MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

The Lightning Process  (LP) is a commercial programme developed by Phil Parker based on ideas from osteopathy, life coaching and neuro-linguistic programming. It has been endorsed by celebrities like Martine McCutcheon and Esther Rantzen, who credits it for her daughter’s recovery from ME. Parker claims that LP works by teaching people to use their brain to “stimulate health-promoting neural pathways”. One young patient once described it as follows: “Whenever you get a negative thought, emotional symptom, you are supposed to turn on one side and with your arm movements in a kind if stop motion, just say STOP very firmly and that is supposed to cut off the adrenaline response.”

Allegedly, the LP teaches 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. The LP involves three group sessions on consecutive days where participants are taught theories and skills, which are then practised through simple steps, posture and coaching.

A few days ago, someone asked my help writing to me: Norwegian newspaper is attacking patients for objecting to a clinical trial of the lightning process which is horrible quackery. LP is being backed by some people in Norwegian health authorities. Could you bring attention to how disgraceful this is please? I promised to look into it. Hence this post.

My searches located just one single trial. It seems to be the only controlled clinical study available. Here it is:

Design: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.

Setting: Specialist paediatric CFS/ME service.

Patients: 12-18 year olds with mild/moderate CFS/ME.

Main outcome measures: The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.

Results: We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. 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 (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. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.

Conclusion: The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.

The trial was designed as an ‘A+B versus B’ study which practically always generates a positive outcome. It did not control for placebo effects and is, in my humble view, worthless and arguably unethical. It certainly does not warrant the conclusion that LB is effective or cost-effective.

I do not doubt that the LP-children improved, but I see no reason to believe that this had anything to do with LP. It could have been (and most likely was) caused by the intense attention that these kids received over three days. Giving them a daily ice-cream and some kindness might (and probably would) have produced even better outcomes.

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.

36 Responses to The ‘Lightning Process’: implausible, unproven, hyped and expensive

  • In the clinical trial that you mentioned here the original primary outcome of school attendance at six months post intervention was changed to a physical function score. School attendance became a secondary outcome, with null results. More than half the participants were also from an earlier feasibility study and their data was used in the clinical trial, which is presumably what allow the authors to perform the outcome swapping to obtain the desired positive result.

    https://www.virology.ws/2017/12/13/trial-by-error-the-smile-trials-undisclosed-outcomes/

    Some Norwegian doctors, including Signe Flottorp at the Norwegian Institute of Public Health cite this trial as evidence the therapy is promising and now want another clinical trial. I believe it is very unlikely that this new clinical trial will be designed in a way that allows distinguishing nonspecific treatment effects from specific ones.

  • That’s a very sloppy article in the guardian, by their health editor.
    It actually quotes the investigator as saying “The main thing is to be absolutely clear to families that we don’t know if the Lightning Process works on its own. I’m not advocating people go out and get the Lightning Process.” yet they run it with the subhead “Trial unexpectedly shows combination of osteopathy, life coaching and neuro-linguistic programming helps children with CFS/ME get better”
    Is this the newspaper trawling through journals to find things to write about, or the university PR department trying to drum up publicity?

  • Thank you for your contribution, dr. Ernst.

    LP clearly isn’t the right treatment against ME/CFS, and could potentially harm the patients! And there are a lot of questions about ethics and methods in this study, which not gets answered.

    It’s a good point that intense attention over days could give children a better feeling after the treatment. ME/CFS or not, we all feel better with good attention, care and love. A sort of placebo. That are making us humans. But this feelings are temporary and transient, not a cure against a serious condition as ME/CFS is.

    Again, thank you.

    Kind regards from Norway.

  • Thank you for this article. After experiencing LP, I will be sharing widely as I still feel robbed of a large amount of money and foolish for letting the desperation to get well, overrule common sense! In my own opinion, it’s just another example of the abuse of the sick and vulnerable.

  • Thanks for writing about this. My main concern is that the Norwegian study will have a similar problematic trial design, relying on questionnaires without blinding patients or therapists and without a proper control group. LP aggressively targets patients’ interpretation of their illness and the language they use to describe it so their response to symptom questionnaire after treatment will likely be biased. Rather than a reliable test of whether the intervention works (as would be the case in a proper blinded and placebo-controlled randomized trial) I worry that this planned Norwegian study will produce unreliable but positive-sounding results that will give the Lightning Process a scientific aura for future sales pitches. Unfortunately, in the Norwegian press, the national ME/CFS patient organisation that raised concerns about the study is being framed as a group of activists, trying to hamper scientific research.

  • Thank you Dr Ernst.

