Lightning Process study in Norway - Given Ethics Approval February 2022

I see what they're saying and agree they seem to assume worsening of symptoms during the course of treatment is psychological rather than due to an exacerbation of physical symptoms because the patient is being instructed to ignore important warning signs.

I'm trying to raise a different point. The assumption is that LP is safe. This is an assumption that should be tested and until it is tested then patients should be protected form all possible harms that could be caused, both physical and psychological.

The nature of the patients' original illness aside, any therapy designed to alter a person's thoughts and attitudes should also test the therapy doesn't inflict psychological damage and, where psych harm has been done, the patient should be supported.

This would mean, regardless of their underlying medical condition, patients who are vulnerable to depression and suicide should be identified and excluded from trial participation. Patients post trial should be reassessed so if they become depressed or suicidal in the year or so after the trial this is identified & they receive appropriate support. The therapists involved in this safety wrapper being independent of the LP trial itself and unbiased (as far as that's possible).

This would be in addition to patients being referred to an appropriate specialist if they become worse during the trial - an appropriate specialist for an ME patient being and expert in ME and not a psychologist.

If they're going to say the trial is safe when it could obviously have significant impact on participants' mental health then the participants' mental health should be thoroughly checked before and in the period after the trial. This is addition to protecting participants from a worsening of the condition that made them eligible to take part in the trial.

 

From Live Landmark respons 10 oct 2020 to REC Central (REK midt) assessment (Application Procedure/process)

"A three-day course is a short intervention and we expect any effect to occur quickly. Experience indicates that the effect comes immediately after the course. We still want to see if the effect persists and will measure effect at 6 weeks and 10 weeks, where we have chosen 10 weeks as the primary endpoint. In a previous study, an effect is shown at approximately 12 weeks (Crawley et al., 2017).

We will also make a measurement of primary and secondary outcome measures at 6 months to investigate whether a possible effect is maintained over time.

Any change after this, both in a positive and negative direction, will be difficult to link to the intervention."

ya....don't u say???

 

Do we know yet what the outcome measures are? The above wording suggests they are already specified.

Presumably we can be reasonably certain they are subject self ratings or questionnaires.

 

If the effect isn't maintained over time, that will be proof that LP works, but needs to be applied continuously.

Need I say more squire? A nod's as good as a wink to a blind horse.

 

At least they are learning from all the previous trials of ineffective behavioural 'treatments'. Sadly, they have learnt to get their excuses in early for why the 'treatment' didn't work, rather than that they should stop trying to use the repeatedly ineffective 'treatments'.

 

*Primary endpoint (10 weeks) Physical function: SF-36 (RAND) (Ware & Sherbourne, 1992)

Secondary outcomes baseline, 6weeks, 10weeks and 6 mo
*Physical function: SF-36 (RAND) (Ware & Sherbourne, 1992)

Chalder Fatigue Questionnaire (Chalder, Berelowitz, Hirsch, Pawlikowska, Wallace & Wessely, 1993)

Brief Pain Inventory (Klepstad, Loge, Borchgrevink, Mendoza, Cleeland & Kaasa, 2002)

A Brief Questionnaire to Assess Post-Exertional Malaise (Cotler, Holtzman, Dudun & Jason,
2018)

The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) (Tennant, et al., 2007)

Patient Global Impression of Change (PGIC) (Dworkin, et al., 2008)

Quality of relationships / dyadic function (Fletcher, Simpson & Thomas, 2000)

A 10-point version of Big Five Inventory (Rammstedt & John, 2007)

Brief Illness Perception Questionnaire (Broadbent, Petrie, Main & Weinmann, 2006)

Hospital Anxiety and Depression Scale (Zigmond, AS & Snaith, RP (1983)

Insomnia Psychological assessment and management (Moring CM, 1993)

Questions about guilt, suicidality and other treatment in / outside the health care system

----
diagnostic criteria CCC2003

 

Showing that the failure is systemwide, because such an admission is based on the choice of a terrible methodology that effectively cannot tell anything and should obviously lead to the proposal being rejected, hell being mocked for being blatant pseudoscience. This places the failure to regulate to the medical authorities who approve of this, but they are fine with it because nobody cares in the system cares about this patient population.

