The only one to benefit is Parker.

The last of three blogs on the SMILE trial. Part one is here and part two here.

 

The SMILE trial was deeply flawed: criteria used were too broad, participants self-selected, it was not properly controlled and it relied upon subjective measures when participants were unblinded. Like the Lightning Process (LP) itself, it is worthless.

It was completed almost four years ago, but results have still not been published. The concern is that this poorly conducted trial, based on criteria wide enough to include patients with generic ‘chronic fatigue’, did indeed find that some patients reported subjective improvement. If true, SMILE did nothing more than provide false scientific justification for quackery.

The trial has already been of considerable benefit to Phil Parker, a man with no professional qualifications who has designed an intervention with no scientific basis: he is said to receive a fee from each LP provider for every course participant. Since the trial was in the Bristol and Bath area, he may well himself have been one of the LP providers as he ‘leads experienced teams’ in the region.

He has also used the mere fact of the trial as a form of endorsement on his site:
NHS and LP
The Lightning Process has been working with the University of Bristol and the NHS on a feasibility study; full information can be found here.  Two papers have been published and you can find a link to them both here:
1. The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)
2. Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial)

The trial acts as an advertisement not just to patients but to potential trainers. The only way to ‘qualify’ as an LP provider is via one of Parker’s own courses which cost £2100 (including VAT). Parker insists anyone who wants to continue as a certified provider must pay him an annual licence of £495 (incl VAT) in the UK or £750 internationally. These practitioners then go out to find more potential patients to generate more money for Parker.

This misadventure was funded by the Linbury Trust and the Ashden Trust for £172,200.

The actual cost of the trial is unknown as staff and NHS costs, so-called non-core costs, cannot be calculated. They were paid by public funds and must be added to that figure for the total trial expenditure.

I made a Freedom Of Information Act request to the University of Bristol to discover how much they paid for these courses and to find out if there was some kind of arrangement with Parker. At first they refused to tell me how much the courses cost, but an ICO decision rejected their claims the information was exempt from the Act.

The mean cost of a course for trial participants was £567, less than the figure (£620) given in the paper for the then current approximate cost. I asked the university if Parker offered a cut of some kind, but they replied: ‘There is no information held relating to any discount or special deal that was arranged with the providers of ‘Lightning Process’ courses.’ If there was some sort of discount, then Parker not only benefited from the trial and had a financial interest in the outcome but actually subsidized it and so effectively part-funded it.

25 in the group assigned to the intervention went through with the course, so 25 x £567, that is £14,175.

Over £14,000 wasted on a junk intervention.

If there is a ‘full study’ as Crawley concludes there should be, there’ll be a lot more spent on this quackery. Any slight evidence of effect will be used not just to promote this nonsense further but also, no doubt, to claim his mumbo-jumbo should be funded by the NHS.

The only person to benefit from this costly disgrace is Parker.

 

See also:

http://blogs.plos.org/mindthebrain/2016/09/23/before-you-enroll-your-child-in-the-magenta-chronic-fatigue-syndrome-study-issues-to-be-considered/

https://www.coyneoftherealm.com/search?q=smile+trial

http://www.skepdic.com/lightningprocess.html