Monday, 7 August 2017
When it comes to my illness, I've learned to listen to my symptoms, trust my body, and give it the one thing it really needs: rest.
Posted on August 6, 2017, at 10:46 a.m.
It took 11 medical appointments across 20 weeks of pain and despair before I finally got a diagnosis.
For months, I’d been suffering from exhaustion so extreme that bit by bit, I’d had to let my whole life drop away. For a long time I tried to ignore it – after all, who stops doing anything just because they're tired? – but life became simply impossible. So first I cut down on my activities – like going for a run or seeing my friends – then, as my condition got worse, I cut them out completely. As for my job, I tried working from home, and I tried working half days. But my body just wouldn't play ball, and I had to stop working completely.
The tiredness was on a par with the worst flu you've ever had: Remember trying to drag yourself to the bathroom, or being hungry but barely strong enough to make food? As well as the fatigue, there were all sorts of aches and pains: a soreness in my spine, headaches and heavy limbs.
But this had lasted way longer than any flu. And now, here I was. After many fruitless discussions with GPs and inconclusive tests, I was finally in front of a specialist. He’d been able to put a clear label on my illness: a diagnosis of chronic fatigue syndrome. And he was now telling me that he had a track record of helping patients to recover. I nearly wept at my good fortune.
The doctor gave me an exercise program. “We’ll start small and build up from there,” he told me. “Stick to the routine and you'll see results.” He also said it was important that I stayed positive and didn't get too "lost" in my symptoms. “Try not to give them too much space in your mind, because you run the risk of magnifying them.”
The exercise started at a level I was comfortable with: five minutes of walking each day for the first week. At week two, five minutes became six, and so on. But by week four the nonstop walking had gotten to be too much. Weirdly, I was OK while doing the actual walk itself; it would hit me afterwards and I'd have to lie down, and I'd wake the next day feeling as though I'd run a marathon.
I discussed it with the doctor. “You're deconditioned,” he said. “You've been resting too much. Don't be afraid of exercise – it's good for you.”
I knew this made sense; exercise is good for you, isn't it? Besides, the doctor was a specialist – he'd seen it all before and he was assuring me this was the way to get better.
“I'll keep going,” I said.
“That's the right attitude,” said the doctor. He also reminded me not to dwell on my symptoms.
I didn't think I was dwelling. But when you have to lie down for days on end, it's hard to stay positive and upbeat, and it's hard not to think about the pain you're in. So I carried on walking, and hurting, and trying not to think about the hurting, and walking some more.
By week six, I had fallen behind on the programme and was feeling worse than ever. But the doctor told me that I wasn't trying hard enough. So I kept trying, and I kept paying the penalty. I didn't know what else to do, and it didn't occur to me that a doctor could consistently deny a patient’s reality. I thought maybe if I just tried a little harder, pushed a little further, I could prove the doctor right – and my own body wrong.
Going into week eight, I knew that I needed to stop. But I didn't want to give up. I held on and on to the hope of improvement – I didn't want to let my chance of recovery go. And I didn't want to stop and admit, even though by now it was clear, that not only was I not going to recover this way, but the treatment to which I'd so diligently applied myself had been making me worse.
I didn’t want to admit that, but eventually I had no choice. And when, one morning, I couldn't even make it to the kitchen to make my cup of coffee – let alone shower or dress – it was a relief to let it all go. Relief not simply because I could stop hurting, but because I could stop hurting myself. And with that I could cease the huge mental effort of trying to convince myself, in the face of all evidence, that I had been doing the right thing.
It soon became clear just how much I’d been fooling myself, as the payback for my efforts set in. Even now, even when I’ve experienced that same state of body and mind many times, it’s hard to convey what it’s like to be that sick. Hard to convey the crushing weight on my chest and limbs. Hard to convey the soreness, the shivers and the burning, the headaches, the other aches; the inability to concentrate on anything other than the feeling that every atom of my being was somehow spewing poison.
