Myalgic encephalomyelitis/chronic fatigue syndrome and the biopsychosocial model: a review of patient harm and distress in the medical encounter

Methods: A narrative review methodology is employed to synthesize the evidence for potential iatrogenesis.

Results: We identify seven potential modalities of iatrogenesis or harm reported by patients:

  1. difficulties in reaching an acceptable diagnosis;

  2. misdiagnosis, including of other medical and psychological conditions;

  3. difficulties in accessing the sick role, medical care and social support;

  4. high levels of patient dissatisfaction with the quality of medical care;

  5. negative responses to controversial therapies (cognitive behavioral therapy and graded exercise therapy);

  6. challenges to the patient narrative and experience;

  7. psychological harm (individual and collective distress).

Conclusion: The biopsychosocial framework currently applied to ME/CFS is too narrow in focus and fails to adequately incorporate the patient narrative. Misdiagnosis, conflict, and harm are observable outcomes where doctors’ and patients’ perspectives remain incongruent. Biopsychosocial practices should be scrutinized for potential harms. Clinicians should consider adopting alternative patient-centred approaches.

  • Implications for rehabilitation
  • Patients with ME/CFS may report or experience one or more of the modalities of harms and distress identified in this review.

  • It is important health and rehabilitation professionals seek to avoid and minimize harms when treating or assisting ME/CFS patients.

  • There are conflicting models of ME/CFS; we highlight two divergent models, a biopsychosocial model and a biomedical model that is preferred by patients.

  • The ‘biopsychosocial framework’ applied in clinical practice promotes treatments such as cognitive behavioral therapy and exercise therapy, however, the evidence for their success is contested and many patients reject the notion their illness is perpetuated by dysfunctional beliefs, personality traits, or behaviors.

  • Health professionals may avoid conflict and harm causation in ME/CFS by adopting more concordant ‘patient-centred’ approaches that give greater prominence to the patient narrative and experience of illness.

SourceKeith J. Geraghty & Charlotte Blease (2018) Myalgic encephalomyelitis/chronic fatigue syndrome and the biopsychosocial model: a review of patient harm and distress in the medical encounter, Disability and Rehabilitation, DOI: 10.1080/09638288.2018.1481149

An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis

Abstract:

Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) are considered to be enigmatic diseases. Several studies propose that the combination of cognitive behaviour therapy with a graded activity protocol (CBT+), justified by a so-called (bio)psychosocial (explanatory) model, is an effective treatment option for CFS (ME).

Objective :A critical review of five Dutch hallmark studies that allegedly support this claim.

Methods: An analysis of the five CBT+ studies with special attention to the patients studied, the criteria (subjective and objective measures and cut-off scores) used to select participants and to define improvement and recovery, the consistency of the definitions of caseness (being diagnosed as a CFS patient at entry) versus the definitions of improvement and recovery after CBT+, and the objective effects.

Results: The studies investigated suffer from various methodological flaws. Apart from these methodological shortcomings, the claim that CBT+ is an effective treatment option for CFS is not substantiated by the data reported. Some studies investigated CFS patients, other studies investigated CF patients, labelled as CFS patients, or combinations of CFS and CF patients. No study investigated the effect of CBT+ in a group of patients meeting the (original) diagnostic criteria for ME. The effects of CBT+ on subjective measures, for example fatigue and disability, if present, are insufficient to achieve normal values. Impressive recovery and improvement rates are based on very loose criteria for subjective measures. Cut-off scores for subjective measures used to define improvement and recovery in studies show overlap with cut-off scores for CFS caseness in one or more of the other studies. More importantly, looking at the objective measures, the proof of clinical improvement after CBT+ is lacking.

Conclusion: Solid evidence of effectiveness of CBT+ for CFS, let alone ME, is lacking in the five hallmark studies. The lack of objective improvement indicates CBT+ is ineffective. This finding confirms the outcome of the large-scale PACE-trial in the UK.

Source: Twisk FNM (2017) An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis. Gen Med Open, 2017 doi: 10.15761/GMO.1000117 (Full article)

Systemic exercise intolerance disease: What’s in a name?

