The SMILE trial is published – with press release, science media centre ‘expert reactions’, and media coverage | 21 September 2017

Note: This blog has been updated at 08.22 on 25 September, with details of the Daily Mail article.

The SMILE Trial – a randomised trial of specialist medical care and the commercial ‘Lightning Process' in adolescents with ME/CFS – has now been published in the BMJ Journal, Archives of Disease in Childhood.

The ME Association has been quoted in the Guardian, Daily Mail, and by BBC News along with Tymes Trust. We have also featured in a more balanced piece from NetDoctor. (See below.)

We are aware of the claim made against the ME Association on the Today programme earlier this morning, where it was erroneously said we did not support research in children, Dr Shepherd was afforded a right to reply and appeared on the programme on Friday, 22 September at 06.50.

It was interesting to note in the original BBC Today Programme that ‘Anne' – the anonymous patient who had M.E. at 16 years of age – found activity management (which some refer to as ‘Pacing' – the management tool that is endorsed by the ME Association) helped her to recover. She had not in fact used the Lightning Process.

We will be providing a critical review of the actual trial results in due course, but in the interim we would refer you to the statement we prepared ahead of the release of these results:

‘The Lightning Process is a commercial treatment programme which has been promoted as a cure for ME and CFS. A combination of neurolinguistic programming and osteopathy, its exponents claim it can cure the condition in three days.'

‘Dr Charles Shepherd, medical adviser for the ME Association, said:

“The Lightning Process is not a treatment that we endorse or recommend for people with ME/CFS.

 

“Patient evidence, gathered from our members over many years, indicates that some people who have gone through the LP try to make rapid and unrealistic improvements in their physical and mental activity levels. However, this is followed by a relapse or significant worsening of symptoms.

 

“Others who have gone through the LP programme, report that they have spent huge amounts of money with no obvious benefit.

 

“There has been a very significant growth in biomedical research globally into M.E. in the past decade. This over-simplistic and largely psychological model of ME/CFS causation that is being put forward to patients is totally out of step with emerging scientific evidence as to the cause of ME/CFS.

 

“We will be looking at the release of the SMILE trial results very closely indeed.”

 

 

University of Bristol, Press Release
‘Study investigating effectiveness of The Lightning Process® programme to treat children with mild or moderate CFS or ME finds symptoms improve.'

Extracts:

The study’s findings indicate that LP offered in addition to specialist medical care is effective and probably cost effective for children and young people who have been diagnosed with mild/moderate CFS/ME.

Professor Esther Crawley, Professor of Child Health in the University's Centre for Child and Adolescent Health and Consultant Paediatrician at the Royal United Hospital, said:

“I was surprised that the LP provided additional benefit to specialist medical care. This is an important study as it provides another treatment approach that some children may find helpful. Ultimately, our aim is to find the most effective treatments that can help improve the debilitating symptoms of CFS or ME in children.

“However, while these results are promising, further research is needed to establish which aspects of the LP are helpful and whether it is an effective treatment on its own and whether it could be used to help more severely affected patients. Many children and families in our service did not want to have LP and therefore, this approach is not for everybody so we must continue to investigate other treatment approaches.”

The Research
‘Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.'

Science Media Centre Expert Reaction

Views from the assembled experts were mixed, with Professor Bishop expressing most caution:

Prof. Dorothy Bishop, Professor of Developmental Neuropsychology, University of Oxford, said:

“The gains for patients in this study do seem solid, however, I am still rather uneasy because while the patient allocation and statistical analysis of the trial appear to be done to a high standard, the intervention that was assessed is commercial and associated with a number of warning signs. The Lightning Process appears based on neurolinguistic programming, which, despite its scientific-sounding name, has long been recognised as pseudoscience.

“I am sympathetic to the authors’ decision to evaluate the Lightning Process (LP), given that they had patients who had used it and reported favourably on it, and it could be argued that to fail to do so would indicate a degree of closed-mindedness. But the commercial nature of LP really creates problems. We cannot tell which aspect of LP is responsible for the gains in patients who took part.

“I noticed, for instance, that LP involves group sessions, whereas the comparison group undergoing standard medical care were treated individually. So it may be that the benefits derive from interacting with other children with chronic fatigue syndrome/ME, rather than the specific exercises and training. This is, of course, something that could be investigated in future research but meanwhile the concern is that this report will in effect act as positive publicity for a programme that is being proposed for a wide range of physical conditions (including chronic pain, low self-esteem, multiple sclerosis, and depression, to name just a few) and has to date been promoted largely through celebrity endorsements.”

Read the other views from assembled experts.

The Guardian
‘Controversial Lightning Process ‘helps children with chronic fatigue syndrome'

Extracts including comment from the ME Association (below):

‘A controversial treatment for chronic fatigue syndrome (CFS) called the Lightning Process can help children get better, a trial has shown, much to the surprise of the doctor who put it to the test.

