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HuckleB

(35,773 posts)
Sat Jan 7, 2012, 05:59 PM Jan 2012

Why Do We Really Need Clinical Trials?

http://www.sciencebasedmedicine.org/index.php/why-do-we-really-need-clinical-trials/

"A point I make over and over again when talking about new or alternative therapies that are not supported by good clinical trial evidence is that lower-level evidence, such as theoretical justifications, anecdotes, and pre-clinical research like in vitro studies and animal model testing, can only be suggestive, never reliable proof of safety or efficacy. It is necessary to begin evaluating a new therapy that does not yet have clinical evidence to support it by showing a plausible theory for why it might work and then moving on to demonstrate that it actually could work through pre-clinical research, which includes biochemistry, cell culture, and animal models. These sorts of supporting preclinical evidence are what we refer to when we refer to the “prior plausibility” of a clinical study. But this kind of evidence alone is not sufficient to support using the therapy in real patients except under experimental conditions, or when the urgency to intervene is great enough to balance the significant uncertainty about the effects of the intervention.

In support of this conclusion, we can consider the inherent unreliability of individual human judgments and all the many ways in which inadequately controlled research can mislead us. And we can reflect on how promising results in early trials often melt away when better, larger, more rigorous studies are done that better control for bias (the so-called Decline Effect). And it is not at all difficult to compile a large list of examples of the harm inadequately studied medical interventions can cause.

But what I’d like to do here is focus on a particularly good specific example of why thorough clinical trial evaluation of promising ideas is not just a nice extra to confirm what we already believe is true, it is the only way to genuinely know whether our treatments to more good than harm.

...

I think much of the success of the “integrative medicine” meme has been based on the lack of an adequate understanding among health professionals about the serious limitations of low-level evidence. The SELECT illustrates nicely how even a plausible intervention with enough low-level evidence to justify a major clinical trial can prove not only less helpful than originally hoped but even actively harmful. The same principle applies to an even greater degree to less plausible hypotheses. High-quality clinical trials are not simply icing on the cake confirming what we already know, they are the cake without which we know a lot less than we usually think."



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A worthy read, IMO.

16 replies = new reply since forum marked as read
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mzteris

(16,232 posts)
2. well of course we need clinical trials. . .
Sat Jan 7, 2012, 06:39 PM
Jan 2012

but even good medicine can do "bad things" to *some* people. (Allergies, drug interactions, etc...)

and medicine can be used "off-treatment designation" to do things they never expected . . .

AND sometimes, for some people it may not do a damn thing at all.



For people who are the anomalies, the minorities, those "anecdotes" can go a long way towards making them feel like they are NOT crazy. And if ENOUGH of them come out, then just maybe someone will say, "hey! maybe we should take a closer look at *that* result/problem/condition. . ."

Remember when "fibromyalgia" was concered to be all in a women's head?

When post-partum depression was all in a women's head?

That women became 'moody" during their periods because deep down they were "sorry they weren't pregnant" because that's what women's bodies are FOR . . .

All once tried and true "medical opinion"

And let's not forget - being gay used to be a mental disorder.

Need I go on?

HuckleB

(35,773 posts)
3. I'm not sure what any of that has to do with piece in the OP.
Sat Jan 7, 2012, 06:44 PM
Jan 2012

It does indicate that science moves forward and uses evidence to improve health care. On the other hand, "integrative medicine" doesn't respond to evidence. Instead it opts for use of small, self-selected preliminary studies in order to justify treatments that simply are not supported by the actual spectrum of evidence. Pointing out that science moves forward from the past mistakes does not change that.

mzteris

(16,232 posts)
4. because sometimes that "evidence"
Sat Jan 7, 2012, 07:06 PM
Jan 2012

are those "anecdotal" incidents you seem to hate so much.

Get enough of them and some scientist/doc - says "hey - maybe there's something to this thing. We should do a study!"

HuckleB

(35,773 posts)
5. Your post doesn't seem to be responding to the content of my post.
Sat Jan 7, 2012, 07:14 PM
Jan 2012

Further, neither of your posts seem to be responding to the content of the OP.

Anecdotes are not justification for ongoing "integrative medicine" treatments. They might offer reason to study a diagnosis or a treatment, but they are justification for implausible and unproven treatments.

mzteris

(16,232 posts)
6. Well in MY mind - the way I was reading
Sat Jan 7, 2012, 07:38 PM
Jan 2012

and interpreting your post - which is what happens when you read something - you have your OWN thoughts about it and not necessarily the thoughts that the poster - or even the author - intended.

Anecdotes are a method of communicating different incidents between the non-majority non-popular non-mainstream individuals. At least you admit they may offer reason for study. You're making progress, I'm proud of you!

HuckleB

(35,773 posts)
8. Anecdotes do not justify "integrative medicine," which does not adjust to anecdotes, evidence ...
Sat Jan 7, 2012, 08:23 PM
Jan 2012

... and clinical studies.

Thus, something is not congruent with your responses.

mzteris

(16,232 posts)
9. did you even read your own post?
Sat Jan 7, 2012, 08:57 PM
Jan 2012


Maybe congruence is in the eye of the beholder.

Or maybe it's MY intertextuality experience vs. yours . . .

HuckleB

(35,773 posts)
10. This has nothing to do with me, or with you.
Sat Jan 7, 2012, 08:58 PM
Jan 2012

And that's only part of where your incongruent responses go awry.

mzteris

(16,232 posts)
11. I think your inability to understand me
Sat Jan 7, 2012, 09:02 PM
Jan 2012

does have something to do with it.

They aren't "incongruent" in MY opinion. It's mine, not yours. You're free to have your own opinion. What you are NOT allowed to do is dictate MY opinion!

Do you know the meaning of "intertextuality"?

Warpy

(111,267 posts)
7. Well, fibromyalgia is all in our heads, just not the way patronizing doctors said it was.
Sat Jan 7, 2012, 07:59 PM
Jan 2012

It's being more and more understood as a neurological disease, even though we've still been palmed off on rheumatologists..

But yes, when enough people come up with a cluster of symptoms, that's when they do start looking at it a little more closely rather than prescribing tranquilizers and sending suffering people on their way, hoping they'll be too sedated to come back.

HuckleB

(35,773 posts)
14. This needs a kick, it seems.
Fri Jun 15, 2012, 06:49 PM
Jun 2012

So many preliminary studies are getting a whole gob of play on the health page, and the OPs are not pointing out the type of study they are.

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