Sly Saint
Senior Member (Voting Rights)
Bias, misleading information and lack of respect for alternative views have distorted perceptions of myalgic encephalomyelitis/chronic fatigue syndrome and its treatment
Abstract
The PACE trial is one of the most recent studies evaluating cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome. These interventions are based on a model which assumes that symptoms are perpetuated by factors such as misguided beliefs and a lack of activity. Our analysis indicates that the researchers have shown significant bias in their accounts of the literature and may also have overstated the effectiveness of the above treatments.
We submit that their approach to criticisms undermines the scientific process and is inconsistent with best practice.
In his editorial, Geraghty (2016) reviewed some of the factors that have made it difficult to interpret the findings of the PACE trial. Given its flaws, we have been surprised that scientists familiar with this illness consider the trial to have been carefully designed, rigorously conducted and ‘scrupulously analysed and reported’ (British Association for CFS/ME (BACME), 2011; Crawley, 2013; Miller, 2011). Like Geraghty and others, we have noted the differences in outcomes when the analysis used the original criteria for recovery detailed in the protocol compared to the less stringent ones reported in the paper (White et al., 2013; Wilshire et al., 2016). Moreover, we are disappointed that the researchers have continued to ignore sound evidence in order to promote the view that fear plays a major role in the aetiology of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and that increasing activity can lead to significant improvements (Spencer, 2015; White et al., 2011).
In this article, we focus on the researchers’ bias and lack of respect for alternative approaches. We believe that this has led to a misrepresentation of the illness, the minimisation of the reported adverse reactions to graded exercise therapy (GET) and a less sympathetic attitude towards patients (Liddle, 2015).
Recent examples of the researchers’ views can be found in the media coverage which followed the publication of the data collected more than 2 years after randomisation (Sharpe et al., 2015). Below a headline proclaiming that ‘ME can be beaten by taking more exercise’, one of the scientists involved in the trial was quoted as stating that ‘patients become terrified of exercise and physical activity for fear that it will make their illness worse. These fears can be overcome by cognitive behavioural therapy or a gradual increase in exercise’ (Spencer, 2015). He went on to say that these ‘are not magic cures – but this is the only game in town in terms of evidence-based treatments’.1
We recognise that articles in the media are not subjected to peer review and that people can be misquoted, but in the case of the PACE trial, many healthcare professionals have echoed these opinions in the medical literature. The message since the first article in The Lancet has been that both cognitive behaviour therapy (CBT) and GET are ‘safe and effective’ (BACME, 2011; Sharpe et al., 2017) or at least more effective than specialised medical care and adaptive pacing therapy (APT; White et al., 2011, 2017).
Given that the results of the trial were published in one of the most prestigious journals in the world, readers will have assumed that the article had been subjected to rigorous peer review. We can therefore understand that many will have been mystified by the negative reactions of patients, support groups and a number of highly qualified health professionals (Davis et al., 2016; Shepherd, 2015).
What most will not know is that for various reasons, scientists in the United Kingdom and the Netherlands have not been offered an objective and balanced view of the rationale behind the CBT and GET protocols for ME/CFS (Goudsmit, 2016; Sunnquist, 2016). Nor will they be aware of the flaws in the design of the various randomised controlled trials (RCTs), and the editorial policies which tend to relegate alternative views to the correspondence sections (Goudsmit and Stouten, 2004).
Other commentaries on the PACE trial have focused on different aspects of the basis, design and reporting of results. We wish to draw attention to the approach adopted by a number of the researchers behind the promotion of CBT and GET which may help to explain some of the anger in the patient and scientific community.
Bias, misleading information and lack of respect for alternative views have distorted perceptions of myalgic encephalomyelitis/chronic fatigue syndrome and its treatment - Ellen Goudsmit, Sandra Howes, 2017 (sagepub.com)
Abstract
The PACE trial is one of the most recent studies evaluating cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome. These interventions are based on a model which assumes that symptoms are perpetuated by factors such as misguided beliefs and a lack of activity. Our analysis indicates that the researchers have shown significant bias in their accounts of the literature and may also have overstated the effectiveness of the above treatments.
We submit that their approach to criticisms undermines the scientific process and is inconsistent with best practice.
In his editorial, Geraghty (2016) reviewed some of the factors that have made it difficult to interpret the findings of the PACE trial. Given its flaws, we have been surprised that scientists familiar with this illness consider the trial to have been carefully designed, rigorously conducted and ‘scrupulously analysed and reported’ (British Association for CFS/ME (BACME), 2011; Crawley, 2013; Miller, 2011). Like Geraghty and others, we have noted the differences in outcomes when the analysis used the original criteria for recovery detailed in the protocol compared to the less stringent ones reported in the paper (White et al., 2013; Wilshire et al., 2016). Moreover, we are disappointed that the researchers have continued to ignore sound evidence in order to promote the view that fear plays a major role in the aetiology of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and that increasing activity can lead to significant improvements (Spencer, 2015; White et al., 2011).
In this article, we focus on the researchers’ bias and lack of respect for alternative approaches. We believe that this has led to a misrepresentation of the illness, the minimisation of the reported adverse reactions to graded exercise therapy (GET) and a less sympathetic attitude towards patients (Liddle, 2015).
Recent examples of the researchers’ views can be found in the media coverage which followed the publication of the data collected more than 2 years after randomisation (Sharpe et al., 2015). Below a headline proclaiming that ‘ME can be beaten by taking more exercise’, one of the scientists involved in the trial was quoted as stating that ‘patients become terrified of exercise and physical activity for fear that it will make their illness worse. These fears can be overcome by cognitive behavioural therapy or a gradual increase in exercise’ (Spencer, 2015). He went on to say that these ‘are not magic cures – but this is the only game in town in terms of evidence-based treatments’.1
We recognise that articles in the media are not subjected to peer review and that people can be misquoted, but in the case of the PACE trial, many healthcare professionals have echoed these opinions in the medical literature. The message since the first article in The Lancet has been that both cognitive behaviour therapy (CBT) and GET are ‘safe and effective’ (BACME, 2011; Sharpe et al., 2017) or at least more effective than specialised medical care and adaptive pacing therapy (APT; White et al., 2011, 2017).
Given that the results of the trial were published in one of the most prestigious journals in the world, readers will have assumed that the article had been subjected to rigorous peer review. We can therefore understand that many will have been mystified by the negative reactions of patients, support groups and a number of highly qualified health professionals (Davis et al., 2016; Shepherd, 2015).
What most will not know is that for various reasons, scientists in the United Kingdom and the Netherlands have not been offered an objective and balanced view of the rationale behind the CBT and GET protocols for ME/CFS (Goudsmit, 2016; Sunnquist, 2016). Nor will they be aware of the flaws in the design of the various randomised controlled trials (RCTs), and the editorial policies which tend to relegate alternative views to the correspondence sections (Goudsmit and Stouten, 2004).
Other commentaries on the PACE trial have focused on different aspects of the basis, design and reporting of results. We wish to draw attention to the approach adopted by a number of the researchers behind the promotion of CBT and GET which may help to explain some of the anger in the patient and scientific community.
Bias, misleading information and lack of respect for alternative views have distorted perceptions of myalgic encephalomyelitis/chronic fatigue syndrome and its treatment - Ellen Goudsmit, Sandra Howes, 2017 (sagepub.com)
