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 with ME/CFS

Abstract:

Benign Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS) is a debilitating disease which, despite numerous biological abnormalities has remained highly controversial. Notwithstanding the medical pathogenesis of ME/CFS, the (bio)psychosocial model is adopted by many governmental organizations and medical professionals to legitimize the combination of Cognitive Behavioral Therapy (CBT) and Graded Exercise Therapy (GET) for ME/CFS. Justified by this model CBT and GET aim at eliminating presumed psychogenic and socially induced maintaining factors and reversing deconditioning, respectively.

In this review we invalidate the (bio)psychosocial model for ME/CFS and demonstrate that the success claim for CBT/GET to treat ME/CFS is unjust. CBT/GET is not only hardly more effective than non-interventions or standard medical care, but many patients report that the therapy had affected them adversely, the majority of them even reporting substantial deterioration.

Moreover, this review shows that exertion and thus GET most likely have a negative impact on many ME/CFS patients. Exertion induces post-exertional malaise with a decreased physical performance/aerobic capacity, increased muscoskeletal pain, neurocognitive impairment, “fatigue”, and weakness, and a long lasting “recovery” time.

This can be explained by findings that exertion may amplify pre-existing pathophysiological abnormalities underpinning ME/CFS, such as inflammation, immune dysfunction, oxidative and nitrosative stress, channelopathy, defective stress response mechanisms and a hypoactive hypothalamic-pituitary-adrenal axis.

We conclude that it is unethical to treat patients with ME/CFS with ineffective, non-evidence-based and potentially harmful “rehabilitation therapies”, such as CBT/GET.

 

Source: Twisk FN, 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 with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99. https://www.ncbi.nlm.nih.gov/pubmed/19855350

 

Chronic fatigue syndrome

Comment in: Graded exercise for chronic fatigue syndrome: too soon to dismiss reports of adverse reactions. [J Rehabil Med. 2010]

Comment on: Chronic fatigue syndrome: an approach combining self-management with graded exercise to avoid exacerbations. [J Rehabil Med. 2008]

 

Sir, We read with interest the special report by Nijs et al. (1), entitled “Chronic fatigue syndrome: an approach combining self-management with graded exercise to avoid exacerbations”. The paper proposes to provide an integrated model for graded exercise therapy (GET) in patients with chronic fatigue syndrome (CFS).
The authors state that current GET programmes for people with CFS exacerbate symptoms. This is a familiar and mistaken criticism of GET, often quoted from the 2001 Action for myaligic encephalomyelitis (ME) (AfME) survey, which reported that 50% of patients with CFS/ME who received graded exercise felt worse (2). A follow-up survey reported that, in many cases, exercise was being undertaken independently, without the supervision of a therapist trained to deliver GET to patients with CFS (3). In other words, it was not GET.

You can read the rest of this comment here: https://www.medicaljournals.se/jrm/content/abstract/10.2340/16501977-0261

 

Source: Clark LV, White PD. Chronic fatigue syndrome. J Rehabil Med. 2008 Nov;40(10):882-3; author reply 883-5. doi: 10.2340/16501977-0261. https://www.medicaljournals.se/jrm/content/abstract/10.2340/16501977-0261

 

Increase in prefrontal cortical volume following cognitive behavioural therapy in patients with chronic fatigue syndrome

Abstract:

Chronic fatigue syndrome (CFS) is a disabling disorder, characterized by persistent or relapsing fatigue. Recent studies have detected a decrease in cortical grey matter volume in patients with CFS, but it is unclear whether this cerebral atrophy constitutes a cause or a consequence of the disease. Cognitive behavioural therapy (CBT) is an effective behavioural intervention for CFS, which combines a rehabilitative approach of a graded increase in physical activity with a psychological approach that addresses thoughts and beliefs about CFS which may impair recovery.

