RE: Clinical trials20 Apr 2025 20:16
Shychap, what is interesting is I watched the presentation again earlier and on closer inspected of the slides I was feeling the other way to you, I actually became more comfortable with the group sizes.
The reduction of stress claims were measured by the ‘Well-Being Manifestations Measure Scale’, which is a scale consisting of 25 factors and 6 sub-scales, and there were 44 participants in that.
The sleep improvement claims featured 21 participants, and involved daily application of the product or the placebo for 1 month, and included use of the EMFIT QS Ballistography Sleep evaluation questionnaire, which seems to be used as a sleep evidence collection mechanism in hundreds of scientific papers of all kinds.
The part of the study which only contained 13 participants was where the claim is around relaxation, and this part involves taking measurements using an EEG, an electroencephalogram, which is one of those rugby-looking head devices which measures brain activity. I can only imagine how long the setting up and analysing of this data would take, so if the results are clear after 13 of them, why do 100?
We all know the saying from Einstein about the definition of insanity doing the same thing over and over and expecting different results. After 13 EEG tests, if 7 product tests showed relaxation and 6 placebo tests showed nil, I’m comfortable with that if Croda are.
Quick research into the methods used show the testing of the participants that were involved was deep and thorough, especially when compared to the opinions gathered to ‘validate’ products currently on the market.
I, like many, would previously have made an assumption that these sorts of studies would use hundreds of participants, however looking at it from the inside out, I now feel my previous point of view was a bit daft. They are trying to prove something that they basically already know from laboratory testing, and the methods used are costly and time consuming. I will no longer be seeing the group sizes as a negative myself, unless anyone can counter anything new?