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Is a therapy truly effective if it does not have an effect?

Posted by JohnM on 02 Aug 2012 at 20:08 GMT

The authors of the present study state that “Adding cognitive behaviour therapy or graded exercise therapy to specialist medical care was found to be more effective in reducing both fatigue and disability than adding adaptive pacing therapy or specialist care alone”, (1) which is an oft-repeated refrain of proponents of CBT or GET for ME/CFS. However while CBT and GET have been found to improve some patients’ self-report scores on some questionnaires in some studies, whether CBT or GET actually result in reduced disability and/or improved functioning for ME/CFS patients as claimed is highly questionable and when objective data on the subject is considered such claims become fairly unsupportable.

A 2010 meta-analysis of 3 trials which used the same type of ‘rehabilitative CBT’ for ME/CFS that was used in the PACE trial found that the activity levels of patients who were treated with ‘CBT’ did not improve vs. controls when measured by actimeter data. (2) Worryingly, even though the explicitly stated intent of the ‘CBT’ offered was to improve patients’ activity levels, this actimeter data was not included in the results of the studies in question but was only published several years later, a finding which raises serious questions regarding selective reporting of data. A 2007 study by this same group found that patients’ cognitive functioning also did not improve following a trial of the ‘rehabilitative CBT’ offered by their group. (3) Note, the moniker ‘CBT’ is being put in quotation marks due to the fact that the ‘CBT’ offered by these groups does not conform with more the recognized forms of CBT used in chronic illnesses which aim to help a patient cope with their illness, despite this often being claimed by its proponents. In fact, the Dutch group of researchers on whose work PACE cites as a reference (4) state that- “The fact that many CFS patients have been suffering from symptoms for quite some time before they are referred for CBT does not contribute to their developing an optimistic outlook as far as a full recovery is concerned. In addition, patients who are referred to a psychotherapist for CFS generally assume that they will learn to cope with their complaints rather than learn to perceive themselves as healthy individuals again. This is why shedding the “patient” label should be one of the first points on the treatment agenda.” (5) In no other form of ‘CBT’ that I am aware of is it claimed that there is no intention of helping a patient cope with their illness but instead claims that a patient will recover from their chronic illness as a result of the therapy, however it is on precisely this premise that the ‘CBT’ and GET used in the PACE trial were based. (6)

While the PACE trial at one point in time was to include the use of actimeter data as one of only two objective measures of outcome in the trial, with the ‘rehabilitative CBT’ that was offered in PACE being based on the same premise of increasing patients’ activity levels as the trials mentioned above, the use of actimeter data as an objective measure of outcome in PACE was eventually dropped by the authors. This is relevant due to the fact that previous CBT trials which used actimeter data have reported there being no overall increase in patients’ activity levels throughout the trial but rather patients would simply substitute the activity portion of the therapy for, and proportionally reduce, such daily activities as housework, etc. (7) Thus such results call into question whether the ‘CBT’ offered in these trials (including PACE) has even been implemented as intended, not to mention whether such results could accurately be said to indicate improvements in patients’ functioning and/or reducing disability. As the authors of the present study note, the levels of patients receiving disability benefits actually increased across all four treatments, a finding which does not seem congruent with the idea that patients’ levels of disability had been successfully reduced as claimed by the authors.

The suggestion that CBT or GET reduces patients’ disability is further called into question when the results from the only objective measure of outcome included in PACE, ie that of the 6 minute walk test, are taken into account. While patients in the GET group did show a marginal improvement over the other groups in the trial, the 6MWT scores of the ‘CBT’ group were actually slightly less than those of the standard medical care group and the mean 6MWT scores of all of PACE’s trial groups at 52 weeks after baseline were still below those of patients with various cardiopulmonary disorders and patients with class III heart failure as well as scores of 80-89 year olds, a result which doesn’t exactly scream good health. (8, 9, 10)

Finally, a multi-centre, nationwide evaluation of 5 Belgian healthcare clinics which offered ‘rehabilitative CBT’ and GET to over 850 patients with a confirmed diagnosis of ME/CFS was recently conducted at the behest of the Belgian government. (11) While PACE had 600+ participants in total it was a four-armed trial, therefore the number of patients in the Belgian evaluation was almost three times the number of patients that were in the ‘CBT’ and GET groups of PACE. Crucially, clear and objective measurements of physical functioning were emphasized in the evaluation specifically as a result of the lack of supportive evidence for improvements in this area existing in the research literature. As can be seen in the 2008 report which summarized the evaluation’s findings, the results were far less promising than what is commonly espoused regarding the putative ability of CBT and GET to reduce patients’ disability and/or improve functioning- “Treatment was ended in only 2.8% of the cases by the patient himself, so the motivation of the patients for the treatment seemed to be high. In 71% the team considered the patient to have reached his maximal capacity — although no patient had been cured. Therapy provided systematically included CBT and GET. After treatment duration of 41 to 62 hours of rehabilitation per patient of which 83% group based, spread over 6 to 12 months, patients’ subjective feelings of fatigue were improved, but results concerning quality of life were equivocal. Psychological problems or psychiatric co-morbidities improved, but still fell outside the range of healthy adults. Physical capacity did not change; employment status decreased at the end of the therapy. It is difficult however, to judge these results, since no control group had been included.” (12)

