Research requires funds and universities have overhead costs. The contributions of the Wessely School to research on ME/CFS are described in earlier posts. Here I start a series of posts on the funding sources of the universities involved.
Professor Sir Simon Wessely is the Regius Professor of Psychiatry, Director of King’s Centre for Military Health Research and, until recently, President, Royal Society of Medicine, 2017-2020.
Sir Simon Wessely is an eclectic presenter who taps effortlessly into a large store of knowledge from science, literature and the arts. He is a strategic thinker, who chooses his words carefully and deliberately. On this occasion, his topic is: “Everything you always wanted to know about mental health but were afraid to ask”.
Sir Simon is on home turf, an easy wicket on which to play smooth, well-timed strokes, with plenty of panache. No beating around the bush, Sir Simon’s first slide goes straight to the point: his competing interests. Here I quote directly from Sir Simon’s Swiss Re slide:
• Lots of funding from UK Research Councils, Wellcome, medical, military and veterans charities, UK Ministry of Defence and US Departments of Defense.
• Never had a penny from Pharma
• But frankly, my university will take money from anyone provided it comes with overheads.
Really? Can this be true?
Well, erm, yes, it is. In a later post, I will list a few specific funding sources.
A Significant Figure
In case it had escaped our attention, Sir Simon’s next slide shows a glimpse of the high circles he moves in.
A photo of a meeting with Mrs Theresa May, UK Prime Minister 2016-19.
Global Burden of Disease
The following slide turns to the meat of the presentation, mental health, and the huge global burden of disease, especially neuropsychiatric disease:
About 1 in 4 people who see their GP have such symptoms.
In a neurological outpatient setting, it is 1 in 3 patients or more
Stress is mentioned, insecurity, smoking, drinking, drugs, self-harm, internet abuse, almost everything to do with mental health, but nothing about MUS.
Skipping over 30 slides, available here – until they are taken down – Sir Simon finishes as he started, with humour and panache. Slide 34:
WHY I NEVER GIVE ADVICE
Then, slide 35:
BUT IF I DID…
• Never neglect the co morbidities • Please don’t encourage anything that gives us more labels/diagnoses
• Be careful with your language – it can influence for good and ill
Sir Simon draws to a close with slide 36’s
“Who in the rainbow can draw the line where the violet tint ends and the orange tint begins? Distinctly we see the difference of the colors, but where exactly does the one first blendingly enter into the other? So with sanity and insanity. In pronounced cases there is no question about them. But in some supposed cases, in various degrees supposedly less pronounced, to draw the exact line of demarcation few will undertake tho’ for a fee some professional experts will. There is nothing namable but that some men will undertake to do it for pay.”
“Billy Budd”, Herman Melville. 1888
I will return to this interesting conclusion later.
Imagine the conversation, which must have gone something like this:
Unum executive: Hi, how are you Mansel?
Aylward: Nor bad, thank you, I think I’ve got my ducks in a row with the university and the department.
Unum exec: Oh, great, your funding applications are being given serious attention.
Aylward: That’s wonderful, is there anything more I can do in return?
Unum exec: Well, yes, please keep plugging that biopsychosocial model thingy. Would be very good for our customers and, umm, well, yes, the profit margins of the company.
Aylward: Well, yes, sure, that’s exactly what we’re doing. We’re full steam ahead on it at the DWP also. We’ve got a new book about it coming out very soon.
Unum exec: Great. How about the book cover? Can you make it the same as our 2002 annual report?
Aylward: Well, yes, I’ll have to check with the publisher, of course, but I’m sure we can manage something quite similar.
Unum: This is why I like working with you guys, you are so cooperative.
Aylward: The feeling is mutual. Did you say the cheque’s in the post?
There’s nothing like a cartoon to get your point across. Here’s one chosen by Sir Mansel.
This picture is a favourite slide of inner circle member, Mansel Alyward, in a talk about disability medicine.
Another of Sir Mansell’s slides suggests the existence of strong scientific evidence that “we could reduce sickness absence due to common health problems by 30-50%, reduce number going on to chronic incapacity by 30-50% and, in principle, by much more” (Aylward, 2005).
In Aylward’s own words lies the policy agenda for Unum, DWP, and the Wessely School all rolled into one:
‘Get people on sickness benefits back to work as quickly as possible’.
And if you can’t get them back to work, make sure their diagnosis is mental health not physical health.”
That’s the Holy Grail, a quick sharp shock (no pun intented) of GET and CBT, or no insurance payments for the rest of your unemployed life.
Under the imprint of the Royal Society of Medicine, Waddell and Aylward (2009) applied this approach in a comprehensive analysis of sickness and disability in common health problems, e.g. back pain and CFS.
Basically, it’s all about blaming the victim.
Dog whistles everywhere
Blaming-the-victim attitudes are contagious. They may be strong in Britain but in the popularist world they are spreading absolutely everywhere. Especially in disability medicine.
The European Union of Medicine in Assurance and Social Security EUMASS met in September, 2019. Its Vice President, Dr Gert Lindenger, gave a presentation entitled: How can social security/insurance better benefit from Cochrane Reviews?
One of Lindenger’s first slides reproduces the cartoon above. The joke sends a message. The audience smirks and smiles.
Nice to see Sir Mansel’s handiwork disseminating across Europe. The sophistication of the science may not bowl one over but, hey, nobody’s perfect. Look at this piece of epidemiological wisdom:
I bet you didn’t know that!? It’s got nothing to do with the government or Brexit or COVID-19. Dr Lindenger’s arrow is arriving near you.
More seriously, another of Dr Lindenger’s slides shows the sick leave figures from across Europe, 1987-2018.
The dog whistles are becoming a little shrill, perhaps, especially for the disability medics in Norway. But three cheers, for Sir Mansel and Sir Simon, the UK is up to speed and currently producing some of the lowest numbers of sick leavers right across Europe.
Another of Dr Lindenger’s slides asks: What is the essence of a work disability claim? he gives some straightforward answers:
• Very few medical conditions will with certainty lead to a completely reduced work ability.
• An assessment of work ability often involves interpretations which includes evaluations of where the limit is drawn for what strains and pressures that should normally be tolerated – what is reasonable for asking a claimant to contribute to his/hers own support?
Just an aside, from Unum’s perspective, a third related point, does the claimant perhaps have a work-related insurance policy that can’t pay out? If so, lovely jubbly!
Insurance Companies’ Involvement
Mansel Aylward, with most other members of the Wessely School, formed strong connections with the insurance industry and with UnumProvident and Swiss Re in particular. Here I discuss the profile of Unum.
In 2005 the California Department of Insurance investigations into Unum and found “widespread fraud”, prompting California Insurance Commissioner John Garamendi to describe Unum as an “outlaw company.”
In 2012 legal website LawyersandSettlements.com reported, “Unum continues to suffer from a global reputation that it denies, delays or discontinues benefits in an alleged attempt to wear down policyholders in their pursuit of legitimate benefits.”
The Unum/Provident Scandal
Unum provides the largest share of private sickness unemployment insurance in the US and UK. It isn’t all good news for Unum however. A Unum class action lawsuit in the US has been called “The Unum/Provident Scandal.”
Unum (known then as Unum/Provident) was alleged to have denied or terminated thousands of legitimate disability claims starting in the 1990s and continuing until 2002.
The Unum class action lawsuit came about after an investigation by the US Department of Labor that put the long history of Unum claim denial under the microscope. The investigation also looked into Unum’s subsidiary companies, which at the time were Unum Life Insurance Company, Paul Revere Life Insurance Company, and Provident Life and Accident Insurance Company.
The Department of Labor found the company was acting “unfair and unjust” by deliberately resorting to fraudulent tactics of claim denial as a cost control measure. The claims involved employee group disability policies. In an investigation that involved insurance regulators from 48 states, lawsuits against Unum were granted class action status for violation of ERISA laws.