Frankly I can't fault the grifters here, they are abusing a system that wants them to abuse it. The fault is entirely on the people who are supposed to safeguard against cheating and instead chose to be derelict in their obligations.

 

Henrik Vogt and others from Recovery Norge have written a response to Nina E. Steinkopf and prof. Saugstad's opinion piece about the LP study.
It's still not possible to google translate Steinkopf/Saugstad's text, but the one from Recovery Norge worked.

Original: Forsk på metoder som gjør frisk!
google translation: Research on methods that make you healthy!

Several of our members have used the Lightning Process (LP) course. That it should work is fully compatible with a scientific model of ME/CFS. Elements from this method will now finally be researched in a study on a three-day intervention in ME/CFS.

Recovery Norway is involved in the study through user representatives, and we think it is worrying and despairing that certain patients and relatives, with a different understanding of the condition, actively go out and try to stop this planned project .

 

It varies a lot. Some questionnaires are basically owned by corporations who require royalties (especially if used for commercial interests), but sometimes grant fee waivers upon application by scientists.
Some seem to be freely used without payment.

 

Nina E. Steinkopf and prof. Ola D. Saugstad has already written a reply to Vogt and Recovery Norge.

Bred enighet om at ME er en alvorlig fysisk sykdom
Google translation: Broad agreement that ME is a serious physical illness

..one must follow a research protocol that asks the right questions, the research management must be impartial and unbound by financial and other interests. And one must be reasonably confident that the method is not harmful.

Our objection to NTNU's LP study is that these conditions are not met. There is reason to believe that with this design you will get another simply performed study with the purpose of proving that LP has an effect. It is wrong to spend valuable research funds on such a project which can also contribute to subjects becoming sicker.

 

Finally I'm able to google translate the first opinion piece in this newspaper from Nina E. Steinkopf and prof. Ola Saugstad from last week

google translation: The ME controversy: Study on Lightning Process at NTNU

The study is designed to have a positive result and is in our opinion cynical, unethical and indefensible.

 

After the United Kingdom now also seems to be turning its back on ME,

Any idea what they mean by that? Surely the only turning of the back has been in respect of GET and CBT.

 

Just a bad translation. They say that as also UK now is changing its view on ME, Vogt and co stand behind with no supporters left.

 

A news site about research has an article about the criticism towards the study.

The leader of the project, professor Leif Edwards Ottesen Kennair is interviewed and doesn't understand any of the criticism.
Professor Kristian Sommerfelt is also interviewed, and says the trial is badly designed and probably will show a positive effect, without any real way to know if it's placebo effects.

Live Landmark just wants to examine if some can have effect from this approach, and to do it scientifically.

Studie på kurs for ME-pasienter vekker strid
google translation: Study on course for ME patients raises controversy

Kristian Sommerfelt, on the other hand, believes that Kennair's study can be dangerous:

- It does not pass on the research on the usefulness of LP. And when the study is designed so that the result will look like the benefit of LP, it can lead to more patients on the wrong basis performing LP. Then some may get a clear worsening of the disease. I have met patients who have experienced this, says Sommerfelt.

- This is a strange, scientifically unfounded and gross claim, Kennair answers.

He disputes the claim that the study design will ensure positive results for LP:

- I do not care if the result is positive or negative for the method, there I am completely open. I have never used LP as a method and will not do so. My only motivation is that the discussion should take place scientifically, instead of people thinking on the basis of anecdotes and reader contributions, he says.

He also does not want to take into account the protests outside the research community:

- We need knowledge. It is not okay for someone who is very upset to decide what knowledge is to emerge and what we are going to research. I can be frustrated about that, says Kennair.

 

‘Except when they say what we want to hear’. The LP relies very heavily on glowing ‘testimonials’ from happy customers in its own advertising and promotional literature and the proposed research is to be evaluated solely on subjective reports, that is the personal views of the participants [completing the course].