    You may be interested in reading a paper by Phil Parker & al (the inventor of LP): “Understanding the Lightning Process Approach to CFS/ME; a Review of the Disease Process and the Approach”, published in the “Journal of Experiential Psychotherapy”. Here is a link: https://jep.ro/images/pdf/cuprins_reviste/82_art_2__v.pdf

    I would appreciate your thoughts on the bold claims made by Parker in this article… if you don’t mind going through lengthy “explanations” and proposed “links” between different concepts, that are not backed by any data at all.

  • The study is to be conducted by a phD candidate, Live Landmark, who is herself an LP coach. The university which she is a candidate is NTNU, and her main supervisor at NTNU is Leif Edward Ottesen Kennair. One co-supervisor will be Vegard Wyller from University of Oslo, and Esther Crawley (the author of the SMILE trial) has also been mentioned as someone who will help with the study.

    Funding has been received from the research council of Norway (https://prosjektbanken.forskningsradet.no/#/project/NFR/312152/Sprak=en) and will also be supported by certain muncipalities if I remember correctly. In the application to the research council LP is not mentioned by name, it is called a “three day intervention”.

    Vegard Wyller recently published a study on CBT together with music therapy as a treatment for postviral fatigue in adolescents, with a control group that received “treatment as usual” which in effect is no treatment at all. The trial is registered as a full scale randomized trial, but published as a feasability study. The primary outcome was average steps/day three months after treatment, and the intervention group did worse than the controls. However, they did show tendencies of improvement on two subjective secondary outcomes that are not included in the preregistration of the trial nor the statistical analysis plan. These two subjective measurements are highlighted in the conclusions, while the results of the primary outcome is not mentioned. One of the peer reviewers stated he did not read past the abstract. Michiel has written a more in-depth analysis about the problems with this study that can be read here: https://bmjpaedsopen.bmj.com/content/4/1/e000620.responses

    Thanks for writing about this.

    • Since the name on the Research council’s page isn’t Kennair I thought I’d give some more info. The project is a “public sector Ph.D” which means public actors, in this case a Centre for Development of Institutional and Home Care Services in Viken muncipality, can apply for funding if they have a candidate and a degree-conferring institution (here NTNU). There are supervisors both from the public actor and from the university involved.

      The names of the people involved and their institutions can be found in the first page of the project description as it was sent to the research council: https://lillemeglede.files.wordpress.com/2020/05/prosjektbeskrivelse.pdf

      Besides those mentioned on the first page, some others are mentioned in section 3.2 “Aktører” (a quick translation would be “acting bodies”):
      Norwegian institute of public health, professor Per M. Magnus (same as on the first page)
      University of Bristol, professor Esther Crawley
      Recovery Norge*, Henrik Vogt M.D.

      In section 3.3 “Støttespillere”/supporting bodies are these mentioned:
      Norwegian institute of national health, Geir Stene-Larsen and Morten Græsli
      Competance center for ME/CFS Norway, Ingrid B. Helland**

      *Recovery Norge is a small patient/user organization of patients that have recovered using mental health techniques like LP. Some of its users are LP coaches themselves.
      **A large campaign to change the board of the competance center failed in Norway two years ago. The reason for this campaign was in part that the center has given support of the view that ME/CFS can be treated with methods such as these.

  • I very recently heard Esther Rantzen on BBC radio, and she referred to her daughter still having chronic fatigue syndrome or ME. Similarly, in a recent article in The Sun Martine McCutcheon is no longer claiming to be cured, but says she’s is much better as she is pacing herself and concentrating on her home life. In other words, she would seem to have finally ditched the LP methods and come to terms with her illness.

    • Emily Ranzen (Esther’s daughter) was later found to have Coeliac Disease. She said when she was finally correctly diagnosed, that she was very relieved. She was really sick of trying to pretend she was well when she wasn’t.

  • I have M.E. and have had it for 13 years. I did the Lightning Process several years ago. I believed it could and would work. It didn’t. It left me disappointed and in debt.
    Many people who do it and don’t see improvement, blame themselves. You are told that you are not applying it correctly or often enough or you aren’t believing in the process enough. Patients end up being ridden with guilt and are often left with a sense of deep failure.
    I stopped short of that, fortunately. I did exactly what I was told to do and it categorically did NOTHING for me. In hindsight, if this method were as successful as it claims to be, then there’d be thousands of people on social media
    singing about it from the rooftops or even mountain tops! There aren’t.
    There are a select few. We do not know that these people had M.E. Some say they did and are adamant that the Lightning Process helped them.
    Do a sweep of Instagram and search the hashtag. Many people set up accounts when they embark on the process and slowly but surely the path is mostly always the same. Convince themselves they are getting better and stronger. Do a few new activities. Slip back. Blame themselves. Try to apply the approach with renewed enthusiasm. Run on adrenaline.
    Then their accounts drop off and go quiet. They then re-emerge and lo and behold, they are struggling once more – sometimes worse off due to pushing themselves too much for the past several months.
    I have watched accounts like these very carefully. They tell my story. Amongst these, there is one person I know who believes she recovered using the L.P. but she never terms her illness M.E. It was ‘burnout.’
    I’m not going to disparage the Lightning Process. I am telling you my experience of it. I am sharing with you what I have learned of other people’s experiences with it, as I have witnessed through their online accounts.
    That is all friends,
    Take good care of yourselves. Stay strong.