Under court order, Unum was directed to reopen more than 200,000 denied claims, and to reevaluate the claims based on their merit. Unum was charged with overhauling the methods by which they evaluate and process claims. Unum was also ordered to pay a fine of $15 million to several states.
Lesson Not Learned
After such legal actions and repercussions, Unum should have learned a lesson and learned to play by the rules. Not so.
According to the American Association for Justice in a document entitled: “The Ten Worst Insurance Companies in America“, where Unum is honoured with 2nd place, by 2007 Unum confessed that only 10 percent of the claims earmarked for reopening under the terms of the previous legal settlements had been reviewed.
New cases are ongoing
The Wessely School sure did choose some fine bedfellows.
Sir Mansel is now at a different Welsh university. Did something go wrong at Cardiff? Or is Swansea just nicer than Cardiff?
Oblivious to the context, I contributed by invitation a chapter to Halligan and Aylward’s book on The Power of Belief. My chapter about ‘subjective validation’ concerns a process that happens when one’s beliefs are confirmed by ambiguous or contrary evidence. It is especially prevalent in the field of the anomalous experiences e.g. the paranormal. I had already critiqued the biopsychosocial model in a co-authored textbook on Health Psychology, currently in its 6th edition. Awareness of the abuse of the BPSM in disability denial deepened this critique significantly.
In a series of ten posts, I have reviewed ten major planks in the Wessely School’s psychosomatic approach to ME/CFS. This St Patrick’s Day ‘end of term report’ indicates my grades as an independent assessor of the School’s performance to date. The bulk of the assessed work was completed prior to the COVID-19 pandemic. However an adjustment to the final piece of work, which moves from a U to a 1, compensates for the possible detrimental effects of the pandemic.
The information detailed in this post is drawn from the extensive detective work of David Tuller, Senior Fellow in Public Health in Journalism at the Center of Global Public Health, School of Public Health, University of California, Berkeley, California.
Unusually, the SMILE trial was published twice, first in 2018, then again, in corrected form in 2019, with an explanatory editorial and a different set of authors:
What was the SMILE trial? What were the findings? And why was it necessary to correct the trial report?
“The Lightning Process® (LP) is a trademarked intervention derived from osteopathy, life-coaching and neuro-linguistic programming, delivered over three consecutive days as group sessions. Although over 250 children with CFS/ME attend LP courses each year, there are no reported studies on the effectiveness or cost-effectiveness.
This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England. Children and young people with CFS/ME (n = 80 to 112), aged 12 to 18 years old will be randomised to specialist medical care (SMC) or SMC plus the LP. The primary outcome will be physical function (SF-36 physical function short form) and fatigue (Chalder Fatigue Scale).
This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone. This study will also provide detailed information on the implementation of the LP and SMC.”
Fears About Ethics and Safety
The ME Association and The Young ME Sufferers Trust made a joint statement saying that they “do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process.” A survey of 4,217 people carried out by the ME Association on the management of ME/CFS found that over a fifth of those who had tried the Lightning Process were made worse (7.9% slightly worse,12.9% much worse). If any trial is to be held, it should first be on adults, who can give informed consent. The statement continued by disputing its underlying theory:
The theory upon which the Lightning Process is based, together with its claim that the prolonged nature of the illness is caused by ‘the adrenaline, nor-adrenaline and cortisol loop’ is not scientifically proven. Moreover, the Advertising Standards Authority recently ruled that an advertisement in an internet sponsored link containing claims of its effectiveness by a Lightning Process practitioner should be removed. We understand that the practitioner will be involved in this study and we find this concerning…We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated ‘process’ with adults.
What were the findings?
According to the corrected report, the findings at six months from 81 of 100 participants who started the trial were as follows:
Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5 [95% CI 4.5 to 20.5], p=0.003) and this improved further at 12 months (15.1 [95% CI 5.8 to 24.4], p=0.002). At 6 months, fatigue and anxiety were reduced and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm.
Conclusion The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.
So, according to the report, LP is effective and is probably cost-effective. But is it safe? And…
Why was it necessary to correct the trial report?
The short answer to this question is that it was owing to the painstaking investigations of David Tuller.
In September, Archives of Disease in Childhood published a study called “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial” . Like many studies of this illness, it was an open-label trial with self-reported outcomes—a study design known to be highly vulnerable to bias.
The researchers have received criticism for their initial decision to conduct a pediatric trial of the Lightning Process–a commercial, pseudo-scientific intervention that combines elements of life-coaching, osteopathy, and neurolinguistics programming. The intervention encourages participants to report that it has made them better, another source of potential bias. Beyond the decision to study the Lightning Process, the study suffered from major cross-contamination between treatment arms and significant loss-to-follow-up, among other problems.
The letter also mentions a “methodological anomaly” as originally reported by David Tuller:
“An earlier feasibility trial was extended into the full trial even as the researchers swapped primary and secondary outcomes following a review of the feasibility trial results. The researchers received ethical approval for these study design changes but failed to mention them in the Archives paper, although the changes enabled the findings to be presented in a much more positive light than would otherwise have been the case.”
The letter explained specific concerns as follows:
*The researchers registered the study as a prospective trial. But more than half the sample were apparently participants recruited for the feasibility trial, starting almost two years before the registration date. The Archives paper did not mention this fact or explain the discrepancy in dates.
*In the feasibility trial protocol, school attendance at six months was the primary outcome, and self-reported physical function at six months was a secondary outcome. After reviewing results from the feasibility trial, the researchers swapped these outcome measures for the full trial—school attendance at six months became a secondary outcome, and self-reported physical function at six months became the primary outcome. The Archives paper did not disclose the outcome-swapping that occurred after more than half the sample had provided data as participants in the feasibility trial.
*As its main finding, the Archives paper highlighted the reported benefits in the Lightning Process group for self-reported physical function at six months, the new primary outcome. Self-reported school attendance at six months, now a secondary outcome, yielded null results and received scant mention in the Archives paper. Thus the outcome-swapping allowed the researchers to report positive results for their primary outcome. Had they not switched the outcomes after more than half the sample had provided data, they would have had to report null primary outcome results
*Not surprisingly, the media coverage of the Archives paper focused on the reported benefits in the Lightning Process arm for the revised primary outcome of self-reported physical function at six months. The null results for school attendance at six months, the original primary outcome, were largely ignored. The outcome-swapping that occurred after more than half the sample had provided data—and that the Archives paper did not mention—ensured that the reported findings received more positive media coverage than they otherwise would have.
The Science Media Centre, for whom one of the trustees is – guess who – Professor Sir Simon Wessely, gave expert reactions to the SMILE trial by four ‘experts’. IMHO, their comments on the study are damning with faint praise, almost zero praise, to be precise. In fact, these commentators chosen for their likely positive take on the study, raised issues about the biased and uncontrolled methodology.
Prof. Alastair Sutcliffe, Professor of General Paediatrics, UCL:
“A recent systematic review of neurolinguistic programming (NLP) stated “There is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.” [Br J Gen Pract. 2012 Nov; 62(604): e757–e764. Published online 2012 Oct 29. doi: 10.3399/bjgp12X658287, PMCID: PMC3481516]. But now we have this interesting study by Crawley, a well-conducted single blind clinical trial that suggests NLP, in combination with other therapies and described as the ‘Lightning Process’, is effective for some children with the very hard to treat condition of chronic fatigue syndrome (CFS).
“Although in my view the effects described show some benefit and are therefore to be welcomed, this could be due to placebo which would still be GOOD news. Costs are modest and therefore this study is to be welcomed.
If the SMILE trial is only acting as a placebo effect, then much cheaper placebos are available and so LP would therefore not be a great choice.