Abstract:

The syndrome characterized primarily by chronic, disabling fatigue without adequate explanation has been of interest to patients, clinicians and researchers. Chronic fatigue syndrome (CFS) is a widely used term for this condition in scientific and lay literature but is not acceptable to many patients because of perceived stigma due to implied psychological causation.

CFS has recently been replaced by systemic exercise intolerance disease (SEID) by the Institute of medicine with the objectives of providing and disseminating evidence-based criteria and to provide a more acceptable name for this condition. Simultaneously, changes have taken place in DSM-5 with regards to this condition. Mental health professionals need to be aware of this change in the interests of patient care.

The need to replace CFS with SEID and the nosological changes also indicate an inability to do away with the Descartian mind-body dualism despite efforts to the contrary and a need to debate the failure of the bio-psycho-social model to ‘mainstream’ and destigmatize psychiatry.

Copyright © 2016 Elsevier B.V. All rights reserved.

 

Source: Sen MS, Sahoo S, Aggarwal S, Singh SM. Systemic exercise intolerance disease: What’s in a name?Asian J Psychiatr. 2016 Aug;22:157-8. doi: 10.1016/j.ajp.2016.06.003. Epub 2016 Jun 23. https://www.ncbi.nlm.nih.gov/pubmed/27520920

 

Comment

Lily Chu 2016 Sep 14 8:50 p.m.

As a member of the Institute of Medicine Committee, I talked to multiple patients, caregivers, clinicians, and researchers. The problem they have with the name “CFS” goes beyond psychological stigma. For one, fatigue is only one symptom of the disease but not even the most disabling one for patients. Post-exertional malaise and cognitive issues are. Secondly, most patients and families are concerned about psychological implications not because of stigmatization but simply because CFS is NOT a psychological or psychiatric condition. Some patients experience co-morbid depression, acknowledge its presence, and receive treatment for it. In support groups, patients discuss depression and anxiety without fear of stigma. The problem comes when clinicians or researchers conflate patients’ depression with their CFS and conclude that they can treat the latter condition with cognitive behavioral therapy or with SSRIs. An analogy would be if tomorrow, patients experiencing myocardial infarcts and major depression were told aspirin, B-blockers, cholesterol medication, etc. would no longer be the treatments for myocardial infarcts but instead SSRIs would be. Could you imagine how patients would feel in that circumstance? That is why they are concerned.

Overcoming the barriers to the diagnosis and management of chronic fatigue syndrome/ME in primary care: a meta synthesis of qualitative studies

Abstract:

BACKGROUND: The NICE guideline for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) emphasises the need for an early diagnosis in primary care with management tailored to patient needs. However, GPs can be reluctant to make a diagnosis and are unsure how to manage people with the condition.

METHODS: A meta synthesis of published qualitative studies was conducted, producing a multi-perspective description of barriers to the diagnosis and management of CFS/ME, and the ways that some health professionals have been able to overcome them. Analysis provided second-order interpretation of the original findings and developed third-order constructs to provide recommendations for the medical curriculum.

RESULTS: Twenty one qualitative studies were identified. The literature shows that for over 20 years health professionals have reported a limited understanding of CFS/ME. Working within the framework of the biomedical model has also led some GPs to be sceptical about the existence of the condition. GPs who provide a diagnosis tend to have a broader, multifactorial, model of the condition and more positive attitudes towards CFS/ME. These GPs collaborate with patients to reach agreement on symptom management, and use their therapeutic skills to promote self care.

CONCLUSIONS: In order to address barriers to the diagnosis and management of CFS/ME in primary care, the limitations of the biomedical model needs to be recognised. A more flexible bio-psychosocial approach is recommended where medical school training aims to equip practitioners with the skills needed to understand, support and manage patients and provide a pathway to refer for specialist input.

