History of MS Centres in the UK and the MS National Therapy Centres
In 1982 a group of patients in Dundee decided, after trying hyperbaric oxygen treatment in a diving chamber, to start their own centre. An old RAF chamber, first used in Farnborough in 1944 to study the ‘bends’ in aircrew, was transported from a farm in Bedford to Dundee and installed in an industrial unit – number 12a in Peddie Street. Several hundred MS patients were treated over the following year and these patients, having found benefit, inspired others to start their own centres in Scotland, often in the face of determined opposition. Centres were soon started in England, followed by Wales and then Northern Ireland. So now there are over 64 centres in operation. This includes three in the Republic of Ireland, which requires the overall title to be the MS National Therapy Centres of the Islands off Brittany, rather than the British Isles. Joining together under the title of the MS National Therapy Centres is critically important as witnessed recently by the problems created by the introduction of the Private and Voluntary Healthcare Regulations.
The Expert Patient
Many things have changed over the last 28years, and one of the most dramatic changes has been in the attitude of senior doctors, in accepting that patients can be experts. A Department of Health document entitled “The Expert Patient: A New Approach to Chronic Disease Management in the 21st Century” outlines the challenges our society faces because so many people are living longer. At last there is the recognition by doctors, nurses and other health professionals that when patients have suffered for years, they “understand their disease better than we do.” Disease means not being at ease and it is obvious that those who experience symptoms know them best. The document goes on to refer to this experience as an untapped resource and a partnership is needed between patients and doctors which is based on mutual respect and perhaps doctors will spend more time listening. It is stated that patients “can become key decision makers in the treatment process.” This is restating the position of the General Medical Council, that doctors are there to advise patients and warns that they must not allow their personal beliefs to influence the patient’s choice of treatment. This is very important for patients attending the Centres because many doctors, not having been taught the importance of pressure in oxygen delivery at medical school, often state that they do not believe in hyperbaric oxygenation. Note also that doctors cannot ‘consent’ to a treatment, that right belongs solely to the patient. It should be remembered that patients are much more motivated to get better than their doctors are to make them so! One of the chronic illnesses mentioned in the ‘Expert Patient’ is, not surprisingly, multiple sclerosis – ‘MS’ and the importance of self help is emphasised. Self help has been the cornerstone of the MS National Therapy Centre movement in providing oxygen treatment, physiotherapy and other therapies within the community.
The Private and Voluntary Health Care Regulations
The second development, which Centres have viewed with mixed feelings, is the introduction of the Private and Voluntary Health Care Regulations. Originally designed to regulate private medicine, such as cosmetic surgery and abortion clinics, they were broadened to include the voluntary sector. The regulations introduced terms like purchaser and provider, which are not appropriate to a self help movement, because patients treat themselves in just the same way as taking over-the-counter medicines. The introduction of a responsible person has also caused some concern, but this responsibility is only for the equipment, for example, the chambers used for hyperbaric oxygen treatment and the premises, but it is not for the treatment itself. The Centres enable access to the treatment, but it is the patient’s choice to go into the chamber and to breathe the extra oxygen. This is accepted by the Department of Health. The question of insurance has been raised many times but it is most important to understand that the insurance covers the building, the chamber, the associated equipment and its operation. It is not insurance for the treatment, that is breathing oxygen, because it is self administered. Perhaps an example will help clarify the situation. Aspirin can be bought from a chemist – or even a supermarket – without a prescription. It is the patient’s choice to take it without any insurance to cover the risks involved, although of course the NHS provides some cover by treating the side effects! If a patient were to choke on the tablet, or bleed from a stomach ulcer they would not sue the chemist who sold them the drug or the manufacturer that made it.
