PACE Trial: CBT & GET do Not Treat ME and CFS

[Guest guest]

From: Kemp

The PACE Trial Results

The PACE Trial results (White et al.

2011) for 'improved' show that:

Graded Exercise Therapy (GET) had an

effect for 16%

and Cognitive Behaviour Therapy (CBT)

for 14% over and above the control

group.

The results for 'normal ranges' show that

GET had an effect for 13% and CBT for

15%.

The results produce a 'number needed to

treat' figure of 7 (Sharpe. 2011). When

7 patients are treated, one will improve

due to treatment.

The PACE Trial Protocol (White et al

2007) states:

" GET will be based on the illness

model of deconditioning and

exercise intolerance " .

" CBT will be based on the illness

model of fear avoidance " .

For 2 different theories and

treatments to result in such similar

outcomes is potentially problematic.

Clinical Trials are designed to avoid

such coincidences.

However, this might not be a

coincidence because the theories and

therapies have some important

similarities:

* Both theories believe that

there is no pathophysiology

(excepting 'deconditioning').

* Both believe that the patient

is only using a small amount of

their potential for activity.

* Both rationalize symptoms and

* Both are 'based on a graded

exposure to activity' (White et

al. 2011)

Therefore the 2 theories and therapies

are fundamentally the same which could

explain their similar results.

The CBT arm was based on 'fear

avoidance'.

Fear avoidance refers to anxiety about

activities that the patient believes will

be painful or cause them harm.

This is theorised to be an obstacle to

rehabilitation.

Addressing fear avoidance is

straightforward and similar to treating

phobia with desensitization.

'Systematic disconfirmation' (Asmundson

et al 2004) or 'graded exposure' (

and Zeppieri 2009) are established

approaches.

There is even evidence that including

'fear avoidant' participants in research

could give better results for a therapy

because these patients record greater

improvements ( and Stryker.

2011).

Patients with 'Severe ME' were

excluded from the PACE Trial.Therefore

the testing was largely carried out on

those representing the 75% of patients

that do not have the severe form of the

illnesses.

Those who are still working or studying

could be included.

Participants who are parents may still be

looking after children and many will be

maintaining family/social relations,

managing personal and household care

and other activities.

Evidence from patients shows that many

strive to maintain as much of a normal a

life as they possibly can.

This does not sound like significant

'fear avoidance'.

The fact that the 640 participants

willingly joined and remained throughout

the PACE Trial, shows that 'fear

avoidance' does not affect to them to a

very significant degree.

If it did, they would have stayed at

home. Therefore participant's fear

avoidance should be moderate and

treatable.

Deconditioning should also be

straightforward to treat.

Anyone that does more than they did on

the previous day will, within a week or a

month be well on their way to full

fitness.

With no physical illness or injury to

prevent this (according to the theory),

people with ME and CFS should soon

be fully recovered from deconditioning.

The PACE Trial represented the

culmination of many years of theorising

and research efforts by the

investigators to prove their theories

about ME and CFS.

It took 9 years and cost the

taxpayer £5 million.

The researchers produced specialized

treatment manuals for therapists and

patients.

Therapy was closely supervised and

participants were followed-up for a

year.

Participant retention, adherence and

satisfaction were very high. This was

an all-out effort for the researchers to

prove their theories. Yet the results

prove their theories are wrong.

85% of participants did not

'improve' or reach 'normal

ranges' due to GET or CBT.

This shows that the theories on which

the treatments were based are wrong.

If the researcher's theories were correct,

it would be reasonable to expect the

recovery of the majority as a result of

GET or CBT. It seems probable that if

85% of participants had 'improved' due

to GET or CBT the researchers would

claim that this unequivocally proved

their theories.

The opposite should also be true. 85%

failure unequivocally disproves their

theories.

The PACE Trial has shown

emphatically that GET and CBT

do not treat ME and CFS.

Therefore it is reasonable to speculate

that the 15% that responded to these

treatments were misdiagnosed.

Those participants may have had

illnesses that included deconditioning

and fear-avoidance ameliorable with the

therapies.

People with ME and CFS should not be

expected to make-do with treatments

that have been shown to be ineffective

for their illnesses.

GET and CBT should not be

recommended to patients with these

illnesses. They are a waste of time and

money.

These are important findings of the PACE

Trial, yet this information has not been

publicized; it has been ignored in favour

of information that appears to serve the

purposes of the researchers.

The evidence of the PACE Trial strongly

supports the opinions of those who

believe that there is underlying

pathophysiology in ME and CFS.

This opinion rationally explains the failure

of GET and CBT to treat ME and CFS.

Kemp

REFERENCES

Asmundson, Gordon J.G., Vlaeyen, Johan

W.S., Crombez, Geert editors. 2004.

Understanding and Treating Fear of

Pain. Oxford University Press. New

York.

, S. Z, Zeppieri G. 2009. Physical

therapy utilization of graded exposure

for patients with low back pain. Journal

of Orthopaedic Sports Physiotherapy.

Jul;39(7).

, Z., Stryker, E.

2011. Fear-Avoidance Beliefs and

Clinical Outcomes for Patients Seeking

Outpatient Physical Therapy for

Musculoskeletal Pain Conditions. Journal

of Orthopaedic Sports and Physical

Therapy. 2011;41(4).

Sharpe, Professor M. 2011. COMPARISON

OF TREATMENTS FOR CHRONIC FATIGUE

SYNDROME. Health Report. [Online

transcript]. Available at:

http://bit.ly/N2aOq7 (Accessed July 4th 2012)

White, Professor P. D., et al. 2007.

Protocol for the PACE Trial. BMC

Neurology. [Online]. Available at:

http://bit.ly/N2b4FK (Accessed Aug 1st

2012)

White, Professor P. D., et al. 2011.

Comparison of adaptive pacing therapy,

cognitive behaviour therapy, graded

exercise therapy, and specialist medical

care for chronic fatigue syndrome

(PACE): a randomised trial. The Lancet.

2011; 377: 823-36.