Be interesting to see a "study" on the Lightning Process that isn't allowed to say exactly what happens on the LP.
It's not too early to ask Crawley about these issues via FOIA or any other process, since their SMILE feasibility study was published at the end of 2013. We must've discussed this study when it was released but I don't recall it.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235039/
The study has two arms. One is "Specialist Medical Care" which offers the usual not-much-treatment besides CBT and GET. "Children and their families were offered a variety of treatment options [
9] centred around graded activity." There is no mention of actual medical care being offered to these young patients.
The other arm is SMC plus "Lightening Process". This study doesn't seem to have any treatment results, but it does discuss that patients in this arm found a rather large contradiction between the concept of gradually increasing activity as promoted by SMC and the exhortations of LP that they should resume all activities immediately and control their symptoms via LP mind magic.
Crawley et al said:
Conflict between interventions
Four parents and children randomized to the specialist medical care and Lightning Process arm described differences between the two interventions in terms of the language and approach used, which meant that the approaches conflicted with each other.
P9 [Parent 9]: ‘It has been a bit confusing, I have to say, because obviously we have got the [Lightning Process practitioners] approach, where, “Right, finally, done this, now you don’t need to do the pacing; you can just go back to school full time.” I think, the physical side of things, YP9 [Young Person 9] has had to build herself up more rather than just suddenly go back and do that’. (Post intervention)
The research team discussed the issue of conflict with the CFS/ME team and the Lightning Process practitioners, who agreed to respect the different approaches and support parents and children. Parents and children on subsequent courses did not report conflict. Children appeared to cope with differences between the two approaches by using best practice from both to fit with their current health needs.
Haha, this a great trial design. Researchers actually have no idea what "treatment" patients in the SMC + LP cohort actually received. There is every possibility that patients in this group may have simply ignored the LP "treatments" and only did "SMC" treatment, which is also subject to huge variation from patient to patient. Is this something that can be overcome with proper statistical analysis and large enough cohorts?
As one might expect, there is little discussion of harms:
Serious adverse events
Serious adverse events were reported by clinicians from the clinical team or members of the research team to the principle investigator and the sponsor within 24 hours. All serious adverse events were reviewed by the research and development committee.
----------------
Two serious adverse events were reported during this part of the study. Both concerned admissions to hospital, one of a child and one of a parent. Neither was related to their involvement in the SMILE study. Both were reported as per routine procedures and no action was necessary by the study team.
Even though they admit that "there are currently no reported studies investigating the effectiveness or possible side effects of LP in children" they don't seem to have a protocol to look for and record harms that are less than "serious adverse events" requiring hospital admission. I suspect that researchers who design drug trials would find this woefully inadequate.
Even though they never analyzed any data regarding treatment outcomes, presumably they collected some. We need to see it so others can analyze it.