Prof. Dorothy Bishop, Professor of Developmental Neuropsychology, University of Oxford:
“The gains for patients in this study do seem solid, however, I am still rather uneasy because while the patient allocation and statistical analysis of the trial appear to be done to a high standard, the intervention that was assessed is commercial and associated with a number of warning signs. The Lightning Process appears based on neurolinguistic programming, which, despite its scientific-sounding name, has long been recognised as pseudoscience.
“I am sympathetic to the authors’ decision to evaluate the Lightning Process (LP), given that they had patients who had used it and reported favourably on it, and it could be argued that to fail to do so would indicate a degree of closed-mindedness. But the commercial nature of LP really creates problems. We cannot tell which aspect of LP is responsible for the gains in patients who took part.
“I noticed, for instance, that LP involves group sessions, whereas the comparison group undergoing standard medical care were treated individually. So it may be that the benefits derive from interacting with other children with chronic fatigue syndrome/ME, rather than the specific exercises and training.”
Again, the comment draws attention to the problems with LP – its warning signs of NLP and pseudoscience, badly designed study using dissimilar group conditions, inability to tell what aspects made a difference, if any.
Dr James Thompson, Honorary Senior Lecturer in Psychology, UCL:
“The treatment in this study looks like it had an effect, at least by the standard of most clinical trials. To be extra robust I would have liked to see more objective measures, but unfortunately chronic fatigue syndrome is not an objective diagnosis, it is a leftover category and fatigue is subjective.
“One limitation is that self-report scales can be subject to placebo effects, however if the patients feel better in the experimental condition in which they receive extra help, even if everyone knows it, then that is something and the pupils miss less school, which is an objective measure. In this case it may not have been the CBT element of the treatment, but it looks like it.”
Once again, a placebo effect is suggested, with subjective outcomes, so not a positive comment.
Prof. Michael Sharpe, Professor of Psychological Medicine, University of Oxford
Finally, the comments from an ‘inner circle member’:
“Chronic fatigue syndrome (CFS) is a name for an illness with symptoms of long lasting and disabling fatigue. It affects many young people and can interfere with their education. Whilst some people call it myalgic encephalomyelitis (ME) it is not clear if this is the same or a different condition.
“This trial tests the effectiveness of a commercially available brief intensive talking therapy for CFS called the Lightning Process. The treatment has similarities to cognitive behaviour therapy (CBT) and is given in groups. The treatment was found to be better than usual care in fatigue, physical function and school attendance, with benefit seen as long as a year later. It was also safe. The study does not tell us how it works however.
“This is a robust study because patient were allocated to one of the two treatments at random ensuring that any difference seen in outcome between these treatments, is not due to pre-existing differences in the patients. The main limitation is that, as it is not possible to hide which treatment they received from the patients, their self-ratings of fatigue and functioning could potentially be biased by their views on the treatment they received. However, differences in the school attendance a year later were also noted; it seems likely that these could be due to such a bias.
“Commercially available treatments like this one that are being used by patients should be rigorously tested. This is especially important for an illness like this one about which much misinformation is spread using social media. We need more studies and less polemic.”
Again, there are negative comments about the design, which Professor Sharpe believes could have biased the findings.
The SMILE trial contained one of the major methodological problems that occurred in the PACE trial – outcome swapping. The original outcome measure, school attendance at six months, yielded a null result.
Repeating the errors of the PACE trial, the SMILE trial used self-reported physical function, a subjective outcome measure rather than an objective one.
Media coverage reported the positive outcome (improved self-reported physical function) but tended to not mention the null result concerning school attendance.
In seeing a distorted view of the findings, authorities in other countries such as Norway have been persuaded to run further trials on the Lightning Process and to recommend its use for pwME/CFS.
Here I review research by the Wessely School on the Lightning Process (LP). LP is a pseudoscientific cult founded by Phil Parker, a Tarot reader, specialist in auras and spiritual guides, and an osteopath. It has triggered a spate of shoddy evidence and false claims that brings a new low level to the checkered history of ME/CFS research and care, and takes the Wessely School with it to rock bottom.
Phil Parker’s qualification as a trainer/therapist have been described by him as follows:
“Phil Parkeris already known to many as an inspirational teacher, therapist, healer and author. His personal healing journey began when, whilst working with his patients as an osteopath. He discovered that their bodies would suddenly tell him important bits of information about them and their past, which to his surprise turned out to be factually correct! He further developed this ability to step into other people’s bodies over the years to assist them in their healing with amazing results. After working as a healer for 20 years, Phil Parker has developed a powerful and magical program to help you unlock your natural healing abilities. If you feel drawn to these courses then you are probably ready to join.”
I, for one, am pleased that I do not feel drawn to Phil Parker’s courses. I had the chance. They were running above my local grocers in Crouch End, London. I would have happily run a mile to avoid them.
What is the Lightning Process?
The LP is described as “a neuro-physiological training programme based on self-coaching, concepts from Positive Psychology, Osteopathy and Neuro Linguistic Programming” (Parker, Aston & Finch, 2018).
The developer of LP Phil Parker describes it in these words: LP “Is a training programme that teaches you to change the way your nervous system controls your body.Its empowering tools involve gentle movement, meditation-like techniques and mental exercises.With practice you’ll learn how to switch on pathways which promote health and switch off ones which aren’t so good for you….With practise you can use them to change the way your nervous system works, switching on pathways which promote health and switching off ones which aren’t so good for you.”
LP has attracted a following in the UK, Norway, and other countries. LP practitioners are trained to promote it as a treatment for many serious medical conditions including ME/CFS. The approach can be easily identified as pseudo-science.
· Perform magical rituals such as standing in circles drawn on paper with positive keywords inscribed.
· Learn to render short rhymes when you feel the symptoms, no matter where you are, as many times as necessary for the symptoms to go away.
· Speak only in positive terms and think only positive thoughts .
· If symptoms or negative thoughts occur, extend your arms with the palm of your hand pointing outwards and shout “ Stop! «.
· You are responsible for having ME. You choose to have ME yourself. But you are free to choose a life without ME if you want to.
· If the method does not work, you are doing something wrong.
What the Experts Say
David Tuller, DrPH, Senior Fellow in Public Health and Journalism, Center for Global Public Health, School of Public Health, University of California, Berkeley has commented: “The Lightning Process is the woo-woo pseudo-nonsense that trains people to reject their illness and engage in positive affirmations, among other strategies.”
Brian Hughes, PhD, Professor in Psychology, University of Galway, Ireland, points out that LP “comprises a number of modalities that are normally classified as pseudosciences. It is based largely on NLP, which is a completely discredited practice…All told, there is nothing to suggest that the ‘Lightning Process’ is a promising clinical modality. It has no scientific plausibility; it exists because commercially-minded providers of pseudoscientific treatments have successfully identified a market for it. In that regard, it occupies the same space as, say, crystal therapy.”
Edzard Ernst MD, PhD, FMedSci, FRSB, FRCP, FRCPEd, Emeritus Professor at the University of Exeter, has commented: “So, what do we call a therapy for which numerous, far-reaching claims are being made, which is based on implausible assumptions, which is unproven, and for which people have to pay dearly? The last time I looked, it was called quackery.”
Lightning Process and the Wessely School
In 1989, Professor Wessely wrote about alternative therapies as follows: “Almost all patients referred to hospital with CFS will have tried a variety of ‘alternative’ therapies… The patients’ faith in treatments which may be beneficial to specific individuals should not be undermined but not all such therapies can be given approval…It is a doctor’s duty to protect the patient from such exploitation, which may be medically and financially harmful. The willingness to try such untested treatments should be viewed as a reflection of the patients desperate need for help” (Wessely, et al. 1989).
Things have changed. Research on one particular alternative therapy, LP, which they call a ‘training’, has become an active research topic at the Wessely School with two publications to date:
Author Lisa de Rijk, is a visiting research fellow at King’s College London as well as a Neurolinguistic Programming “master trainer,” change consultant, and applied psychologist, according to her Linked In profile. The other author has a KCL degree but does not appear to have a current affiliation.
