Lightning Process to be Evaluated in Research Study on Children

[Esther12]

Just out of interest - how might you blind controls in a trial such as this with a 'therapy' such as this?

I guess you could 'fake it' or get the kids to practice relaxation therapy or something... then the outcome would be compared to 'listening to relaxing music'.

Wonder how LP would stack up against CBT - if that were used as a 'control'.

I don't think it makes sense to talk about blinding participants for 'treatments' like this, and blinded assessment is really hard for CFS too. More objective outcome measures that should be less prone to bias would be things like actometers and time spent at work/education.

'Relaxation' seems like a pretty poor control for bias to me. Something like homeopathy would probably be better so long as included a sense that the patients were responsible for taking medication correctly and in a way that would lead to their recovery (which seems ethically no worse than the LP approach... bleurgh!)

 

[Bob]

I don't think it makes sense to talk about blinding participants for 'treatments' like this, and blinded assessment is really hard for CFS too. More objective outcome measures that should be less prone to bias would be things like actometers and time spent at work/education.

'Relaxation' seems like a pretty poor control for bias to me. Something like homeopathy would probably be better so long as included a sense that the patients were responsible for taking medication correctly and in a way that would lead to their recovery (which seems ethically no worse than the LP approach... bleurgh!)

It's not really possible to blind this sort of trial, but I think it is possible to include some sort of placebo control.

 

[Bob]

Like I have said many many many times before, if someone was willing to pay for me to attend these sessions - and I was able - I'd give them a whirl and tell everyone about it afterwards.

Part of the training is not discussing it with anyone afterwards, including signing a contract of confidentiality.
Also, the training is based around brain-washing the trainee to ignore their illness and to 'believe' that they are well.
So if you told us that it cured you, or that your symptoms improved, your opinions wouldn't have much credibility.

If someone feels they have recovered by this, or any other method - be it medical treatment or therapy or 'quack' treatment - I dare say the individual doesn't give a fig as to the scientific value of it, placebo or otherwise.

Indeed, and we must try to be sympathetic and empathetic to those who say that they've benefited from non-medical interventions, such as faith healing etc.
There may be many reasons why people benefit from such a training course.
However, to suggest that positive thinking, or faith healing, is a medical 'treatment' for any biomedical illness is simply not supported by any evidence.

...I am not opposed to it being done on kids - not when so many are seemingly being fed like cannon-fodder to this commercial venture: must cost the parents a fortune!

I can't understand why anyone thinks it's acceptable to:
a) Propose that CFS/ME can be 'treated' with a positive thinking training course.
b) Expose children to potentially psychologically damaging mind-washing sessions.
c) Invalidate children's experiences, by telling them that you don't believe that they have any symptoms or illness.
d) Expose children to dangers of post-exertional exacerbations.
e) To train children to disregard pain and fatigue.

 

[Esther12]

It's not really possible to blind this sort of trial, but I think it is possible to include some sort of placebo control.

I'm a bit uncomfrotable about just talking of 'placebo control' as that could indicate that just giving people a sugar pill is a sufficient way of accounting for bias. 'Placebo' can mean different thing to different people, and it's seems like a bit of a difficult one to talk about concisely.

Part of the training is not discussing it with anyone afterwards, including signing a contract of confidentiality.
Also, the training is based around brain-washing the trainee to ignore their illness and to 'believe' that they are well.
So if you told us that it cured you, or that your symptoms improved, your opinions wouldn't have much credibility.

I wouldn't go that far. LP certainly seems like the sort of thing which would lead to problems with people trying to speak more positively about their health, but I don't think it is the sort of thing which could truly 'brain wash' people who were still so ill they could barely leave the house into insisting that they had full recovered.

(Possibly OT, and I think we're actually saying very similar things in slightly different ways).

 

[MeSci]

Part of the training is not discussing it with anyone afterwards, including signing a contract of confidentiality.
Also, the training is based around brain-washing the trainee to ignore their illness and to 'believe' that they are well.
So if you told us that it cured you, or that your symptoms improved, your opinions wouldn't have much credibility.


Indeed, and we must try to be sympathetic and empathetic to those who say that they've benefited from non-medical interventions, such as faith healing etc.
There may be many reasons why people benefit from such a training course.
However, to suggest that positive thinking, or faith healing, is a medical 'treatment' for any biomedical illness is simply not supported by any evidence.


I can't understand why anyone thinks it's acceptable to:
a) Propose that CFS/ME can be treated with a positive thinking training course.
b) Expose children to potentially psychologically damaging mind-washing sessions.
c) Invalidate children's experiences, by telling them that you don't believe that they have any symptoms or illness.
d) Expose children to dangers of post-exertional exacerbations.
e) To train children to disregard pain and fatigue.

Exactly. Whatever happened to the precautionary principle? Is psychoquackery somehow exempt?

 

[Firestormm]

A fair bit of bias expressed on this thread - including by me.

 

[Bob]

A fair bit of bias expressed on this thread - including by me.

If you mean that we have preconceived ideas about the Lightning Process, before waiting for the results of the trial, then I plead guilty. Positive thinking, or ignoring symptoms, or a 'belief' in wellness, is not a 'treatment' for a biomedical illness. Simple as that.

