Graded exercise therapy and cognitive behavior therapy do not improve employment outcomes in ME/CFS

1 Introduction:

In a 1989 article, Wessely et al. [1] proposed a model of the onset and perpetuation of chronic fatigue syndrome, the illness often called myalgic encephalomyelitis and now frequently referred to as ME/CFS. In this model, patients’ symptoms were attributed to the effects of deconditioning following an acute illness. The symptoms were said to be perpetuated by patients’ persistent but purportedly unwarranted conviction that they continued to suffer from a medical disease that was exacerbated by exertion. The proposed treatment strategy combined gradual increases in activity to reverse the presumed deconditioning with efforts to alter patients’ supposedly misguided perceptions about their ailment.

ME/CFS has long been associated with marked disability and long-term sickness absences [2], with estimated rates of unemployment among patients ranging from 35% to 69% [3]. From the start, the promotion of behavioral and psychological rehabilitation has been intertwined with questions about whether ME/CFS patients with limited capacity to work should be able to receive some form of income or disability support. In a section on “sickness benefits” in the 1989 paper [1], the authors argued that decisions about social welfare payments should be linked to patients’ willingness to undergo behavioral and psychological interventions. “It is reasonable to expect a patient to cooperate with treatment before being labelled as chronically disabled,” noted the authors, notwithstanding the theoretical and unproven status of their model.

This rehabilitative approach achieved dominance over the next couple of decades, not only in the UK but in the US and many other countries. Graded exercise therapy (GET) and an illness-specific form of cognitive behavior therapy (CBT) became the predominant and most heavily researched ME/CFS interventions and were enshrined in multiple clinical guidelines. A 2005 review of the natural history of the illness [4], which found that only 5% of patients fully recovered spontaneously, noted “increasing evidence” for GET and CBT and therefore advised that “medical retirement should be postponed until a trial of such treatment has been given.”

While many studies have included employment status as a demographic data point [2, 3], fewer have specifically examined the relationship between GET and CBT and employment-related outcomes. Nonetheless, the results from the latter group are consistent and clear: The interventions do not lead to improved outcomes in employment status [5–13].

This question has taken on renewed urgency given the overlaps between ME/CFS and the phenomenon known as long Covid, or more formally as post-acute sequelae of SARS CoV-2 (PASC). A significant proportion of patients with prolonged symptoms after a coronavirus infection appear to suffer from the same cluster of symptoms that characterize ME/CFS, including pronounced exhaustion, relapses after minimal exertion known as post-exertional malaise (PEM), cognitive impairments, and orthostatic intolerance, among others. Like ME/CFS patients, many of this new PASC cohort have found that they are unable to sustain their previous level of employment. While the similarities between the two conditions have been widely noted by clinicians and medical investigators, they have also led to efforts to promote the traditional ME/CFS rehabilitation paradigm for this large wave of post-viral patients.

2 Employment outcomes in the PACE trial

After gaining momentum during the 1990 s and 2000 s, the GET/CBT approach was significantly reinforced with the 2011 publication in the Lancet of the first results of the PACE trial, the largest study of the two interventions for ME/CFS [5]. Additional PACE results were published in 2012 and 2013 [6, 7]. The study was partially funded by the UK’s Department for Work and Pensions (DWP). Officials at the agency presumably believed or hoped that the trial would provide robust data to support the use of these two strategies.

The PACE investigators presumably hoped for that as well; key members of the team maintained strong links with disability insurance companies, advising them that GET and CBT were effective in helping this group of challenging patients recover. In a 2002 essay for a UNUMProvident report on trends in disability [14], Michael Sharpe, a lead PACE investigator, wrote that “symptoms and disability” in patients with unexplained conditions “are shaped by psychological factors,” and in particular by “patients’ beliefs and fears.” He suggested that the promotion of biological disease models by ME/CFS patient advocates could impact health outcomes among insurance claimants.

Commenting on how public messaging and related “social factors” influenced the course of illness for these patients, Sharpe wrote: “Relevant factors include the information patients receive about the symptoms and how to cope with them. This information may be helpful or may stress the chronicity of the illness and promote helplessness. Such unhelpful information is found in “self-help” (!) books and increasingly on the Internet (see for example www.meassociation.org.uk)…Other social factors that perpetuate illness are anger with the person or organisation the illness is attributed to, or toward the insurer for not believing them.” In the article, Sharpe further argued that receiving financial benefits ultimately discouraged such claimants from getting better.

