THE SMILE TRIAL (part 1)

Why the trial should never have been allowed in the first place.

The first of three blogs on the SMILE trial. Part two is here.

 

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 https://www.actionforme.org.uk/children-and-young-people/introduction/

 

 

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8 thoughts on “THE SMILE TRIAL (part 1)

  1. Have psychologizers ever once apologized?

    Have psychologizers ever once apologized for the damage they have
    done?
    Did psychologizers ever say to an AIDS patient “I’m sorry I blamed your
    illness on you because of your lifestyle”?
    To a woman with PMS “I’m sorry I said you were a hysterical female”?
    Someone with ulcers from H – Pylori, “I’m sorry I kept telling you it was
    stress when it was really a bacterial infection”?
    Tuberculosis; “I’m sorry I told you that you brought this illness upon
    yourself by having a nervous disposition”?
    Thyroid; “I’m sorry that I said your weight problem was from a lack of
    discipline in your diet”?
    ADD/ADHD: “I’m sorry that I told you that this was from your bad choice of
    sugar laden foods”?
    Autism; “I’m sorry that I slapped your child and tried to shake him out of
    it”?
    SIDS/Cot Death; “I’m sorrry that I accused you of killing your own
    child”?
    Munchausen: “I’m sorry that I wrongly took your children away forever”?

    What do psychologizers plan to say to CFS/MS sufferers when
    psychologizers finally realize that they were wrong again and that CFS/ME
    is exactly what sufferers say it is?

    Is there any illness in history that didn’t have psychologizers
    standing in the way of sick people seeking medical help by saying “They
    don’t need that kind of help. They just need to change their attitude”.
    When the etiology of any illness was finally found to be “Not
    Psychological”, did psychologizers ever make the slightest attempt to undo
    the damage they created?
    Did psychologizers ever try to restore the credibility they stole from
    those they falsely told “It’s All In Your Head”?
    Or did they scamper off to concentrate their “help” on the next
    “unexplained medical illness” they could find?
    How many more examples of this process do we need to go through before
    society prevents psychologizers from pronouncing their victims “Guilty! –
    until proven innocent of mental illness?

    -Erik Johnson

    Competing interests:
    None declared

    http://www.bmj.com/rapid-response/2011/10/30/have-psychologizers-ever-once-apologized

    Liked by 2 people

  2. Thank you for covering this John. It’s a part of M.E history that we must not let slip away. And once again, fascinating that the Bad Science-type skeptics are invisible when it is a professional colleague involved.

    I took the Lightning Process about 6 years ago along with perhaps a dozen people from my local group who I am aware of. At that time, Michael Broughton of the Sussex M.E/C.F.S service was recommending it, having attended a course, as observer himself.

    Coincidentally, a friend of mine used to work as a business coach and was trained in NLP to the highest accreditation. He instantly recognised the L.P (Lightning Process) technique as a very basic NLP exercise. There’s a variation of the simple ‘Stop’ self-coaching diagram in most introductory NLP books. The same is true of the Gupta programme. Since it has fallen from fashion and favour, most people still trying to market NLP will present it as their own personal variation, but this is really obfuscation. This is true of the famous faces involved too: Anthony Robbins, Derren Brown etc.

    What’s interesting is that anyone trained in NLP is told never to use the techniques as treatments for physical illness.

    Several of the people I know did have some slight initial improvement which slowly settled back to their normal levels after a few months. For myself I pushed on for 18 months, extraordinarily somehow managing to avoid P.E.M even after quite strenuous activities. After 20 years illness I was determined to recover or die trying.

    Unfortunately, the second option is very nearly what happened. After 18 months, the P.E.M hit all at once, along with the grief of dashed hopes.As a direct result I made a suicide attempt and was dashed to E.R. 6 years later I am still broken, emotionally and physically.

    I am really happy to take responsibility for my own stupidity, bad faith and desperation. I felt I had nothing to lose (this is never true I now believe) and was happy to try to make a positive affirmation come true just through sheer will power. But for an adult to put a child in that situation is abusive on several levels. I really don’t use that word lightly.

    Liked by 2 people

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