Addendum to some Concerns about the NICE Draft Guideline

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ADDENDUM to Some Concerns

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about the NICE Draft Guideline on " CFS/ME "

Margaret

(Nominated Respondent with The 25% ME Group for the

Severely Affected)

22nd October 2006

The NICE Draft Guideline gives cognitive behavioural therapy

(CBT) and graded exercise therapy (GET) a ringing

endorsement and recommends CBT/GET for all adults and

children with " CFS/ME " who wish to get better.

Apart from advising that symptoms should be managed

" conventionally, as per usual clinical practice " , no other

intervention is recommended.

The NICE Draft Guideline relies upon the updated Systematic

Review carried out by the York Centre for Reviews and

Dissemination that is published in the Journal of the Royal

Society of Medicine (Interventions for the treatment of patients

with chronic fatigue syndrome/myalgic encephalomyelitis: an

updated systematic review. Duncan Chambers, Anne-Marie

Bagnall, ne Hempel, Carol Forbes. JRSM

2006:99:506-520).

The systematic review team stated that only randomised or

controlled clinical trials were eligible for inclusion in their review,

which resulted in 8 trials meeting the inclusion criteria for

assessment of CBT (or modified CBT) and 5 trials for

assessment of GET. Given that only 5 of the CBT trials score 10

or above out of a possible 20 on the Review team's own " validity

scale " – and that one of these is non-significant -- this is a very

small " evidence-base " indeed upon which to make such

resounding recommendations for what is effectively a

wall-to-wall management regime.

The small sizes of the patient groups in the CBT trials alone

(less than 50 participants in the CBT arm in all but one trial)

means that no reliable conclusions can be drawn from them, yet

the impression is conveyed that what is recommended are

well-researched, effective treatments.

The most worrying thing is that reliance only on clinical trial

" evidence " means that the York Review team has virtually

confined itself to research generated by a handful of UK

psychiatrists and their continental adherents.

As Dr Neil Abbot of ME Research UK says in the latest issue of

the Warwickshire Network for ME e-magazine:

" RCTs (random controlled trials) are the best evidence of

efficacy, all things being equal. But in ME/CFS the majority of

RCTs are biopsychosocial trials of non-specific management

strategies (ie. CBT/GET). Such trials are expensive to conduct,

and it is the biopsychosocial experts who have been able to

access the funding to conduct them. This means that any time a

'review' of the literature is done, the dominant 'therapies' are

psychosocial ones. The fact that these trials of CBT and GET

have had relatively unspectacular results is less important to

reviewers than that fact they are 'positive'. This is very nice

indeed for the psychosocial professionals, but a disaster for the

large number of patients with signs and symptoms of a

biomedical illness who need detailed clinical assessment and

biomedical investigation instead of strategies to manage their

'illness beliefs'. In short, the accepted strategy of looking at

formal 'evidence' is flawed in the case of ME/CFS because the

evidence-base is skewed " .

In other words, review conclusions are based on NUMBER and

QUALITY of positive and / or negative trials, and since the

psychiatric lobby wins hands down on a purely NUMERICAL

count of published studies (because no comparable funding has

been made available for biomedical studies), the outcome can

safely be predicted, as indeed has happened.

If ever there was a " vicious circle " in ME/CFS, far from it being

due to patients' fear of activity leading to deconditioning leading

in turn to on-going fatigue, as Wessely School psychiatrists

relentlessly assert, it is the vicious circle that has been created

by the psychiatric lobby itself to ensure that only its own views

prevail.

Further, in the text of the JRSM article the York Review team only

mentioned the immunological or pharmaceutical interventions

that had negative side-effects, yet one (included) study which

treated hormone and nutritional deficiencies was ranked 19 but

was not even mentioned in the text (none of the CBT studies

scored as high as 19).

For the Review team to fail to discuss studies of interventions

other than CBT/GET that by their own measures scored better

than the average for CBT (which was 9.5) is surely remarkable,

and raises the issues as to how recommendations for CBT/GET

can be made on such a defective body of evidence, and at

whose insistence.