Parker and his two KCL-affiliated co-authors describe the 14 studies they found after a search of the literature. The study has been eloquently reviewed by David Tuller. Six studies were identified as surveys, three as qualitative studies, two as (non-survey) quantitative studies, one as a case report, one as a “proof-of-concept” study, and one as a randomized clinical trial. Six of them were identified as having been peer-reviewed.
According to the conclusions, the review “identified an emerging body of evidence supporting the efficacy of the LP for many participants with fatigue, physical function, pain, anxiety and depression. It concludes that there is a need for more randomised controlled trials to evaluate if these positive outcomes can be replicated and generalised to larger populations.”
The evidence of purported efficacy is not at all convincing and there are reports of bullying and unethical behaviour. According to the Norwegian ME association ME Foreningen in (2012), Lightning Process is one of the treatments that has done the most harm to patients. LP resulted in 50% of the ME patients reporting that LP had made their condition worse, 25% seriously worse. 30% reported that LP had no effect on symptoms.
Yet, ‘experts’ affiliated to the Wessely School have been swarming like flies to applaud a recent LP study, including Michael Sharpe. But more on this later.
By lending credibility to the pseudoscientific cult that is the Lightning Process, the Wessely School has finally reached rock bottom.
Following the exposure of a King’s College London grandee, Hans Eysenck, and the scandal of the PACE trial, the Wessely School is about to take another major hit.
The LP ‘training process’ dares not to describe itself as a therapy for fear of recriminations.
LP training has been rejected by NICE and sinks to the bottom to join the Wessely School and other forms of quack medicine.
Thanks to Tom Kindlon for his feedback on an earlier version of this post.
One of the first studies on the hypothesized attentional biases of pwCFS was by Rona Moss-Morris and Keith J. Petrie from the Department of Health Psychology, the University of Auckland, New Zealand (Moss-Morris & Petrie, 2003). They tested whether pwCFS have an “attentional information processing bias for illness-related information and a tendency to interpret ambiguous information in a somatic fashion”. Twenty-five CFS patients were compared to 24 healthy matched controls on a modified Stroop task and an ambiguous cues task in which they heard a tape-recorded list of 15 ambiguous illness words (e.g., vein/vain) and 15 unambiguous words. The participants were asked to write down the first word that came into their heads.
Moss-Morris and Petrie found no evidence for illness-related words creating greater attentional interference than neutral words on the Stroop task. However, on the ambiguous cues task, pwCFS made significantly more somatic interpretations than controls and this bias was associated with the extent to which they currently reported symptoms. Moss-Morris and Petrie concluded that :CFS patients have an interpretive bias for somatic information which may play a part in the maintenance of the disorder by heightening patients’ experience of physical symptoms and helping to maintain their negative illness schemas. Although patients did not show an attentional bias in this study, this may be related to the methodology employed” (p. 195). An interpretative bias is not an attentional bias, so this 2003 study produced a null result.
investigated whether pwCFS show attentional bias towards health- threat information. On this occasion, the sample consisted of 14 pwCFS and 18 healthy controls.Hou et al. used a visual probe task which presented health-threat and neutral words and pictures for 500 ms and self-report questionnaires to assess CFS symptoms, depression, anxiety, and social desirability. Compared to a control group, the CFS group showed an “enhanced attentional bias (AB) towards health-threat stimuli relative to neutral stimuli.” The finding of an enhanced AB towards health-threat information in pwCFS is claimed by the authors of being supportive of “models of CFS which underlie cognitive behavior therapy”. However, it would be a long and dangerous leap from this modest result of a difference between groups (which may have a vast number of interpretations) to any kind of inference of causality.
continued to investigate attentional bias towards health-threat stimuli with enlarged samples of 27 CFS patients and 35 healthy controls. The participants did a Visual Probe Task to measure attentional bias, and an Attention Network Test measuring executive attention, alerting and orienting. They also completed self-report measures of CFS and mood symptoms. Compared to the control group, the authors state that the “CFS group showed greater attentional bias for health-threat words than pictures; and the CFS group was significantly impaired in executive attention. Furthermore, CFS individuals with poor executive attention showed greater attentional bias to health-threat related words, compared not only to controls but also to CFS individuals with good executive attention” (p. 9).
systematically reviewed experimental studies of attention and interpretation bias towards negative and illness-related information in people with CFS and healthy controls to December 2014. The results were overall inconclusive: “Some people with CFS have biases in the way they attend to and interpret somatic information. Such cognitive processing biases may maintain illness beliefs and symptoms in people with CFS” (italics are mine). When the stated conclusion is identical to the starting hypothesis, as in this case, it is safe to assume there were no new findings. Their review highlighted methodological issues in experimental designs.
The Nijmegen connection
Jointly with two colleagues in Nijmegen, Stephanie Nikolaus and Hans Knoop, Hughes et al. (2018) replicated a UK study with a Dutch CFS population. The authors claim that in two cultures, “people with CFS demonstrate biases in how somatic information is attended to and interpreted”. What has not been shown in either culture, however, is that these biases cause or exacerbate ME/CFS symptoms which is a fundamental claim in the Wessely School theory of ‘boom and bust’ ME/CFS.
conducted a systematic review and suggested a general theory of what they term “functional cognitive disorder (FCD)” which is a disorder of cognitive dysfunction in the absence of an organic cause. They claim FCD is becoming increasingly prevalent and that the cognitive profiles in fibromyalgia (FM), chronic fatigue syndrome (CFS) and functional neurological disorders (FNDs) provide a ‘template’ for characterising their proposed new syndrome suggesting common underpinnings. They hypothesise that “pain, fatigue and excessive interoceptive monitoring produce a decrease in externally directed attention. This increases susceptibility to distraction and slows information processing, interfering with cognitive function, in particular multitasking. Routine cognitive processes are experienced as unduly effortful” (Teodoro, Edwards and Isaacs, 2018).
The results indicated that pwCFS do not show generalised abnormalities of attention or any general syndrome of a functional cognitive disorder. However, the review suggested to Teodoro et al. that some studies have shown that CFS patients may be prone to distraction in the Stroop task but this finding was not confirmed in all studies. Again, attentional bias to threat and towards emotionally negative information have been observed but unconfirmed. Owing to the very mixed bag of heterogeneous findings and “methodological shortcomings”, the authors were unable to make any general conclusions about the proposed new syndrome, or about CFS in particular.
To date, not a single published study confirms the hypothesis H3 that attentional bias causes or exacerbates symptoms of ME/CFS.
A mixed bag of heterogenous studies of mainly low quality containing multiple unresolved methodological issues. Two systematic reviews also yielded no definite conclusions about the association between attentional bias and ME/CFS.
As is the case for both H1 and H2, hypothesis H3, creates a chicken-egg problem: which comes first, attentional bias or the illness? Without controlled prospective studies, this question will remain unanswered, and the hypothesized causal link purely speculation.
This is the third hypothesis out of three in the Wessely School’s explanation of ME/CFS aetiology that receives no empirical support in the now extensive literature.
The theory, and its associated baggage of rag-tag treatments, should be abandoned.
Future posts will examine treatments recommended by the school, their effectiveness and safety.
A previous post examined the Wessely School hypothesis that ME/CFS is caused by unhelpful beliefs. This idea was exploded as a myth. Here I examine a second Wessely School hypothesis (H2) that states:
Deconditioning causes, or exacerbates the symptoms of, ME/CFS and MUS.
