Discussion in 'Latest ME/CFS Research' started by Firestormm, Dec 6, 2013.
Sorry, being a bit thick today. Does this mean they have done a study to see if they should do a study and the result of that study is that yes they can do the study?
I would love to know what an NHS M.E clinic considers to be 'specialist medical care' I can imagine what it is = nothing that actually involves SPECIALIST medical care a la klimas or De Merleir.
Also slightly concerned with the statement that 'Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is relatively common in children' Where is the evidence to back this up? Apart from my own child I have never met any other children with CFS/ME and neither has my daughter or any of my other 3 children who have been to various schools throughout Britain over a period of the last 18 years or so.
Thanks anyway Firestormm for posting
@justy Yes. In answer to your first question. This means they feel they can proceed with a Randomly Controlled Trial of the Lightening Process in children and compare it to Standard Medical Care - which if memory serves from the PACE Trail, comprised a leaflet and a chat!
Personally, I can't be arsed to read the full paper, but as I have always said, if someone want to give me £600 I would happily undergo the LP and report back. In the interest of 'science' I am happy to be the secret squirrel
I've always wondered whether ME in children is a different disease entirely to that in adults, I believe Prof. Newton wrote a paper on it a few years ago. Does anyone know what exactly the lightening process is - 'I've researched a little but never got a full answer... It always struck me as overpriced quackery but I'm still intrigued by it to a degree.
SMILE Trial Protocol 2010:
Interventions (Page 2):
“In addition to the Specialist Medical Care detailed above, young people and their parents will be asked to read the information about the Lightning Process on the Website….”
BUT – Since Dr Crawley’s SMILE Trial was instigated, and proceeded, the Information on Phil Parker’s Lightning Process Website has been deemed Illegal by the UK Advertising Standards Authority (ASA).
So, the Online material which Dr Esther Crawley advised youngsters and their parents to read, as part of the SMILE Trial, has since, been deemed illegal by the Advertising Standards Authority:
Surely that should invalidate the Trial…. Because the material that the youngsters and their parents were told to read, as preparation for taking part in the Trial… was Illegal…..
I have a child with ME and have been told about another 4 other children within the same area. I think often children are not well enough to attend school.
It is based on affirmations and counteracting negative thoughts. Dorothy got back to Kansas using the Lightning Process -- there's no place like home, there's no place like home, there's no place like home.
Lightning Process | Advertising Standards Authority adjudication on Phil Parker Group Ltd | 22 August 2012
“Unethical” study involving children"
'A plan to recruit children with ME/Chronic Fatigue Syndrome to a scientific trial comparing the efficacy of an unproven psychologically-based training programme with specialist medical care is “unethical”, say two of Britain’s leading ME/CFS charities – The ME Association and the Young ME Sufferers Trust.
In a joint statement issued yesterday evening (4 August 2010), the two charities say:
We are issuing this joint statement due to widespread public concern, together with our own serious reservations, about a forthcoming study of the psychologically-based Lightning Process on children.
The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care. It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study.
The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups. The document ‘MRC Medical Research Involving Children’ is quite clear on this issue. It poses the question: ‘Does the research need to be carried out with children?’ In answer, the MRC states: ‘Research involving children should only be carried out if it cannot feasibly be carried out on adults.’
The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process.
A survey of 4,217 people carried out by the ME Association on the management of ME/CFS found that over a fifth of those who had tried the Lightning Process were made worse (7.9% slightly worse,12.9% much worse). If any trial is to be held, it should first be on adults, who can give informed consent. No rigorous RCTs into the application of the Lightning Process have ever been undertaken.
Despite many years of scientific research there is still no single diagnostic test for ME/CFS, nor is there a curative treatment. The theory upon which the Lightning Process is based, together with its claim that the prolonged nature of the illness is caused by ‘the adrenaline, nor-adrenaline and cortisol loop’ is not scientifically proven. Moreover, the Advertising Standards Authority recently ruled that an advertisement in an internet sponsored link containing claims of its effectiveness by a Lightning Process practitioner should be removed. We understand that the practitioner will be involved in this study and we find this concerning.
The Trading Standards departments of two local authorities have also taken action over therapeutic claims by Lightning Process practitioners following referrals by Dr. Charles Shepherd of the ME Association. The Lightning Process calls itself a training programme, not a medical treatment, combining concepts from Neuro-Linguistic Programming, Life Coaching and Osteopathy. It claims to be effective for ME/CFS and psychological problems such as anxiety, stress, depression, guilt, low self esteem. Any evidence for this effectiveness on ME/CFS is purely anecdotal. ME has long been classified by the World Health Organisation as a neurological illness, not a psychological condition.
We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated ‘process’ with adults.
Furthermore, we have serious concerns about the primary outcome measure, which is school attendance after six months. Children have a legal right to ‘suitable education’ for their particular needs, which may or may not include school attendance.