For several weeks, I was too sick to make it to the clinic, so my last conversation with the doctor was by telephone. And he didn’t seem particularly surprised or concerned to hear I’d decided not to return in person.
“I really urge you to have another go at some point,” were his parting words, as though it was simply a matter of my mustering the motivation. “That is,” he added, “if you really do want to get better.”
I hung up with the impression that, contrary to what I'd been told at the start, failures weren't so uncommon. I felt I was being shunted off the books, like a low-achieving pupil being excluded so that the school could maintain its high pass rate.
It turns out that the only thing more scary than developing a life-changing disease is finding that there is no effective help available. Reality drops away from you. Nothing in your previous life carries any weight any longer; nothing can give you strength or sense; all is swallowed into an enormous void, and the void is waiting for you, and it says: You’re on your own, and there is no resisting me.
After the worst phase of physical punishment for my efforts had passed, I also found that I'd lost the little function that I'd had before starting the exercise program. And when you get as bad as I was then, you become unable to advocate for yourself. You can’t leave your bed, and even if you could, you can’t hold a conversation in real time, because your brain won’t process things quickly enough.
There I lay, abandoned by the medical establishment – or had I abandoned it? Either way, I was full of fear, and the self-doubt instilled in me by the doctor remained. Should I try again, at some point? And what was going to become of me?
It was at that point, lost, alone, that I decided to do my own research. Sure, I’d done some light googling before, enough to find out that graded exercise was the only real option open to me (it was either that or cognitive behavioural therapy, designed to persuade me that I should think more positively and get active again – sound familiar?). But now I took a different approach, going beyond the official literature. I joined discussion forums, I started asking questions on social media, and, eventually, I learned to make sense of scientific papers.
As I dug deeper, I found that I wasn't alone in finding the exercise programme damaging. Around the world there were hundreds of thousands – possibly millions – of people stuck in their beds like me, and in the UK a sizeable proportion believed they had been put there by exercise therapy. And the rest of the world kept on spinning, and nobody knew.
From my bed, I learned that chronic fatigue syndrome, or CFS, is sometimes also known as myalgic encephalomyelitis, or ME. And I learned that the history of ME/CFS is a story of people bewildered, in pain, and often severely disabled, and suffering the even greater cruelty of being told their symptoms are only in their mind.
On the internet I met people who had been told they were “sick, not ill”. I met people who had been informed that “you must want to die, then”. (And I spoke to several who at times had felt that death would indeed be preferable.) I read the stories of children who had been removed from their families due to their parents’ refusal to force them to exercise.
I also met – online of course – several sufferers who had lived for months or years in darkness, unable to speak or interact, just strong enough to drink liquidised meals and drag themselves to the bathroom when necessary. But in this darkness I also found hope, support, and a sense of community.
On the scientific side of things, I learned that outside the UK, postexertional malaise, a flu-like delayed response to exertion, is known to be the hallmark of the disease (in fact, the US Institute of Medicine recommended renaming it on this basis). I read studies that showed that people with ME/CFS have restricted cardiovascular ability, and that they experience an overwhelming buildup of lactic acid with exertion.
I learned also that scientists had started to unpick the biological foundations of ME/CFS. Research groups in the US and Norway have now identified the disease as a sort of restricted metabolic state where the body can't manufacture energy in the normal way. No wonder exercise made me and so many others worse.
The science hasn't reached most doctors yet, but it will do. This means that help will, eventually, be on the way. Although there aren't yet any drug treatments for ME/CFS, some approaches have shown early promise.
Am I angry that I was given the wrong advice? Of course. And my heart breaks every time I read another story of how graded exercise put another person with ME/CFS in bed. More than this, though, I'm angry at how needlessly we have suffered. Why was biomedical research not begun earlier? Why were psychiatrists allowed to squash exploration in this field, by taking it and calling it their own? Why, even now, are people being told to undertake exercise programmes without being informed of the risks?