(I'm not even aware that positive thinking, or ignoring symptoms, or a 'belief' in wellness are proven treatments for any psychological illnesses, let alone biomedical illnesses.)

If the Lightning Process is 'proven' to be successful for CFS in children, I think this must surely the first time that (secular) faith healing will ever have been prescribed as an evidence-based treatment.

Perhaps they should role it out for other diseases in children. Why stop with CFS? Will positive thinking perhaps reduce tumour sizes, or grow back missing limbs? (Sorry to be crude, but I'm making a serious point.)

 

[Bob]

I'm a bit uncomfrotable about just talking of 'placebo control' as that could indicate that just giving people a sugar pill is a sufficient way of accounting for bias. 'Placebo' can mean different thing to different people, and it's seems like a bit of a difficult one to talk about concisely.

Well, yes, it is difficult to talk about it concisely. But placebo controls are well established in the medical literature. Well designed trials incorporate controls to account for biases including placebo effect. Badly designed trials don't include such controls. The best trials are blinded, but this trial conveniently cannot be blinded.

Part of the training is not discussing it with anyone afterwards, including signing a contract of confidentiality.
Also, the training is based around brain-washing the trainee to ignore their illness and to 'believe' that they are well.
So if you told us that it cured you, or that your symptoms improved, your opinions wouldn't have much credibility.

I wouldn't go that far. LP certainly seems like the sort of thing which would lead to problems with people trying to speak more positively about their health, but I don't think it is the sort of thing which could truly 'brain wash' people who were still so ill they could barely leave the house into insisting that they had full recovered.

I didn't say that all patients are successfully brainwashed by the Lightning Process. And 'brain-washing' is a difficult term, I acknowledge. But the fundamental nature of the program, is that it trains people to 'believe' that they are well, and to deny any acknowledgement (to themselves or to others) of having any symptoms or illness. To acknowledge or to say that you have symptoms is to fail at the program. So this does seem to me like a form of brainwashing. Obviously, if someone is still bed-ridden after a course of Lightning Process, then they will have been told that they are not trying hard enough, and have failed to take the course seriously, because they still 'believe' that they are ill and disabled. To believe that you have any illness, or disability, is to fail the course. So bed-ridden patients would not be telling us that they had been cured or successfully treated.

 

[MeSci]

If you mean that we have preconceived ideas about the Lightning Process, before waiting for the results of the trial, then I plead guilty. Positive thinking, or ignoring symptoms, or a 'belief' in wellness, is not a 'treatment' for a biomedical illness. Simple as that.

(I'm not even aware that positive thinking, or ignoring symptoms, or a 'belief' in wellness are proven treatments for any psychological illnesses, let alone biomedical illnesses.)

If the Lightning Process is 'proven' to be successful for CFS in children, I think this must surely the first time that (secular) faith healing will ever have been prescribed as an evidence-based treatment.

Perhaps they should role it out for other diseases in children. Why stop with CFS? Will positive thinking perhaps reduce tumour sizes, or grow back missing limbs? (Sorry to be crude, but I'm making a serious point.)

Ah, but other illnesses have clear biomedical data, whereas ME only has abnormal cytokine activity, abnormal mitochondria, poor temperature control, aberrant heart rate and blood pressure, poor fluid control, abnormal cortisol secretion, swollen lymph nodes and glands...a few other abnormalities...obviously all in the mind.

 

[MeSci]

Ah, but other illnesses have clear biomedical data, whereas ME only has abnormal cytokine activity, abnormal mitochondria, poor temperature control, aberrant heart rate and blood pressure, poor fluid control, abnormal cortisol secretion, swollen lymph nodes and glands...a few other abnormalities...obviously all in the mind.

...low blood volume, sluggish and/or blocked lymph flow, impaired nutrient absorption, gut dysbiosis, high levels of certain autoantibodies, higher incidence of certain genetic variations than in the general population...amazing what the mind can do.

 

[A.B.]

amazing what the mind can do.

I think I've really started to understand the psychonuttery.

It all stems from a misunderstanding of the placebo effect. These people think placebos are capable of curing illness. Therefore, all the quacky positive thinking, belief based interventions are justified because as long as the patient has a positive attitude and warm feelings, everything will be allright. As consequence, if beliefs can cure illness, surely they can also cause illness, or so the line of thought is. Therefore patients are to blame for their illness, and their harmful beliefs must be fought.

In reality, placebos have no effect on objective measures, but since they never check reality by (perhaps intentionally) limiting themselves to subjective measures, the illusion can persist. Ironically, the practitioners frequently accuse patients of holding false beliefs about reality.

 

[Dolphin]

Saw this posted on an ME mailing list. Haven't looked in to it:

NHS National Research Ethics Advisors’ Panel: PACE, SMILE, & CoIs minutes


National Research Ethics Advisors’ Panel PACE minutes [extracts]

https://dl.dropboxusercontent.com/u/89858260/NREAP on PACE.pdf

National Research Ethics Advisors’ Panel SMILE minutes [extracts]

https://dl.dropboxusercontent.com/u/89858260/NREAP on SMILE.pdf

National Research Ethics Advisors’ Panel Conflict of Interests minutes [extracts]

https://dl.dropboxusercontent.com/u/89858260/NREAP on Conflicts of Interest.pdf