Dear Editor,
Your recent article on the study in The Lancet refers to chronic fatigue syndrome and chronic fatigue indiscriminately and gives the impression that cognitive behavioural therapy (CBT) and graded exercise are “safe and effective for all” (‘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).
The PACE criteria included post-exertional ‘fatigue’ as a key symptom, not ‘malaise’, and in any case no severely affected patients were included in the study.
For those ME patients who have the key symptom of post-exertional malaise, graded exercise has proved dangerous, as surveys by the major ME charities have repeatedly shown. Many patients with post-exertional malaise would refuse to take part in such a study, as they are well aware of the risk.
Would any drug for whom so many adverse effects have been reported been declared ‘safe and effective’ with no caveat, when selection criteria had been so broad and no trials had been done on the sickest patients?
Veronica Jones,
BA Hons (London) PGCE (Cantab),
Coleford,
Gloucestershire,
UK.
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PACE’s sister trial, the FINE trial, did indeed look at severely affected patients and found only a “clinically modest” reduction in fatigue with no improvement whatsoever in physical function, which was the other primary outcome measure. If the PACE authors had kept with the outcome measures described in PACE’s published protocol as the FINE trial authors did, one wonders if they too would have reported similar results. It is worth noting that the FINE trial published its results prior to PACE and therefore the PACE trial authors presumably would have been well aware of the FINE trial’s outcomes; perhaps this was behind the PACE authors’ significant alterations in both primary and secondary outcome measures, as well as measurements of adverse reactions?
For one example of changes to the PACE trial, according to PACE’s original protocol a SF-36 Physical Function score of >/=75 was necessary for a participant to even be classified as being a “positive outcome” for one of the two primary outcome measures, a score equivalent to that in the FINE trial, and a score of >/= 85 (including other criteria) was necessary to be classified as being a ‘recovery’ for a secondary outcome measure, however in the published results both of these outcome measures were eliminated, with the authors instead choosing to refer to anyone having a SF-36 PF score >60 as having ‘normal functioning’, despite ‘recovery’ being stated in the trial protocol as being the goal of the trial. This is also despite a SF-36 PF score of
There should be a full-scale government investigation into the massive waste and spurious conclusions reached by the PACE trial authors, with the trial data being re-analysed according to the original protocol. What is the point of even publishing a trial protocol if the authors can alter the outcome measures, and thus the results and conclusions, so drastically as the PACE authors did? By their actions, the PACE trial authors have made a mockery of the idea of the RCT, the funding process which granted them the £5 million of taxpayer monies to begin with and have caused yet further harm to millions of ME/CFS patients around the world, as they have done throughout their entire careers, which can end not a moment too soon for the millions of ME/CFS patients around the world who are desperately in need of large quantities of competent biomedical research into this extremely devastating disease.
I am a CFS patient.
Dear John,
Apologies that this part of your post was cut. This was due to the admin site recognising certain symbols as being HTML code. Hope this clarifies your post:
This is also despite a SF-36 PF score of less than or equal to 65, allowing one to enter the trial to begin with and thus a trial participant could have a lower score at the end of the trial than they did at the beginning, yet still be considered by the authors as having “got back to normal”!
References-
Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract
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
http://www.biomedcentral.com/1471-2377/7/6
Fatigue Intervention by Nurses Evaluation – The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol.
http://www.biomedcentral.com/1741-7015/4/9
The Guardian
Study finds therapy and exercise best for ME
http://www.guardian.co.uk/society/2011/feb/18/study-exercise-therapy-me-treatment
ME is a neurological disease. The Department of Health accepts it is a severe neurological disease. The PACE trial used a patient entry criteria, called the Oxford criteria, that excludes those with neurological signs. Therefore there could be NO patients with ME in the PACE trial, and the trial was for people with fatigue. So why is the Medical Research Council who funded the study, and NICE, saying that this was anything to do with the neurological disease ME?
The results of this study for fatigue showed that only around 40% of those in the study improved and only by about 8%. The only objective measure, a six-minute walking test, showed that participants could still not walk as far as someone with major head trauma. But in this study they decided that such measures would be acceptable to say someone had recovered!!! Who is fooling who here? The same went for all the subjective measures, that again showed the study to have failed for fatigue.
Also, the adaptive pacing that they tested in this study was not pacing that patients and good doctors know works. It was a form of graded exercise.
An investigation needs to be launched into why £5 million has been wasted on a study that never looked at the patients it claims to have. They have tricked everyone and it is appalling that the Government is letting them get away with it.