The concept of self help is accepted by the Department of Health and it is critically important not to lose sight of the fact that those attending the Centres are helping themselves. It is easy to forget this, especially when Centres are becoming more sophisticated and are involving more professionals. Self help is the central principle in the operation of our centres. Patients coming to Centres must actually join the group, otherwise a ‘them and us’ situation is created. Although the fees charged by the Regulators are an obvious burden, there are many positive aspects from the recognition by the Department of Health, not least of which is the right to access this treatment, which is denied to patients in the Health Service. To have the most powerful intervention in medicine in the hands of patients in the community is a privilege which would be impossible in many other countries in the World. An editorial in the British Medical Journal in 1984 referred to the use of oxygen under hyperbaric conditions as ‘high technology’ and in most countries the medical profession has adopted this view, restricting hyperbaric oxygen treatment to highly selected chronic conditions like problem wounds and in the USA a session can cost up to $1500. The document ‘Independent Healthcare’ which accompanies the regulations unfortunately states that the Centres are owned by the MS Society despite the fact that we pointed out that this was not correct in a response to the Consultative Document. The Regulations allow patients to use hyperbaric treatment for ‘neurological conditions’ such as multiple sclerosis and cerebral palsy and neurological conditions includes patients with stroke and head injury. There is no comment on the value of the treatment because the Department of Health does not possess experts to express such an opinion but it requires an evidence based approach.
The National Centre for Clinical Excellence
In the past the Department of Health has endorsed treatment based on the opinions of the NHS consultants in the appropriate speciality, but often it has been the powerful groups such as the cardiac surgeons who have had the lion’s share. Now it turns to quangos such as the National Centre for Clinical Excellence, (NICE) to bring together the best objective evidence for a given treatment, because the medical profession is notoriously susceptible to the whims of fashion. Fashionable ideas promoted by those eminent in a particular field have a very powerful influence on thinking especially because the same doctors are also likely to be involved in teaching medical students. This cycle often reinforces some bizarre opinions, such as immunosuppressive drugs in the treatment of patients with multiple sclerosis. NICE has commissioned a review of the use of hyperbaric oxygen (note the incorrect term) for MS patients and concluded that there is no evidence and so it should not be used. This has obviously raised concern in the Centres but it is incorrect. To understand why the doctors who conducted the review reached their opinion it is necessary to examine the evidence based medicine approach used. The first stage is that oxygen must be regarded as a drug which requires to be tested as if it is a new drug. Drugs have been having some bad press recently following the comment by Allen Roses a senior executive at Glaxo Smith Kline that more than 90 percent of drugs work effectively in only 30 to 50 percent of patients. It is easier to view oxygen as a drug when it is described as hyperbaric because it then appears to be somehow different to the ordinary oxygen we breathe. If oxygen is regarded as a drug then an examination of the trials should indicate if there is sufficient evidence to endorse oxygen treatment. The grammatically correct term hyperbaric oxygenation is often degraded to hyperbaric oxygen, which tends to imply that the oxygen is somehow different – not the same oxygen we breathe or use in hospital. An editorial in the Lancet in 1997 discussed a remarkable parallel to the use of oxygen treatment for the symptoms of MS.