Such findings are in complete agreement with the results of over a dozen patient surveys on the subject featuring responses from thousands of patients and which have been conducted across decades and on different continents which have consistently rated the benefit of CBT as being negligible while simultaneously rating GET as the treatment most likely to make patients worse. (13)

For proponents of CBT to keep ignoring the overwhelming majority of the evidence base which underlies their supposedly ‘evidence based’ treatments in regards to objective outcome measures is unconscionable and subjects ME/CFS patients to further harm by giving the false impression that CBT and GET are anything more than completely optional and adjunctive therapies which have not only not been shown to be effective in improving patients’ disability levels and/or physical or mental functioning but have actually repeatedly been shown to not be effective in improving the same as determined by numerous and independent objective measures of outcome.

1. McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, et al. (2012) Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis. PLoS ONE 7(8): e40808. doi:10.1371/journal.pone.0040808
2. Wiborg et al. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity Psychol Med. 2010 Aug;40(8):1281-7
3. Knoop et al. The effect of cognitive behaviour therapy for chronic fatigue syndrome on self‐reported cognitive impairments and neuropsychological test performance J Neurol Neurosurg Psychiatry. 2007 April; 78(4): 434–436. doi: 10.1136/jnnp.2006.100974
4. Prins et al. Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial The Lancet, Volume 357, Issue 9259, Pages 841 - 847, 17 March 2001 doi:10.1016/S0140-6736(00)04198-2
5. Ellen Bazelmans, Judith Prins, Gijs Bleijenberg Cognitive Behavior Therapy for Relatively Active and for Passive Chronic Fatigue Syndrome Patients Cognitive and Behavioral Practice, Volume 13, Issue 2, May 2006, Pages 157-166
6. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, et al. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377: 823–836.
7. Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue syndrome: is
improvement related to increased physical activity? J Clin Psychol. 2009;65:423–42.
8. Steffen et al. Age- and Gender-Related Test Performance in Community-Dwelling Elderly People: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and Gait Speeds Physical Therapy February 2002 vol. 82 no. 2 128-137 http://physicaltherapyjou...
9. Lipkin et al. Six minute walking test for assessing exercise capacity in chronic heart failure. Br Med J (Clin Res Ed) 1986; 292 : 653 doi: 10.1136/bmj.292.6521.653
10. Kadikar A, Maurer J, Kesten S. The six-minute walk test: a guide to assessment for lung transplantation. J Heart Lung Transplant. 1997 Mar;16(3):313-9.
11. Evaluatierapport over de referentiecentra voor het Chronisch vermoeidheidssyndroom (CVS) (Dutch or French languages only)
12. KCE reports 88A- Chronic Fatigue Syndrome: diagnosis, treatment and organisation of care (full report is in English with a French summary at the beginning)
13. Kindlon, T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Bulletin of the IACFS/ME. 2011;19(2):59-111

Competing interests declared: ME/CFS patient

RE: Is a therapy truly effective if it does not have an effect?

ZigZag replied to JohnM on 03 Aug 2012 at 00:31 GMT

In the published PACE Trial paper, CBT failed to meet the threshold for a clinical useful outcome (clinically useful difference from SMC) for one of the two primary outcome measures, physical disability (SF-36 physical function), and was found to be 'moderately effective' only for fatigue (Chalder fatigue). Therefore CBT was found to be clinically ineffective at reducing physical disability. This primary outcome result was supported by a secondary outcome measure, the only objective measure used in the PACE Trial, the six minute walking distance test, in which CBT was found to be ineffective at reducing disability.

In terms of the proportion of participants who achieved a clinically useful outcome (clinically useful difference from SMC), the results were as follows:

CBT physical function 13% (NNT = 1 in 8)
CBT fatigue 11% (NNT = 1 in 9)

GET physical function 12% (NNT = 8)
GET fatigue 15% (NNT = 7)

By contrast, 58% (physical function) and 65% (fatigue) of the SMC group achieved a clinically useful outcome.

No competing interests declared.