the CAM professional organisations in the UK. Sarah Budd's presentation launched the updated version of this study which is the main reference document describing CAM organisations in the UK and includes contact details for all the bodies surveyed. The 1997 report had recommended integrative moves in all CAM fields; this second study inquired about the progress organisations had made towards integration.

The main demographic findings of the new survey were:

There are approximately 50,000 CAM practitioners in the UK, some of whom are members of more than one organisation.

There are approximately 10,000 statutory health professionals who practise some form of CAM.

Up to 5 million patients have consulted a CAM practitioner in the last year.

True figures are difficult to ascertain as many practitioners will not be members of any organisation, and some organisations will not have responded to the survey.

Despite the desire for greater integration expressed in the last report and generally encouraging movement since, there was in fact some evidence of greater diversification. The report contains a section on emerging and complex organisations and a pilot study of the processes involved in improving co-ordination within on therapy (reflexology).

Sarah Budd highlighted the fact that over the last two years regulation has become one of the main concerns for CAM.

Mr M. Willoughby: Herbal Standards

CCHS has been working in collaboration with the British Herbal Medical Association to produce quality standards for herbal medicines. The CCHS received a large grant from the European Union in 1994 to support various efforts. These include:

• Overcoming problems which arise because many herbs, once processed, look the same. Different products can be identified using thin layer chromatography and microscopy. Results from this work have been collected together in the British Herbal Pharmacopeia for manufacturers to use as reference material.

• Producing the Phytonet web-site for information about herbal medicine. This web-site includes a reporting system for any adverse effects.

• Producing ESCOP monographs on the medicinal uses of plant drugs. These monographs use the 'core SPC' (Summary Product Characteristics) format and are being considered by the European Medicines Evaluation Agency for use in assessing licensing applications across Europe.

Mr M. Bovey: Acupuncture Resource Research Centre

Mr Bovey began his presentation by describing his work running the Acupuncture Resource Research Centre. The centre was set up in 1994 by the British Acupuncture Council, and is wholly funded by them; it promotes acupuncture generally and encourages research mindedness. In order to do this the Centre:

Responds to requests

Provides direct support for practitioners

Interprets research by producing briefing papers

Supports other research groups by giving lectures, hosting symposiums etc.

Supplies a purpose built data base and literature searches for treating patients with unusual conditions.

Professor B. Goodwin: Academic Challenges

Professor Goodwin is a professor of biology and was first external examiner for CCHS. He currently teaches a module at the Centre which attempts to bring together alternative and conventional theories of health. The part of the module he discussed in this talk concerned complexity theory and health.

Student Presentations

In order to give an idea of the diverse work of the CCHS, several students gave brief presentations on the progress of their studies at the Centre. These were:

Lizzie Baines — an MA candidate who also works as a specialist palliative care nurse. She discussed her dissertation : 'An audit of Tibetan medical practice in the UK.'

Helen Cooke — an MA candidate who also works as the therapy director for Bristol Cancer Help Centre and is a registered nurse. She discussed her dissertation: 'An evaluation of the role of the Bristol Cancer Help Centre in helping patients and their supporters through its advice on complementary therapies and self -help techniques.

Reg d'Souza — a BPhil graduate who works as a physiotherapist and an acupuncturist. He discussed his dissertation: ' Trigger point acupuncture and ultrasonic therapy in low back pain.'

Penny Franklin — an MA candidate who also works as a health visitor and a nurse. She discussed her dissertation: 'Parental perceptions of the effects of lack of sleep on the couple relationship of parents with children between the ages of 12 and 30 months.'

Jessie Ng Fong Tiao — an MA graduate who works as a nurse, an acupuncturist and a Chinese herbalist. She discussed her dissertation: 'A single blind, cross-over study to measure the effect of acupuncture on low back pain.'

Ian Oliver — an MPhil candidate who also works as a homeopath. He discussed his dissertation: 'The homeopathic treatment of benign breast tumours.'

Vicki Pitman — an MPhil graduate who works as a medical herbalist. She discussed her dissertation: ' The relationship between ancient Greek and Ayurvedic medicine.'

Bridget Simpson — an MA graduate who works as a dental surgeon. She discussed her dissertation: 'An investigation into 'dry socket': a pilot study of a new herbal treatment.'

Frances Turner — an MPhil candidate who also works as an acupuncturist and Chinese herbalist. She discussed her dissertation: ' An evaluation of whether some form of standardisation of the English vocabulary of Chinese medicine would raise the standards of understanding and practice of Chinese medicine in the UK.'

Tina Wong — an MA and PhD graduate who also works as an acupuncturist, a nurse and a mid-wife. She discussed her dissertation: 'The use of traditional medicine and rituals in the prevention and treatment of post-natal depression among the Kadazan/Dasan and Bajan/Malay communities of East Malaysia.'