The statutory guidance ‘Access to Education for Children and Young People with Medical Needs’ explains that whilst it is desirable for children to be educated in school, other forms of education must be provided for those who need it. The Chief Medical Officer’s Working Group Report on CFS/ME (DOH 2002) stated that most children with ME will need education in their homes at some time, potentially for a considerable period. In 2009 the Education White Paper ‘Back on Track : A strategy for modernising alternative provision for young people’ included virtual education. Chapter 7, ‘Learning from the best and supporting innovation’, spoke of ‘e-learning and virtual provision, particularly for pupils who cannot attend school due to health needs.’ Accessible education is also provided for in disability discrimination law.
If school attendance is the primary outcome measure of this study, families involved may then feel pressurised into avoiding alternative forms of education which would benefit their children and to which they are legally entitled.
For all these reasons, it is our considered opinion that this study of the Lightning Process in children is unethical and should be abandoned.
NOTES TO EDITORS
‘£164,000 awarded for new research into the treatment of a chronic childhood condition’.
Press release issued by The Royal National Hospital for Rheumatic Diseases, which can be found at their press release page:
Advertising Standards Authority ruling:
Interesting that the primary outcome measure has now been changed. I wonder if that was out of these concerns and if the MEA and Tyme have anything further to add in light of this change? I doubt it will change their concern but I will ask.
Smile - the full trial is already well underway (randomisation started Sep 2012)
The authors said:
Its been commented elsewhere recently, though I don't recall where, perhaps by Tom Kindlon? that using attitude changing techniques then measuring outcome by a change in attitude is deliberately increasing risk of bias. Its a bad study design if there are no objective outcome measures.
To this I would like to add that changing the outcome measures like this probably worsens the ethical status of the study.
PS School attendance is a secondary outcome measure. What I want to know though is what happens to their grades, social life, sports and hobbies. Attendance is a poor measure in itself.
This thread comes to mind
I have looked through the pre-publication history and more papers are planned
Are you sure?
It says here SMILE is a feasibility study:
It would be good if one or more people posted comments on the journal's site re: http://www.trialsjournal.com/content/14/1/415/abstract
This doesn't seem very wise to me given that LP involves 3 days of hypnosis/similar where participants are trained not to "do M.E." i.e. they're trained to say they're well and have no problems doing things if people ask.
Objective outcome measures like motion-sensing devices would seem preferable for trials of such interventions.
All participants i.e. in both arms also receive an intervention involving encouraging graded activity
so again it would be good to have objective measures.
Brief review of SMILE study
I think it's very healthy that the authors trialed their approach and asked for feedback from patients so as to make future work more effective. Specifically the discovered that
patients found filling in questionnaire too much hassle (relative to the amount of treatement) so they dropped outcome measurent at 6 weeks
patient in the Lightning Process + 'Specialised Medical Care' found the advice conflicting between the two approaches (eg gradual improvement vs ' you're ready to go back to School full time now') and changed the info they gave to patients as a result (take the best bits from both, oddly)
a significant number of patients and parents thought that school attendance wasn't a good measure of real world activiy eg what is 100% during and in the run up to A levels? Whether the decision to downgrade school attendance to a secondary outcome measure is the right answer to this issue is debateable.
They also imrpoved follow-up rates by using phonecalls and letters
So that's all the good stuff out of the way
It was a little odd that study participants found the info material too complicated and/or too damn dull but they didn't make changes there.
Only a third of those eligible undertook therapy
And the biggest omission was that even though only 50 people (a 32%) received therapy out of 156 eligible they didn't aim to improve that process or investigate whether the large number of people who didn't agree to take part might tell them something very important. 15 people said they weren't interested, 7 that it was 'too much' and 59 didn't return to consent forms =46% (71/156) didn't give consent to the study. A further 13 declined after randomisation.
The problem is that people may not be declining at random, and so the results from such studies might not generalise eg if the results were good then it wouldn't be safe to assume that the results apply to all adolescents with ME/CFS.
More than a quarter of the sample had 'recovered' physical function before treatment
PACE definied recovered physical function as 60 points (100 is full activity): 25% of the control group scored 65 or more before treatment and 25% of those getting LP scored 70 or more. So probably about a third would have scored 60 or more overall. Probably one for PACE afficionados only.
Taking a break to do something more interesting, maybe more later
This comment highlights why many of us thinking LP can be dangerous:
For me the problem with the LP is that we still do not know if they are studying/practising on patients/paying customers who all have the same disease/health/lifestyle problems.
In one respect I am left thinking 'yeah whatever works for you is fine by me' - just as I am for any other remedy/anti-virus/vitamin/name-your-poison and/or expert approach: but not when something like this Trial might come along and say 'hey guys this is good for ME'.
But I would be happy/willing to give it a whirl. I wonder if should this Trial proceed and prove successful (by whatever measure) it would then be that LP becomes available on the NHS? How would that effect Phil's empire?
Don't reply if a reply will take this thread - on research - off track. But I couldn't help me self
I think the NHS would find it hard to justify paying for the LP if there is no RCT with good outcome measures. Though their track record suggests an RCT with poor outcome measures that is statistically significant might be fine by them.
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