Caution is still required on GET and ME

[Guest guest]

A bombastic letter from Tom Kindlon to the Irish Medical Times on the

PACE trial! Well done Tom!

Source: Tate

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http://www.imt.ie/opinion/2011/04/caution-is-still-required-on-get-and-me.html

Caution is still required on GET and ME

April 7, 2011

Dear Editor,

According to your recent article (`Cognitive behavioural therapy not

harmful in chronic fatigue', Irish Medical Times, March 18, 2011,

http://www.imt.ie/clinical/2011/03/cognitive-behavioural-therapy-not-harmful-in-\

chronic-fatigue.html),

" patient groups' concerns that cognitive behavioural therapy (CBT) and

graded exercise therapy (GET) could be harmful for the treatment of

chronic fatigue syndrome (CFS) can be allayed " due to the PACE trial's

results, published recently in The Lancet (Lancet 2011

doi:10.1016/S0140-6736(11)60096-2).

It is true that the results contrast sharply with patient surveys — so

much so that we have wondered what exactly was tested.

The stated aim of both CBT and GET is to increase activity levels in

CFS. If PACE trial participants did not increase activity levels as

planned, we would not get good information on the safety of programmes

that do involve increased activity levels.

A review of three Dutch studies using actometers to investigate CBT

for CFS found only minimal increases in total daily activity levels,

and that there were no differences compared to the control groups

(Wiborg et al., 2010). A similar result was previously reported by a

US team (Friedberg and Sohl, 2009), which found, using detailed

analysis of patient diaries along with objective measurements, that

patients had simply substituted the activity component of the

programme (regular walks) in place of other activities they had been

doing, resulting in no overall activity increase.

In the PACE Trial, actometers were not used. The only objective

outcome measure was the six-minute walk test, which only increased for

CBT participants by 21m to 354m, a change that was actually slightly

smaller than that of the control group. The GET group increased by a

bit more, to 379m after 12 months.

However, this still is a very low absolute walking distance for a

group with a mean age of 40. By comparison, a group of older adults

(mean age: 65) covered an average distance of 631m (Troosters et al.,

1999). In addition, data was unavailable for 31 per cent of GET

participants and 24 per cent of those who undertook CBT; it may be the

case that sicker patients were less likely to try the test.

These data could be explained by only a small fraction of the

participants actually engaging in increased activity or exercise; the

only reported measure of treatment adequacy was the number of

appointments attended, not the type, intensity, or duration of

activity/exercise performed each week.

Lack of objective outcome measures, the possible biasing effects of

missing data and the uncertainty regarding whether trial subjects

actually implemented CBT/GET as planned severely limit conclusions

about efficacy and safety that can be drawn from PACE. Thus the

results may not be truly inconsistent with the high rates of adverse

effects from graded activity/exercise programmes repor-ted by CFS

patients in surveys across the world.

Given the numerous biological abnormalities that have been associated

with exercise in CFS (reviewed in Twisk and Maes, 2009), we will

continue to recommend caution regarding graded exercise and activity

programmes for the condition.

Tom Kindlon,

Information Officer,

Irish ME/CFS Association