One in every 100 children of secondary school age has CFS, also known as ME, and it can wreck their lives. Those affected miss a year of school on average, many of them getting to classes on just two days a week. Half are bedbound at some stage.

Esther Crawley, a paediatrician and professor of child health at Bristol University, runs the biggest centre for children with CFS in the country, seeing about 400 patients a year. She embarked on a trial of the commercial Lightning Process because the children she cares for and their parents were interested in it.

“Every single week in my clinic, children came up to me and said we want to know about the Lightning Process. People have told us to try it. Should we have it?” she said. “It was fascinating at the time. We heard about people getting better and people getting worse. I was kind of curious. I never expected that it would work.” If anything, said Crawley, she set up the trial in a way that would make it harder for it to be shown to work.

…

“Every single week in my clinic, children came up to me and said we want to know about the Lightning Process. People have told us to try it. Should we have it?” she said. “It was fascinating at the time. We heard about people getting better and people getting worse. I was kind of curious. I never expected that it would work.” If anything, said Crawley, she set up the trial in a way that would make it harder for it to be shown to work.

…

Crawley says CFS is caused by a biological response, usually to a viral trigger. Children can be genetically susceptible and do not recover fully after an infection. “CFS is really common and uses up vast amounts of NHS resources,” she says.

…

“At medical school people are told not to go into [CFS]. As researchers they are told not to go into it because you get so much abuse,” she said. “We still have a condition which is really common and really disabling and children begging for treatment and begging for answers, but people won’t go into it.

“When I think about leaving, which I do a lot, I think about the children who come to my clinics who have miserable lives because current treatment is not effective enough. We have to do research.”

…

The ME Association said it had “spoken out robustly” about the trial since it first heard about it in 2010. It said it believed such a trial in children was unethical.

“The Lightning Process is not a treatment that we endorse or recommend for people with ME/CFS,” said its medical adviser, Dr Charles Shepherd.

“Patient evidence, gathered from our members over many years, indicates that some people who have gone through the Lightning Process believe that they are able to quickly increase their physical and mental activity levels. However, this is can be followed by a relapse or significant worsening of symptoms.

“Others who have gone through the Lightning Process treatment report that they have spent huge amounts of money with no obvious benefit.”

To read the full article, visit the Guardian.

The Telegraph, Science:
‘M.E. ‘Lightning Process' trains the brain to ward off tired thoughts'

Extracts including comment from the ME Association (below):

‘A controversial therapy for ME that involves intensively training the mind to ward off negative thoughts helps get children back to school, a new study has found.

‘Written off as “pseudoscience” by some experts, the Lightning Process also improves anxiety and physical function in teenagers, according to a trial by the University of Bristol.

…

Professor Esther Crawley, who led the research, said that if the findings were confirmed by larger studies, NHS bosses should consider funding the treatment, which currently costs £620 per child.

“These are children that really suffer, they don't go to school, their parents stop working, they have depression and anxiety,” she said.

“This is a study that shows that with this additional treatment, children are walking further, are climbing more stairs, they are less fatigued, less anxious, they are less depressed. It looks like they have less pain.”

To read the full article, visit the Telegraph.

BBC News
‘Chronic fatigue therapy ‘could help teenagers', study says'

Extracts:

‘The Lightning Process, a type of brain therapy, was used alongside specialist medical care.

‘But ME charities said they did not recommend or endorse the process.

‘The NHS currently recommends behavioural and exercise therapy.

…

Esther Crawley, lead study author and professor of child health at the University of Bristol, decided to research the Lightning Process after the parents of her patients asked her about it in her clinic.

“I have to say that I never expected it would work,” she said.

…

What is the Lightning Process?

• a training course that teaches how to use the brain to improve the body's level of health
• it is run over three half-days in group sessions and costs about £650
• it focuses on using simple exercises, movements and gestures to help stimulate recovery
• it combines elements of osteopathy, life coaching and neurolinguistic programming
• the scientific community is sceptical of it
• no previous research had been done to investigate how effective it is
• it is not available on the NHS

…

Prof Crawley said there were limitations to the study – they did not know why LP had worked and could not say whether it would help adults or younger children.

And she said more research was needed to find out if the same results could be achieved again and to understand more about the process, before it could be incorporated into NHS care.

…

‘Over-simplistic'

Dr Charles Shepherd, medical adviser for the ME Association, said:

“The Lightning Process is not a treatment that we endorse or recommend for people with ME/CFS.

“It may well be that there are some people with a general fatigue state resulting from stress, emotional or psychological problems who could benefit from a ‘mind over matter' retraining approach such as this.”

But he said this was not to be confused with ME/CFS.

He said: “There has been a very significant growth in biomedical research globally into ME/CFS in the past decade which has demonstrated clear abnormalities in brain, muscle and immune system function.

