This has been bothering me a lot too, not necessarily the 30 person trial, but the insistence that a large, double blind trial is the only way to scientifically prove anything.mrhodes40 wrote:Nice post Marc! You are smart and on it as usual... I am sorry to hear you were sick. I am so glad you are back and on the mend! I hope it is s uneventfl recovery.
This keeps me awake nights....................... I am serious.It makes me wonder how much real information can be derived from a 30 person study such as the one at Buffalo. It would seem to make sense to work out the technical aspects of performing the
procedure first before trying to measure it's efficacy
Politicians say that it's not till we do a big trial that we'll know it's safe. That doesn't make sense to me - it's only by studying different cases to learn what should and shouldn't be done that will add to the safety profile. I suppose they mean that such a trial will at least show whether any actual efficacy justifies the risk. But this thinking has been extrapolated to mean that "we won't believe that all of these people have actually had improvements until we see the statistically significant number showing that they actually had improvements." So, if someone has shown 30% improvement, and the trial overall shows 10% improvement over placebo, some would tell those with dramatic improvements that only 10% of what they're feeling is real.
The large scale double blind trial is a regulatory hurdle, and I suppose it's the best that the feds have to justify marketing approval, but I don't think that such a trial should be considered the final scientific answer. I would still seek treatment for my husband based on anecdotal reports even if the trial was a bust - it would only be harder to find someone to do the procedure then.
WK, I hope you're feeling better!