 

Source: Bayliss K, Goodall M, Chisholm A, Fordham B, Chew-Graham C, Riste L, Fisher L, Lovell K, Peters S, Wearden A. Overcoming the barriers to the diagnosis and management of chronic fatigue syndrome/ME in primary care: a meta synthesis of qualitative studies. BMC Fam Pract. 2014 Mar 7;15:44. doi: 10.1186/1471-2296-15-44. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3973969/ (Full article)

 

Chronic fatigue syndrome: Harvey and Wessely’s (bio)psychosocial model versus a bio(psychosocial) model based on inflammatory and oxidative and nitrosative stress pathways

Abstract:

BACKGROUND: In a recently published paper, Harvey and Wessely put forward a ‘biopsychosocial’ explanatory model for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), which is proposed to be applicable to (chronic) fatigue even when apparent medical causes are present.

METHODS: Here, we review the model proposed by Harvey and Wessely, which is the rationale for behaviourally oriented interventions, such as cognitive behaviour therapy (CBT) and graded exercise therapy (GET), and compare this model with a biological model, in which inflammatory, immune, oxidative and nitrosative (IO&NS) pathways are key elements.

DISCUSSION: Although human and animal studies have established that the pathophysiology of ME/CFS includes IO&NS pathways, these abnormalities are not included in the model proposed by Harvey and Wessely. Activation of IO&NS pathways is known to induce fatigue and somatic (F&S) symptoms and can be induced or maintained by viral and bacterial infections, physical and psychosocial stressors, or organic disorders such as (auto)immune disorders. Studies have shown that ME/CFS and major depression are both clinical manifestations of shared IO&NS pathways, and that both disorders can be discriminated by specific symptoms and unshared or differentiating pathways. Interventions with CBT/GET are potentially harmful for many patients with ME/CFS, since the underlying pathophysiological abnormalities may be intensified by physical stressors.

CONCLUSIONS: In contrast to Harvey and Wessely’s (bio)psychosocial model for ME/CFS a bio(psychosocial) model based upon IO&NS abnormalities is likely more appropriate to this complex disorder. In clinical practice, we suggest physicians should also explore the IO&NS pathophysiology by applying laboratory tests that examine the pathways involved.

 

Source: Maes M, Twisk FN. Chronic fatigue syndrome: Harvey and Wessely’s (bio)psychosocial model versus a bio(psychosocial) model based on inflammatory and oxidative and nitrosative stress pathways. BMC Med. 2010 Jun 15;8:35. doi: 10.1186/1741-7015-8-35. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2901228/ (Full article)

 

Treatment of chronic fatigue syndrome: findings, principles and strategies

Abstract:

Chronic fatigue syndrome (CFS) is a debilitating condition characterized by serious medically unexplained mental and physical fatigue. The high prevalence and both direct and indirect health costs of CFS patients represent a huge problem for contemporary health care. Moreover, the prognosis of CFS, even when treated, is often poor. In this paper, we first critically review current evidence based treatments of CFS. Second, we discuss the growing insights into the etiopathogenesis of CFS, and the need to translate and integrate these insights into future treatments. In particular, we formulate a pragmatic and empirically testable treatment approach, tailored to the individual needs of patients, which aims at restoring the mental and physical equilibrium of CFS patients by trying to bring about sustained life style changes.

 

Source: Luyten P, Van Houdenhove B, Pae CU, Kempke S, Van Wambeke P. Treatment of chronic fatigue syndrome: findings, principles and strategies. Psychiatry Investig. 2008 Dec;5(4):209-12. doi: 10.4306/pi.2008.5.4.209. Epub 2008 Dec 31. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2796012/ (Full article)

 

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

 

Central sensitization: a biopsychosocial explanation for chronic widespread pain in patients with fibromyalgia and chronic fatigue syndrome

Abstract:

In addition to the debilitating fatigue, the majority of patients with chronic fatigue syndrome (CFS) experience chronic widespread pain. These pain complaints show the greatest overlap between CFS and fibromyalgia (FM). Although the literature provides evidence for central sensitization as cause for the musculoskeletal pain in FM, in CFS this evidence is currently lacking, despite the observed similarities in both diseases. The knowledge concerning the physiological mechanism of central sensitization, the pathophysiology and the pain processing in FM, and the knowledge on the pathophysiology of CFS lead to the hypothesis that central sensitization is also responsible for the sustaining pain complaints in CFS.