As for me, I am improving slowly, but it will be a long time before I can travel anywhere or work again. I've learned great patience, and even greater compassion for others; I'm truly thankful for that. These are qualities that will stay with me for life, because I have seen the cruelty and the grace of the world that we each experience, and the love that holds it all together.
And when it comes to my illness, I've learned to listen to my symptoms, trust my body, and give it the one thing it really needs: rest.
Wednesday, 2 August 2017
(If only they would say ME, Myalgic Encephalomyelitis, instead of CFS)
By Andy Coghlan
Inflammation biomarkers may help doctors diagnose chronic fatigue syndrome (CFS), a poorly-understood condition in which people feeling continually exhausted. These biomarkers could also give new clues to what causes the condition, and how to treat it.
The biomarkers were discovered when a team of researchers screened the blood of 192 people with chronic fatigue syndrome for cytokines – substances used by the immune system to control inflammation. The team compared the levels of 51 different cytokines in the people with CFS and 392 people who didn’t have the condition, and found that 17 cytokines rose in tandem with how bad a person’s CFS was.
“These 17 go up by various degrees in a straight line with severity,” says José Montoya, of Stanford University.
Overall, only one cytokine was consistently higher in people with CFS. But when severity was taken into account, the other 16 emerged from the analysis as being linked to the condition. For example, three-times as much of the appetite hormone leptin, which is part of the cytokine family, was present in people with very bad cases of CFS.
It is not yet clear whether the increase in inflammation markers could be a cause or result of the condition.
However, Montoya says the results support mounting evidence that CFS is a physiological condition, not a psychosomatic disorder. “There’s no question this is something that’s biologically based,” he says. “This is a disease that does not get cured with psychological treatments, counselling or anti-depression drugs.”
Montoya’s team want to use the biomarkers to develop ways to diagnose CFS, also known as myalgic encephomyelitis, and monitor its severity. These cytokines may also help identify new CFS treatments that dampen inflammation, Montoya says.
“The results and how they were obtained are encouraging, as finding markers for subsets and categorisations within the illness is much needed for future research and treatments,” says Chris Armstrong, of the University of Melbourne, Australia.
Armstrong’s own team have found that the fatigue of CFS may be caused by disrupted metabolism and energy production in the body. “The metabolic changes we found suggest a physiological stressor in the body is affecting the cells,” he says. “The cause of that stress is unknown, but is likely to be immune-based given the mounting evidence in that direction – this new study included.”
A team in Norway has had some early success in treating CFS by targeting the immune system and reducing inflammation. They have been using a drug called rituximab to wipe out the white blood cells that may make inflammatory antibodies.
Montoya says it’s unclear what causes the increase in cytokines they have seen in CFS, but he thinks something is triggering inflammation in the body – possibly an infection like the herpes virus.
Journal reference: PNAS, DOI: 10.1073/pnas.1710519114
Tuesday, 1 August 2017
By Greg Crowhurst
27th July 2017
Sir Andrew Dillon,
Dear Andrew Dillon,
Re : Myalgic Encephalomyelitis
I have cared full time, for 25 years, for my wife who has a diagnosis of Very Severe ME, my Nursing Standard article "Supporting people with severe myalgic encephalomyelitis" is referenced by NICE in the original 2007 guidelines. In 2015 I was third place finalist, BJN, Nurse of the Year, for which I received an award specifically for my work in raising awareness of and advocating for people with Severe ME. I was Secretary of the 25% Severe ME Group charity for many years and represented the Group at the Gibson Parliamentary Inquiry.
In February the Joint Commissioning Panel for Mental Health document published Guidance for Commissioners of services for people with medically unexplained symptoms – practical mental health commissioning, which misinformed Commissioners that Myalgic Encephalomyelitis is a Somatoform, mental health disorder.
The response, in a letter to me, dated March 2nd, from the Co-Chairs of the Expert Reference Group for JCPMH Guide on Commissioning for MUS and the Co-Chairs of the JCPMH claimed that the: "The content of the MUS guide is fully in line with NICE guidelines and with current practice. Should the relevant NICE guidelines alter, or the evidence in this area change, then we will revise the guide accordingly."
