ME Association response to PACE trial recovery paper | 15 February 2013

The following letter has been sent to Psychological Medicine in response to the paper they published on January 31 on Recovery from chronic fatigue syndrome after treatments given in the PACE trial

INTENDED FOR PUBLICATION

16 February 2013

Editor

Recovery from chronic fatigue syndrome after treatments given in the PACE trial

To most doctors and patients the term ‘recovery’ has an unambiguous common sense meaning: a sustained return to symptom-free normal health with the ability to repeatedly and reliably participate in all aspects of normal life – employment, education, social activities, etc.

However, important data from the PACE trial (White et al 2011) that should have been used as objective measures of recovery was omitted from the paper describing recovery in ME/CFS (White et al 2013). This is both puzzling and disturbing – as are the reasons given for the omission.

Considering the enormous cost of the PACE trial, it should have been possible to obtain any missing information, as well as asking participants a very simple question: Have you recovered as a result of cognitive behaviour therapy (CBT), graded exercise therapy (GET) or Pacing?

There are three specific markers of recovery where data should have been reported but was not:

Firstly, receipt of a state sickness or disability benefit. Claiming a state sickness benefit is clearly incompatible with recovery and data on benefit status was included in the cost analysis study (McCrone et al 2012). This analysis reported that: Receipt of benefits due to illness or disability increased slightly from baseline to follow-up. Consequently, the recovery paper should have provided information on the individual benefit status in everyone who had recovered.

Secondly, employment or education status. The recovery paper argues unconvincingly that Return to work is not, however, an appropriate measure of recovery if the participant was not working before their illness and is influenced by other factors such as the job market. However, a sustained return to meaningful paid employment, or education, or the ability to do so, is a very robust measure of recovery. This information should have been included.

Thirdly, recovery in a condition whose cardinal clinical features relate to mobility – exercise-induced muscle fatigue and weakness – must be matched with an ability to mobilise in a normal and timely manner. The overall results for all the treatments in the PACE trial relating to changes in the six-minute walking test from baseline to 52 weeks do not represent a return to normal levels of activity. In fact, the figures for all the treatment groups at 52 weeks are below the 402m reported to be present in patients with class 3 heart failure (Lipkin et al 1986). So why were the results for those who have recovered – who should now be achieving a much higher distance – omitted? And in relation to overall physical functioning, I am unable to understand how it is possible to meet the entry criteria for the PACE trial with a short form-36 physical function subscale score of 65 yet leave the trial as recovered with a score as low as 60.

I welcome the fact that behavioural interventions such as CBT and GET can result in improvement in some people who come under the wide range of clinical phenotypes that equate to ME/CFS. However, patient evidence continues to indicate that most people with ME/CFS find CBT to be ineffective (or even harmful); around half consistently report that GET makes them feel worse; and the vast majority report that pacing is the most acceptable and effective form of activity management (Managing my ME, ME Association, 2010). This is hardly surprising given the increasing research evidence involving abnormalities in the central nervous system (Cader et al 2009, Puri et al 2011), muscle energy metabolism (Jones et al 2012) and immune system function (Lorusso et al 2009) that are not compatible with a primarily psychosocial model of causation.

There is widespread concern in the patient community about the way in which these research results relating to CBT and GET are being distorted in the media and adopted by organisations such as the National Institute for Clinical Excellence (NICE) as a ‘one size fits all’ approach to management. To conclude that they are safe and effective for everyone with mild or moderate ME/CFS, as NICE currently does, is simply wrong.

Dr Charles Shepherd
Hon Medical Adviser, ME Association

7 Apollo Office Court
Radclive Road
Gawcott
Bucks MK18 4DF

References

Cader S, O’Donovan DG, Shepherd C, Chaudhuri A (2009). Neuropathology of post-infectious fatigue syndrome. Journal of the Neurological Sciences, S60 – S61.

Jones DE, Hollingsworth KG, Jakovljevic DG, Fattakhova G, Pairman J, Blamire AM, Trenell MI, Newton JL (2012). Loss of capacity to recover from acidosis on repeat exercise in chronic fatigue syndrome: a case-control study. European Journal of Clinical Investigation, 42, 186 – 194.

Lipkin DP, Scriven AJ, Crake T and Poole-Wilson PA (1986). Six-minute walking test for assessing exercise capacity in chronic heart failure. British Medical Journal (Clinical Research Edition) 292, 653

Lorusso L, Mikhaylova SV, Capelli E, Ferrari D, Ngonga GK, Ricevuti G (2009). Immunological aspects of chronic fatigue syndrome. Autoimmunity Reviews, 8, 287 – 291.

Managing my M.E. What people with ME/CFS and their carers want from the UK’s health and social services (2010)
www.meassociation.org.uk/wp-content/uploads/2010/09/2010-survey-report-lo-res4.pdf Accessed 10 February 2013

McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD (2012). Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS One, 2012, 7, e408084

Puri BK, Jakeman PM, Agour M, Gunatilake KDR, Fernando KAC, Gurusinghe AI, Treasaden IH, Waldman AD, Gishen P (2011). Regional grey and white matter volumetric changes in myalgic encephalomyelitis (chronic fatigue syndrome): a voxel-based morphometry 3-T MRI study. British Journal of Radiology, 85, e270 – 273.

White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M (2011). Comparison of adaptive pacing, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized controlled trial. Lancet, 377, 823 – 836.

White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M (2013). Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine, 2013, January 31, 2013: 1-9 Epub ahead of print.

ENDS

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