However, the data from PACE did not provide evidence that GET and CBT were effective in helping ME/CFS patients in the employment domain [6]. With 641 participants, PACE was the largest treatment trial for ME/CFS [5]. The investigators themselves referred to it as the “definitive” test of the two interventions [15]. In touting it as a success, they reported that around 60% had improved and 22% had recovered after treatment with GET and CBT, much more than in the other groups [5, 7]. However, these positive findings were all from subjective, self-reported measures. When such measures are paired with unblinded treatments, as in the PACE trial, they are subject to an unknown amount of bias.

PACE also included an employment measure as one of four objective outcomes, along with whether or not the participant was receiving social welfare or disability benefits, a step-test to assess fitness, and a six-minute-walking test. The results were uniformly poor. The first three measures produced null findings across the board, with no advantages conferred by the interventions [6, 7]; in the six-minute walking test, the GET group showed a statistically significant but clinically insignificant improvement [5]. In terms of employment, the percentage of participants in the GET group reporting lost days of work increased from 83% at baseline to 86% at 12 months after randomization; in the CBT group, the percentage was 84% both before and after treatment. In all study arms, the percentage of participants receiving unemployment or disability benefits was higher after treatment [6].

In promoting GET and CBT as effective, the PACE authors downplayed the findings on employment, receipt of disability or unemployment support, and other objective results, suggesting these should be ignored when determining whether patients had improved and recovered. In correspondence, they challenged the reliability and even the objectivity of the measures they themselves had pre-designated as objective. As they wrote: “Recovery from illness is a health status, not an economic one, and plenty of working people are unwell, while well people do not necessarily work. Some of our participants were either past the age of retirement or were not in paid employment when they fell ill. In addition, follow-up at 6 months after the end of therapy may be too short a period to affect either benefits or employment.” [16].

It is indisputable that other factors besides health status play a role in employment outcomes. Nonetheless, if the PACE trial’s reported results of significant improvement and recovery were accurate, then a measurable benefit from GET and CBT in employment and in the receipt of financial support would have been expected. As has been well-documented, the investigators weakened key subjective outcome measures in ways that dramatically improved their reported results; published re-analyses of trial data have found that no one achieved “recovery” from either of the therapies, and rates of improvement were so marginal that they were likely due to bias and expectation effects [17, 18]. Given these findings, the similarly disappointing results for employment outcomes in PACE should not be surprising.

3 Other studies on CBT/GET and employment outcomes

In a review of treatment studies that included employment outcomes, Vink and Vink-Niese [8] found that the standard interventions did not have an overall positive effect on work status. Besides PACE, among the studies reviewed were two other randomized trials and five observational studies based on data from clinical services. The two other trials, one in the Netherlands with 278 participants and one in England with 153, both investigated CBT and reported no statistically significant differences in employment outcomes between the intervention and control groups [9, 10]. The largest observational study included 952 patients seeking care at specialty clinics in England, although a great many did not provide post-treatment outcomes; among a subgroup of 394, 18% reported having returned to work or increased work hours, while 30% reported having stopped work or reduced work hours [11]. According to a Belgian report, a review of 655 patients attending domestic clinics found that “employment status decreased” when assessed after treatment while the percentage of those “living from a sickness allowance” rose from 54% to 57% [12].

Other observational research had similarly unpromising findings. In the most recent study, Stevelink et al. [13], of 508 patients who attended clinical services between 2007 and 2014, only 316 provided information about post-treatment employment status, among other measures. Of those, 9% had returned to work after not having worked at baseline. On the other hand, 6% had stopped working after having been working at baseline, leaving a net return-to-work after treatment of just 3%–a handful of people. Moreover, that figure is likely to be overstated, given the high loss-to-follow-up from the initial sample of 508. The drop-outs were more seriously ill at baseline, so they might be expected to have worse employment outcomes than those who ended up providing data at the final time point.

According to the authors, “unhelpful beliefs such as fear of activity and exercise and concerns about causing damage, combined with all or nothing behaviour and behavioural avoidance, were associated with not working” [13]. This statement is problematic because “fear of activity,” “concerns about causing damage” and related indications of caution should be considered reasonable and prudent perspectives, not “unhelpful beliefs,” among patients with the core ME/CFS symptom of PEM. Beyond that, the study itself documented little or no change after treatment in the domains of “fear-avoidance,” “catastrophizing,” “embarrassment avoidance,” “symptom focusing,” “all-or-nothing behaviour,” and “avoidance/resting behaviour,” even though such factors were “specifically targeted in CBT and, to some extent, GET.”