The very nature of reporting harms in any intervention is that it is a cumulation of anecdotes or individual reports. Quite how are you to access any harms if anyone reporting them is to be ignored them because you think they are ‘very upset’, especially as being ‘very upset’ is a decidedly appropriate response to such as the suicide of your son or daughter. It is only reasonable to reject such criticism if you can demonstrate in previous research and clinical practice there has been serious recording and investigation of harms including the various suicides reported as arising from the intervention and if there are robust independent systems for reporting any harm or adverse responses in the proposed research, which certainly has not been the case in previous trials.

It strikes me that this research is designed on the basis of an unevidenced belief that LP can not cause harm, and that the researchers are deliberately seeking to exclude any consideration of previously reported harm arising from the intervention from the debate by demonising those raising them as irrational activists.

[changes shown in square brackets]

 

That's the saddest part

 

The Chairman of the Norwegian ME Association has an opinion piece today in forskning.no about this article. It turns out he was interviewed for the article, but forskning.no decided not to include the interview. Forskning.no thus had access to all the objections from the ME Association against this study but did not include them in the article. The Chairman finds it odd that forskning.no chose to aim the article in such way that the ME Association is strictly against the LP-study rather than the ME Association being strictly pro securing a high level of quality and ethics for research trials into ME.

Dette mener ME-foreningen om intervensjonsstudien på ME og LP - Bjørn K. Getz Wold
google translation: This is the ME Association's opinion about the intervention study on ME and LP

We fully recognize that Professor Kennair and his team have the academic freedom to research what they want, including using public funds to research an alternative treatment for ME.

But the ME association questions research design and method in this study and points out that the intervention study seems to fail basic ethical research principles.

 

Another annoying article in the same newspaper from the same journalist. It was published two days ago. The article was behind a paywall and it seems it has received very little attention. Which is probably for the best, but here's anyway a short summary:

In the article Lightning Process is presented as a seminar in stress coping. A mental training program with elements from cognitive therapy, positive psychology and stress physiology.

Regional Committees for Medical and Health Research Ethics has received eight complaints about the study. This is described as a "storm of complaints".

Chairman of the Norwegian ME Association says people have reported harm from LP and that the study is not designed to pick up on such deterioration. A psychologist will be following the patients up, but why not a medical doctor?

Professor Ola D. Saugstad (an ME researcher, but in the article he is presented as an "ME debater") says he has met with several ME patients who have been told to believe themselves well again, and after a while deteriorated and ended up even worse than to begin with.

The Norwegian Society for Lightning Process rejects that participants are told to believe themselves well.
- To take responsibility for your own health, is not the same as it being your own fault that you're ill, says Live Landmark.

The researchers behind the study says the claims about deterioration is an important reason FOR the study.
- If they're right, they should be thankful that this will be thoroughly documented. It they're wrong, they should be thankful that a treatment many ME patients are trying, isn't as dangerous as the ME Association has been afraid of, says prof. Wyller.

He also says it's criticisable and unfortunate that a patient organisation is making such complaints and delaying research which can provide important answers.
- I think the ME Association's attitude to research and science is shocking. They claim to be interested in research, but being interested in research is also about being open to the truth being something other than what you think, says Wyller.

He also refutes the criticism about financial interests behind the study
- If one should stop all research where there are financial interests, there wouldn't be much medical research left. We would for instance not have had any vaccines against covid-19 if it wasn't for the pharmaceutical companies, which of course have financial interests.

Henrik Vogt says
- Several of our members have experienced improvement with LP. They want this to be researched, so that one can develop better help and so that what helped them, might become more available for those who are still sick.

 

As always the BPS answers / responses to things that have been said is to answer to something that was never said. The usual BPS diversionary tactic.

It is blaming the patient but not "as it being your own fault you're ill" but blaming the patient if they do not respond positively to LP and do not get well. That is where the blame comes in. Because LP works. Based on trials designed to prove that. Any other position is just being spiteful to true believers.