Deconditioning refers to multiple, potentially reversible changes in body systems brought about by physical inactivity and disuse. The theory proposes that patient’s claims of an inability to exercise or exert themselves is due to a reluctance to or fear of exercise. Psychological interventions in the form of CBT are indicated to help the patient overcome their dysfunctional beliefs and physical exercise such as GET is offered to help the patient to recondition their body. Without properly controlled trials and investigations it is impossible to determine which is cause and effect, the illness or the deconditioning. If deconditioning causes or contributes to ME/CFS, then signs of deconditioning should be more pronounced in the sicker patients and less pronounced in the less sick ones. In this section, I review the evidence for and against the deconditioning hypothesis of ME/CFS and MUS. Relevant studies have been conducted over a period of 20+ years. An early uncontrolled study suggested an association between CFS and deconditioning (De Lorenzo et al. (1998). To take a study seriously it must meet the minimum criteria for a controlled study: groups matched at baseline, blinded testing, with objective measures.
Fulcher and White (2000)
measured strength, aerobic exercise capacity and efficiency, and functional incapacity in pwCFS who did not have a current psychiatric disorder. Compared with sedentary controls, pwCFS were found to be physically weaker, had a significantly reduced exercise capacity, and perceived greater effort during exercise, but were equally unfit. Fulcher and White concluded that pwCFS were weaker than sedentary and depressed controls and as unfit as sedentary controls. The data were consistent with the hypothesis that physical deconditioning helps to maintain physical disability in CFS and that a treatment designed to reverse deconditioning would help to improve physical function. However there was a problem with the procedures used to test the participants. However, as the authors acknowledge, the lack of ‘blind’ testing and other issues could have biased the results: “ We would in any case advise caution in interpreting and generalising from these data because of the bias inherent in a case-control study, the need for replication of these data, the lack of blindness in some of the measures, and the few comparison patients with a major depressive illness.” (Fulcher & White, 2000, p. 307).
Timmers et al. (2002)
found that head-up tilt evokes postural tachycardia or (pre)syncope in a minority of CFS patients. The authors concluded that observations in head-up tilt-negative CFS patients of a higher heart rate at baseline together with a marked decrease in stroke volume in response to head-up tilt could point to deconditioning.
Not so fast! Please read on to the end…
A narrative review
by Clark and White (2005) concluded that: “Patients with CFS are at least as deconditioned as sedentary but healthy controls. Supervised graded exercise therapy reduces fatigue and disability in ambulant patients with CFS; efficacy may be independent of reversing deconditioning…Further work is necessary to elucidate the risks, benefits, and mechanisms of such treatment, especially in children and the severely disabled” (p. 237).
A subjective measure and high drop-out rate
Moss-Morris, Sharon, Tobin and Baldi (2005) investigated GET in a sample of 49 CFS patients who were randomized to a 12-week graded exercise programme or to standard medical care. After treatment the group who had received GET rated themselves as significantly more improved and less fatigued than the control group. A decrease in symptom focusing rather than an increase in fitness mediated the treatment effect. The authors concluded that GET “appears to be an effective treatment for CFS and it operates in part by reducing the degree to which patients focus on their symptoms” (p. 245). The main problem with this study was the use of subjective measures of illness improvement and the high drop-out rate of 47% (23/49) from the physiological tests and the non-significant physiological improvement with ten patients refusing to have a second test as they believed the initial test was harmful to them.
A skeptical Catalonian study
concluded that “the decrease in the peak workload achieved in arm or leg exercise by CFS patients would not be justified exclusively by their personal characteristics or deconditioning” (Javierre et al., 2007).
A curiously Contrarian study
Harvey, Wadsworth, Wessely and Hotopf (2008) reviewed the aetiology of CFS and tested hypotheses relating to immune system dysfunction, physical deconditioning, exercise avoidance, and childhood illness experiences, using a large prospective birth cohort consisting of 4779 participants from the National Survey of Health and Development. Participants were prospectively followed for the first 53 years of their lives with 20 separate data collections. The authors identified CFS through self-report during a semi-structured interview at age 53 years with an additional case notes review. Of 2983 participants assessed at age 53 years, 34 percent reported a diagnosis of CFS and were no more likely to have suffered from childhood illness or atopy. Interestingly, the authors found that “increased levels of exercise throughout childhood and early adult life and a lower body mass index were associated with an increased risk of later CFS. Participants who later reported CFS continued to exercise more frequently even after they began to experience early symptoms of fatigue…Continuing to be active despite increasing fatigue may be a crucial step in the development of CFS” (p. 488). Based on Harvey et al.’s prospective evidence, which can give a valid interpretation of causality, exercising rather than its lack appears as a possible cause of later ME/CFS.
This temporal, dose–response relationship suggests that psychiatric disorders, or shared risk factors for psychiatric disorders, are likely to have an aetiological role in some cases of CFS/ME.
An inconclusive update
of an earlier review (Larun et al., 2014) observed that: “Exercise therapy did not worsen symptoms for people with CFS. Serious side effects were rare in all groups, but limited information makes it difficult to draw firm conclusions about the safety of exercise therapy” (Larun, Brurberg, Odgaard-Jensen & Price, 2019). The authors arrived at a set of appropriately modest conclusions. In comparing exercise therapy with a ‘passive’ control, they state:
“Exercise therapy probably reduces fatigue at end of treatment… We are uncertain if fatigue is reduced in the long term because the certainty of the evidence is very low…We are uncertain about the risk of serious adverse reactions because the certainty of the evidence is very low…Exercise therapy may moderately improve physical functioning at end of treatment, but the long‐term effect is uncertain because the certainty of the evidence is very low. Exercise therapy may also slightly improve sleep at end of treatment and at long term. The effect of exercise therapy on pain, quality of life and depression is uncertain because evidence is missing or of very low certainty.” In sum, no definite conclusions about exercise and CFS patients could be reached.
The literature’s a mess
Nijs et al. (2011) conducted a systematic review to examine whether pwCFS differ from healthy sedentary controls in physiological exercise capacity, physical activity level and muscle strength. They refer to the conflicting data concerning physiological exercise capacity of pwCFS but suggest that the “weighted available evidence points towards a reduced physiological exercise capacity in CFS. Future studies should use a wash-out period for medication use, blinded assessments, a priori power calculation and a sedentary control group comparable for age, gender, body weight, body length and current physical activity level” (p. 1493).
A deleterious immunological effect of GET predicted
Another review by Pierce, Pierce and Campus (2008) discussed the deleterious immunological effect that is likely to follow the use of GET in pwME: “initial over-exertion (a period of metabolic stress) in conjunction with viral infection depletes concentrations of the metabolic regulator glutathione, initiating a cascade of physiological dysfunction…the exacerbation of symptoms for the majority is not subjective but has a physiological basis. Blanket recommendation of GET is not prudent for such a heterogeneous group of patients, most of which are likely to respond negatively to physical activity” (p. 55).
Finally, a properly controlled cardiological study
As noted, previous studies have established that effort intolerance along with a prolonged recovery from exercise and post-exertional exacerbation of symptoms are characteristic features of ME/CFS. Finally, Van Campen and Visser (2018), two cardiologists in the Netherlands, carried out a well-controlled investigation entitled: “The abnormal Cardiac Index and Stroke Volume Index changes during a normal Tilt Table Test in ME/CFS patients compared to healthy volunteers, are not related to deconditioning.”
At last, a well-controlled cardiological study of the deconditioning hypothesis that leaves no doubt about its findings.
Figure 2: shows the percent change of the stroke volume and cardiac index in ME/CFS patients with mild, moderate and severe disease according to the ME criteria.Reproduced from van Campen and Visser (2018).
There were no significant differences between the three groups suggesting that deconditioning does not explain the larger decrease in stroke volumes and cardiac output in ME/CFS patients compared to healthy volunteers.
Over the 20-+ year period since research on ME/CFS and deconditioning first began, this is the first controlled investigation that looks at disease severity in a test of the conditioning hypothesis. The study clearly indicates that deconditioning is NOT causally associated with ME/CFS severity, contrary to H2.
After 20+ long years, a study by two cardiologists in the Netherlands, van Campen and Visser, have laid to rest the idea that ME/CFS symptoms are caused by deconditioning.
It seems far more likely that ME/CFS causes deconditioning, not vice versa.