Here, we test the hypothesis that cerebral atrophy may be a reversible state that can ameliorate with successful CBT. We have quantified cerebral structural changes in 22 CFS patients that underwent CBT and 22 healthy control participants. At baseline, CFS patients had significantly lower grey matter volume than healthy control participants. CBT intervention led to a significant improvement in health status, physical activity and cognitive performance. Crucially, CFS patients showed a significant increase in grey matter volume, localized in the lateral prefrontal cortex. This change in cerebral volume was related to improvements in cognitive speed in the CFS patients.

Our findings indicate that the cerebral atrophy associated with CFS is partially reversed after effective CBT. This result provides an example of macroscopic cortical plasticity in the adult human brain, demonstrating a surprisingly dynamic relation between behavioural state and cerebral anatomy. Furthermore, our results reveal a possible neurobiological substrate of psychotherapeutic treatment.

Comment in: Can CBT substantially change grey matter volume in chronic fatigue syndrome? [Brain. 2009]

 

Source: de Lange FP1, Koers A, Kalkman JS, Bleijenberg G, Hagoort P, van der Meer JW, Toni I. Increase in prefrontal cortical volume following cognitive behavioural therapy in patients with chronic fatigue syndrome. Brain. 2008 Aug;131(Pt 8):2172-80. doi: 10.1093/brain/awn140. Epub 2008 Jun 28. http://brain.oxfordjournals.org/content/131/8/2172.long (Full article)

 

Chronic fatigue syndrome: an approach combining self-management with graded exercise to avoid exacerbations

Abstract:

Controversy regarding the aetiology and treatment of patients with chronic fatigue syndrome continues among the medical professions. The Cochrane Collaboration advises practitioners to implement graded exercise therapy for patients with chronic fatigue syndrome using cognitive behavioural principles. Conversely, there is evidence that exercise can exacerbate symptoms in chronic fatigue syndrome, if too-vigorous exercise/activity promotes immune dysfunction, which in turn increases symptoms.

When designing and implementing an exercise programme for chronic fatigue syndrome it is important to be aware of both of these seemingly opposing viewpoints in order to deliver a programme with no detrimental effects on the pathophysiology of the condition.

Using evidence from both the biological and clinical sciences, this paper explains that graded exercise therapy for people with chronic fatigue syndrome can be undertaken safely with no detrimental effects on the immune system. Exercise programmes should be designed to cater for individual physical capabilities and should take into account the fluctuating nature of symptoms.

In line with cognitive behaviourally and graded exercise-based strategies, self-management for people with chronic fatigue syndrome involves encouraging patients to pace their activities and respect their physical and mental limitations, with the ultimate aim of improving their everyday functioning.

Comment in: Chronic fatigue syndrome. [J Rehabil Med. 2008]

 

Source: Nijs J, Paul L, Wallman K. Chronic fatigue syndrome: an approach combining self-management with graded exercise to avoid exacerbations. J Rehabil Med. 2008 Apr;40(4):241-7. Doi: 10.2340/16501977-0185. https://www.ncbi.nlm.nih.gov/pubmed/18382818

 

Chronic fatigue syndrome in a 15-year-old girl

Abstract:

Fatigue and lack of energy are frequent symptoms in children and adolescents. A diagnosis of chronic fatigue syndrome should be considered in children and adolescents who complain of chronic fatigue associated with other symptoms without a demonstrable physical cause. Lack of knowledge about this syndrome and late diagnosis may have a negative impact on the normal development of affected children and adolescents. Treatment should be based on a rehabilitation program with cognitive behavioral therapy and a gradual increase in activities.