Moreover, the authors reported no change in subjective fatigue scores, and only a marginal increase in subjective physical function scores, with participants remaining seriously disabled even after treatment. Thus, although the authors noted correctly that “meaningful occupation is important for well-being and psychosocial needs,” their study documented that their approach failed to impact factors presumed to be essential to helping participants achieve that important goal. (Since Stevelink et al’s senior author was one of the lead PACE investigators, it is unclear why the paper did not mention the null employment results from that “definitive” study.)

The theoretical illness model underlying all of these studies is essentially the one outlined by Wessely et al. more than three decades ago [1]. That illness model is at odds with the extensive physiological abnormalities that have been found in ME/CFS [17, 19]. Research findings have also undermined two core assumptions of the model–specifically, that ME/CFS patients are deconditioned and have an unwarranted fear of activity or exercise. [20–22]. In 2017, the US Centers for Disease Control and Prevention dropped its recommendations for GET and CBT as ME/CFS treatments. In 2021, the UK National Institute for Health and Care Excellence (NICE) reversed its earlier support for the interventions in new ME/CFS guidelines; in its analysis, NICE assessed the quality of the evidence supporting GET and CBT as either “very low” or merely “low” [23]. These developments are consistent with the failure of GET and CBT to lead to improved employment outcomes in PACE and other studies.

4 Conclusion

In a recent study of employment status among clinic attendees, Stevelink et al. [13] wrote that “work-related outcomes should be targeted” in treatment for ME/CFS. It is certain that people with ME/CFS experience disrupted occupational lives and that it would be desirable to identify treatments that could restore their full capacity for employment. However, the most common behavioral and psychological interventions— that is, GET and CBT–have already been tested sufficiently to reach a conclusive assessment that they do not lead overall to meaningful improvements in work status. These poor results are consistent across randomized trials, including the high-profile and “definitive” PACE study, as well as observational studies of patients seeking clinical services for their illness.

Some investigators and medical experts continue to promote GET and CBT as treatments for ME/CFS patients based on subjective findings from flawed studies. They also seek to extend these recommendations to patients with long Covid, or PASC, many of whom are receiving ME/CFS diagnoses and facing employment challenges. It is time to state the obvious: The objective data on work outcomes indicate that GET and CBT do not lead to readily apparent benefits in this domain. In consequence, they should no longer be recommended to ME/CFS patients as a strategy for achieving occupational rehabilitation and related benefits.

Source: Tuller D, Vink M. Graded exercise therapy and cognitive behavior therapy do not improve employment outcomes in ME/CFS. Work. 2023 Mar 10. doi: 10.3233/WOR-220569. Epub ahead of print. PMID: 36911962. https://content.iospress.com/articles/work/wor220569 (Full text)

The Draft Report by the Institute for Quality and Efficiency in Healthcare Does Not Provide Any Evidence That Graded Exercise Therapy and Cognitive Behavioral Therapy Are Safe and Effective Treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Abstract:

The German Institute for Quality and Efficiency in Healthcare (IQWiG) recently published its draft report to the government about myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The IQWiG concluded that graded exercise therapy (GET) and cognitive behavioral therapy (CBT) should be recommended in the treatment for mild and moderate ME/CFS based on two CBT and two GET studies. In this article, we reviewed the evidence used by IQWiG to support their claims, because their conclusion is diametrically opposed to the conclusion by the British National Institute for Health and Care Excellence (NICE) in its recently updated ME/CFS guidelines.

Our analysis shows that the trials IQWiG used in support suffered from serious flaws, which included badly designed control groups; relying on subjective primary outcomes in non-blinded studies; alliance and response shift bias, including patients in their trials who did not have the disease under investigation, selective reporting, making extensive endpoint changes and low to very low adherence of treatments.

Our analysis also shows that the report itself used one CBT and one GET study that both examined a different treatment. The report also used a definition of CBT that does not reflect the way it is being used in ME/CFS or was tested in the studies. The report noted that one study used a wrong definition of post-exertional malaise (PEM), the main characteristic of the disease, according to the report. Yet, it ignored the consequence of this, that less than the required minimum percentage of patients had the disease under investigation in that study.

