The trial
investigators did not use objective outcome measures apart from a six
minute walking test in which patients in the CBT arm were able to walk
an extra 21 metres in 6 minutes (354m) compared to baseline [1] - a
distance well below that of healthy elderly subjects (631m) [2]. The
clinical benefit is insignificant in relation to the trials cost.
It would be more consistent if the researchers had adhered to their
initial intention of using actigraphy at the end as well as the
beginning of the trial [3] to see if patients traded their other daily
activities for exercise. The hypocrisy of the researchers is
demonstrated by their comments [4] especially as patients chosen for
the trial had to be well enough to attend clinics.
Of the 3158
patients screened for eligibility for the trial from secondary fatigue
clinics 1011 did not meet the inclusion criteria, the Oxford criteria
[2]. These criteria exclude those with neurological signs and symptoms
so by definition this trial had nothing to do with myalgic
encephalomyelitis (ME) as classified by WHO [5].
It is therefore
important that the trial results are not extrapolated to justify
effectiveness of CBT/GET for patients diagnosed with ME.
The purpose
of medical research should be to benefit patients.
It is not
in patient groups’ interests in mixing patient cohorts and trying to
find a one-size-fits-all management technique.
The PACE
trials lack credibility, do not benefit ME patients, are flawed and the
result of poor and unprofessional research.
References:
1/. Prof PD
White MD,KA Goldsmith MPH,AL Johnson PhD,L Potts MSc,R Walwyn MSc,JC
DeCesare BSc,HL Baber BSc,M Burgess PhD,LV Clark PhD,DL Cox PhD,J
Bavinton BSc,BJ Angus MD,G Murphy MSc,M Murphy FRCP,H O'Dowd PhD,D Wilks
FRCP[Ed],Prof P McCrone PhD,Prof T Chalder PhD,Prof M Sharpe MD,on
behalf of the PACE trial management group 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 - 18 February 2011 DOI:
10.1016/S0140-6736(11)60096-2.
2/. Butland
RJA, Pang J, Gross ER, Woodcock AA, Geddes DM: Two-, six-, and 12-minute
walking tests in respiratory disease. BMJ 1982; 284:1607-8.
3/. White
PD, Sharpe MC,Chalder T, DeCesare JC and Walwyn R for the PACE trial
group. Protocol for the PACE trial: A randomised controlled trial of
adaptive pacing, cognitive behaviour therapy, and graded exercise as
supplements to standardised specialist medical care versus standardised
specialist medical care alone for patients with the chronic fatigue
syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurology
2007, 7:6.
4/ ”..
we decided that a test that required participants to wear an actometer
around their ankle for a week was too great a burden at the end of the
trial…”. PD White, MC Sharpe, T Chalder, JC DeCesare, R Walwyn, for
the PACE trial management group. Response to comments on “Protocol for
the PACE trial”. BMC Neurol.
2007, 7:6doi:10.1186/1471-2377-7-6.
Further References:
Postscript:
The theme for the 6th Invest in ME International ME/CFS Conference 2011
on 20th May in London is The Way Forward for ME - A Case for Clinical
Trials. It reflects
our view that translational biomedical research is perhaps the best way
forward now – allowing patients to participate in research and to have
treatments used/developed which can be passed on quickly and safely to allow patients
to reclaim their lives back.
Conference
home page -
click here
Invest in ME
Registered UK Charity Nr. 1114035
PO BOX 561, Eastleigh SO50 0GQ,
UK
www.investinme.org
The Way Forward for ME - A Case for Clinical Trials
6th International ME/CFS Conference
20th May 2011 Westminster, London
http://tinyurl.com/22kfekc