On March 15, NICE assured me that CG53 does not list ME as a somatoform disorder. Therefore the MUS guidelines cannot be correct.
I raised the misinformation in the JCPMH Report with the Department of Health, who confirmed that the Government recognises the WHO classification of ME as a neurological disease. They advised me to take the issue up personally with you.
I am interested to know what you can do to correct the misinformation that the JCPMH has given to Commissioners, especially given the serious potential implication in regard to the current consultation on CG53?
I also have the following questions, given that NICE has confirmed that it does not consider ME to be a Somatoform Disorder:
1. Can you tell me why NICE itself lists ME under "Depression and anxiety disorders" on the IAPT webpage and can you reassure me that it will be removed? That surely is as great a misrepresentation of ME as the JCPMH document, especially given the recognition in CG53 that “the physical symptoms can be as disabling as multiple sclerosis, systemic lupus erythematosus and congestive heart failure .”
2. Can you explain the nature of IAPT’s involvement in ME, especially in light of the the CDC’s recent decision not to recommend CBT and GET? http://www.meassociation.org.uk/2017/07/cdc-removes-cbt-and-get-as-recommended-treatments-for-mecfs-11-july-2017/
3. Can you tell me what role, if any, IAPT played in the drafting of the recent CG53 Surveillance Document, which has been heavily criticised by all major ME Charities and thousands of patients for:
* its adherence to the widely disputed CBT/GET paradigm, which has been shown to make patients, especially the most severely affected, much worse. http://stonebird.co.uk/psurvey.pdf
* its many references to the universally discredited PACE Trial
* its reliance upon vague diagnostic criteria that do not clearly identify or separate ME from mental health Chronic Fatigue (WHO F48). A wide definition helps no one; surely it is time to acknowledge that ?
* its scant regard for biomedical evidence
* its extraordinary decision not to update the 10 year old guidance which not only was condemned as “unfit for purpose” at the time, but continue to deny patients, like my profoundly physically ill wife, equal access to health care
* its failure to accurately represent international clinical practice
* its failure to remove outdated treatment recommendations and its pronounced self-circular psychiatric bias.
4. I am very curious to know the composition of the Topic Experts and their knowledge base and impartiality. What biomedical representation, if any, did you have? What clinical input, outside of the biopsychosocial school, was involved for unbiased appraisal of the biopsychosocial content? Can you tell me who the Topic Experts were? Were any of the Royal College’s involved?
5. Can you tell me why NICE only gave stakeholders two weeks to respond to the 56 page Surveillance document, making it incredibly difficult for those people who have ME themselves or full time carers, to have enough time to contribute adequately or at all.
6. Can you explain why NICE has relied heavily on an unfounded psychiatric theory of ME that is nothing more than that, with no real evidence itself, while ignoring the more than 9000 published papers that have been published world wide, detailing the biomedical abnormalities in ME?
7. Can you explain, given the statement in 2014 by Professor Mark Baker, Director of the Centre for Clinical Practice, at a Forward- ME meeting, that the Guideline failed to address the real issues in ME/CFS, does not promote innovation and has had a disappointing impact on specialist care and commissioning issues, why NICE has continued to stick to its outmoded, inappropriate, dangerous guidance?
The Surveillance document does nothing, in my opinion, to challenge the misperception that ME is a mental illness, in fact it's decision to come off the static list, not for medical reasons, but because of the FITNET CBT/GET Trial reinforces the apparent psychosocial bias of the whole document and attitude of NICE.
