Making integrative medicine available to all sufferers of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) The Optimum Health Clinic Foundation
Making integrative medicine available to all sufferers of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) Our mission Our mission at the Optimum Health Clinic Foundation (OHCF) is to make integrative medicine available to all as a treatment for ME/CFS. The objective of this document is to set out the next major steps towards achieving our mission and to seek your support. About ME/CFS Whilst the cause of ME/CFS is still under debate, what is clear is that it is a very real physical illness (World Health Organisation s International Classification of Disease 10:G93.3). Symptoms range from severe and persistent fatigue unrelieved by sleep, to muscle pains, cognitive difficulties and chronic sleep disturbance. ME/CFS often creates long term illness and disability. Having treated thousands of patients in 34 countries, the majority in the UK, we believe that ME/CFS involves a process in which multiple systems, both physical and psychological, are interacting together in a dysfunctional way resulting in the various symptoms experienced. At the OHCF, we believe that ME/CFS actually encompasses a complex group of conditions including Fibromyalgia, Post Viral Fatigue Syndrome (PVFS), Chronic Fatigue and Immune System Dysfunction Syndrome (CFIDS) as well as Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME). For the sake of simplicity, we shall use the term ME/CFS to refer to all these conditions. What is integrative medicine? The Consortium of Academic Health Centres for Integrative Medicine (CAHCIM) defines Integrative Medicine as the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, health care professionals and disciplines to achieve optimal health and healing. 1
This consortium of medical schools has been established to transform undergraduate curricula so they reflect the vision of Integrative Medicine. CAHCIM includes 54 highly esteemed academic medical centres, including those at Harvard, Yale, Stanford and McGill. Why is integrative medicine so important for ME/CFS sufferers? We believe that integrative medicine is extremely important for ME/CFS sufferers because: it is estimated that ME/CFS affects around 250,000 people in the UK (www.nhs.uk/conditions/pages/hub/aspx) and 17 million worldwide (the Worldwide Patient ME/CFS Alliance). In comparison, other chronic illnesses such as Multiple Sclerosis (100,000 patients in the UK), and Parkinson s Disease (130,000 patients in the UK) are much more widely understood, supported and publicised. ME/CFS affects men and women, the young and old, and is one of the most misunderstood, poorly supported and under diagnosed conditions of our generation; very little hope of recovery is offered by conventional treatments for ME/CFS. These treatments are generally aimed at attempting to manage symptoms rather than identifying the causes and treating their complex interactions; conventional treatments such as Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET) have been shown to be effective in some cases. However, in our experience many patients have difficulty engaging with these therapies. CBT is invariably seen to be blaming the patient for his or her thought patterns, and GET can be physically damaging if implemented at the wrong time, which is often the case. In our experience, Integrative Medicine plays a very positive role in helping patients to recover from ME/CFS and we therefore believe that Integrative Medicine should be made available to as many ME/CFS sufferers as possible. What is special about our approach to integrative medicine? ME/CFS is so complex that there are almost as many versions of ME/CFS as there are individual sufferers. What is special about our approach is that it takes account of this complexity. Our approach is patient centred which means that we put our patients at the centre of the treatment process by: recognising the physical and psychological complexity of ME/CFS; embracing the biochemical individuality of each patient; applying a unique combination of psychology, nutrition and traditional medicine. Our three teams work together to create a tailor made treatment plan for each patient: 2
the psychology department is composed of practitioners trained in clinical hypnotherapy, neuro- linguistic programming, life coaching, emotional freedom technique and psychotherapy; the nutrition department draws on functional medicine tests, dietary advice and nutritional supplementation; the medical department provides a diagnostic service and overall support for our Integrative Medicine approach to the practitioner team. What makes our patient centred approach special is that it is based on considerable personal experience of ME/CFS. Eleven of our staff, including 7 out of 8 psychology practitioners, have suffered from ME/CFS and fully recovered from it. Even our trustees have personal experience of this illness. This personal experience gives us the knowledge, the confidence and the belief that full recovery from this awful illness is possible and we are able to share our experience and impart that sense of belief to our patients. This experience is a vivid example to our patients who, perhaps for the first time, can see and talk to people who have truly recovered from ME/CFS and are leading active lives. This represents a fundamentally different starting point to that of conventional treatments. No other private clinic offers our approach to Integrative Medicine backed by so much personal experience and understanding of ME/CFS. Why now? We believe this is the right time to engage with the NHS in pursuit of our mission because: major changes to the structure and operation of the NHS make funding of external treatment possible. These changes are intended to create more efficiency in healthcare, and to give patients and healthcare professionals a greater say in the treatments offered, especially for chronic, disabling conditions such as ME/CFS; recent changes to the benefits system in the UK have adversely affected those with ME/CFS because the complex and fluctuating nature of the illness falls outside the parameters of the measures used. This means that patients in an already extremely vulnerable situation are at best having to fight difficult battles to retain their benefits or at worst losing them altogether. The psychological and physical distress that this engenders is substantial, particularly significant at a time when people with ME/CFS need the most support with their health. These changes make it imperative that we secure funding from the NHS in order that all ME/CFS sufferers may have the option to choose our treatments at the OHCF. 3