  • I looked into LP about a year after I first became ill, so 16 years ago. It turned up on a web search.
    It did not make any sense to me. I contacted Amir Norris and had correspondence with him, asking what these practitioners think is the trouble.
    I was told it was hyperarousal, adrenalin surging all the time and not being turned off.

    Ok. Follow that reasoning.
    High adrenalin (via corticotropins) leads to high blood pressure.
    pwME have low blood pressure. Adrenailn doesn’t surge everywhere like mad when stressed and anxious, it’s cortiocotropins that do, and overstimulation of those leads to a breakdown in the feedback mechanism, resulting in depression. Dexamethasone suppressor test etc.
    (going back vaguely to my memories of OU studies in ’94) but whatever, their simplistic theory did not fit in with my knowledge, or my low blood pressure. They’d just pinched some sciencey-sounding words.
    I decided not to bother giving him any money. Or Mickey Mouse therapy, which is precisely the same sort of garbage.

    I have yet to see anybody picking LP up on this mysterious lack of high blood pressure in sufferers.

  • The project description is not finalised, but an invitation with a project description was sent to all the municipalities that were invited to praticipate.

    http://opengov.cloudapp.net/Meetings/AHK/Meetings/Details/397489?agendaItemId=205095&fbclid=IwAR375P_pCnlL0p_18PobemYEAwT0ds1qX0RVMygdzLFtJ7JcdKuELRyMbDI

    They want new patient “ho do not identify themselves with the disease (ME). The deisgn is a stepped wedge, wherehalf of the patients receives treatment while the other half – the control group is placed on a waiting list for ten weeks before they receive treatment. In other words, after 10 weeks you have no control group.
    It is not clear what they are going to measure, but there is something about looking at work participation after two years.
    The project description contains the names and affiliations of everyone involved in the study.

    There are ethical questions, among them the question og harm. A publicly funded Norwegian agency, NAFKAM, a kind of watchdog for alernative treatments, have received numerous reports of ME patients getting worse from doing what they learn on LP courses. Users surveys done by the Norwegian ME Association consistently show that most havae no effect from LP, but that more ME patients experience harm than those who recover. The SMILE study you mention above is cited by the researcher on the new study as evidence that LP does not cause harm.

  • I was rather surprised to hear about Esther Rantzen in this context. When I was a teenager she used to host a very entertaining TV programme called “That’s Life” which was dedicated to exposing frauds, scams and poor service of all kinds.

  • “That’s Life” was an absolutely pioneering TV show in its day. Up until then, there really had been no concept of consumer rights.

    It was That’s Life that brought out and dusted down the Sale of Goods Act 1893, which bit of English law required goods to be “of merchantable quality”.

    People before That’s Life, simply didn’t realise that they had strong consumer rights. That’s Life helped to highlight, and put an end to, many shoddy goods and services. Subsequent consumer programmes, like Watchdog, owe everything to That’s Life.

    Ms. Rantzen however, is very long since retired from consumer affairs programming, and I suppose if you have a daughter suffering from CFS/ME, and you read about a ‘treatment approach’, and you are not a medical scientist, or have not yet carried out proper reading about it, you might well want to try something for your daughter’s health. I don’t suppose Ms Rantzen turns her fiercest scrutiny upon every single item or service she buys.

    But really, we could do with a regular TV show just to investigate SCAM products and services. I recall that for a time, That’s Life had a slot called “Heap of the Week”, in which some household product or item or furniture which was shoddy and the owner had given up on trying to get satisfaction over, was destroyed in some imaginative way. Manufacturers and retailers were named and shamed when this was done.

    There could be something like that for SCAM treatment of the week, though how it would be destroyed, I’m not sure.

    OK, I’ve now just about written a Treatment for a TV show – having written it down, I’ve produced an “original work” in terms of the Copyright Designs and Patents Act 1988 – so it’s my Intellectual Property! (or so I am claiming, anyway….)