If CG53 continues to contribute to a situation where people with ME are:
* misinterpreted as having a mental health issue
* where biomarkers are not sought for and relevant tests are proscribed
* where health professionals of every level are misinformed and their awareness skewed wrongly towards a biopsychosocial interpretation of a serious physical disease with ignored multi-system dysfunction, endangering lives and leading to mistreatment, misinterpretation, neglect and harm
* where the guidance on Severe ME fails to recognise the terrible suffering and multiple physical symptoms patients experience, making it dangerously irresponsible. http://www.stonebird.co.uk/principles%20of%20care.pdf
* where ME is still not separated from and confused with mental health Chronic Fatigue and other poorly diagnosed diseases
* where services are geared towards a psychiatric diagnosis of wrong illness thought and deconditioning
* where patients are offered treatments that are inhuman, cruel, inappropriate and dangerous, because they are in direct denial of their physical reality- the potential for harm is enormous and terrifying in ME
then surely that is in contravention of your obligations under the Human Rights Act and the Equality Act?
The ME Community has been insisting for years that CG53 is not and never has been appropriate for patients with Myalgic Encephalomyelitis; the way forward is for ME to have its own biomedical Guideline and pathway, categorically without psychiatric interpretation and involvement.
Tuesday, 25 July 2017
24 July 2017
By David Tuller, DrPH
The Countess of Mar, a well-known advocate for ME/CFS patients in the House of Lords, has received a negative response to her request for the names of the experts involved in the review of the NICE guideline for CFS/ME. The ME Association has not yet received a response related to the same question, nor have I. But the response to the countess indicates that the process is proceeding with a lack of full transparency.
Here’s the response from the Department of Health:
“The National Institute for Health and Care Excellence (NICE) routinely consults a range of topic experts as part of its surveillance review process. NICE is currently consulting on a review proposal for its clinical guideline on the diagnosis and management of chronic fatigue syndrome and myalgic encephalomyelitis. NICE does not routinely publish the names of topic experts as they are not part of the decision making [sic] process for the surveillance review.”
This answer is of course unsatisfactory. The last sentence is the operative one, so let’s deconstruct it. In the first part of the sentence, NICE is telling us that it does not routinely publish the names of topic experts. But just because it doesn’t routinely do something is not necessarily relevant to whether it should take this step now. Perhaps no one has asked for these names before. Presumably the development or review of most guidelines is not so controversial as this particular one for CFS/ME. (The patient-preferred name for the illness, and the most appropriate one, is of course just ME, without the CFS tacked on.)
It is also not routine that more than 15,000 people sign petitions expressing serious dissatisfaction with existing clinical guidelines. But that’s how many have put their names to the petition launched by the ME Association. That’s a huge number of unhappy patients and advocates; NICE would be well-advised not to ignore them. Perhaps the strict adherence to routine measures—like not disclosing the names of topic experts involved in the process—should be reconsidered in the current urgent context. (The petition drive closed today to coincide with the deadline for the stakeholder comments on the NICE guidelines.)
The second part of the sentence explains the purported reason for not sharing the topic expert names: they are not part of the decision-making process. First of all, what does that mean? Given that topic experts have been consulted in this instance, it is bizarre to read that they are “not part of the decision-making process”? Is their advice then ignored completely? Are they just a fig leaf to create the appearance of consultation while NICE does what it wants? If their advice is reviewed and considered rather than tossed right in the trash, why does the statement declare that they are not part of the decision-making process?
Perhaps the statement means that the topic experts are not officially in the room or on the conference call when the final approval is made. But even if that were the case, why would that mean their names should be kept from the public? Is the development process of NICE guidelines an official state secret that demands utmost protection?
And if the topic experts are not involved in the decision-making, as the statement asserts, then what exactly is their function? And who are the people involved in making the decision? Are they themselves experts, or just functionaries listening to others? Is it the group that originally developed the 2007 guideline? That group includes Professor Esther Crawley [Correction–see below], a close colleague of the PACE authors-—so that’s not a particularly good sign. Given the enormous impact of these guidelines, it is imperative that the process be conducted as openly as possible—which, given the response to the Countess of Mar’s question, is so far not the case.
Correction, July 24th: In the initial post, I mistakenly wrote Professor Trudie Chalder.
Monday, 17 July 2017
C H Spurgeon's Morning Devotional for 17th July
“Knowing, brethren beloved, your election of God.”