 

Source: Díaz-Caneja Greciano A, Rodríguez Sosa JT, Aguilera Albesa S, Sánchez-Carpintero R, Soutullo Esperón C. Chronic fatigue syndrome in a 15-year-old girl. An Pediatr (Barc). 2007 Jul;67(1):74-7.[Article in Spanish] https://www.ncbi.nlm.nih.gov/pubmed/17663911 (Full article available in Spanish)

 

Overview of medical treatment and management of chronic fatigue syndrome

Abstract:

A tailor-made management plan that includes various combinations of non-pharmacologic and pharmacologic therapy for patients withchronic fatigue syndrome (CFS) is important. We present an overview of four aspects of our medical treatment and management for CFS: introduction of our medical management system, summary of our management strategy, non-pharmacologic therapy, and pharmacologic therapy; according to foreign guidelines and the latest studies. The main non-pharmacologic therapies for CFS are rehabilitation and lifestyle guidance. Using a graded exercise therapy, we have constructed a broad management strategy for CFS. Herein we introduce our graded exercise therapy. If the symptoms continue despite careful management of the program by the physician, consultation with a psychiatrist or psychosomatic medicine specialist is necessary.

 

Source: Yoshihara K, Kubo C. Overview of medical treatment and management of chronic fatigue syndrome. Nihon Rinsho. 2007 Jun;65(6):1077-81. [Article in Japanese] https://www.ncbi.nlm.nih.gov/pubmed/17561700

 

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

Abstract:

BACKGROUND: Chronic fatigue syndrome (CFS, also called myalgic encephalomyelitis /encephalopathy or ME) is a debilitating condition with no known cause or cure. Improvement may occur with medical care and additional therapies of pacing, cognitive behavioural therapy and graded exercise therapy. The latter two therapies have been found to be efficacious in small trials, but patient organisations surveys have reported adverse effects. Although pacing has been advocated by patient organisations, it lacks empirical support. Specialist medical care is commonly provided but its efficacy when given alone is not established. This trial compares the efficacy of the additional therapies when added to specialist medical care against specialist medical care alone.

METHODS: 600 patients, who meet operationalised diagnostic criteria for CFS, will be recruited from secondary care into a randomised trial of four treatments, stratified by current co morbid depressive episode and different CFS/ME criteria. The four treatments are standardised specialist medical care either given alone, or with adaptive pacing therapy or cognitive behaviour therapy or graded exercise therapy. Supplementary therapies will involve fourteen sessions over 23 weeks and a booster session at 36 weeks. Outcome will be assessed at 12, 24, and 52 weeks after randomisation. Two primary outcomes of self-rated fatigue and physical function will assess differential effects of each treatment on these measures. Secondary outcomes include adverse events and reactions, subjective measures of symptoms, mood, sleep and function and objective measures of physical activity, fitness, cost-effectiveness and cost-utility. The primary analysis will be based on intention to treat and will use logistic regression models to compare treatments. Secondary outcomes will be analysed by repeated measures analysis of variance with a linear mixed model. All analyses will allow for stratification factors. Mediators and moderators will be explored using multiple linear and logistic regression techniques with interactive terms, with the sample split into two to allow validation of the initial models. Economic analyses will incorporate sensitivity measures.

DISCUSSION: The results of the trial will provide information about the benefits and adverse effects of these treatments, their cost-effectiveness and cost-utility, the process of clinical improvement and the predictors of efficacy.

 

Source: White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; 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 Neurol. 2007 Mar 8;7:6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2147058/

 

How relevant are exercise capacity measures for evaluating treatment effects in chronic fatigue syndrome? Results from a prospective, multidisciplinary outcome study

Abstract:

OBJECTIVE: To evaluate the outcome of a multidisciplinary treatment programme for patients with chronic fatigue syndrome, including health-related quality of life (HRQoL) and psychosocial variables, and exercise capacity measures.

DESIGN: A six-month prospective outcome study.

SETTING: University outpatient rehabilitation clinic; group setting.

SUBJECTS: One hundred and sixteen women fulfilling chronic fatigue syndrome criteria.

INTERVENTIONS: Cognitive behaviourally and graded exercise-based strategies; emphasis on adaptive lifestyle changes.

