IiME Submission to Lancet - Response to PACE Trials
Invest in ME Statement
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  - a distance well below that of healthy elderly subjects (631m) . 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  to see if patients traded their other daily activities for exercise. The hypocrisy of the researchers is demonstrated by their comments  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 . 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 .
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.
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.
5/ WHO Diseases of the nervous system (G00-G99) http://apps.who.int/classifications/apps/icd/icd10online/?gg90.htm+g933
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.
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