This is the second of the Wessely School myths that has been exploded.
The use of GET for ME/CFS patients should be banned immediately.
ME/CFS patients must be listened to. At this stage, they are the only genuine experts, so it would appear.
The Wessely School approach to ME/CFS and MUS hypothesizes a causative role for unhelpful beliefs (H1), deconditioning (H2), and biased attention (H3).
The evidence related to these three hypotheses is reviewed in turn. Here I consider H1: that unhelpful beliefs cause, or exacerbate, the symptoms of ME/CFS and MUS.
Future posts will review the evidence for H2 and H3.
Do unhelpful beliefs cause, or exacerbate, the symptoms of ME/CFS and MUS?
Unhelpful or dysfunctional illness beliefs referred to by the Wessely School include:
The belief that ME/CFS symptoms are the result of a physical illness (Note: if ME/CFS actually is a physical illness, the belief would be a true belief, and the only way it could be said to be unhelpful would be for a therapist wanting to claim otherwise)
The belief that exercise or too much activity has “harmful effects” which leads to “fear of exercise” (so-called ‘kinesiophobia’)
There is a huge evidence-base from studies relevant to beliefs, ME/CFS and MUS, which can be estimated to number in the thousands. However not all beliefs are dysfunctional beliefs. Also, as is typical in psychological research, the vast majority consist of cross-sectional studies which carry no evidential weight for or against any causal hypotheses.
Another sizable section of articles consists of narrative reviews, which, like this article, are intended to provide an interpretation of the evidence but do not and cannot provide a definitive case for or against causation. A small section of studies are randomised controlled trials (RCTs) which, if well-designed with appropriate controls and outcome measures, can indicate causal associations between treatments and outcomes. A small number of prospective, observational studies offer support for the role of beliefs in illness, but not specifically ‘unhelpful beliefs’.
The table presents a set of studies which have been chosen to be representative of the literature.
Table 1. Research on Unhelpful Beliefs, Illness and Interventions
CONCLUSIONS AND/OR INTERVENTIONS
Cancer preventionand prologationof life
Narrative reviewinterpreting ‘unsafe’ data
Eysenck, H. J. (1987). Some publications by Hans Eysenck on this topic were deemed ‘unsafe’ by a KCL Enquiry. To date, 86 papers are retracted or flagged for concern (Retraction Watch Database, 2021). However, several dozen of H J Eysenck’s publications based on the same ‘unsafe’ data-sets remain unretracted and this form part of the scientific literature.
None reported. However it has been established that the tobacco industry had secretly contributed large sums towards the project (Buchanan, 2010; Pelosi, 2019).
Hans Eysenck’s conclusion was stated as follows: “A detailed discussion is given of work …on the relationship between psychosocial factors and cancer. including the prophylactic use of behaviour therapy …to make possible the prevention of cancer or the prolongation of life in patients who are incurably ill.” In spite of the fact that Hans Eysenck’s research on personality and cancer was funded by undeclared tobacco industry sources, the publications remain in the scientific literature. Evidently, the host institution (King’s College London), the journal publishers and editors are all content to allow these grossly misleading publications to remain uncorrected and unretracted in the scientific literature as citable contributions to science and medicine.
Wessely, David, Butler, & Chalder (1989)
“You have had an acute illness, probably infectious in origin, which forced you to become inactive for a period of time. Subsequently you have begun to experience fatigue on exertion and as a result you have started to limit or avoid activity of all sorts…This means that you develop symptoms at increasingly lower levels of exercise…When you experience these symptoms, you have also experienced associated thoughts, such as ‘If I carry on I may become worse’, or ‘There must be something seriously wrong with me to make me feel like this’. These symptoms are real, but… you may have incorrectly attributed them to a recurrence of the original infection. This is particularly likely because the symptoms of muscle pain, breathlessness, dizziness, fatigue and others are similar to those experienced initially. This has led to a vicious circle of increasing avoidance, inactivity and fatigue.”
Coronary heart disease and mortalityNarrative reviewinterpreting ‘unsafe’ data
Eysenck, H.J. (1991). See note above.
None reported but the tobacco industry contributed large sums towards the project.
“autonomy (i.e., the ability to be independent in one’s thoughts, feelings, and actions, even under stress) is important for survival and is a valuable countermeasure as far as cancer and CHD are concerned.”
Moss-Morris, Petrie & Weinman (1996)
Auckland Institute of Technology Interim Research Committee.
“organic CFS patients have distorted perceptions of effort and sensation which may contribute to their functional disability”.
Post-traumatic stress disorderRCT
Marks, I., Lovell, K., Noshirvani, H., Livanou, M., & Thrasher, S. (1998)
Wellcome Trust, London, England.
“Patients were taught to spot dysfunctional thoughts and thinking errors, elicit rational alternative thoughts, and reappraise beliefs about themselves, the trauma, and the world.”
Rehabilitation to workNarrative review
Waddell & Burton (2004)
Department for Work and Pensions, UK
“…symptoms are by definition subjective and therefore at least partly a matter of perceptions.” “Changing dysfunctional perceptions, attitudes and behaviour is central to rehabilitation of many common health problems.”
Browne & Chalder (2009)
“Two models of understanding CFS, a cognitive behavioural model and a deconditioning model, are then introduced alongside the treatments on which they are based. Both cognitive behavioural therapy and graded exercise therapy have been recommended by the National Institute for Health and Clinical Excellence as they are the treatments for which there is most evidence.” See Figure 3. Note: NICE changed its guidance in 2020 suggesting that GET should be avoided and CBT is less effective than previously assumed.
Knoop H, Prins JB, Moss-Morris R, Bleijenberg G (2010).
Dutch MS Research Foundation (Stichting MS Research).
“Three different cognitive processes may play a role in the perpetuation of CFS symptoms. The first is a general cognitive representation in which fatigue is perceived as something negative and aversive and CFS is seen as an illness that is difficult to influence. The second process involved is the focusing on fatigue. The third element is formed by specific dysfunctional beliefs about activity and fatigue.”
ME/CFS PACE trialRCT with multiple methodologic-al flaws
White et al. (2011)
UK Medical Research Council (MRC G0200434 ), the Department of Health for England, the UK Department for Work and Pensions, and the Chief Scientist Office of the Scottish Government Health Directorates.
“CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.”
Medically unexplained symptoms Narrative review
Deary, V., Chalder, T., & Sharpe, M. (2007)
“Hotopf (2004) has compared the role of doctors in MUS to that of parents of sick children. Both can reinforce unhelpful illness behaviour and symptom interpretations.” “The links so far found between central nervous system processes, such as the HPA axis, and immunological processes are intriguing but far from conclusive; the causal relationships are unclear”. “High neuroticism may offer an underlying common mechanism for distress sensitivity and intolerance which lowers the threshold for symptom detection (both mental and physical), and leads to increased propensity to conditioned responses, more attention to threat stimuli and more avoidant coping. The neuroticism concept captures many of the factors hypothesised to be at work in MUS.”
Multiple sclerosisCross-sectional study
Dennison, L., Moss-Morris, R., Silber, E., Galea, I., & Chalder, T. (2010)
UK MS Society. NIHR Biomedical Research Centre, South London and Maudsley NHS Foundation Trust / Institute of Psychiatry King’s College London.
“Illness severity factors explained only 2.2% of the variance in distress (p>.05) while cognitive and behavioural variables accounted for 37.1% (p<.001). Unhelpful beliefs about the self were the strongest predictor.”
Mortality and diabetic foot ulcersProspective observational study
Vedhara K, et al. (2016).
Medical Research Council, UK (MC_U145079313). JNVM receives salary support from the RAND Corporation.
“illness beliefs have a significant independent effect on survival in patients with diabetes and foot ulceration.”
Irritable bowel syndrome Systematic review
Windgassen et al. (2017)
National Institute of Health Research, HTA 11/69/02. TC partly funded by the Biomedical Research Centre for the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry.TC received travel expenses and fees for workshops on irritable bowel syndrome.
