From The Johnthejack Blog.
A trial so flawed as to be worthless.
The second of three blogs on the SMILE trial. The first is here.
The SMILE trial was ‘a pilot randomized trial with children (aged 12 to 18 years) comparing specialist medical care with specialist medical care plus the Lightning Process‘.
A report was published in December 2013. The trial has been over for almost four years but the results have yet to be published. A paper was submitted to The Lancet Psychiatry in August 2016 but was unsuccessful. A paper was resubmitted (to an unnamed journal, which may or may not be The Lancet Psychiatry) on 11th May 2017 (revealed in ‘Freedom of Information Request: Reference FOI17 193 – Information from the SMILE study’; decision currently under review).
The report itself, though, reveals a number of flaws in the study:
First, the choice of trial participants meant there was no real randomization.
The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service (43 patients were excluded for being too far away). It is debatable how representative such a relatively affluent area is, particularly as a course of the LP normally costs over £600. The charity, the clinic and Phil Parker, the inventor of the LP, are all located there. It’s likely that publicity and word-of-mouth have increased awareness and demand for the course in Bristol and Bath, which in turn may have attracted people with ‘chronic fatigue’ and also made those patients more susceptible to belief in the intervention.
To read the rest of this story, click on the link below: