PACE trial: adverse events for CBT (89%) and GET (93%) in ME/CFS are very common

Frank NM Twisk, Michael Maes, Cort Johnson:

Letter to the Editor,


Cognitive behaviour therapy/graded exercise therapy is not an effective treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Frank NM Twisk, Michael Maes, Cort Johnson.


According to White et al. (1) "either cognitive behaviour therapy (CBT) or graded exercise therapy (GET), when added to specialist medical care (SMC), are effective treatments for chronic fatigue syndrome (CFS)".

The size of this effect is however very moderate, while 60% reported they did not see a positive result in Global Impression of Health Scale benefit.

The Work and Social Adjustment scale indicated the average CBT/GET patient was still at the borderline of being 'very severely impaired'.

The conclusion is that these treatments cannot be considered to be effective (1) or curative (2).

More importantly, due to the selection criteria, the participants cannot be considered to be CFS patients, e.g. 47% met criteria for psychiatric disorders, while the two subjective measures fatigue and physical function are largely insufficient to establish recovery:

cut-off scores on these measures do not correspond with a CFS diagnosis.

Moreover, an improvement in "fatigue" is not reflected by a significant objective improvement,
e.g. in physical activity (3).

When looking at the only objective measure (1), i.e., meters walked in 6 minutes (CBT: 354; GET: 379; compared to 349 for SMC after treatment), CBT and GET hardly qualify as "moderately effective".

As recently has been confirmed (4),

CBT and GET are not effective and even potentially harmful for many ME/CFS patients (5).

According to (1)

non-serious adverse events for CBT (89%) and GET (93%)

are very common.



Therefore the claim that

"CBT and GET can safely be added to SMC" (1)

cannot be substantiated.


References:

1. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, et al. 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 2011 Feb 17. doi: 10.1016/S0140-6736(11)60096-2.
2. Wessely, S. Chronic fatigue syndrome - trials and tribulations. JAMA 2001; 286; 1378-9. doi: 10.1001/jama.286.11.1378.
3. Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med 2010; 40: 1-7. doi: 10.1007/s10067-009-1339-0.
4. Núñez M, Fernández-Solà J, Nuñez E, Fernández-Huerta JM, Godás-Sieso T, Gomez-Gil E. Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up. Clin Rheumatol 2011 Jan 15. doi: 10.1007/s10067-010-1677-y.
5. Twisk FNM, Maes M. A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients. Neuro Endocrinol Lett 2009; 30: 284-99.