It’s not often that I have just met one of the key players in a medical media story, but this was the interesting situation I found myself in a couple of weeks ago when the SMILE Trial into the efficacy of a treatment for teenagers with non-severe Chronic Fatigue Syndrome hit the news. Only a couple of months ago I met Phil Parker, inventor/designer of the Lightning Process (LP), at an Academy of Physical Medicine live stream, and you can read about that here. Having ascertained from my own brief searches that there was not yet a huge amount of evidence into the efficacy of LP, I was truly delighted to see that a paper on the SMILE Trial had been published from the University of Bristol showing positive results.
SMILE stands for Specialist Medical Intervention and Lightning Evaluation and here is the actual paper. If you want to know what it says but also want to make life easy for yourself, read a concise but thorough summary here. It featured in Archives of Disease in Childhood, which as far as I know is a reputable journal. It was also reported in, amongst others, the Guardian, the Independent, the Telegraph and the Science media centre where it was described variously as brain training, positivity therapy and brief intensive talking therapy. The lead researcher, Professor Esther Crawley, who heads the largest centre in the country for children with ME/CFS was interviewed on Radio 4’s Today Programme and You and Yours, in an item which attracted just about the most calls they had ever received. I think ME is up there with “controlled crying” as one of those things that gets people heated.
What did they do and why?
Because of numerous questions from her patients about LP, Professor Crawley decided it needed investigating further.
“We heard about people getting better and people getting worse. I was kind of curious. I never expected that it would work.”
If anything, said Crawley, she set up the trial in a way that would make it harder for it to be shown to work. The researchers, based in Bristol , took 100 teenagers diagnosed with mild to moderate ME/CFS, gave half of them usual specialist medical care (i.e. graded exercise, CBT, activity management), and the other half the same usual care plus LP. The conclusion was that it worked “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” (Prof. Michael Sharpe, Professor of Psychological Medicine, University of Oxford)
Well, this is marvellous news, I thought; a win-win news story with no down side. Great for osteopathy, as Phil Parker is one of our very own profession; great for teenagers with ME/CFS for whom it might give some hope; great for the NHS, who might consider this as a cost-effective option to treat a condition which not only drains the patients but also the treasury coffers: wonderful for skeptics, who are finally seeing at least one “alternative treatment” put to proper scientific test, and great for the wider ME community, because presumably all research is helpful and points towards fruitful avenues for future research. Happy day!
How wrong, how foolish, how naïve could I have been? These research findings were deeply unpopular with two highly motivated groups: there are the ME sufferers who are fed up with being thought to be not “really” ill; also the skeptical crowd who abhor anything that seems a bit alternative, even if it is part of a proper trial.
But first, what is the Lightning Process?
The Lightning Process was put together by Phil Parker in the 1990s. The process involves 3 days of intensive CBT/NLP/hypnotherapy/physiology education, in this case held in groups. It costs about £620. It attracts people with various conditions, however it seems to have gained particular fame for “working” with CFS/ME , partly through the celebrity endorsements of people like Martine McCutcheon (Tiffany on Eastenders), Esther Rantzen (TV presenter) and Austin Healey (of rugger and “Strictly” fame).
What were the criticisms of the study?
- Bias – OK, as an objective observer I admit Esther Crawley got longer and seemingly a more sympathetic hearing on the Today programme than ME Association medical advisor Dr Charles Shepherd – he got a shorter 6.50am slot, the following day, to voice his criticisms, and I read that he was not given the option of a phone interview, despite him being ill himself – however I don’t think this is any great conspiracy, probably the fact that the radio 4 journalists are not acquainted with the sensitivity, controversy and complexity of the subject. He did manage to assure listeners that the ME Association is “passionate about research”, but evidently not this particular piece of research, which they have been opposing since 2010.
- It’s a commercial treatment – well, until something is validated and recommended by NICE and provided by the NHS, treatments have to be private and commercial, on the whole. Not many therapists could afford to work for free. And anyone who thinks medicine in general is not commercial should watch the recent BBC documentary “Billion Dollar Deals and how they changed the world.”