“change in illness‐specific cognitions is a key process by which psychological treatments may have an effect on the outcomes of symptom severity and QoL.” The only significant effect related to so-called identity beliefs (‘How much do you experience symptoms?’), not beliefs that are specifically ‘unhelpful’.
Mortality and predialysis chronic kidney diseaseProspective observationalstudy
Muscat, P., Weinman, J., Farrugia, E. et al. (2020)
“CKD patients’ perceptions of treatment control, perceptions of a chronic timeline and perceived illness identity predict survival independently of clinical prognostic factors, including kidney function and co-morbidity. Illness perceptions are important and potentially modifiable risk factors in CKD.” ________________________ The beliefs that were evaluated cannot be specifically classified as ‘unhelpful’.
Paediatric chronic fatigue syndromeCross-sectional study
Loades, M., Crawley, E., Chalder, T., & Flannery, H. (2021)
National Institute for Health Research; Department of Health via the NIHR Specialist Biomedical Research Centre for Mental Health award to the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry at King’s College London.
“the Lightning Process, based on Neurolinguistic Programming (NLP), when offered in addition to treatment as usual (TAU), was more clinically and cost effective compared to TAU alone (Crawley et al., 2017).”
Interpretation of the findings
An overall appraisal of the findings suggests that no published study has yet provided any empirical evidence of a causal relationship between unhelpful beliefs and ME/CFS symptoms.
The majority of ME/CFS studies have used a correlational approach, which as noted, has no evidential value in relation to causation. Cross-sectional studies are irrelevant to a causal hypothesis. The difference between correlational and causal relationships is fundamental but often it alludes even seasoned investigators.
Some studies used the Revised Illness Perception Questionnaire (IPQ-R) (Moss-Morris, Weinman, Petrie, Horne, Cameron & Buick, 2002). Although the authors often talk about illness beliefs and illness perceptions, they do not measure ‘unhelpful beliefs’. Studies that do not measure unhelpful beliefs are not relevant to H1. The IPQ-R measures identity, timeline, cyclical timeline, treatment control, personal control, coherence, causes and emotion reaction. None of these factors can be construed as a measure of unhelpful beliefs. For example, illness identity is measured by symptoms in which patients have to report whether they experienced the symptoms and, if so, whether they attributed the symptom to their illness. The number of symptoms attributed to their illness is summed with higher scores indicating increased illness identity. However, the latter score could equally be a measure of illness severity.
Petrie and Weinman (2012) claim that: “Illness perceptions change rapidly in response to diagnostic results and have been associated with emotional distress, recovery, and disability, as well as with treatment-related behaviour such as adherence”. However illness perceptions are not unhelpful beliefs and the only studies reviewed by them that used a prospective design did not measure unhelpful beliefs.
The largest RCT known as the ‘PACE trial’ (White et al., 2011) was in part concerned with the efficacy of CBT to control unhelpful beliefs but owing to a catalogue of methodological errors, the trial has been discredited (Marks, 2017;Wilshire, Kindlon, Matthees & McGrath, 2017; Wiltshire et al., 2018). Another RCT called the ‘FINE’ trial involving gradually increasing activity designed collaboratively by the patient and the therapist and supportive listening found no evidence of efficacy (Wearden et al., 2006).
Two MUS studies with patients with foot ulcers (Vedhara et al., 2016) and chronic kidney disease (Muscat, Weinman, Farrugia et al., 2020) used a prospective, observational design enabling conclusions about causation. However the beliefs that were measured were not unhelpful beliefs but beliefs related to ‘identity’ (‘How much do you experience symptoms?’) as noted above. This question can be interpreted as a measure of symptom severity and thus the observed effect on increased risk of mortality may only be attributed to greater symptom severity not to beliefs at all.
Eysenck and Grossarth-Maticek’s publications on unhelpful beliefs or similar constructs (e.g. helplessness and hopelessness) are retracted, listed with expressions of concern, or regarded by this author as unsafe (see Marks & Buchanan, 2018, for details).
In the opinion of this author, the hypothesis that unhelpful beliefs cause or exacerbate symptoms of ME/CFS and MUS receives no empirical support in the research literature.
If true, this conclusion has several implications:
As previously suggested, there is a plausible scientific explanation of ME/CFS in terms of a breakdown of homeostasis. If the biological explanation is true then ME/CFS patients’ beliefs that their symptoms are physically real are accurate.
2. The claim by therapists that patients who say they experience physical symptoms are holding unhelpful beliefs is a falsehood.
3. One has a right to ask the question: to whom are the so-called ‘unhelpful beliefs’ unhelpful – patients or therapists?
4. Patients who have CBT and/or GET to change their ‘unhelpful beliefs’ are fighting a losing battle. It is a no win situation. Refuse the therapy and you are being unhelpful (proving the therapist right). Do the therapy and show no improvement and when you say you’re not feeling any better, you’re being unhelpful all over again. A Catch 22 situation.
CBT Therapists out there: If you consider that my interpretation of the evidence is incorrect, please send me full details of the contradicting studies, and I will reconsider my position.
In a series of posts I review the Wessely School’s influence on science, treatment and – most importantly – ME/CFS patient experience. In previous posts I outlined here the likely biological basis of ME/CFS and here treatment harms to patients. This post introduces the Wessely School’s approach to ME/CFS and medically unexplained symptoms.
What is ME/CFS?
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating multisystemic disease of unknown aetiology, affecting thousands of individuals worldwide. The severity of symptoms can range from mild to severe with incidence peaks between age 10-19 years and 30-39 years. Women are more often affected than men in a 3:1 ratio. ME/CFS has been described as an “incurable, invisible contested and unsupported illness” (Farrell Delaney, 2020). The report by the Institute of Medicine (IOM) of the Academy of Sciences in the USA in 2015 concluded that ME/CFS is a physiological/medical, not a psychiatric illness (Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, 2015; Clayton, 2015). The International Consensus Criteria (Carruthers et al., 2011), the Centers for Disease Control and Prevention (2018), the ICD-10, and the ICD-11 (World Health Organisation, 2018), all classify ME/CFS as a neurological disease.
In spite of evidence that the disease is associated with marked biological changes (Loebel et al., 2016, Schreiner et al., 2020; Sotzny et al., 2018; van Campen et al., 2020) and what appears to be a breakdown in homeostasis (Marks, 2021), the disease is often perceived by doctors and nurses as having a psychological or psychosomatic origin that is ‘all in the head’ (Åsbring & Närvänen, 2002; Dickson et al., 2007; Ware, 1992). This ‘all in the head’ perception causes stigmatization as an extra burden for patients with ME/CFS.
Paediatrician Ola Didrik Saugstad has stated: “A reorientation of the understanding and attitude to ME patients occurs worldwide. ME patients, especially the worse cases, suffer enormously. Among them, the paediatric patients are most vulnerable, representing a special challenge due to the occurrence in the midst of somatic growth and emotional development. We are waiting for a biomarker of this disease, and some are in the pipeline. And even more, we are hoping for an effective treatment. Still, it is already now time for the medical profession as well as the whole society to repent, as these patients have previously often not been treated with the respect and care they need and deserve” (Saugstad, 2020).
In addition to the stigma and stress burdens, the most used therapies for pwME/CFS based on the psychosocial model have caused significant harms to patients that are well documented in the literature.
Owing to the absence of an established biomarker, current diagnostic methods proceed by a process of eliminating other diseases with similar symptoms and there is no universally agreed or empirically derived definition of ME/CFS. The illness was first described in the mid-1980s when almost nothing was known about its underlying biology. Some clinicians explained to patients that “there is nothing wrong.”
