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Other Physical Treatments

Other forms of physical treatment which have been investigated include the use of NADH (nicotinamide adenine dinucleotide), marketed as Enada, which was said to have produced some benefit in a minority of patients in a small randomized, double-blind, placebo-controlled crossover study,[57] but the statistical analysis was subsequently challenged.[58] A study of growth hormone showed no improvement in the quality of life during treatment of people with ME and low growth hormone levels.[59]

Yet further treatment approaches are designed to mitigate or ameliorate clinical features of the disease, such as sleep abnormalities, in which it has been suggested that pharmacological and behavioural methods that improve the quality of sleep could be important elements in a treatment programme for ME,[60] while an Australian study of 56 patients concluded that a subgroup of people with ME, who manifested significant daytime sleepiness and REM sleep abnormalities, could benefit from symptomatic treatment.[61] A similar symptomatic approach has been adopted for orthostatic hypotension (low blood pressure associated with changes in position), which is found in some but not all people with ME. A trial of treatment with saline produced benefits in many but not all patients.[62] In those who did not benefit, it was hypothesized that they may have had an abnormal renin-angiotensin-aldosterone system, underlying the importance of the identification of specific subgroups of ME, in terms both of pathological changes and of clinical manifestations, in order to be able to make sensible and meaningful interpretations of the outcomes of treatment.

Some types of therapy have been controversial, and have attracted considerable misgivings among some patients with ME. One such is graded exercise, a regime in which patients undertake steadily increasing physical activity, irrespective of their clinical state. The study comparing fluoxetine and graded exercise has already been referred to.53 This showed that graded exercise was capable of bringing about improvements in functional work capacity. This finding was confirmed by another randomized controlled trial of 66 patients without psychiatric disorders or sleep disturbance.[63] However, it is likely that both these studies were conducted in particular subgroups of ME patients (for example, not including the severely incapacitated, who may account for a quarter of all people with ME), and the findings may not therefore be applicable to people with ME as a whole.

Psychological Treatment

Particular concern has been expressed by some ME patients about the use of psychological therapies in treatment. Reference has already been made to a relatively early Australian study which did not show any specific response to psychological therapy,[14] but this may have been a feature of either the interventions practised, or the subset of ME patients in whom they were applied. Since then, much research activity has concentrated upon a specific set of psychological interventions known as Cognitive Behaviour Therapy (CBT). This is a form of psychological therapy which emphasises self-help and aims to help the patient to recover by bringing about alterations in understanding, beliefs and behaviour. Two recent trials in the UK, each of 60 patients, demonstrated functional improvements,[64],[65] though few patients were cured.[66] A recent Cochrane review[67] concluded that 'cognitive behaviour therapy appears to be an effective and acceptable treatment for adult out-patients with chronic fatigue syndrome', but this assessment was based on just three clinical trials. A clinical trial in America reported that CBT may be useful in treating ME patients with cognition-related depressive symptoms,[68] while an earlier UK study[42] reported a high refusal rate and difficulty in treating affective disorders, and that a successful outcome was less likely where the patient attributed his or her symptoms to physical causes.

The problem with all these studies is that the selection of patients appears unrepresentative of the ME population as a whole. These studies have largely been conducted in departments of psychiatry with an interest in ME, so it appears likely that patients with ME referred to them in the first place are those with significant psychiatric comorbidity. It is also unclear that the term CBT is always being used to describe similar sets of interventions. Thus, at one extreme, it appears to set as its objective bringing about substantial alterations in patients' beliefs in the nature of their illnesses, while at the other extreme, it is concerned, in the absence of more specific therapy, with helping patients to acquire coping skills to enable them to live with their very disabling physical conditions. It is in this latter sense, for example, that it has been shown to be of benefit to patients with cancer. The difficulty many patients with ME have in accepting CBT is that, where it has been asserted to have been successful, this appears to many to carry an implicit assertion that this indicates that the underlying disease process is essentially psychological and not physical in nature. Indeed, where the claim is that CBT operates by altering underlying illness beliefs, this does indeed appear to be the implication. The problem remains that CBT may indeed be valuable in teaching coping skills, but is both dangerous and illogical to infer that the acquisition of coping skills implies anything at all about the underlying nature of the disease. The question is thus one essentially of legitimation, which is obviously extremely important for patients who have in many cases grown used over many years to disbelief and criticism from a medical establishment which, while belatedly becoming more enlightened, still harbours a great many pockets of ignorance.

