Published in the Journal of Health Psychology, 29 August 2017.
Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys
In 2015, the ME Association published results of a large illness management survey that had been conducted over a period of 4 months and had elicited detailed answers about patient experiences of cognitive behavioural therapy (CBT), graded exercise therapy (GET), and Pacing (PT).
|‘Cognitive behavioural therapy and graded exercise therapy are promoted as evidence-based treatments for myalgic encephalomyelitis/chronic fatigue syndrome. This article explores patients’ symptom responses following these treatments versus pacing therapy, an approach favoured by many sufferers. We analyse data from a large cross-sectional patient survey (n = 1428) and compare our findings with those from comparable patient surveys (n = 16,665), using a mix of descriptive statistics and regression analysis modelling.’|
Dr Keith Geraghty, founder of the ME/CFS research group, has recently published a review comparing the ME Association survey evidence with findings from 10 other similar surveys from other ME/CFS charity organisations to better understand treatment efficacy from the patient’s point of view and try to determine why patient survey responses differ from those reported in clinical trials.
⇒ Dr Geraghty is an Honorary Research Fellow in Population Health, Health Sciences Research and Primary Care, where his work focuses on M.E. and CFS. The ME Association provided funding to help cover the costs of this recent study, and has made a further grant of £25,000 for Dr Geraghty to challenge and review the theoretical basis and clinical application of CBT and GET in the NHS.
The main findings
The paper reviewed patient’s symptom changes following treatment courses. It analysed data from the ME Association 2015 survey and compared it to ten other patient surveys – from the UK, Norway and the Netherlands – making the sample size around 18,000.
Analysis of the surveys found that:
- CBT was seen as beneficial to a relatively small number of patients (8% MEA 2015 vs. 35% average from other surveys),
- GET generally brought about a significant negative response in terms of symptom deterioration following treatment (54% average from other surveys vs. 74% MEA 2015) and,
- Pacing was found to be the most beneficial treatment in terms of symptom improvement (45% MEA 2015 vs. 82% average from other surveys) and lack of deterioration.
Findings from the ME Association 2015 (Primary) survey
The total percentage of patients reporting a change in symptoms following any combination of treatments were as follows:
- 32% reported worsening of symptoms after treatment,
- 49% reported no change in symptoms after treatment, and
- 19% reported improvement in symptoms after treatment.
This clearly demonstrates that current treatment approaches for people with ME/CFS are far from ideal.
Out of all the different treatment methods:
- Pacing Therapy (PT) was reported as the most beneficial (44%, versus 8% in CBT and 12% in GET) in terms of number of patients reporting symptom improvement following treatment, and,
- GET generated the largest negative response (74%, versus 18% in CBT and 14% in PT) in terms of number of patients reporting symptom worsening following treatment.
Interestingly, men reported a significantly better improvement in their symptoms post-treatment than women, and patients who answered that they thought their treatment course was “not appropriate” experienced significant worsening of symptoms post-therapy compared with those who found their course to be appropriate. However, this could be because participants were making responses in hindsight e.g. who would rate a course ‘appropriate’ if it had led to worsening symptoms?
Findings from the secondary surveys
Results from the other patient surveys found that:
- CBT resulted in improvement in symptoms in 35% of patients,
- GET improved symptoms in 25% of patients, and
- PT resulted in improvement in 82% of patients.
Although these findings were slightly more favorable towards the benefits of CBT/GET than the results from the ME Association 2015 survey, they show a similar pattern of GET producing a worsening of symptoms in 5/10 patients and PT benefiting 8/10 patients.
As with the 2015 ME Association survey report, this review noted several limitations that inevitably come from using survey evidence to draw conclusions. For example, it can be difficult for patients to determine the exact nature of treatment courses in hindsight, or when they aren’t always apparent, or where they can overlap other methods.
However, recall bias was to some extent limited as the review focused on single treatment courses (e.g. CBT only) to minimise this concern, but the extent to which treatment courses can be said to have affected symptoms should be treated with a measure of caution.
It is arguable whether treatment courses across all NHS ME/CFS specialist services are delivered in the same way, unlike in a clinical trial where delivery is considered to be more uniform and results can perhaps be more readily compared. However, very few clinical trials have compared to pacing therapy – they tend to focus on CBT and GET – and therefore the usefulness of these surveys should not be underestimated.
|‘While survey evidence may include several biases, this does not mean that survey evidence is wholly unreliable. A study to compare unsolicited ratings of care from patients across 146 acute general hospital trusts in England found that patients’ unsolicited feedback correlated well with conventional research findings (Greaves et al., 2012).’|
No clinical trial has satisfactorily explored pacing therapy to the extent that the treatment is recognised as the type recommended to people with ME/CFS, and as this seems unlikely to occur – ME/CFS charity organisations like the ME Association are more invested in the pursuit of biomedical research – utilising patient evidence in this way is the most that can be expected. However, as the importance of listening to the ‘patient voice’ and involving patients in research is becoming more widely recognised, such surveys provide important data that should become a key part of the evidence-base.
