Protocols and outcomes for the PACE trial were changed after the start of the trial. These changes made substantial differences, leading to exaggerated claims for the efficacy of cognitive behavior therapy and graded exercise therapy in myalgic encephalomyelitis/chronic fatigue syndrome. The small, self-reported improvements in subjective measures cannot be used to say the interventions are effective, particularly in light of the absence of objective improvement. Geraghty’s criticism of the trial was reasonable and supported by the evidence.
De KimpeACrijnenBKuijperJ, et al. (2016) Care for ME—Survey of ME patients about their experiences with health care in The Netherlands, August. Available at: http://www.me-cvsvereniging.nl/sites/default/files/Rapport.pdf (accessed 19 January 2017).
9.
DealeAHusainKChalderT. (2001) Long-term outcome of cognitive behaviour therapy versus relaxation therapy for chronic fatigue syndrome: A 5-year follow-up study. American Journal of Psychiatry158: 2038–2042.
GeraghtyKJ (2016) PACE-Gate: When clinical trial evidence meets open data access. Journal of Health Psychology22(9): 1106–1112.
14.
HaywoodKLStaniszewskaSChapmanS (2012) Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review. Qual Life Res. Feb; 21(1):35–52.
KerrJRCunniffeVSKelleherP. (2003) Successful intravenous immunoglobulin therapy in 3 cases of parvovirus B19-associated chronic fatigue syndrome. Clinical Infectious Diseases36(9): e100–e106.
18.
KindlonT (2011) Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME19: 59–111.
19.
LilienfeldSORitschelLALynnSJ. (2014) Why ineffective psychotherapies appear to work: A taxonomy of causes of spurious therapeutic effectiveness. Perspectives on Psychological Science9: 355
20.
ME Association (2015) Our CBT, GET and Pacing Report calls for major changes to therapies offered for ME/CFS. Available at: http://www.meassociation.org.uk/2015/05/23959/ (accessed 19 January 2017).
21.
Moss-MorrisRSharonCTobinR. (2005) A randomized controlled graded exercise trial for chronic fatigue syndrome: Outcomes and mechanisms of change. Journal of Health Psychology10: 245–259.
PaulLWoodLBehanWM. (1999) Demonstration of delayed recovery from fatiguing exercise in chronic fatigue syndrome. European Journal of Neurology6: 63–69.
24.
RamsayMA (1988) Myalgic Encephalomyelitis and Post Viral Fatigue States: The Saga of Royal Free Disease (2nd edn). London: Gower Medical Publishing.
25.
ReevesWCWagnerDNisenbaumR. (2005) Chronic fatigue syndrome—A clinically empirical approach to its definition and study. BMC Medicine15(3): 19.
26.
SmithMEBNelsonHDHaneyE, et al. (2016) Diagnosis and treatment of myalgic encephalomyelitis/chronic fatigue syndrome. Evidence Reports/Technology Assessments, No. 219. Rockville, MD: Agency for Healthcare Research and Quality (US) (2014December, July2016 Addendum). Available at: http://www.ncbi.nlm.nih.gov/books/NBK379582/
27.
StordeurSThiryNEyssenM (2008) Chronisch Vermoeidheidssyndroom: Diagnose, behandeling en zorgorganisatie [Fatigue Syndrome: Diagnosis, treatment and organisation of care]. Technical report 88A (in Dutch). Brussels: Belgian Healthcare Knowledge Center (KCE). Available at: https://kce.fgov.be/sites/default/files/page_documents/d20081027358.pdf (accessed 26 February 2017).
28.
StoutenB. (2005) Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution. BMC Health Services Research13(5): 37.
29.
StulemeijerMDe JongLWFiselierTJ. (2005) Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: Randomised controlled trial. BMJ330(7481): 14, Erratum in BMJ2005330(7495): 820.
30.
Van GeelenSMBakkerRJKuisW. (2010) Adolescent chronic fatigue syndrome: A follow-up study. Archives of Pediatrics & Adolescent Medicine164: 810–814.
31.
VinkM (2016) The PACE trial invalidates the use of cognitive behavioral and graded exercise therapy in myalgic encephalomyelitis/chronic fatigue syndrome: A review. Journal of Neurology and Neurobiology2(3): 1–12.
32.
VinkM (2017) Assessment of individual PACE trial data: In myalgic encephalomyelitis/chronic fatigue syndrome, cognitive behavioral and graded exercise therapy are ineffective, do not lead to actual recovery and negative outcomes may be higher than reported. Journal of Neurology and Neurobiology3(1): 1–10.
33.
WhitePDChalderTSharpeM, et al. (2017) Response to the editorial by Dr Geraghty. Journal of Health Psychology22(9): 1113–1117.
34.
WhitePDGoldsmithKJohnsonAL. (2013) Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine43: 2227–2235.
35.
WhitePDGoldsmithKAJohnsonAL. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): A randomised trial. Lancet377: 823–836.
36.
WhitePDNyeKEPinchingAJ. (2004) Immunological changes after both exercise and activity in chronic fatigue syndrome: a pilot study. J Chronic Fatigue Syndrome12: 51–66.
37.
WhitePDSharpeMChalderT. (2007) 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 medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurology7: 6.
38.
WiborgJFKnoopHStulemeijerM. (2010) How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychological Medicine40: 1281–1287.
39.
WilshireCKindlonTMattheesA. (2017) Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and pre liminary re-analysis of the PACE trial. Fatigue BioMed Health Behav: 1–14.