An Evidence Based Non Sense
We all stop breathing during sleep, usually only for a few seconds, but some patients stop breathing for much longer. It is known as sleep apnoea and is usually associated with some degree of airway obstruction and so is associated with snoring. Because these patients have very disturbed sleep, they are constantly tired during the day. Their quality of life can be dramatically improved by continuous positive airway pressure (CPAP) and the rest of us can also be safer on our roads because, untreated, such patients have a seven fold increase in driving accidents! Thousands of patients around the World use CPAP equipment every night, although only one double blind controlled trial has ever been done which was positive. In 1996 the North Yorkshire Health Authority, concerned about the rising costs of sleep clinics and CPAP, – the equipment costs £600 – withdrew funding. To justify this they cited a literature review of CPAP which, of course, pointed out that there was only one trial and chose to ignore the many uncontrolled studies and enormous clinical experience. In essence what was being challenged was the importance of sleep, of breathing and of the substance that requires us to breathe, oxygen. All of these are measured in patients with sleep apnoea before the equipment is prescribed. The patients do not like wearing the masks, much like MS patients! I do not know what happened in North Yorkshire, but I assume that patients won the day because they would be strongly supported by their consultants. Sadly, despite several positive trials of oxygen treatment in patients with very long standing MS, they have had to fight for more oxygen without support from the neurologists who have actually opposed this treatment. The majority of patients, including those with MS trust doctors not to discard something that will help, especially when it is natural and without side effects, but this trust has been betrayed. The use of oxygen for patients with MS is supported by the best double-blind, randomised, controlled trial in the history of medicine. This is termed by NICE Class 1 evidence, but the review of the studies used by NICE chose to include poorly done studies where the bias of the investigators was clear. The great majority of doctors do not understand the importance of barometric pressure or even oxygen itself and they are afraid. It is difficult to imagine a more serious confrontation with a doctor than to suggest they do not know how to use oxygen properly. So is there an evidence base for oxygen? Quite simply nothing ever gets better without it! However, the trials conducted in the 1980’s certainly showed benefit from oxygen but only one was properly conducted and this will be discussed later.
Hyperbaric Oxygen Treatment and Expert Patients
The patients who founded the MS National Therapy Centres did so simply because they have found it helpful to breathe a higher dose of oxygen than is normally available in hospitals. They had not been influenced by a massive advertising campaign and understood the object was not to produce a miracle cure, but to improve their quality of life and to reduce the rate of the progression of their disease. The self help movement has now involved over 15,000 patients and in excess of 1.7 million sessions have been completed without a significant incident. The concepts of pressure and a high dosage of oxygen make many doctors uncomfortable. Indeed many doctors claim that they have never seen a chamber, not realising that commercial aircraft are pressure chambers. Note that they are even equipped with oxygen breathing systems and if pressurised on the ground would make excellent MS Therapy chambers. But the concept of a dosage of oxygen is foreign to doctors mainly because it is a gas. They are taught at Medical School simply to specify a number of litres a minute by a mask and do not know how much oxygen is actually retained within the body. Imagine how puzzled everyone would be if we specified that an MS patient in a Therapy Centre should have 800gms of oxygen in their hour in the chamber! Doctors are also not taught about the importance of atmospheric pressure in the delivery of oxygen and in giving 100% oxygen in hospital they ignore the fact that the amount the patient actually receives depends upon the barometric pressure. As everyone knows, barometric pressure changes with the weather and so affects our lives every day. In Scotland the barometric pressure change is actually more than 10%. In other words a critically ill patient in intensive care can have the oxygen level they are receiving fall by 10% in a day, as barometric pressure falls due to the arrival of a low pressure area.
A pressure chamber can of course adjust for this variation and also allow much more oxygen to be given, in other words, a larger dose. Unfortunately the technology is not explained in our medical schools and once doctors qualify it is very difficult to re educate them about fundamental concepts such as the correct use of oxygen. Not surprisingly they are affronted when it is suggested that they do not know how to use oxygen properly. This problem constantly spills over into clinical hyperbaric medicine, because they also have not been taught about hyperbaric chambers and many are frightened by the sight of the equipment. Although the chambers used in relation to diving operate at very high pressures, there is more pressure in household cold water pipes then in the chambers used in the MS Therapy Centres. Because of all of these problems hyperbaric medicine is often classified with alternative and complementary medicine.