Another treatment approach which has shown some benefit has involved the provision of self-help materials. This was shown to be better than no treatment, but its efficacy was not assessed in more severely ill patients.[69]

Holistic Care

Given the lack of specific treatments of consistent and confirmed efficacy, the focus of therapy has essentially to be on the implementation of problem orientated management plans which are holistic in nature and seek to address the whole range of practical difficulties affecting patients with ME. One such approach reported in the literature involved nutritional advice, homoeopathic prescribing; and psychotherapy, and each aspects of the treatment was shown to have an independent beneficial effect.[70] This is rather similar to the approach adopted by Teitelbaum,[71] in which treatment is multifocal, designed to address comorbidities such as fibromyalgia, hypothyroidism, hypoadrenalism, immune dysfunction (as indicated by the presence of bowel parasites or Candida infections), or psychopathology (which was not so much a comorbidity as an error of diagnosis in the first place). This approach requires very intensive investigations in order to establish the presence or absence of these concomitant conditions, and underlines once again the importance of identifying specific subgroups in order to tailor treatment to the specific needs of each patient.

Subgroups

It is clear from the above discussion that ME is a very heterogeneous disease,[72] as regards it causes, its pathophysiology, its severity and its response to treatment. It is therefore very important that the question of subgroups be addressed, both from the point of view of patients, who are clearly entitled to the best available treatment for their specific conditions, and from that of clinical scientists, as it is essential to interpretation and understanding of the outcomes of care. Subgroups may be defined according to severity, and many draw the distinction between the more severe patients with ME, who may number around a quarter of the total, and less severely affected patients, who may be labelled as Chronic Fatigue Syndrome (CFS). They may also be defined by disease stage[73] or response to treatment.[74]

They may be recognized by the presence of clinical features in some patients and not in others, such as for example orthostatic hypotension[62],[75] and other forms of hypotension,[76] or of other features which may be seen either as part of the syndrome or as comorbidities, such as seasonal affective disorder[77] or sleep abnormalities.[61],[78] Clearly, treatment designed to alleviate these particular clinical features will be ineffective in those patients which do not manifest them. Similarly, subgroups may be recognized in terms of pathological processes. Thus alpha-interferon has been shown to be effective in alleviating diminished NK cell function, but only in that subgroup of patients who manifest that feature.[38]

The distinction between heterogeneous clinical features of the disease, comorbidities, and overlapping syndromes, is largely a semantic one; different views are taken depending on differences in perception of the illness. Thus ME, fibromyalgia, and temporomandibular disorder may be seen as different diseases, but possessing many clinical features in common.[79] Wesseley et al. would regard these, and other conditions such as irritable bowel syndrome, as functional somatic syndromes, and claim that the similarities between them outweigh the differences.[80] Others would not agree with this conclusion. The bases for defining subgroups are listed in figure 2.

Patients' and Doctors' Attitudes

Patients' attitudes and those of doctors are clearly of primary importance in the successful management of ME. A Dutch study[81] concluded that patients who considered their illness to be serious reported a greater degree of impaired physical, mental and social functioning than other patients, which may seem obvious, while a fairly recent study from Kings College Hospital[82] reported that illness beliefs were less important in prognosis than work previously reported.

As regards doctors, many still do not accept ME as a genuine diagnosis. A recent study of Australian GPs indicated disbelief in 31% of respondents,[83] while in Ireland a similar nationwide sample study found that 58% accepted it as a distinct clinical entity, 34% were undecided, and 8% rejected it.[84] A formal study of this nature still remains to be carried out in the UK, but clearly negative attitudes must still be widespread, as a study which involved interviewing patients about the responses they had received from health care professionals found widespread dissatisfaction with the support received.[85]

This of course brings us back full circle to the Chief Medical Officer's Working Group, and underlines why this initiative has been necessary. ME is a condition that many doctors find difficult and challenging, both because of the difficulties involved in making the diagnosis, and both because of the lack, at present, of any specific treatment of unequivocal effectiveness. The emphasis for doctors, for the moment, has therefore to be on supportive management and general patient care. This approach was summed up by a recent article by Professor Tony Pinching,[86] who makes the point that supportive care is made much easier if patients '… feel they have been listened to and believed.' He stresses the importance of managing activity to assist natural recovery, i.e. pacing, which is an entirely different matter from the graded exercises mentioned above, and is tailored to the particular needs of the individual patient. Meanwhile, it is important to treat symptomatically intrusive and unpleasant features of the illness such as sleep disturbance. Elements of cognitive behaviour therapy can be helpful in assisting patients to develop coping strategies; such an approach does not and should not carry with it an implicit labelling of the disease as 'psychiatric'.