It also ignored the absence of improvement on most of the subjective outcomes, as well as the fact that the IQWiG methods handbook states that one should use objective outcomes and not rely on subjective outcomes in non-blinded studies. The report concluded that both treatments did not lead to objective improvement in the six-minute walk test but then ignored that. The report did not analyze the other objective outcomes of the studies (step test and occupational and benefits status), which showed a null effect.

Finally, the report states that the studies do not report on safety yet assumes that the treatments are safe based on a tendency towards small subjective improvements in fatigue and physical functioning, even though the adherence to the treatments was (very) low and the studies included many patients who did not have the disease under investigation and, consequently, did not suffer from exertion intolerance contrary to ME/CFS patients. At the same time, it ignored and downplayed all the evidence that both treatments are not safe, even when the evidence was produced by a British university.

In conclusion, the studies used by the report do not provide any evidence that CBT and GET are safe and effective. Consequently, the report and the studies do not provide any support for the recommendation to use CBT and GET for ME/CFS or long COVID, which, in many cases, is the same or resembles ME/CFS, after an infection with SARS-CoV-2.

Source: Vink M, Vink-Niese A. The Draft Report by the Institute for Quality and Efficiency in Healthcare Does Not Provide Any Evidence That Graded Exercise Therapy and Cognitive Behavioral Therapy Are Safe and Effective Treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Diseases. 2023 Jan 16;11(1):11. doi: 10.3390/diseases11010011. PMID: 36648876; PMCID: PMC9844345. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844345/ (Full text)

The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS

The British National Institute for Health and Care Excellence (NICE) recently published its updated guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). NICE concluded, after an extensive review of the literature, that graded exercise therapy (GET) is harmful and should not be used, and that cognitive behavioural therapy (CBT) is only an adjunctive and not a curative treatment. Leading proponents of the cognitive behavioural model (CBmodel) find it difficult to accept this paradigm shift.
In, for example, an article in The Lancet, they try to argue that the new NICE guideline is based on ideology instead of science. In this article we reviewed the evidence they used to support their claims. Our analysis shows that the trials they used in support suffered from serious flaws which included badly designed control groups, relying on subjective primary outcomes in non-blinded studies, including patients in their trials who didn’t have the disease under investigation or had a self-limiting disease, selective reporting, outcome switching and making extensive endpoint changes, which created an overlap in entry and recovery criteria, using a post-hoc definition of recovery which included the severely ill, not publishing results that contradict their own conclusion, ignoring their own (objective) null effect, etc.
The flaws in these trials all created a bias in favour of the interventions. Despite all these flaws, treatments that are said to lead to recovery in reality do not lead to objective improvement. Therefore, these studies do not support the claim that CBT and GET are effective treatments. Moreover, the arguments that are used to claim that NICE was wrong, in reality, highlight the absence of evidence for the safety and efficacy of CBT and GET and strengthen the decision by NICE to drop CBT and GET as curative treatments for ME/CFS.
Source: Vink M, Vink-Niese A. The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS. Healthcare. 2022; 10(5):898. https://doi.org/10.3390/healthcare10050898 https://www.mdpi.com/2227-9032/10/5/898/htm (Full text)

Is It Useful to Question the Recovery Behaviour of Patients with ME/CFS or Long COVID?

Abstract:

For the last few decades, medical guidelines have recommended treating patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) with graded exercise therapy (GET) and cognitive behavioural therapy (CBT). Moreover, doctors have questioned the recovery behaviour of these patients and stimulated them to follow these treatments so that they would be able to go back to work. In this article, we reviewed trials of GET and CBT for ME/CFS that reported on work status before and after treatment to answer the question of whether doctors should continue to question the recovery behaviour of patients with ME/CFS.

Our review shows that more patients are unable to work after treatment than before treatment with CBT and GET. It also highlights the fact that both treatments are unsafe for patients with ME/CFS. Therefore, questioning the recovery behaviour of patients with ME/CFS is pointless. This confirms the conclusion from the British National Institute for Health and Care Excellence (NICE), which has recently published its updated ME/CFS guideline and concluded that CBT and GET are not effective and do not lead to recovery.

Studies on CBT and GET for long COVID have not yet been published. However, this review offers no support for their use in improving the recovery of patients with an ME/CFS-like illness after infection with COVID-19, nor does it lend any support to the practice of questioning the recovery behaviour of these patients.