    • “we could do with a regular TV show just to investigate SCAM products and services”
      YES!
      and it could be both informative and entertaining.
      NO IDEA WHY PROGAMM MAKERS DON’T DO ONE

      • I think you are so right, about the potential for it to be entertaining, as well as informative. That’s Life used to manage a good balance, sometimes featuring stories that were truly tragic, and then leavening it with something lighter.

        The BBC have managed some decent coverage in the past – quite a long time ago. There was the exquisitely designed homeopathy trial on the Horizon programme, and years before, a documentary (now on YouTube) that featured Dr David Reilly.

        A series of 45-minute documentary type shows, with a ‘consumer fraud’ slant if handled properly could be both serious and amusing. Such subjects can be explored in telling ways – like chemist Miles Power’s preparation and drinking of homeopathic Domestos on YouTube, and of course James Randi’s overdose of homeopathic sleeping pills (there was a mass demonstration of that in London, wasn’t there?)

        I feel certain that the ‘consumer fraud’ angle is the right way to go. It has been interesting (this is only tangentially related) to see how professional associations in the USA who promote the idea that you can change your sexual orientation by purchasing psychology consultations, very quickly changed their Mission Statements, after the Southern Poverty Law Center won their consumer fraud case against a body called JONAH.

        People nowadays, unlike back in the era when That’s Life began, are very aware of their consumer rights, and of getting what they are paying for. So to hold up these SCAM modalities to the light of evidence, and show that people are NOT getting what they think they are paying for, would strike a chord, I am sure.

        Professor Ernst, I have been aware of your work since the new Professorial chair at Exeter was first announced (I think I read about it in The Independent newspaper) and at the time, I thought, what an excellent idea; that it was time someone looked properly at the evidence, and followed where it led. I am not a medical person, but I served for some years on the Board of Directors of a patient support charity (the Natonal Eczema Society), and attended a lot of events. Over the years, it became ever clearer to me that SCAM just didn’t amount to much, in terms of helping patients – though I had long had an interest in various aspects of SCAM and had read quite widely.

        Some involved with SCAM are fond of suggesting that pressure from Big Pharma mitigates against SCAM. Actually, I am quite willing to believe that in the case of such a TV show as we are discussing, things will be the other way round, and that pressure from powerful proponents of SCAM will be applied against the idea of such programming.

        Co-incidentally, I have received in the post this morning, a glossy brochure for a Magnetic Pulse pain relief device…..

  • Dear Edzard,
    I was surprised by your response to ‘RG’ at 15:51.

    You quote various reviews, including a disastrous Cochrane review by Larun that is only still up because the authors refused to agree to David Tovey’s request to withdraw it (Cochrane rules do not allow withdrawal without author approval!).

    These reviews discuss cognitive behavioural therapy and graded exercise therapy. Although these are practiced within the ‘establishment’ they are no different from the Lightning Process in that their theoretical basis is incoherent and the trials are valueless – just as you point out for LP. In fact the evidence shows strongly that they do not work. (I am a retired physician asked to comment on treatments for ME/CFS by NICE, MRC, NIH etc..) If your judgment is that LP is quackery then CBT and GET deserve the same analysis.

    RG may express absurd views but seems to have a point here.We need a level playing field. Nothing cosy I am afraid.

    Best wishes

    Jo Edwards

  • Indeed, CBT for ME/CFS is just the Lightning Process with less slick marketing. And studies of the impact of CBT on ME/CFS suffer from many of the same problems, with subjective outcomes combined with unblinded treatments and cognitive manipulation. The study “Long-term Effect of Cognitive Behavioural Therapy and Doxycycline Treatment for Patients With Q Fever Fatigue Syndrome: One-year Follow-Up of the Qure Study” by Raijmakers et al 2019 is a good one to look at.

    A group of people with QFS (ME/CFS following Q fever) given CBT and a control QFS group started out with close to the same reported fatigue scores. After treatment, the CBT group had somewhat improved reported fatigue, with the mean being slightly below the level the authors deemed to be severe fatigue. One year after treatment, the CBT group and the control group had fatigue scores that could not be differentiated statistically (with the control group mean actually being better than that of the CBT group). Rather than seeing this result as evidence that training people to answer fatigue questionnaires more positively has no impact on the course of the illness, the authors interpreted the result as meaning that more research is needed to work out how to make the transient reported improvement last longer.

    What the paper does not report is the psychological impact of telling people who remain unwell after Q fever (and their families) that they could be better if they just thought more positively and ignored their symptoms. Not only are the people in the CBT group just as fatigued one year after treatment as those who received no treatment, they may feel shame for not having been morally strong enough to become well. It’s a treatment that adds insult to injury.

    The field of psychology is ripe for scrutiny by people with a skeptical outlook; the line between pseudoscience and psychology is unfortunately often very thin.

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