SMILE – Specialist Medical Intervention and Lightning Evaluation
What is SMILE?
SMILE is a randomised controlled trial for children and young people with CFS/ME. The trial recruited children and young people (aged 12 to 18 years old) from a specialist paediatric CFS/ME service in the south west of England. Participants were randomised to receive either specialist medical care (SMC) or SMC plus the Lightning Process (LP).
SMILE started as a feasibility study as we were not sure whether it would be possible to recruit children and young people in to this study. We have published our report on the feasibility phase and you can find it here (PDF, 458kB)
The feasibility phase helped us design the full trial and we have published our protocol which you can look at here (PDF, 565kB)
We have finalised the analyses plan which you can look at here (PDF, 696kB)
We have now finished recruting, completed the analyses and published the results on the 21st September, and you can find the results here
A press release about the results can be found here: SMILE (PDF, 395kB)
Frequently Asked Questions
Why is research in children needed?
Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions.
Should research be done in children before adults?
Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.
How can we take part in the study?
We have finished recruiting in to SMILE.
Why did you do the SMILE trial
We did the trial because paediatric CFS/ME is common and disabling. Even with the best treatment available, over a third of children have not recovered at 6 months. Children with CFS/ME deserve better treatment. Many children asked us if LP was effective and should they have it. But we needed a trial before we could provide an answer. We have now done that trial
Is LP available in the NHS?
LP is not currently available in the NHS
Did you hve a conflict of interest in doing the SMILE trial
How involved were LP with the trial?
The LP team were not involved in designing or running the trial or analysing the results or writing the paper. They provided the LP treatment. Phil Parker and the LP team provided advice and information on costs.
Can we do it/where can we do it?
The Lightning Process is not offered in the NHS and therefore it is not part of our service. Our study only showed that it worked in addition to specialist medical care. We have not shown this is works on its own.
Can it be done as well as FITNET-NHS?
Some children in our study said that doing two treatments was confusing. The results from our study showed that those who had specilialist medical care plus the lightning process did about as well as those in previous studies who had a full course of CBT. If you have FITNET-NHS, we would recomment that you do that first. If you do decide to do the LP as we, please let us know.
Why are we offering a study comparing standard treatment when lightening process has been proven to work?
We have only shown that LP improves function and fatigue in addition to specialist medical care. However, most children did not want to go into the trial and many did not want LP. We still need to work on finding new treatments, particularly for those who do not have speclialist medical care and for those who cannot travel.
What ethical review has SMILE received?
The ethical approvals received are documented in the Protocol.
The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials.
An amendment for 'Assessing the feasibility and acceptability of comparing the Lightning Process? With specialisit medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) - pilot Randomized Control Trial' was reviewed at the meeting of the Sub-Committee held on 31 May 2011, which can be found here (PDF, 301kB)