Source: Vink M, Vink-Niese F. Is It Useful to Question the Recovery Behaviour of Patients with ME/CFS or Long COVID? Healthcare (Basel). 2022 Feb 18;10(2):392. doi: 10.3390/healthcare10020392. PMID: 35207003. https://www.mdpi.com/2227-9032/10/2/392 (Full text)

The draft updated NICE guidance for ME/CFS highlights the unreliability of subjective outcome measures in non-blinded trials

Abstract:

The National Institute for Health and Care Excellence (NICE) recently published its draft updated guideline on the diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). NICE concluded that ME/CFS is a complex multisystem chronic medical condition for which graded exercise therapy should not be used and cognitive behavioural therapy is only a supportive therapy and not a treatment or cure. The draft guidance also highlighted the unreliability of subjective outcome measures in non-blinded trials. High quality randomised controlled ME/CFS trials are now needed to find pharmacological treatments that lead to substantial objective improvement and restore the ability to work.

Source: Vink M, Vink-Niese A. The draft updated NICE guidance for ME/CFS highlights the unreliability of subjective outcome measures in non-blinded trials. J Health Psychol. 2021 Jan 28:1359105321990810. doi: 10.1177/1359105321990810. Epub ahead of print. PMID: 33506707. https://pubmed.ncbi.nlm.nih.gov/33506707/

Could Cognitive Behavioural Therapy Be an Effective Treatment for Long COVID and Post COVID-19 Fatigue Syndrome? Lessons from the Qure Study for Q-Fever Fatigue Syndrome

Abstract:

An increasing number of young and previously fit and healthy people who did not require hospitalisation continue to have symptoms months after mild cases of COVID-19. Rehabilitation clinics are already offering cognitive behavioural therapy (CBT) as an effective treatment for long COVID and post-COVID-19 fatigue syndrome based on the claims that it is effective for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)-the most common post-infectious syndrome-as no study into the efficacy of CBT for post-COVID-19 fatigue syndrome has been published. Re-analyses of these studies, however, showed that CBT did not lead to objective improvements in heterogeneous groups of ME/CFS patients, nor did it restore the ability to work.

The group of patients with long COVID and post-COVID-19 fatigue syndrome, on the other hand, is homogeneous. We therefore analysed the Dutch Qure study, as it studied the efficacy of CBT in a homogeneous group of patients who developed Q-fever fatigue syndrome-which affects up to 30% of patients-after the largest reported outbreak of Q-fever, to see if CBT might potentially be an effective treatment for long-haulers after COVID-19 infection.

Our reanalysis found that the Qure study suffered from many serious methodological problems, which included relying on one subjective primary outcome in a study without a control group for the non-blinded CBT treatment group, using a post hoc definition of improvement, waiting 2 years before publishing their objective actometer results and ignoring the null effect of said results. Moreover, only 10% of participants achieved a clinically meaningful subjective improvement in fatigue as a result of CBT according to the study’s own figures.

Consequently, CBT has no subjective clinically meaningful effect in nine out of every ten patients that are treated with it. Additionally, the subjective improvement in fatigue was not matched by an improvement in disability, even though the disability was fatigue related according to the researchers. On top of this, CBT did not lead to an objective improvement in physical performance. Therefore, it cannot be said that CBT is an effective treatment for Q-fever fatigue syndrome either. It seems therefore unlikely that CBT will reduce disability or lead to objective improvement in long COVID or in post-COVID-19 fatigue syndrome.

Source: Vink M, Vink-Niese A. Could Cognitive Behavioural Therapy Be an Effective Treatment for Long COVID and Post COVID-19 Fatigue Syndrome? Lessons from the Qure Study for Q-Fever Fatigue Syndrome. Healthcare (Basel). 2020 Dec 11;8(4):E552. doi: 10.3390/healthcare8040552. PMID: 33322316. https://www.mdpi.com/2227-9032/8/4/552 (Full text)

Graded Exercise Therapy Doesn’t Restore the Ability to Work in ME/CFS. Rethinking of a Cochrane Review

Abstract:

Background: Cochrane recently amended its exercise review for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in response to an official complaint.

Objective: To determine if the amended review has addressed the concerns raised about the previous review and if exercise is an effective treatment that restores the ability to work in ME/CFS.