1 Thessalonians 1:4
Many persons want to know their election before they look to Christ, but they cannot learn it thus, it is only to be discovered by "looking unto Jesus." If you desire to ascertain your own election;-after the following manner, shall you assure your heart before God. Do you feel yourself to be a lost, guilty sinner? go straightway to the cross of Christ, and tell Jesus so, and tell Him that you have read in the Bible, "Him that cometh unto me, I will in no wise cast out." Tell Him that He has said, "This is a faithful saying, and worthy of all acceptation, that Christ Jesus came into the world to save sinners." Look to Jesus and believe on Him, and you shall make proof of your election directly, for so surely as thou believest, thou art elect. If you will give yourself wholly up to Christ and trust Him, then you are one of God's chosen ones; but if you stop and say, "I want to know first whether I am elect," you ask you know not what. Go to Jesus, be you never so guilty, just as you are. Leave all curious inquiry about election alone. Go straight to Christ and hide in His wounds, and you shall know your election. The assurance of the Holy Spirit shall be given to you, so that you shall be able to say, "I know whom I have believed, and I am persuaded that he is able to keep that which I have committed to Him." Christ was at the everlasting council: He can tell you whether you were chosen or not; but you cannot find it out in any other way. Go and put your trust in Him, and His answer will be-"I have loved thee with an everlasting love, therefore with lovingkindness have I drawn thee." There will be no doubt about His having chosen you, when you have chosen Him.
"Sons we are through God's election,
Who in Jesus Christ believe."
Thursday, 13 July 2017
In America, the Centers for Disease Control and Prevention (CDC) has updated its website information for ME/CFS, improving diagnostic criteria and removing previous recommended treatments – CBT and GET.
While it seems that we must wait to see if this new information is reflected in updated guidance for medical professionals, it is nonetheless being heralded as an important development.
Yesterday, in the UK, NICE published its consultation document which confirmed the recommendation to take no action with regards to the current guideline.
The ME Association is protesting this decision and is currently considering its written response as a stakeholder in the consultation process.
We feel there are many aspects of the current guideline that warrant review including the continued recommendation of CBT and GET.
The ME Association’s online petition ‘The NICE guideline for CFS/ME is not fit for purpose and needs a complete revision‘, has attracted over 4,000 supporters in less than 24 hours.
It will close on Monday 17th July at 5pm, when we will present it to the review committee for delivery to Sir Andrew Dillon (chief executive, NICE guidance executive).
David Tuller in his latest blog, Trial By Error: The CDC Drops CBT/GET, explains in more detail what has happened at the CDC and why this may herald an important and fundamental change for ME/CFS.
We have selected pertinent extracts from his blog, and reproduced them below:
“Just as The Lancet has published more “evidence” for graded exercise, the CDC has moved decisively in the opposite direction. In revamping the information on the part of its website geared toward the general public, the agency has “disappeared” all mention of CBT and GET as treatment or management strategies. Patients and advocates have long pushed for this step, as did Julie Rehmeyer and I in a New York Times opinion piece in March. Although the revised text is dated as having been reviewed on May 30th, it apparently went live sometime during the first week of July. (The CDC has still not revised the pages designed for health care providers, although old information has been removed. The agency calls the illness ME/CFS.)”
“For advocates, the CDC’s removal of the CBT/GET recommendations represents a major victory. “I think it’s huge,” said Mary Dimmock, an advocate who has long pressured the CDC to revise its website. Given the agency’s stature, she added, the decision could have widespread impact, not just in the U.S. but internationally as well. Many health care providers and institutions here and abroad look to the CDC for guidance in public health matters.”
“So many patients have been made worse by the treatments,” said Dimmock, who became an advocate after her son became seriously ill several years ago. “While there is more to be done, removing these recommendations is a significant step forward in protecting ME patients from harm.”
