Our BJN Response on the PACE Trial

Re: College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules.

Greg Crowhurst

Greatly criticised by the ME Community and virtually all ME Charities, the PACE Trial allegedly :

1. Brought together (conflated) two diseases that the WHO rightly categorizes separately-neurological "ME/PVFS" (ICD-10-G93.3) and psychiatric "Fatigue Syndrome" (ICD-10-F.48.0) - and misrepresented the latter as the former. (Hooper 2011)
2. Mixed at least three taxonomically different disorders in the trial cohort-those with ME/CFS (ICD-10 G93.3), even though the entry criteria exclude such patients; those with fibromyalgia (ICD-10 M79.0) and those with a mental/behavioural disorder (ICD-10 F48.0). (Hooper 2011)
3.Excluded children and those who are severely affected. The results of any trial that excluded those who are severely affected cannot be taken seriously. (Hooper 2011)
4. Included, (PACE Trial) a large number of participants, 47% - who were found to be suffering from one or more psychiatric disorders.
5. Took no biological measurements. Studies of CBT in other conditions including HIV/AIDS and cardiovascular disease, routinely collect data on immune markers or other biological measures in an attempt to understand how and why CBT works in the context of the condition studied.
6. Abandoned the use of an actometer, an instrument to measure activity , which would have provided unequivocal objective evidence of improvement or non-improvement.
7. Found that "pragmatic rehabilitation" (based on CBT/GET) was minimally effective in reducing fatigue and improving sleep only whilst participants were engaged in the programmeand that there was no statistically significant effect at follow-up.
8. Did not conclude CBT/GET/PACING were even cures for the loosely defined CFS or even "effective" treatments for it; they said they were "only moderately effective".
9. Did not return the participants to their health or even close to it.
10. The only reported improvement, an increase of being able to walk an extra 20 steps, cost the nation £5 million.

Every study of CBT and GET, including my own (Crowhurst 2005) reveals that the pacing protocol recommended by the PACE Trial - based on the premise that patients need to change their maladaptive "illness beliefs" is incredibly harmful to people with ME. Some patients have been rendered bed bound for years as a result.

The ‘psychosocial ‘model used to influence ME service provision, one which emphasises “beliefs, coping styles, and behaviours”, colours the perception of Myalgic Encephalomyelitis (ME) right across the board in the UK, from the 2007 NICE Guideline, to the policy of government agencies such as the Department of Work and Pensions and NHS Plus has cost us dearly.

My wife who was Severely Affected has now been diagnosed with Very Severe ME, her life is one of constant, indescribable suffering, yet she is simply left to get on with it; it has been twenty years now with no treatment, no research, no cure - and no hope. This is a gross injustice.

That is why these outcome measures matter so much to us ; it is no exaggeration to state that it is very much a matter of life and death .

References

Crowhurst G (2005) One of the biggest medical scandals in history : a survey of those most severely affected by ME/CFS. Submission to the Parliamentary Inquiry into progress in the scientific research of M.E., by the 25% Severe ME Group http://www.25megroup.org/.../25%25%20submission/25%20final%20sub%20to%20Gibson%20(2).doc

Hooper M (2011)Report: complaint to the relevant executive editor of the lancet about the pace trial articles published by the lancethttp://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm

Competing interests: None declared