- Pseudoscience/quackery – Well, some people just can’t bear anything that looks to them to be “magical” or alternative. But if the scientific basis doesn’t hold up, that’s not to say that evidence of efficacy should be discounted, or not tested, only that the exact mechanism of action is currently not understood. I suppose it’s too much to hope for that skeptics will stop denigrating this as “quack” therapy now it has shown to be effective.
- It is a treatment not approved by the ASA. This criticism was used widely and is a misunderstanding and/or misrepresentation of the ASA. The ASA is not an independent arbiter of the validity of a treatment. It simply responds to complaints by checking to see whether there is evidence for advertising claims. I am rather confused by the logic that “You shouldn’t do a study into something that the ASA has upheld complaints against.” If interventions can only be ASA-approved once research has been done, then presumably those unproven treatments are exactly the ones that should be having research done? Otherwise, we could only approve research on treatments that have already had research done. This makes no sense at all and would mean that no new interventions would be able to be tested.
- Using children in the study is unethical. I am not sure about this but it didn’t seem unethical. All these children and their parents were happy for them to have the treatment, and apparently the study was in line with ethical guidelines. Also Professor Crawley, who sees about 400 children with CFS a year, says that CFS/ME is different in children, e.g. it has a better prognosis and a genetic factor, and so child-specific research is necessary for this subgroup.
- There was no control group – The ME Association thinks the trial should have been 3-armed: one group having LP only, one Specialist Medical Care only, and a control group having no treatment. I think this is a moot point. The Bristol researchers judged that removing any care at all would be unethical. I think you could argue it both ways but it doesn’t invalidate this trial in any way.
- Ad hominem attacks – i.e. having a go at the researcher, personally. Well, there was plenty of this on Twitter, thus lending support to Esther Crawley’s claims that researchers are reluctant to go into the M.E. field because it causes this very reaction. Much of the negativity was along the funny-if-it-weren’t-so-nasty line of “how dare that incompetent , slanderous, fool accuse M.E. sufferers of being abusive?”
More substantial criticisms
1. The patients were no better; they just said they were. As the nature of the treatment is that you tell yourself and everyone else you feel great, critics were scathing that self-report outcomes were used as a measure. Yes this is a tricky one, and I can totally see their point. But how long could you pretend to be better than you are? A whole year? School attendance was one measure and the LP group were better on that. I agree with some critics, though, that more objective measures would be useful in future trials.
2. The LP could be harmful. Even though no adverse events were reported in this study, critics worry that it could cause harm in the following ways:
- Some patients might have a form of the illness for which exercise is damaging, but they are encouraged to mentally override any feeling that they cannot do exercise
- Part of the LP is making people feel they are responsible for their health. If the programme doesn’t work for them, they might feel it to be a personal failure, not a failure of the treatment, adding another layer of psychological harm onto an already unwell and potentially emotionally vulnerable person.
3. The patients didn’t have “true” ME – this is one of the more interesting and potentially valid criticisms. The very fact that we refer to the condition as ME/CFS indicates the confusion around this illness. What is it? ME or CFS? At one end of the spectrum it is thought to be a very serious and currently untreatable neuroimmune illness, with multiple bio-markers, and aggravated badly by exercise. At the other end of the spectrum, it is considered to be a general fatigue syndrome amenable to treatment. (And remember, a ‘syndrome’ characterises an illness by its symptoms, not by the underlying disease process). To quote Charles Shepherd of the ME Association
“It may well be that there are some people with a general fatigue state resulting from stress, emotional or psychological problems who could benefit from a ‘mind over matter’ retraining approach such as this.”
Is he effectively saying that the subjects in this study didn’t have “true” M.E? As Dr James Thompson, Honorary Senior Lecturer in Psychology, UCL, says: “Unfortunately chronic fatigue syndrome is not an objective diagnosis, it is a leftover category and fatigue is subjective.”
Notably the teenagers in the study had mild/moderate ME/CFS, none were housebound, and they were highly self-selecting as there was very low uptake for the trial from the teenagers approached. Professor Crawley herself thinks that ME/CFS is really 3 to 5 separate illnesses, which each need a different approach, and the Action for M.E. includes as one of the priorities for ME research the “stratification” of the illness, i.e. the teasing out and classification of the different types of ME/CFS.