How are we going to achieve our mission? To achieve our mission, we must persuade the NHS to fund our treatments for ME/CFS patients. To do this, we need to carry out a Randomised Controlled Trial (RCT) on their ME/CFS patients in order to demonstrate that our treatments make a positive difference to their recovery from ME/CFS. To convince an NHS hospital to refer their ME/CFS patients to us for an RCT, we need to first carry out a pilot project (a Preliminary Prospective Study) to demonstrate that a full RCT is justified. Our action plan is, therefore, as follows: Stage 1 - Preliminary Prospective Study The first step is to carry out a Preliminary Prospective Study on our own ME/CFS patients and then publish the results in a respected peer reviewed medical journal. We have already invested the funds required for this project (through profits generated from our trading company The Optimum Health Clinic) and completed it with encouraging results. There were clear mean (average) statistical improvements over a three month period in the three treatment groups which consisted of a total of 138 ME/CFS participants. The results of this study were published in the British Medical Journal Open in 2012 (http://bmj.com/content/2/6/e001079.full). Stage 2 - Securing agreement with an NHS hospital to conduct the RCT We shall use the results of the Preliminary Prospective Study as the basis for discussions with an NHS hospital with a view to securing agreement for us to treat their ME/CFS patients and conduct an RCT. Stage 3 - Setting up the RCT Once that agreement is reached, we will set up the project. This will involve: developing and executing formal agreements with the hospital in question and with our suppliers; designing the RCT process; completing the process of ethics approval with the NHS hospital. Stage 4 - Treating NHS patients and recording results (the RCT) During this stage, we will be treating the ME/CFS patients from that particular hospital, and collecting data on the effectiveness of those treatments. There will be three treatment groups, which will be made up of a psychology only group, a nutrition only group and a combined group receiving both psychology and nutrition. We will also have an appropriate active control group. Questionnaires will include a number of 4
research measures, and will be used before treatment starts, at three months, six months and one year (we also intend to collect subsequent time points further down the line to measure long term effects). Stage 5 - Publication of results In this stage we will analyse the results of the RCT and produce a paper. We will submit the paper to a leading scientific journal (such as the British Medical Journal or Lancet), deal with peer reviewers comments and then proceed to publication. Stage 6 - Applying for NHS funding Having published the results of the RCT showing the effectiveness of the OHCF approach, we will be in a position to apply for NHS funding of our treatments. This would be through two potential NHS vehicles: any qualified provider - this is where any service provider that can provide a cost efficient and clinically proven programme can apply for funding from local commissioning bodies; personal health budget - which gives patients with complex conditions such as ME/CFS control over how part of their treatment budget is spent. We expect that the whole process will take about 4-5 years. Once we have started treating the ME/CFS patients from one hospital, we will be then in a position to start discussions with a second hospital, then a third and so on. How much money do we need to raise? We need to raise a further 275,000. A summary of the costs of this project is set out below: Stage Action Cost 1 Preliminary Prospective Study Project completed 2 Securing agreement with NHS Hospital - 3 Setting up Fundraising completed 4 Treating patients and recording results 250,000 5 Publication of results 25,000 6 Applying for NHS funding - Total 275,000 We will be happy to share with you the full details of our costings as and when appropriate. 5
Why support The Optimum Health Clinic Foundation? When it comes to making Integrative Medicine available to all ME/CFS sufferers, we believe that no organisation is better placed than us: we are the only private clinic offering our particular approach to Integrative Medicine as a treatment for ME/CFS; we bring to the patient a depth of knowledge, understanding and empathy that can only come from personal experience of ME/CFS; we have treated more than 5,000 patients since 2004 and we have more than 700 patients in treatment at any one time; our patients come from all walks of life including company directors, GPs, housewives, teachers and students; every one of our patients enjoys the following unrivalled benefits: some of the UK s best practitioners, many with personal experience of ME/CFS; a network of websites providing a huge amount of information and support, which together receive 300,000 unique visits a year (www.freedomfromme.co.uk and www.secretstorecovery.com ) over 100 hours of audio and video support; a huge archive of inspirational recovery stories from our patients; a social network for patients to help support each other; consultations via telephone or Skype for those patients who are too ill to travel or live abroad; a monthly newsletter sent to over 10,000 people. In recognition of the above, CAM (The Complementary and Alternative Magazine) awarded us their Outstanding Practice Award in 2009. We need your help We look forward to discussing with you the possibility of your financial support for this vitally important project for the many thousands of ME/CFS sufferers unable to access our treatments. Thank you. THE OPTIMUM HEALTH CLINC FOUNDATION 6
APPENDIX I The Optimum Health Clinic Foundation (Registered charity number 1131664) Patron Trustees Shirley Conran - international bestselling author, founder President of the Work- Life Balance Trust and current patient. Ian Hatton BSc (Chairman) - pharmacist, research specialist and father of current patient. Tim Bichara - technology entrepreneur and former patient. David Butcher BA (Hons) - former chief executive in financial services and current patient. Company Secretary Senior Team Gillian Farrier Alex Howard BSc (Hons) - Founder and CEO Miguel Toribio- Mateas BSc, MSc - Clinical Director Anna Duschinsky MA (Hons) - Director of Psychology Tanya Page BSc (Hons), Dip, ION, mbant, NTCC, CNHC - Director of Nutrition Glynn Gratrix - Director of Finance and Operations For full biographical details please visit: www.freedomfromme.co.uk/people Trustees Contact Details Ian Hatton ian.hatton@optimumhealthfoundation.com; mobile 07979 603288 Tim Bichara tim.bichara@optimumhealthfoundation.com; mobile 07792 481050 David Butcher david.butcher@optimumhealthfoundation.com; mobile 07785 592751 7
The Optimum Health Clinic Foundation Bickerton House 25-27 Bickerton Road London N19 5JT www.freedomfromme.co.uk 8