Post-exertional malaise (PEM) is a cardinal symptom of ME/CFS reported by many, but not all, patients (Jason, Evans, So, Scott & Brown, 2015; VanNess, Snell & Stevens, 2007; McGregor, Armstrong, Lewis & Gooley, 2019).). In the International Classificatory System, PEM is a mandatory feature of the condition (Carruthers et al., 2003, 2011). Another commonly reported feature of the illness is its tendency to wax and wane (Friedman, Bateman, Bested, & Nahle, 2019; Morris, Anderson, Galecki, Berk & Maes, 2013; Morris & Maes, 2014). The onset and duration of ME/CFS have been debated with some researchers suggesting a sudden onset and others a gradual onset. An interview study revealed descriptions of ME/CFS onset experiences that were both varied and complex indicating that onset can be sudden or gradual in different cases (Evans & Jason, 2018).
For more than thirty years
a group of psychiatrists and psychologists at King’s College London and the Institute of Psychiatry together with a large group of collaborators has advanced a psychosomatic approach to ME/CFS. This group is given the sobriquet ‘Wessely School’ in honour of its leading representative, Professor Sir Simon Wessely. Simon Wessely has been the UK’s leading authority in establishing healthcare for patients with ME/CFS and MUS. According to the Wessely School, ME/CFS is neither a neurological nor an immunological condition but a psychosomatic condition, a functional illness with a primarily psychological origin. For the Wessely School, ME/CFS belongs in a spectrum of medically unexplained symptoms (MUS) including irritable bowel syndrome, non-ulcer dyspepsia, premenstrual syndrome, chronic pelvic pain, fibromyalgia, atypical or non-cardiac chest pain, hyperventilation syndrome, tension headache, atypical facial pain, globus syndrome and multiple chemical sensitivity (Wessely, Nimnuan & Sharpe, 1999). Early in the piece these authors opined that “the existing definitions of these syndromes in terms of specific symptoms is of limited value”.
The psychologists and psychiatrists within the Wessely School favour the
Cognitive Behaviour Therapy (CBT) Model
of emotional distress as proposed by Aaron T Beck (1976). The model distinguishes between developmental predispositions and precipitants of distress, and perpetuating cognitive, behavioural, affective and physiological factors, the so-called “three Ps”: predisposing, precipitating and perpetuating factors (Beck, 1976). This approach is not dissimilar to Hans Eysenck’s view that personality and feelings of hopelessness and helplessness are causal determinants of diseases such as cancer and coronary heart disease (Eysenck, 1991, Figure 1).
In line with Beck’s and Eysenck’s approach, the Wessely School has promoted what it has called a “broadly conceptualized cognitive behavioural model of MUS suggest(ing) a novel and plausible mechanism of symptom generation.” In a nutshell, fears and beliefs about the harmful effects of activity are related to poorer outcomes in ME/CFS (Deary, Chalder & Sharpe, 2007).
The school holds the hypothesis that the ‘three Ps’ inform behaviour such as activity avoidance and the belief that the illness has an organic basis, which, in turn, are said to affect the patient’s physiology and symptoms, providing a vicious circle of symptom maintenance irrespective of symptom type.
Some of the main influencers on the school have been Aaron T Beck, George Engel, Hans J Eysenck and Isaac M Marks. Eysenck’s theory assigns to cortisol and immune deficiency a mediating role between feelings of hopelessness and helplessness and development of the disease (see Figure 1).
Eysenck: Psychosocial -> Biological -> Disease
Figure 1. Hans Eysenck’s theory of personality and stress, dysfunctional feelings, as the causes of cancer. From Eysenck (1991).
Wessely’s theory attributes causal status to fear, behaviour and de-conditioning (Figure 2). Eysenck’s theory and Wessely’s theory share a strongly biopsychosocial orientation but with a difference in the sequence of the three key elements:
Wessely: Biological -> Psychosocial -> Disease
Figure 2. The Wessely School’s theory of the aetiology of CFS. From Harvey and Wessely, 2009.
Treatment of ME/CFS in the Wessely School’s approach focuses on the alleged ‘self-perpetuating cycle’ of inactivity that is assumed to disrupt the “self-maintaining interlock of cognitive, behavioural and physiological responses hypothesised to perpetuate the symptoms” (Deary et al. 2007, pp. 2-3; Harvey & Wessely, 2009; Figure 2).
The role of doctors in MUS is said to be similar to that of “parents of sick children. Both can reinforce unhelpful illness behaviour and symptom interpretations” (Deary et al., 2007, p. 7).
A group of investigators in Nijmegen, The Netherlands, holds a similar hypothesis that emphasizes the role of physical activity in attempting to correct the so-called ‘vicious circle’ of ME/CFS (Vercoulen et al., 1998; Wiborg, Knoop, Stulemeijer, Prins & Bleijenberg, 2010).
Influencers of the Wessely School
There have been several major influencers on the School including:
Hans J Eysenck: a leading theorist in personality theory and behaviour therapy. However, Eysenck’s publications on smoking, cancer and CHD were recently considered ‘unsafe’ in an enquiry within King’s College London.
Key members of an ‘inner circle’ are also shown in the illustration:
Trudie Chalder: Professor of Cognitive Behavioural Psychotherapy, King’s College London. Chalder has co-authored multiple publications on ME/CFS and MUS with Professor Wessely and she was one of the co-principal investigators of the PACE trial.
Peter D White: retired Professor of Psychological Medicine at Queen Mary University of London, United Kingdom, one of the co-principal investigators of the PACE trial.
Michael Sharpe: Professor of Psychological Medicine at the University of Oxford (previously at the University of Edinburgh) and one of the co-principal investigators of the PACE trial.
A larger ‘outer ring’ of collaborators work at King’s College London and at many other institutions all over the world.
The Wessely School’s Contribution
The Wessely School’s influence on the treatment of patients with ME/CFS has been huge. Some main influencers and contributors are listed in the table together with statements and publications reflecting the approach.
INFLUENCERS AND CONTRIBUTORS
PUBLICATIONS AND PERSONNEL
“People are not disturbed by things, but by the views they take of them”.
Thought control in everyday life. (1928). Funk & Wagnalls, New York.
Aaron T Beck
Depression: Causes and treatment. (1967). University of Pennsylvania Press, Philadelphia.
A cognitive approach to behaviour therapy. (1969). Internat. J Psychother, 8, 896-900.
Joseph Wolpe and Arnold Lazarus
Behavior therapy techniques: A guide to the treatment of neuroses. (1966).Pergamon Press.
Hans J Eysenck
Personality, cancer and cardiovascular disease: A causal analysis (1985). Personality and individual differences, 6(5), 535-556.
Isaac M Marks
Fears, phobias, and rituals: Panic, anxiety, and their disorders. (1987).Oxford University Press.
George L Engel
The need for a new medical model: A challenge for biomedicine (1977). Science, 196, 129–136.
Harold Leventhal, D. Meyer and D. Nerenz (1980).
The common-sense model of illness danger. In: Rachman, S., editors. Medical Psychology, Vol. 2. New York: Pergamon, pp. 7–30.
Core Team Members at King’s College London
T Chalder, J Chilcot, P McCrone, K Goldsmith, M. Hotopf, R Moss-Morris, J Weinman, S Wessely
M. Alyward (UnumProvident Centre, Cardiff), C. Bass (Oxford), G. Bleijenberg (Nijmegen), S. Borgo (Rome), K. Brurburg (Norwegian Institute of Public Health), C. Burton (Sheffield), D. L. Cox (Cumbria), E. Crawley (Bristol), V. Deary (Newcastle), L. Dennison (Southampton), R. Horne (UCL), A.L. Johnson (MRC Clinical Trials Unit, London), H. Knoop (Nijmegen), M. Loades (Bath), D.Oakley (UCL), K. Petrie (Auckland), M. Sharpe (Oxford), L. Sibelia (Rome), P. D. White (Queen Mary University of London)
In later posts I present the scientific evidence on the Wessely School’s approach to ME/CFS and MUS.