PACE Trial Comment....2

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PLOS one

Original Article

Adaptive Pacing, Cognitive

Behaviour Therapy, Graded

Exercise, and Specialist

Medical Care for Chronic

Fatigue Syndrome: A Cost-

Effectiveness Analysis

(http://bit.ly/QIVdkB)

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Too many questions still

unanswered by this trial.....

Posted by JoanCrawford

07 Aug 2012

The PACE trial at best showed

modest effect for the

interventions and only for a

small minority of the patients

who took part – around 1/3rd.

Ideally, this would warrant a

more thorough and critical

discussion of its relative

success, cost effectiveness

and limitations, such as:

Patients were selected for

inclusion in the PACE trial

using the Oxford criteria

(Sharpe et al., 1991).

The main symptom

here is: *fatigue*.

This is a symptom of numerous

medical and psychiatric

conditions so there is a problem

with specificity and sensitivity,

and hence it is hard to

generalise the results with such

a heterogeneous group of

participants.

Assumptions that research on

chronically fatigued participants

can be generalised to patients

with ME or CFS remain just that:

assumptions.

Adaptive Pacing Therapy (APT)

as described in the PACE trial

literature is not necessarily the

pacing as used and understood

by patients and charity/support

groups.

Pacing is not a “treatment” and

is used widely in the manage-

ment of many chronic medical

conditions.

Symptom contingent pacing is

unlikely to result in patient

improvement by its very nature

unless the underlying condition

improved simultaneously.

As the underlying condition(s) is

ill-defined at this time it cannot

be claimed that this trial has

meaning for subgroups of

patients who have demon-

stratable, ongoing immune

dysfunction, neurological and

infectious components to their

condition.

If the condition is maintained -

as claimed by the authors of the

PACE trail - by deconditioning

then the modest improvements

attained suggest a more

complex picture.

The lead author of the PACE

trial’s own work objectively

demonstrates that patients are

not necessarily deconditioned

(Fulcher & White, 2000), thus

contradicting themselves.

Peak oxygen uptake (VO2), heart

recovery rate after exercise

challenge and maximum lung

ventilation were not found to be

different between patients and

healthy sedentary controls

(Fulcher & White, 2000) making

deconditioning as a major

reason for persistence of

symptoms too simplistic at

best.

There is no objective evidence

demonstrating that patients

actually adhered to the PACE

trial protocol and complied with

increases in activity during the

trial itself.

It is quite possible that patients

adapted to their condition by

challenging themselves through

increased activity in the

CBT/GET groups and learned

more about their limitations and

by improving well-being by

adapting and staying within

their limits by the end of the

trial, e.g. energy modulation

( et al., 2009) thus raising

the possibility of confounding in

the CBT/GET groups.

Baseline objective measures of

activity (actimeters) were made

in the PACE trial but were not

followed up at the end so we

have no objective measures

that the trial succeeded in what

it intended to do:

objectively increasing patient

activity and simultaneously

reducing symptoms and

improving well-being.

(See my above comment

regarding adaptation.)

One trial provides some overall

information as to the benefit or

otherwise of interventions,

however, it does not provide the

whole context.

Meta-analysis is needed.

It is worth noting that the sister

trial to this one (FINE, Wearden

et al., 2010) promoting increa-

sed activity in this patient

group did not find support for

improved well-being and

outcome post- therapy at one

year follow up.

A Spanish trail (Nunez et al.,

2011) using group CBT/GET

intervention found that post

intervention patients had worse

physical functioning and

increased pain at outcome.

Other CBT/GET trials have had

mixed results too. Also, no trial

to date has demonstrated that

objectively measured increases

in activity confer to improved

well-being, recovery, return to

work and participation fully in

society.

Having demonstrated that some

patients subjectively feel

somewhat better after the PACE

trial’s CBT/GET interventions -

although nothing close to the

expected outcomes - if these

disorders were being maintained

by faulty information biases,

deconditioning and fear avoi-

dance (operant conditioning),

it doesn’t necessarily follow

that it is cost effective to invest

in these therapies especially as

return to work decreased and

medications remained roughly

constant at the end of the trial.

Also, more patients appeared to

use inpatient hospital services

post participation. Suggesting

that these types of interven-

tions will result in objective

cost reductions as reported in

the press running to millions is

perhaps therefore an

exaggeration.

Others have commented on the

definitions of recovery used in

the PACE trial and other

criticisms of the PACE trail were

published in the Lancet in May

2011 (Kindlon, 2011; Feehan,

2011; Giakoumakis, 2011;

, 2011; Kewley, 2011;

Stouten, Goudsmit, & Riley,

2011).

While debate continues

surrounding aetiology it is

important that patients are

supported and appropriate

medical and psycho-social care

is provided that respects the

patient’s condition and expe-

riences.

Over exaggeration of the

benefits at outcome of

research, such as the PACE

trail, is unlikely to bolster

patient confidence and buy

into these type of interven-

tions.

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Fulcher, K, & White, PD. (2000).

Strength and physiological

response to exercise in patients

with chronic fatigue syndrome. J

Neurol Neurosurg Psychiatry. 69,

302-307.

, L., Benton, M.,

-Harding, S., &

Muldowney, K. (2009). The

impact of energy modulation on

physical functioning and fatigue

severity among patients with

ME/CFS. Patient Education and

Counselling. 77, 237–241.

Sharpe et al., (1991). A

report--chronic fatigue

syndrome: guidelines for

research. J R Soc Med 84(2):

118–121.

Wearden, A., et al., (2010).

Nurse led, home based self help

treatment for patients in

primary care with chronic fatigue

syndrome: randomised

controlled trial. BMJ. 340, 959.

Competing interests declared:

Volunteer (unpaid) chair of a

patient support group – Chester

MESH