Conclusions on CBT
|‘Findings from our patient survey and secondary survey analysis show that CBT has little impact on symptom improvement for approximately 70–90% of patients, raising questions about the utility of the CBT model of ME/CFS.’|
It is suggested that CBT may only be beneficial as an adjunct therapy, helping patients to deal with the emotional distress, depression and anxiety generated from suffering with the illness, but not as a sole treatment of the illness itself. If it had been useful in treating the illness then we would have seen a greater number of patients reporting symptom improvements.
Conclusions on GET
|‘GET fails to help the majority of ME/CFS patients improve symptoms and has a marked negative impact on approximately 50% of patients.’|
It is suggested that the reported inappropriateness of GET is because part of this treatment approach involves being told to ‘push-through’ symptom exacerbations and that it fails to recognise or account for ‘ME-specific features’ – such as post-exertional malaise and orthostatic intolerance.
Conclusions on Pacing Therapy
|‘Pacing alone brought about the greatest positive impact on symptom experience, with 44% of patients reporting improvement.’|
The suggested benefits of PT are that it allows the patient to work within the limits of the illness and is a less invasive approach than CBT or GET.
How do these results compare with clinical trials?
|‘Findings from our primary and secondary survey analysis conflict with numerous RCTs (Randomised controlled trials) that report CBT and GET to be superior and safe treatments for ME/CFS (e.g. PACE trial).’|
A suggested reason for this conflict:
|‘ME/CFS is difficult to diagnose and it is speculated that clinical trials often involve volunteer bias and include patients with psychiatric illnesses and milder cases. These patients may respond better to CBT or GET than patients with more moderate-to-severe cases that are captured by surveys.’|
The paper discusses how negative outcomes of clinical trials are often under-reported and that while studies have concluded that there or few or no severe adverse reactions to treatments such as GET, this is contrary to the data reported from patient surveys.
One suggested explanation for this is that CBT and GET encourage patients to view negative experiences as counterproductive and are asked to ignore worsening symptoms, meaning that patients may not view them as ‘harms’ or are conditioned not to report adverse reactions to these treatment approaches.
|‘GET brings about a substantive deterioration in symptoms for almost half of patients and it is the least favoured treatment, compared with pacing, which is most favoured by patients.’
‘Therapists’ views have an impact on patient outcomes, with views of ME/CFS being a physical illness associated with better outcomes than views of ME/CFS being psychological illness.’
Dr Geraghty has conducted a very thorough and critical review, making multiple comparisons, considering every aspect of responses to treatment, and offering explanations for the findings.
The limitations of data from surveys has also been considered but these do not detract from the importance of gathering a “patients view” of these treatments.
The fact that the review has been published in a respected scientific journal is good news and will hopefully form part of the evidence-base that is considered when determining management recommendations for ME/CFS or when future clinical trials are being considered.
This research certainly endorses the recommendations that the ME Association made in its 2015 report:
- We conclude that CBT in its current delivered form should not be recommended as a primary intervention for people with ME/CFS.
- An appropriate model of CBT – one that helps patients learn practical coping skills and/or manage co-morbid issues – could be employed, where appropriate, for ME/CFS as it is for other chronic physical illnesses such as multiple sclerosis, Parkinson’s disease, cancer, heart disease, and arthritis etc.; and we recommend all patients should have access to such courses as well as access to follow-up courses and/or consultations as and when required.
- We conclude that GET should be withdrawn with immediate effect as a primary intervention for everyone with ME/CFS.
- We conclude that GET cannot be regarded as a safe and effective form of treatment for the majority of people with ME/CFS. The fact that many people, including those who consider themselves severely affected, are being referred to specialist services for an intervention that makes them either worse or much worse is clearly unacceptable and in many cases dangerous.
- Pacing was consistently shown to be the most effective, safe, acceptable and preferred form of activity management for people with ME/CFS and should therefore be a key component of any illness management programme.
- The benefit of Pacing may relate to helping people cope and adapt to their illness rather than contributing to a significant improvement in functional status. Learning coping strategies can help make courses more appropriate to needs even if they do not lead to immediate or even longer-term improvement in symptoms. Importantly, it can prevent symptoms from becoming worse.
The ME Association response to the current NICE guideline review and in the recent petition also reflected these conclusions, demanding a change in treatment recommendations. A decision from NICE is expected towards the end of October 2017.
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