Treatment

MRC trial into treatments for ME/CFS

The MRC is currently funding two complementary trials into various treatments options for ME/CFS which aim to improve quality of life for those who are ill. Both trial began recruiting in Autumn 2004.

The Pace Trial

(Pacing, graded Activity and Cognitive Behaviour Therapy: a randomized Evaluation)

The MRC Trial is the largest trial of ME/CFS treatments to date.

PACE aims to compare four approaches to the clinical management of patients with ME/CFS:

Specialist medical care alone
Specialist medical care plus adaptive pacing therapy (APT)
Specialist medical care plus cognitive behavioural therapy (CBT)
Specialist medical care plus graded exercise therapy (GET)

It is the first scientific evaluation of APT. It was recognised by the Chief Medical Officer’s Working Group on ME/CFS, but has not yet been adequately researched. APT has been adapted within PACE to enable it to be studied 0 the trial and the APT trial treatment manual have been developed with the help and support of Action for ME.

The “specialist Medical care alone” and “specialist medical care plus APT,CBT or GET approaches are being delivered by specialist doctors, occupational therapists, nurse therapists or psychologists and physiotherapist, respectively.

It is important to understand whether treatments work, why they may work for some and not for others, or even if they make people feel worse. The trial setting allows careful monitoring of patients, and particular attention will be given to assessing the benefits and negative effects of each of the interventions.

The PACE trial aims to provide high-quality evidence-based answers to address the current uncertainties about which treatment might work best for which individual.

The FINE trial

(Fatigue Intervention by Nurses Evaluation)

FINE will compare:

Usual medical care
Supportive listening delivered by a trained nurse
Pragmatic rehabilitation

Pragmatic rehabilitation was developed by the research team, and is based on an approach that proved popular with patients who took part in previous study. The treatment manual for this trial has been developed in association with those patients. The approach combines helping patients to understand their symptoms and jointly agreeing a programme of rehabilitation. The trial will also evaluate whether the delivery of pragmatic rehabilitation can be easily taught to qualified nurses without the need for lengthy and expensive training. If successful it could provide an invaluable addition to the help on offer in a primary care setting.

The treatments in the trial will be delivered to the highest standard by qualified nurses specially trained for the trial.

Inclusion criteria

The trials will use the Oxford Criteria to determine eligibility to take part. The trials will include people with ME/CFS who may also meet one or more international criteria against which they will also be assessed, once they have enrolled.

The principles of management, taken from Dr E G Dowsett’s “The Enigma and The Paradox of ME” are as follows;

THE PRINCIPLES OF MANAGEMENT

Taken from Dr E G Dowsett’s "The Enigma and the Paradox of ME” are as follows;

AT THE ONSET OF THE ILLNESS OR IN SEVERELY AFFECTED PATIENTS:

Removal from all stress and additional exposure to infection together with a sufficient period of rest and convalescence for the illness to stabilise is recommended. Early signs of stablilisation may be recognised by a slight improvement in memory or an increase in the active versus non active energy ratio over 24 hours.

CONSERVATION OF ENERGY: This is the first and most important principle of management without which further symptomatic or experimental drug treatment cannot be expected to succeed:

Because most sufferers from ME/CFS are already operating at or near their maximum energy capacity while the decrease in brain metabolism following physical or mental over exertion leads to delayed recover and relapse.

Because resting energy expenditure is high in ME/CFS patients which mean that the energy available for physical activity is being diverted to fulfil this increased requirement.

Because in some patients there are additional metabolic defects in skeletal muscle leading to early lactic acidosis and increased pain and weakness following stress.

REDUCTION OF STRESS: This is best managed from the start by accepting that the illness may be long lasting and require a change in life style commensurate with the known reduction in hypothalamic/pituitary adrenal response to stress and the resulting risk of relapse. Support from friends, families, social and financial services should be sought from an early stage but provision for recreation, holidays and interesting hobbies is essential strategy for stress reduction.

Simplification of work

For the household the aim must be to retain independence as far as possible considering financial aid for domestic care and house conversion, and for home tuition or training to facilitate paid work at home in the future.

For those whose illness has stabilised - it is essential to organize a gradual return to education, training or work after checking provision or mobility, modifies time table, exam concessions, and part or flexitime work.

For those fit enough to work or study full time - a choice needs to be made of a suitable career without undue exposure to stress, compulsory immunizations, infection, unsocial hours, difficult travel or environmental requirements. A graded career progression, without exam pressure and with facilities for refreshment breaks and adequate holidays is desirable! NB. An initial period of voluntary work, when exercise and stress capacity can be tested, should be considered.

Which people are most at risk of ME\CFS?

Exposure to infection is the main factor. Occupational risks in Teaching, Health Care and paramedical professions are at least 5 times higher than in similarly stressful jobs, where employees are not exposed to infection. The incidence of ME/CFS is also high in parents or carers of young children, those obliged to receive multiple immunisations for travel, as well as those engaged in sewage, refuse disposal and water industries and participants in recreational water sports. The peak age of onset in both sexes is between 30 and 40 years with a secondary peak at puberty (most marked in females). As in the case of polio, schools appear to be central to amplification and dissemination of infection to the local community.

PROGRESS DEPENDS ON:

The activity of the patient’s immune system (prior contact and adaptation to the infection in childhood may ensure a trouble free host/virus relationship, while youth often appears to be an advantage).
The tendency of any particular strain of virus to induce serious complications (eg cardiac)
The age, gender and domestic/occupational circumstances of the patient.
Genetic factors such as common exposure to infection.

Early diagnosis and appropriate advice management will ensure medical, domestic, educational and occupational support from the start.

RELAPSES MAY BE ASSOCIATED WITH:Immuno suppressive events such as concurrent infection with other microbes, immunisations, steroid or cytoxic therapy. NB smoking reduces local mucosal immunity.

ormone disturbance, including puberty, menstruation, pregnancy but following the menopause, new onset of illness in females falls sharply, but late effects increase.

Mental or physical stress arising from head injury, whiplash, surgery, malnutrition, climatic change, domestic problems, litigation, and social security assessments etc.

Exposure to drugs which are psychoactive or vasoactive including alcohol, anti-depressants or recreational substances and to neurotoxins, pesticides and drugs which interfere with specific neuro transmitters (eg acetylcholine)

Children and Adolescents

Suffer more severely than adults from sleep and learning difficulties, weight, appetite and mood control. It is essential that doctors and parents should liaise from the onset with school and other professional staff to minimize stress and contact with school infections by ensuring adequate sick leave. Home tuition, modification of school work and examination concessions must also be considered as educational deficits can be long lasting, especially in the case long young children, where they may lead to permanent language disability.

Prognosis

This depends not only on the factors mentioned above but also on the knowledge and determination of the individual to use the energy available wisely. Experience gained in the rehabilitation of patients suffering from the post polio syndrome in the USA ( a condition clinically similar to ME/CFS) indicate that once the principle of energy conservation, within the individual limits, has been accepted by the patients themselves, only1 0% fail to stabilise.

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