FINE Trials Experience

FINE Trials - Set Up and Objectives

These trials are funded by the Medical Research Council (MRC) alongside another set of trials called PACE trials. Both are described by the MRC[1] as

• ‘..complementary trials into various treatments options for CFS/ME which aim to improve quality of life for those who are ill.'
• ‘FINE (Fatigue Intervention by Nurses Evaluation) will test two different treatments that are particularly suited to those who are too ill to attend a specialist clinic.'
• 'The FINE trial will involve patients in the North West of England and North Wales.'

The recruitment of patients for both trials was started in 2004 and, according to the MRC, were expected to take up to five years to complete.

The FINE trial is recorded under the "Mental Health in Primary Care" programme in the National Research Register 2004

The FINE trials are headed by Dr. A. Wearden from Manchester University whose background is rehabilitative therapy.

FINE treatments would be delivered in patients’ own homes (‘so the trial is particularly suited to those who are too ill to attend specialist clinics.’ – according to the MRC)

The therapy involves four 90 minute sessions interspersed with six 30 phone conversations over a period of 18 weeks with the addition of an activity manual.

The MRC claim the FINE trials will perform/compare the following –

• Usual medical care


• Supportive listening delivered by a trained nurse


• Pragmatic rehabilitation

The MRC further state -

• Pragmatic rehabilitation was developed by the research team, and is based on an approach that proved popular with patients who took part in a 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.

As with all MRC trials FINE has been subject to extensive peer review (assessment by independent international and UK experts), will be conducted to the highest standard and will be subject to independent scrutiny by a Trial Steering Committee and Data Monitoring and Ethics Committee.

IiME Questions on the above

What is meant by trained nurse? Trained in what?

Pragmatic rehabilitation - Rehabilitation implies the application of remedies to effect a cure. Does this then mean that FINE trials are aiming to cure ME patients? Does this preselect a diagnosis of ME as a psychological illness?

Previous study - what previous study?

can be easily taught to qualified nurses without the need for lengthy and expensive training- what qualifications are required to treat ME which do not require expensive or lengthy training? Can anyone do this? Why are there 250,000 ME sufferers then in the UK alone?

treatments - Treatments are discussed here. How can a treatment be delivered if a proper diagnosis has not been performed using standard clinical guidelines

to extensive peer review - Who? When? Where?

Inclusion Criteria

The MRC claims that the trials will use the most inclusive criteria for CFS/ME to determine eligibility to take part (the Oxford criteria) in order for the results to be generalised to the largest number of people possible.
IiME Comment The Oxford criteria are already known to be flawed for any scientific basis for diagnosis. By including as many as possible from a wide range of diagnosed patients the results will be skewed. Is there any point to producing a generalised result set for a set of expensive trials which are to be applied to an organic illness? What is the reason that the MRC continue to use these outdated and unscientific criteria?

FINE TRIAL COSTS

The FINE trials cost £1,147,000.

IIME Position

Thousands of UK children are now being injected with the measles/rubella vaccine, re­gardless of previous immunizations and discounting any natural immunity acquired through having these diseases. We are told in leaflets and by countless experts that the benefits grossly outweigh the disadvantages.

The FINE trials and the PACE trials seem to be the two ugly sisters of MRC policy on ME - leaving biomedical research eternally to play a Cinderella role.

Their results are pre-judged due to the criteria used for selection and the methods employed in performing

One thing these trials seem to be clearly showing is the myopic and unscientific approach to scientific research being shown by the MRC in concentrating on psychiatric paradigms which, at best, can only attempt to cope with ME and, at worst, will seriously affect a person with ME's health.

The MRC state -

'The Oxford criteria will allow researchers to generalise their findings to the largest possible number of people with CFS/ME and ensure the trial can recruit enough people to give meaningful results.'

This does not seem to be scientific or sensible for useful research.

A definitive set of diagnostic guidelines for clinical diagnosis and research is available with the Canadian guidelines (see Guidelines). Using these would make the FINE trials obsolete (see also Canadian Guidelines acceptance).

It is one of the fundamental issues which needs to be resolved in order for myalgic encephalomyelitis to be treated in the correct way.

Isn't it time to stop this waste of tax payers' money and put it to better use?

Links to other sites on this topic

Look at MEActionUK http://www.meactionuk.org.uk

CMO report on-line: http://www.doh.gov.uk/cmo/cfsmereport