MEASURES: Short Form General Health Survey (SF-36); Symptom Checklist (SCL-90); Causal Attribution List (CAL); Self-Efficacy Scale (SE); maximum progressive bicycle ergometer test with respiratory gas analysis; and isokinetic leg strength test, before and after treatment.

RESULTS: The total group significantly improved on nearly all reported HRQoL/psychosocial variables. Changes in exercise capacity measures were rather modest and did not correlate or only weakly correlated with HRQoL/psychosocial variables. Subgroup analyses indicated that less fit patients improved significantly more on exercise capacity measures than their more fit counterparts. Patients who were fitter at baseline scored better on pretreatment HRQoL/psychosocial variables, but both subgroups improved similarly on these variables.

CONCLUSIONS: Health-related quality of life and psychosocial functioning in patients with chronic fatigue syndrome improves after a six-month cognitive behaviourally and graded exercise-based multidisciplinary treatment programme. Increase in exercise capacity measures is not a necessary condition for reported improvements, except for less fit patients.

 

Source: Pardaens K, Haagdorens L, Van Wambeke P, Van den Broeck A, Van Houdenhove B. How relevant are exercise capacity measures for evaluating treatment effects in chronic fatigue syndrome? Results from a prospective, multidisciplinary outcome study. Clin Rehabil. 2006 Jan;20(1):56-66. https://www.ncbi.nlm.nih.gov/pubmed/16502751

 

Reliability of physiological, psychological and cognitive variables in chronic fatigue syndrome and the role of graded exercise

Abstract:

The objective of this study was to assess variability in symptoms and physical capabilities in chronic fatigue syndrome (CFS) participants both before and after a graded exercise intervention. Sixty-one CFS subjects participated in a 12-week randomized controlled trial of either graded exercise (n =32) or relaxation/stretching therapy (n = 29). Specific physiological, psychological and cognitive variables were assessed once weekly over a four-week period both prior to and after the intervention period. All scores were assessed for reliability using an intraclass correlation coefficient (ICC).

Apart from mental and physical fatigue, baseline ICC scores for all variables assessed were moderately to highly reliable, indicating minimal variability. Baseline scores for mental and physical fatigue were of questionable reliability, indicating a fluctuating nature to these symptoms (R1 = 0.64 and 0.60, respectively). Variability in scores for mental fatigue was reduced after graded exercise to an acceptable classification (R1 = 0.76). Results from this study support a variable nature to the symptoms of mental and physical fatigue only.

Consequently, in order to more accurately report the nature of mental and physical fatigue in CFS, future studies should consider using repeated-measures analysis when assessing these symptoms. Graded exercise resulted in the reclassification of scores for mental fatigue from questionable to acceptable reliability.

Key Points: Chronic fatigue syndrome sufferers often report a fluctuating nature to their symptoms and physical capabilities.Weekly assessment over a four-week period of psychological, physiological and cognitive variables demonstrated that only mental and physical fatigues were of questionable reliability.A 12-week graded exercise intervention resulted in the improvement of ICC scores for mental fatigue to that of acceptable reliability.

 

Source: Wallman KE, Morton AR, Goodman C, Grove R. Reliability of physiological, psychological and cognitive variables in chronic fatigue syndrome and the role of graded exercise. J Sports Sci Med. 2005 Dec 1;4(4):463-71. eCollection 2005. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3899663/ (Full article)

 

Predictors of outcome following treatment for chronic fatigue

Abstract:

We explored the role of baseline characteristics of 105 patients who presented with fatigue in primary care in determining outcome following either graded exercise or cognitive-behavioural therapy. Meeting the criteria for chronic fatigue syndrome was the most powerful predictor of poor outcome and this negative effect was enhanced by greater functional impairment or greater perceived negative consequences, but was not further enhanced by both.

 

Source: Darbishire L, Seed P, Ridsdale L. Predictors of outcome following treatment for chronic fatigue. Br J Psychiatry. 2005 Apr;186:350-1. http://bjp.rcpsych.org/content/186/4/350.long (Full article)