This hypothesis is based on the hyperalgesia and allodynia reported in CFS, on the elevated concentrations of nitric oxide presented in the blood of CFS patients, on the typical personality styles seen in CFS and on the brain abnormalities shown on brain images. To examine the present hypothesis more research is required. Further investigations could use similar protocols to those already used in studies on pain in FM like, for example, studies on temporal summation, spatial summation, the role of psychosocial aspects in chronic pain, etc.

 

Source: Meeus M, Nijs J. Central sensitization: a biopsychosocial explanation for chronic widespread pain in patients with fibromyalgia and chronic fatigue syndrome. Clin Rheumatol. 2007 Apr;26(4):465-73. Epub 2006 Nov 18. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1820749/ (Full article)

 

Report from the Health Council of the Netherlands on the chronic fatigue syndrome: moving away from the body-mind dichotomy with a view to effective prevention and treatment

Abstract:

The Health Council of the Netherlands has issued a report on the chronic fatigue syndrome (CFS). CFS is a real and seriously debilitating condition which imposes limitations on an individual’s personal, occupational and social functioning. It is a syndrome of unknown aetiology without physical signs or biological markers. Although there is no disease, patients both feel ill and give the appearance of being ill. There is no consensus on whether CSF patients are able to work or whether they should be entitled to social security benefits. An imbalance between demand and coping is central in CFS, with stress as an important intermediary factor. It is little use concluding that unexplained signs are ‘psychological’ or that ‘I cannot find anything wrong with you so you must be healthy’. The classical view that mind and body are separate systems is outmoded. The bio-psycho-social model of disease may be helpful in describing the interaction between body, mind and circumstance. Putting the CFS patient at ease and explaining the pathophysiology of the symptoms is a useful approach but many patients and patient associations are still very somatically orientated, thereby sustaining the condition. However, in patients who accept that their problems may be stress-induced and are prepared to participate in therapy, some therapies have been proven to be effective, notably cognitive behavioural therapy.

 

Source: Bolk JH. Report from the Health Council of the Netherlands on the chronic fatigue syndrome: moving away from the body-mind dichotomy with a view to effective prevention and treatment. Ned Tijdschr Geneeskd. 2005 Apr 2;149(14):739-41. [Article in Dutch] http://www.ncbi.nlm.nih.gov/pubmed/15835623

 

Stressors, personality traits, and coping of Gulf War veterans with chronic fatigue

Abstract:

OBJECTIVES: preliminary surveys of Persian Gulf veterans revealed a significant prevalence of self-reported symptoms consistent with chronic fatigue syndrome (CFS). The purpose of this study was to compare self-reported life stressors, combat, and chemical exposures, personality and coping between Gulf War veterans with CFS and healthy veterans.

METHODS: following a complete physical, psychiatric, and neuropsychological evaluation, 45 healthy veterans, 35 veterans with CFS and co-morbid psychiatric disorder, and 23 veterans with CFS and no co-morbid psychiatric disorder completed questionnaires assessing war and non-war-related life stressors, self-reports of environmental exposure (e.g. oil well fires, pesticides), personality, and coping.

RESULTS: measures of personality, self-reported combat and chemical exposures, and negative coping strategies significantly differentiated healthy veterans from those with CFS.

CONCLUSION: a biopsychosocial model of veterans’ illness was supported by the fact that personality, negative coping strategies, life stress after the war, and environmental exposures during the war were significant predictors of veterans’ current physical function.

 

Source: Fiedler N, Lange G, Tiersky L, DeLuca J, Policastro T, Kelly-McNeil K, McWilliams R, Korn L, Natelson B. Stressors, personality traits, and coping of Gulf War veterans with chronic fatigue. J Psychosom Res. 2000 Jun;48(6):525-35. http://www.ncbi.nlm.nih.gov/pubmed/11033371