But charities have been concerned about the study from the start, they have told BuzzFeed News. First, several patients and charities said it was unethical to do the first trial of an untested procedure on children. A spokesperson for 25% ME Group told BuzzFeed News: “We are definitely 100% against the SMILE trial. We are extremely worried about what they’re doing with children in this area.” They expressed concern when the trial was proposed as did other charities including the Young ME Sufferers (TYMES) Trust and the ME Association. Crawley says she doesn’t understand why the charities are so negative, but that the children in her clinic and their parents were keen that the trial be done.



There has been historical mistrust of research into CFS/ME, including controversy over another divisive trial, a study into “graded exercise therapy” that helped lead to the NHS recommending that therapy for CFS/ME sufferers. The PACE trial, as it was known, was savagely criticised by some patients and academics amid accusations of bad trial design and other poor practices. The trial’s authors still stand by it, as does the Lancet journal that published it in 2011.

When the SMILE study was published, many had similar concerns. Jonathan Edwards, professor emeritus of connective tissue disease at University College London, told BuzzFeed News the fundamental problem was that the research was “unblinded, with a subjective outcome”.

In the highest-quality medical trials, subjects are “blinded” – they don’t know whether they’re getting the treatment that’s being tested, or what it’s being tested against. It helps stop the results being biased in favour of the treatment. If you can’t blind the trial, said Edwards, then it’s important to ensure that you measure something that can’t be affected by patients’ perceptions. “You can have an unblinded trial and measure everyone’s blood sodium concentration at the end,” he said. “They can’t do anything to their sodium concentration, so it doesn’t matter if they know whether they’re getting the treatment or not.

“And the other way around is fine: If you blind everything so they patients don’t know if they’ve had the treatment, then you can use a subjective measure. But you can’t have an unblinded trial and a subjective outcome.” But the SMILE trial was unblinded, and Edwards also pointed out that the primary outcome that was measured was changed from an objective measure, school attendance, to a questionnaire. Edwards said such self-reported measures are often prone to bias, as subjects give the answers they think they are expected to give. For that reason, he believes, the trial is “useless”.

In response, Crawley said "all the outcomes were collected as planned, but children didn’t like our recommended primary outcome, school attendance, so we used disability." She added that the primary outcome measure change was made, and reported, before results were collected.

The problems were, in some eyes, made worse by the fact that the methods of the Lightning Process involve making people say that they feel better. “All this trial shows is that if you tell people to say they’re better, and then ask them if they’re better, they’ll say they’re better,” said Edwards. “It's a textbook case of how not to design a trial.”

He claims the SMILE trial’s results also undermine the PACE trial – which also used an unblinded trial with subjective outcomes – by showing that "the same techniques can get you the same answer for a completely quack therapy based on complete nonsense like standing on pieces of paper and telling your disease to stop”.



In response, Parker told BuzzFeed News that “pejorative labels such as ‘quack’ [are] well past their sell-by date” given that the Lightning Process “has been shown, via a peer-reviewed RCT, to have some efficacy”, and that “a number of medical doctors and researchers have observed the Lightning Process – their opinion has been completely the opposite and said that it is based on sound understanding of anatomy, physiology and neuroscience”.

Dorothy Bishop, a professor of developmental neuropsychology at the University of Oxford, told BuzzFeed News she was also concerned about the “wisdom of running a trial [into something] that doesn’t seem to have much scientific basis and is commercial, because if you find a result you end up giving huge kudos to something that may not deserve it”.

“I don’t want to come down like a ton of bricks on Esther Crawley because I think she’s doing her best,” she said, but she was concerned about a “a mega-placebo effect”.

Crawley told BuzzFeed News it was possible that there was some placebo effect involved, but that the questionnaires she used in the trial asked questions about how far you can walk and how much school you attended, rather than simply whether people felt better. She added that self-reported school attendance lined up very well with the schools’ records of attendance.