Not only are there probably several different illnesses presenting similarly under the ME/CFS banner, there is another interesting question: just how many people have undiagnosed “known” illnesses or comorbidities which have a similar symptomatic profile to M.E.? I say this because of the few M.E. sufferers that were mentioned when I was researching this, I discovered that
- Martine McCutcheon was described as having M.E. and depression,
- another had suffered CFS following glandular fever and surgery to remove lymph nodes
- another, on whom LP proved very damaging, later found out that she had been suffering a serious, undiagnosed vascular disease part of which was heart failure
- Esther Rantzen’s daughter, another early poster girl for the LP, later found out that she was actually a coeliac sufferer, which could well have been causing the symptoms thought to be M.E. (LP had still worked marvellously for her, though).
Charles Shepherd referred, on You and Yours, to one clinical referral centre in Newcastle in which 40% ME sufferers referred there were not actually found to have ME when they were properly assessed. Lyme Disease, HIV and hepatitis C have all been misdiagnosed as ME.
Why are some in the ME Community really so opposed to this research?
Well, as someone who struggled confusedly through 12 months of life with undiagnosed glandular fever, only to be told I had “stress”, and that “everyone gets tired, Penny”, I have had a brief glimpse of the dreadful reality of the person whose illness is not believed (by themselves or others) and who is made to feel inadequate, weak or lazy due to the fact that they simply cannot think or ‘try’ their way out of it.
“Gaslighting” is the term for making someone think they’ve got a screw loose, and this is what has reduced some ME sufferers to Dr Foster-style levels of rage, and a determination to be vindicated by showing conclusively that this is a biological disease. Being judged harshly by others, or given bad advice, or thinking you might be doing this to yourself adds a further dimension of suffering to something that is already bad enough. And the way this study was reported by the mainstream media does risk encouraging the attitude that ME sufferers are somehow choosing to revel in martyrdom to a psychological illness with no biological basis, which could be cured if they would only decide to perk up a bit.
The danger is that even though a subsection of CFS patients might have become “stuck in a physiological Catch-22 that continually puts stress on the body causing their lethargy” (Skeptic.com) and gone a bit ‘off track with their thinking’, the unsophisticated layperson might tar everyone with the same brush. The LP is probably excellent for some patients, however for those who have different variants, well; you can see why they haven’t welcomed this research. They are scared that
- they will be taken even less seriously than they are now
- it will divert research into the idea that it is purely a psychological illness
Action for M.E. make their objections explicit:
”What we do know is that this trial cannot be used as evidence to prove that M.E. is a psychological condition.” and does considerable damage to patients by perpetuating the misunderstanding that this devastating condition can be overcome with behavioural treatments.”
- Identifying the different types of ME/CFS is crucial
- I hope the way the study is reported doesn’t cause negativity or more misunderstanding towards people with ME/CFS
- If I ever got diagnosed with ME/CFS I would insist on a full battery of medical tests to make sure they’ve ruled other things out
- I personally think this piece of research is fantastic news, and I’d try LP myself
- “there are no treatment approaches that offer reliable and significant improvements for everyone with M.E (my italics)” say the ME Association. One size does not fit all!
- There is a perennial question underlying most discussion of ME which is “is it a psychological or biological disease?” which demonstrates just how separately people still think of mind and body
- Wear a tin hat if you want to get involved in this debate
- NICE are reviewing their ME guidelines – which are currently CBT and graded exercise – and which are quite unpopular with the ME community
PS – I had a quick look to see if there was any response from Ben Goldacre, Simon Singh, Phil Hammond (who writes Medicine Balls for Private Eye, is sound as a pound, and surely knows Professor Crawley as he works with children with CFS down in Bristol) and even our old friend Edzard Ernst. (Think what you like, these guys know how to read a paper.) However, absolutely nothing; not a dickie bird. I can’t imagine they haven’t noticed this story – they’re journalists – so I hope they are simply looking and digesting, and we’ll hear their analysis soon.
STOP PRESS: I’d forgotten about David Colquhoun, just about to dash off to get a train to Oxford for the Causehealth #Guidelines Challenge, but I’ve just discovered via Twitter that he has managed to find a “solid statistical objection” to SMILE