Method: The authors reviewed the amended Cochrane exercise review and the eight trials in it by paying particular interest to the objective outcomes. We also summarised the recently published review of work rehabilitation and medical retirement for ME/CFS.

Results: The Cochrane review concluded that graded exercise therapy (GET) improves fatigue at the end of treatment compared to no-treatment. However, the review did not consider the unreliability of subjective outcomes in non-blinded trials, the objective outcomes which showed that GET is not effective, or the serious flaws of the studies included in the review. These flaws included badly matched control groups, relying on an unreliable fatigue instrument as primary outcome, outcome switching, p-hacking, ignoring evidence of harms, etc. The review did also not take into account that GET does not restore the ability to work.

Conclusion: GET not only fails to objectively improve function significantly or to restore the ability to work, but it’s also detrimental to the health of≥50% of patients, according to a multitude of patient surveys. Consequently, it should not be recommended.

Source: Vink M, Vink-Niese F. Graded exercise therapy doesn’t restore the ability to work in ME/CFS. Rethinking of a Cochrane review [published online ahead of print, 2020 Jun 14]. Work. 2020;10.3233/WOR-203174. doi:10.3233/WOR-203174 https://pubmed.ncbi.nlm.nih.gov/32568149/

Work Rehabilitation and Medical Retirement for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients. A Review and Appraisal of Diagnostic Strategies

Abstract:

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome leads to severe functional impairment and work disability in a considerable number of patients. The majority of patients who manage to continue or return to work, work part-time instead of full time in a physically less demanding job. The prognosis in terms of returning to work is poor if patients have been on long-term sick leave for more than two to three years.

Being older and more ill when falling ill are associated with a worse employment outcome. Cognitive behavioural therapy and graded exercise therapy do not restore the ability to work. Consequently, many patients will eventually be medically retired depending on the requirements of the retirement policy, the progress that has been made since they have fallen ill in combination with the severity of their impairments compared to the sort of work they do or are offered to do.

However, there is one thing that occupational health physicians and other doctors can do to try and prevent chronic and severe incapacity in the absence of effective treatments. Patients who are given a period of enforced rest from the onset, have the best prognosis. Moreover, those who work or go back to work should not be forced to do more than they can to try and prevent relapses, long-term sick leave and medical retirement.

Source: Vink M, Vink-Niese F. Work Rehabilitation and Medical Retirement for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients. A Review and Appraisal of Diagnostic Strategies. Diagnostics (Basel). 2019 Sep 20;9(4). pii: E124. doi: 10.3390/diagnostics9040124. https://www.ncbi.nlm.nih.gov/pubmed/31547009

Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review

Abstract:

Analysis of the 2008 Cochrane review of cognitive behavioural therapy for chronic fatigue syndrome shows that seven patients with mild chronic fatigue syndrome need to be treated for one to report a small, short-lived subjective improvement of fatigue. This is not matched by an objective improvement of physical fitness or employment and illness benefit status. Most studies in the Cochrane review failed to report on safety or adverse reactions. Patient evidence suggests adverse outcomes in 20 per cent of cases. If a trial of a drug or surgical procedure uncovered a similar high rate, it would be unlikely to be accepted as safe. It is time to downgrade cognitive behavioural therapy to an adjunct support-level therapy, rather than a treatment for chronic fatigue syndrome.

Source: Vink M, Vink-Niese A. Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review. Health Psychol Open. 2019 May 2;6(1):2055102919840614. doi: 10.1177/2055102919840614. eCollection 2019 Jan-Jun. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6498783/  (Full article)

Graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective and unsafe. Re-analysis of a Cochrane review

Abstract:

The analysis of the 2017 Cochrane review reveals flaws, which means that contrary to its findings, there is no evidence that graded exercise therapy is effective. Because of the failure to report harms adequately in the trials covered by the review, it cannot be said that graded exercise therapy is safe. The analysis of the objective outcomes in the trials provides sufficient evidence to conclude that graded exercise therapy is an ineffective treatment for myalgic encephalomyelitis/chronic fatigue syndrome.

Source: Vink M, Vink-Niese A. Graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective and unsafe. Re-analysis of a Cochrane review. Health Psychol Open. 2018 Oct 8;5(2):2055102918805187. doi: 10.1177/2055102918805187. eCollection 2018 Jul-Dec.  https://www.ncbi.nlm.nih.gov/pubmed/30305916