“In the revision, the CDC website has dropped the agency’s 1994 definition of the illness. The new definition, based on the one proposed in a 2015 report from the Institute of Medicine (now the Academy of Medicine), requires the presence of “post-exertional malaise.” In the 1994 definition, that was only one of eight optional symptoms. The immediate implication of the shift is that GET should likely be considered contraindicated, given the premium this intervention places on steadily boosting activity levels. The form of CBT prescribed in PACE could also be contraindicated, since the ultimate goal of that intervention is likewise to increase activity. (The CDC has not adopted the name proposed by the IOM report, “systemic exertion intolerance disease.”)”
“In addition to symptomatic relief, the revised CDC website suggests such management strategies as a balanced diet, nutritional supplements and complementary medicine.”
“Of course, avoiding “push-and-crash” is what patients already do when they practice pacing. The “push-and-crash” language itself appears to be closely aligned with the arguments provided by the PACE investigators and their colleagues; many patients might describe their experiences differently. Nevertheless, removing the CBT/GET recommendations is a welcome step, if overdue. For years, patients and advocates pointed out the problems with PACE and related research, and also cited the evidence that too much exertion caused harm because of physiological abnormalities, not the deconditioning presumed by CBT and GET. But until now, the agency refused to make the necessary changes.”
“The CDC has another urgent obligation: To communicate with the U.K.’s National Institute for Health and Care Excellence, which develops clinical guidelines for various medical conditions. NICE is currently debating whether or not its recommendations for the illness—which it calls CFS/ME–need to be reviewed; of course, these recommendations include CBT and GET as indicated treatments. NICE is soliciting input this month from stakeholders, but the expert panel assessing the situation has apparently made a provisional decision that no review is required.”
“The CDC has a long history of collaborating with key members of the PACE team and others in the U.K. medical and public health establishments; it is not surprising that prescribing CBT and/or GET should have become standards of care in both countries. It is now incumbent on U.S. public health officials to alert their British colleagues, including those at NICE, that they have just abandoned these longstanding recommendations. They should also explain why they have taken that major step, and why NICE should consider doing the same. (More on the NICE guidelines later this week.)”
David’s latest blog can be read in full, here.
Monday, 3 July 2017
Why the trial should never have been allowed in the first place.
There is no evidence the Lightning Process (LP), a mish-mash of elements of cognitive behavioural therapy, neurolinguistic programming, hypnotherapy, life coaching and osteopathy, is anything other than quackery. For decades Phil Parker has made claims for its efficacy, including as a treatment for myalgic encephalomyelitis (ME), but no proper trial has ever supported these claims.
The Advertising Standards Authority (ASA) guidance is clear:
To date, neither the ASA nor CAP has seen robust evidence for the health benefits of LP. Advertisers should take care not to make implied claims about the health benefits of the three-day course and must not refer to conditions for which medical supervision should be sought.
There are people who claim to have been helped, of course, but such claims are made for all bogus therapies. It seems that some people are simply amenable to these interventions. In addition, perhaps there are those who have become stuck in a rut, experiencing a generic chronic fatigue, believing themselves to have ME, and who are helped to kickstart their lives again by the LP. Since there is no biomarker for ME, diagnosis of the illness can be difficult: 40% of patients in an ME clinic may not actually have ME.
There is currently no treatment for ME, so it is understandable that some patients would be easy prey for and would seek more information about interventions hawked about with exaggerated claims.
Parents of children with ME were apparently contacting the charity Association of Young People with ME (AYME) (1) and asking whether it was worth trying the LP. Bewilderingly, Esther Crawley, a Bristol paediatrician and then medical adviser to AYME, instead of telling patients and parents that the LP had no scientific basis and was not worth the considerable amount of money it costs, decided to do a trial. Just as bewilderingly, the SMILE trial received funding and ethical clearance.
First, this trial should never have been allowed. Good science is not just about evidence, but about plausibility, so any such trial immediately gives a spurious credibility to the LP. Asking a question, even sceptically, can offer an implicit endorsement of its premises.
Second, it was the first study of any kind to use the Lightning Process, and it was doing so with children. There had been no opportunity to measure harms: there have been reports of patients who do not respond to the LP who then blame themselves and in desperation contemplate killing themselves. Exposing vulnerable adolescents to such a potential risk would seem particularly irresponsible.