“The over-simplistic and largely psychological model of ME/CFS causation that is being put forward to patients by Lightning Process practitioners is totally out of step with emerging scientific evidence as to its cause.”

‘Vulnerable children'

The ME Association said using children and young people with ME/CFS in trials of this nature was “unethical and potentially damaging to their lives and health”.

Jane Colby, executive director of the Young ME Sufferers Trust, said:

“As a former head teacher, I know that children are vulnerable, especially when they are ill.

“They desperately want to believe the adults around them, but if their body is telling them something different from what the adults are saying, the child must be in conflict about what to believe.”

Action for ME said it did not recommend any single form of intervention or treatment for ME and advised people to “examine with scepticism any treatment, therapy or other approach which claims to offer a cure”.

The National Institute for Health and Care Excellence announced on Tuesday that it would be revising the guidelines on the diagnosis and management of ME/CFS.

Daily Mail
‘Controversial treatment for young ME patients – endorsed by celebrities – DOES work despite being labelled as ‘quack medicine”

…

Dr Charles Shepherd, medical adviser for the ME Association, said: ‘The Lightning Process is not a treatment that we endorse or recommend for people with ME/CFS.

‘There has been a very significant growth in biomedical research globally into ME/CFS in the past decade which has demonstrated clear abnormalities in brain, muscle and immune system function.

‘The over-simplistic and largely psychological model of ME/CFS causation that is being put forward to patients by Lightning Process practitioners is totally out of step with emerging scientific evidence as to its cause.'

In a statement, Action for ME said: ‘The results of this trial indicate that the Lightning Process in addition to specialist medical care reduced participants' feelings of anxiety and depression.

‘However, supporting young people to cope better with the emotional impact of a chronic neurological condition addresses neither the root cause of the condition nor its primary symptoms.'

NetDoctor and Natalie Healey
‘The Lightning Process: Does this controversial (and expensive) chronic fatigue syndrome treatment really help patients?'

Despite new research, ME experts remain sceptical and say it could be damaging

Extracts:

…

‘The Lightning Process is a commercial programme (it's not available on the NHS and costs around £620) which is a combination of osteopathy, life-coaching and brain training. The course lasts for three intensive days.

‘Many experts have dismissed the claims as placebo at best – and damaging to children at worst. The ME Association in particular has spoken out robustly about the LP and campaigned against the new trial since first learning of the launch of its pilot in 2010.

‘The Advertising Standards Authority has upheld complaints related to the claims made by the treatment. And the Trading Standards departments of two local authorities have also taken action over claims made by LP practitioners.

…

‘It's important to note that the trial was relatively small – 100 people aged 12 to 18 took part. Half had the usual treatment at Bristol's Royal United Hospital, while the other half had the normal treatment plus the LP training programme.

‘Results showed that children who went through the LP were feeling better at six months and had improved still by a year compared to those who had just the conventional treatment. The LP group reported less fatigue, anxiety and depression than the control group.

‘Those who had the normal treatment improved too – spending up to three days a week at school after a year on average. But the group who had the LP were in school four days a week.

…

‘But as Crawley herself has admitted there are a lot of limitations with this study. It's impossible to know right now if the Lightning Process would work on its own, for instance.

“I'm not advocating people go out and get the Lightning Process. And we don't know if it works for adults and we don't know if it works for primary school-age children.”

What do other experts think?

‘Dr Charles Shepherd, medical adviser for the ME Association, said that the charity would certainly not be recommending or endorsing the Lightning Process for people with ME/CFS any time soon. He pointed out that the treatment is very expensive and can even lead to relapse in some cases.

“Patient evidence, gathered from our members over many years, indicates that some people who have gone through the LP try to make rapid and unrealistic improvements in their physical and mental activity levels. However, this is followed by a relapse or significant worsening of symptoms. Others who have gone through the LP programme, report that they have spent huge amounts of money with no obvious benefit.”

He also indicated that those who find they benefit from the controversial treatment might not have ME/CFS at all.

“It may well be that there are some people with a general fatigue state resulting from stress, emotional or psychological problems who could benefit from a ‘mind over matter' retraining approach such as this. Such fatigue states are a separate entity and not to be confused with ME/CFS.”

‘While Dorothy Bishop, professor of developmental neuropsychology at the University of Oxford, said that although the study findings look promising, she is concerned that the report will act as positive publicity for a programme that has largely been promoted through celebrity endorsements (such as Martine Mccutcheon and Esther Rantzen) thus far – rather than scientific evidence.

“The gains for patients in this study do seem solid, however, I am still rather uneasy because while the patient allocation and statistical analysis of the trial appear to be done to a high standard, the intervention that was assessed is commercial and associated with a number of warning signs. The Lightning Process appears based on neurolinguistic programming, which, despite its scientific-sounding name, has long been recognised as pseudoscience.”

Read the full article on NetDoctor.

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