Developing Coherent and Comprehensive Services for People with ME

There are as yet few examples of effective management programmes taking a holistic approach and endeavouring to support patients through all aspects of their journey through the illness. Marlin et al.[87] have outlined such an approach in Canada, involving elements of conventional medical management, structured exercise, sleep management, attention to social goals and involvement of the patient's family, and including elements of a cognitive approach to developing coping strategies. Patients participating in this approach appeared to make better progress than patients not receiving treatment.

In Britain, while there are some centres providing care for ME sufferers, the quality and nature of the care available depends very much on where one lives, and is a lottery, with many sufferers denied access to any care at all. The only large scale programme designed to provide a service for ME sufferers throughout an entire geographical area is the county-wide service established in Dorset in 1998. Patient management, as practised by the Dorset CFS/ME service, is directed towards minimizing the impact of disability in order to enable patients to move forward, and to develop coping strategies. This is achieved by individualized treatment programmes, which may include group educational programmes, an individual approach using elements of cognitive behaviour therapy, drug treatment, and advice on balancing rest and activity. There are now upwards of 200 patients who have been, or are, undergoing the programme organised by the county ME centre, and the point is rapidly approaching when it will be possible to report on the results so far.

It could be that the Dorset experience could provide a model which could be emulated by other health authorities. In any event, implementation of the anticipated guidance from the CMO's Working Group is something that should be taken seriously by the NHS, as it is unacceptable that so many patients with ME should be deprived of care. As mentioned at the start of this article, little is known about the burden of illness due to CFS/ME in the UK population. This has serious consequences for planning services and meeting needs. It means that there is no valid basis on which to carry out community-based needs assessment, which for health authorities is a necessary first step to planning a coherent pattern of health and social care services to meet the needs of people with CFS/ME.

Epidemiological Research Needs

A major need, therefore, is to set up a programme of epidemiological research into ME in the UK.

The elements in this work are summarised in Figure 3. There is a need both for better epidemiological information, of which the initial step must be the development of an epidemiological case definition, as existing studies have mostly been done using clinical research definitions which were deigned to enable relatively homogeneous groups of patients to be selected for clinical trials, and which therefore tend to underestimate the true burden of such a heterogeneous disease. Nationwide epidemiological studies then need to be done, and these are most easily conducted through general practice, and then local community-based studies need to be done to validate the findings of national studies, to assess the extent of local variations, and to identify any systematic omissions in the national studies, for example of the more seriously affected patients. There is also a need for evaluation of service provision, so that this information, together with better epidemiological data, can enable health authorities to undertake health needs assessment as a prelude to setting up services for people with ME. These services will then themselves have to reviewed and evaluated, and their impact on long-term outcomes of ME assessed, so that everyone can learn from experience and thereby raise the prospect of steady improvements in the care that can be provided. Finally, the work should also include attitude surveys among health care professionals, and satisfaction surveys among patients, to assist in the design of training programmes for all professionals who come into contact with people with ME, including not just health care professionals, but for example, people working in social care and education

All this amounts to a long-term programme, lasting at least ten years, of research into epidemiological aspects of the disease. What is needed is a National ME Observatory to set this in motion, and to organize and coordinate its development. Much of the work that needs to be done, though crucial, is painstaking and thorough, but not headline-grabbing, and therefore to date has not been attractive to funding agencies. It is likely therefore that those of us who are anxious that the work should begin will have to find other ways to finance it, probably through a direct appeal to the general public. The matter is urgent, because without it, it is likely that the momentum establishment through the formation of the CMO's Working Group will be lost, the recommendations, like so many previous well-intentioned initiatives, pigeon-holed, and the plight of ME sufferers, who have an illness which has blighted so many lives, at all ages and right across the social spectrum, will go unalleviated.

References

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