Given all these factors it is not difficult to see why neurologists have not been enthusiastic about hyperbaric oxygen treatment for patients suffering from multiple sclerosis, but there is another reason. Using oxygen does not fit in with currently fashionable theories that ‘MS’ is due to a virus or auto immunity; a technical term for self destruction. The basis for this popular idea is that the defences of the body normally directed at invading bacteria attack healthy tissue. This has been the rationale for the use of immunosuppressive drugs and so giving oxygen did not appear to fit in with these ideas. Because of patient pressure in the 1970s the National Multiple Sclerosis Society of America funded studies of oxygen treatment under hyperbaric conditions in the animal model used to study aspects of MS. They were successful. Daily sessions of oxygen under hyperbaric conditions stopped the animals developing the disease and in other experiments oxygen treatment improved the symptoms after the disease had developed. This led to the funding of the superb human study already discussed. The cost of the trial ($250,000) was provided by the National Multiple Sclerosis Society of America in New York University which was led by the late Dr B.H. Fischer. For the first time in the history of ‘MS’ a treatment produced improvement in chronic symptoms, despite many years of disability. However, the subsequent trials, which were of very poor quality, were publicised by the issue of a press release through Associated Press in an attempt to discredit the NYU study. It should be remembered that there is a similar range of human frailty in the medical profession that there is in the rest of humanity. The use of hyperbaric oxygen treatment for children with cerebral palsy has been dealt with in the same way, with a very detailed study conducted in McGill University published in the Lancet also being misrepresented. However, the treatment is beneficial and Centres should encourage parents to treat their children – suffer the little children – because it may transform their lives. Again it must be stressed that it is the parents who are responsible and make the decisions for their children. They should, of course, also be involved in the treatment and be with their children in the Centre.
An Hour of Oxygen a Day ……
The principle difficulty for most doctors has been understanding how one hour of additional oxygen a day, that is, one hour in 24 hours, can make any difference. When the principles are explained, most doctors can accept that if a patient is short of oxygen and going blue then it is logical to give a large dose of oxygen. However, now twenty years later scientists working at the cutting edge have revealed just why an hour breathing a high level of oxygen can have astonishing and lasting effects. Everyone knows that oxygen is essential to life and also that if the brain is deprived of oxygen for a short time it dies. Oxygen is used to unlock the energy contained in the molecule glucose and the end products of metabolism are carbon dioxide and water. This, for most doctors, is the sum total of their knowledge and without the marketing muscle generated by the investment of billions it is difficult to see it changing soon. Doctors are quick to point out that oxygen may be toxic by forming free radicals, but most are not aware that without oxygen free radicals we cannot exist. Publications in the 1970’s detailed how oxygen is used as the key antibiotic of the body. White blood cells, having enveloped microbes, kill them by adding an electron to a molecule of oxygen to generate the superoxide radical. At a time when the government has just woken up to the massive problem of bacterial resistance in hospitals it is worth pointing out that bacteria cannot develop resistance to this oxygen derived antibiotic. In other words giving oxygen will combat infection. Recent American studies have shown that giving patients a higher level of oxygen during abdominal surgery and for two hours afterwards halves the infection rate and the rate of post operative nausea and vomiting.
It has been known for many years that breathing more oxygen causes blood vessels to constrict reducing blood flow. Oxygen controls blood flow by involving another gas, one that has been thought for many years to be just a poison – nitric oxide. But there is even more than this to the oxygen story and it is of direct relevance to the disease underlying ‘MS’. Even those doctors who are convinced that the auto immune theory is correct admit that the affected areas of the brain and spinal cord in MS are inflamed. A recent review in the top scientific journal Nature entitled ‘Oxygen and inflammation’ has given the latest information. Inflammation causes the level of oxygen in the tissues to fall and this, in turn, activates a protein system – the Hypoxia Inducible Factor proteins (HIF). One protein, HIF 1 alpha, not only controls the migration of white blood cells into the tissues to control infection, it is also responsible for the growth of new capillaries in wounds. This master protein regulates over 30 genes. So giving a high level of oxygen even has genetic consequences and so it is little wonder that one hour of oxygen in a chamber has effects that last. Finally patients who have used oxygen as a treatment for their MS for all these years have been shown to be correct. It is now time for neurologists to listen to their expert patients.
Professor of Hyperbaric Medicine
The University of Dundee