Third, LP patients are made to accept a number of onerous conditions (such as taking responsibility for their illness) before taking the course. It is ethically questionable to ask trial participants to agree to such conditions in order to take part in a trial of a possible treatment for their illness. Making these demands of children would seem even more ethically dubious.
Fourth, patients are told to ignore their symptoms and to resume normal activity (from SMILE study):
‘It has been a bit confusing, I have to say, because obviously we have got the [Lightning Process practitioners] approach, where, “Right, finally, done this, now you don’t need to do the pacing; you can just go back to school full time.” I think, the physical side of things, YP9 has had to build herself up more rather than just suddenly go back and do that’.
Research, backed up by patient surveys, shows the harms caused by exertion in patients with ME (see Kindlon). The recent report to the US Institute of Medicine found post-exertional malaise to be so central to the illness that it suggested a new name: systemic exertion intolerance disease or SEID. Even in disputed clinical trials such as PACE which use graded exercise therapy, patients are monitored by physiotherapists and nurses and plan a gradual increase in activity. Here service providers with no professional qualifications simply tell child patients that after three sessions in three days they should return to normal activity. It is deeply irresponsible.
Fifth, to anyone with genuine ME, that is ME as defined by the International Consensus Criteria, the Lightning Process is a form of torture. It is a physical torture simply to complete the course, again from the SMILE study:
In addition to specialist medical care, children and their parents in this arm were asked to read information about the Lightning Process on the internet. They then followed the usual LP procedure (reading the introductory LP book or listening to it in CD form) and completing an assessment form to identify goals and describe what was learnt from the book. On receiving completed forms, an LP practitioner telephoned the children to check whether they were ready to attend an LP course. The courses were run with two to four children over three sessions (each 3 hours 45 minutes) on three consecutive days.
That is a very heavy burden. The homework is taxing enough but then to undergo 3 sessions of almost 4 hours each on 3 consecutive days is immense. The effort, the intensity and the busyness, would be punishment to anyone hypersensitized by the illness.
It is also a form of emotional torture as fundamental to the process is that patients take responsibility for their health, their illness and their recovery, from here, here, here and here:
LP trains individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations.
* Learn about the detailed science and research behind the Lightning Process and how it can help you resolve your issues
* Start your training in recognising when you’re using your body, nervous system and specific language patterns in a damaging way
What if you could learn to reset your body’s health systems back to normal by using the well researched connection that exists between the brain and body?
the Lightning Process does this by teaching you how to spot when the PER is happening and how you can calm this response down, allowing your body to re-balance itself.
The Lightning Process will teach you how to use Neuroplasticity to break out of any destructive unconscious patterns that are keeping you stuck, and learn to use new, life and health enhancing ones instead.
The Lightning Process is a training programme which has had huge success with people who want to improve their health and wellbeing.
This responsibility is an enduring one: patients must continue to apply the training to their lives after their course and accept that improvement in their health lies entirely within themselves.
To take chronically ill patients, who want only to get better, and spend three days attempting to brainwash them into believing their illness and recovery lie within their control is deeply unethical. Adult patients in the days after enduring this nonsense, blaming themselves for lack of improvement, have been left in such depths of despair as to want to take their own life. To expose chronically ill adolescents to such a danger was extraordinarily irresponsible.
Of course, with the broad criteria and the self-selection involved in determining who took part in the trial, it may well be that not a single participant actually had ME but had instead simply ‘chronic fatigue’. That would be even worse, though: the results may show that the LP has some effect with ‘chronic fatigue’ but would be used to claim effectiveness for patients with ME. Many children who genuinely do have ME could be gulled into paying for this nonsense only, potentially, to do themselves considerable harm.
This trial was unnecessary, gave spurious credibility to quackery and was unethical. It was also very poorly conducted, as will be shown in part 2.
1. AYME has now ceased trading and its role has effectively been taken over by Action for ME