In the other thread, Laelia said:
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Yes I understand that now, you all made that very clear, thank you. I wasn't trying to suggest that an audit would provide suffient evidence to prove that a particular treatment is effective. I was simply trying to suggest that it might provide some useful information. Jonathan disagrees.
Can we all at least agree that there are some forms of useful evidence in this world that don't come from controlled trials?
We should agree with that proposition.
The Rituximab and cyclophosphamide pilot studies, and the 2015
Rituximab stage II study are both examples of useful evidence, and they were not controlled trials.
They don't provide evidence of a standard that is sufficient for a national health care centre to write a treatment guideline, but that does not mean they don't have value - they can guide further research and also provide evidence for treatment outside the guidelines.
Clinical trials are terrific, but...
Large multi-centre randomised double blinded placebo controlled trials are terrific, but they can also be fetishised. Yes, they're the
highest available standard of evidence. But they are not perfect. They can produce wrong answers via stochastic processes or operator error, (and, when they are sponsored by interested parties they can be run again and again until they produce the wrong answer the interested party likes!).
They are also incredibly expensive. Not every thing that works has been tested in that context yet, but whether or not it works is not dependent on the test. Many things work despite a lack of trial evidence they work (it's a schrodingers cat situation but I believe we do not create the material world by measuring it!). And many things will never be tested in a clinical trial, because there is no perceived risk to them.
The line between regular life and medicine is not as distinct as people would have us believe, and we don't rely on clinical trial evidence for a lot of health-relevant situations, like the house we live in, the specific kind of exercise we take or the specific food we eat. For these things we rely on what we may term common knowledge.
This New York Times piece on cancer drugs is about doctors eager to use a new drug before a clinical trial is over, and their arguments that it is
so obvious the drug is good they don't need that standard of evidence:
http://www.nytimes.com/2010/09/19/health/research/19trial.html?
Doctors also rely far more on received wisdom than they'd like to admit. Does that brand of thermometer measure temperature accurately? Does going round using the title doctor help patients? etc. It's only the pointiest decisions, especially pharmacological ones where there is high cost and/or high risk, where we demand a high standard of evidence that requires full clinical trials.
For these things we rely on observation, or what we may term common knowledge.
So while some people like to claim that anything unsupported by the highest standard of evidence lacks
any evidence, they act as though that weren't true. They pursue, each day, many health-relevant interventions that are unsupported by such evidence.
If these people tell you you're an idiot for doing something for which there is no evidence, tell em to go jump. Ron Davis ran a native American ceremony in his house for Whitney ,for crying out loud.
Evidence is not proof
Even when it comes to major clinical trials than have been run there is reason to continue to hold some doubt in mind.
Some treatments might be very useful for a specific subgroup that will never be included in a clinical trial in sufficient numbers to tip the balance to statistical significance. (The most obvious example: most clinical trial participants are men).
This means some individuals may get serious benefit from things that have been shown to be no better than placebo in populations. It's only if you believe humans are cookie-cutter identical that you think large clinical trials definitively say whether an individual will be helped or harmed by a treatment.
I'd love for there to be a clinical trial of everything, but we don't have infinite time nor infinite money. So we will continue to operate on partial evidence.
Relevance of all this to this thread:
Lots of things that have not gone through large, multi centre, randomised, double-blinded, placebo-controlled trials have some evidence they work for some ME/CFS patients (LDN, ampligen, rituximab, cyclophosphamide, glutathione, Ubiquinol, florinef, antiotics, antivirals, beta blockers, pacing, dietary changes, methylation). It is not the highest standard of evidence (yet!), but that is not the only kind of evidence.