The end of placeboes is in sight

Interesting article about overturning the use of placebo in clinical trials by relying on real-world data instead, to essentially use the patient population as control. It sadly sidesteps some facts about how the placebo-controlled part is sometimes omitted already without properly acknowledging it. PACE is typically referred to as a RCT despite being open label and having multiple treatment arms that muddy interpretation.

It also misses how some segments of medicine are currently specifically based on placebo and as such are impossible to properly control, their very aim is to change perception, not affect physiology. It seems that much of discussion about the rigor of clinical trials and medical research in general is based on aspirations about what they could be, rather than how they actually are.

There is some merit to this idea, to rely on real-world data, but what seems to be forgotten is the issue of patient populations where data is not properly recorded. In our case this would be devastating as most of the information is wrong except for patient-reported outcomes, which are rarely recorded at all and when they do get recorded are very distorted, even on official records.

So there remains the question of whether the comparisons would be fair or based on aspirational things like "50% of IAPT users recover" despite being 50% of a % of a % and the definition of "recovery" being meaningless despite being used in real-world practice. Meanwhile Australia still relies on misleading guidelines that claim 97% recovery rates for "CFS". Those serve as meaningless comparisons as they are completely made-up and further distorted.

https://www.wired.co.uk/article/end-of-placebo-trials

 

considering all the stories I have heard about peoples medical notes histories being very poorly recorded or with the wrong information .even patients notes being mixed in from other patients who have the same first and last names . this is pretty much guaranteed to fail .

 

I don't think this is justified except when the outcome is mortality - and in those cases, I don't think placebo controlled trials are the norm anyway.

 

Not at all relevant here, but I have someone sifting for me some fifteen plus years of unsorted filing, papers, some junk mail and even unopened post. It included two previous attempts at new filing systems only very partially implemented. The proportion of unopened post varies from cardboard box to cardboard box depending on how well or otherwise I was at the time that I gave up on that heap and boxed it. Several months into the process averaging two or three hours per week sorting, the end of next week should see us get back to my original filing system that contains ordered information predating the first significant ME relapse that forced me to stop work completely.

My helper now knows the route to the nearest recycling point very well, and the company managing the site has probably noted a spike in their paper through put. Much of the process felt like losing a burden, particularly at first when we were addressing the last four years of almost totally unopened post, but interestingly now getting further back I am reliving previous relapses, which feels less positive.

What made me think about it in this context is that today we opened the envelope of a long term follow up request relating to the FINE study. It went into the shredding pile unexamined as it so obviously not worth expending any mental energy on now. However it did bring home how problematic follow up results must be in studies like this. What percentage of the drop out in such long term follow up is because the subject was not even well enough to deal with their post at that point?

 

Placebobabble

 

Most importantly in that outcomes are not actually part of those files. Or at least not consistently. They are all dependent on asking the right questions and that almost never happens. There's the additional fallacy of "patient didn't come back to see me therefore the issue is likely resolved".

It makes a lot of sense with diligent and accurate record-keeping. That is not even close to be the case. Some day, just not yet.