Well, here I am going to talk only about how we get fooled by research on anything but for us specifically CRABS. I've wanted to do this for a long time. I am taking abx, but this is not related so if that's not your thing read on with confidence, it's about trials and how they work. People put huge faith in trials, less in personal experiences. This seems scientific and wise. But do we understand trials correctly? They've been sold to us as infallible, repeatedly people point to conflicting ones and are confused, how can both be true?
In this absract <shortened url
> , we see that people correctly guess if they are taking a placebo or the active drug. This is related to the informed consent process:
People must be told what they might experience if they get the active drug. Flu like reactions? must be told. Large swelling of the injection site? must be told IT's an FDA requirement. So people go into the trial with a knowledge of how the active drug reacts. According to this study 70%of people guess correctly which one they got.
THis paper <shortened url
> another on the reactions of participants to studies, indicates that participants tend to judge the "new" medication based on many factors not just what the trial authors are telling them which causes bias.
Oh please. You don't suppose that could be related to the extensive media campaign pre release that builds up expectations. Everything from national coverage to my local station "releasing" such "science" as this might be; 'today, researchers have discovered a new molecule that may mean the end to MS! (pan to people in wheelchairs) Researchers at (where ever) now say that they have discovered a peviously unknown part of the immune system, clinical trilas should start with in the year"
You sit with bated breath, Oh please let it be! You call the station -who's doing the trial?
Many of these little snippets come out causing you to nearly salivate with expectation! Oh if only I can hang on! They are really on to something!
months later you are offered a spot in the clinical trial and you are given your disclosure. After the first injection, you notice the marked side effect they disussed. You KNOW you are getting "IT". You relax. I'm getting the new drug! Whew! I'm going to be among the first to get this, not placebo. And you do better. You tell the doc, I'm getting the real drug, look at this swelling! He thinks also you are better, it's exciting.
Is this blind? No, it's not. My mom has been in three trials and she always knew.
So what, you might say? I tell you it's a big deal
. In other studies on studies and how they work, it has been estimated that a considerable portion of the positive reaction to a drug in such 'blinded' studies are attributed to this knowledge, not to effectiveness of the drug. Essentially the blind study is often not and any slight positive reaction is added to this effective placebo effect being added.
Now think about the original beta interferon studies, is there any way the treated people did not have some knowledge of being treated? flu, sick.
Same for the copaxone trial any way they did not know they were being treated? (My leg on my first cop injection swelled from my thigh to my knee) the placebo guys were saying oh darn, I'm not on it, even if they thought they might have been at first, by the time they went to the clinic and saw jane doe over there with her huge red swelling, doubt crept in.
Now it is common knowledge that placebo effects overall are 35%. If you don't see a better response than that, you are not beating placebo. In public lecture from a local well known MS neuro, he admonished us many years ago that this 35% accounts for the "results" of fish oil etc. He chastized us to be very leery of such scams (this was '94 or so)
But wait, the CRABs barely beat this placebo, though in their trials, the placebo THEY got was much lower than the usual 35%, which is how they talk about the differences. (um gee, cause people figured it out?)
IF THERE WAS A VIRTUAL PLACEBO GROUP THAT EVERY TRIAL USED, IN OTHER WORDS THEY STOP GIVING PLACEBOS BUT USE THE 35% NUMBER, NEITHER COP OR BETA WOULD HAVE BEATEN THIS NUMBER EARLY ON.
Imagine this: so these drugs are shelved, and other approaches are tried. Looking for something that actually is better, maybe even in terms of disability. Has the "success" of these drugs cost us advancement of the research into more fruitful arenas?
Why would it matter you might say, the lesions decreased that can't be related to their thinking they were on the real drug....that's can't be a placebo...
OH YES, it can. Why? because the ones who figured out they were getting it were relieved, their HPA axis was influenced. They made endorphins. This has a profound effect on the body and immune system. This is also why counseling helps if it is successful in reducing the anxiety. The HPA axis is tied to our perceptions and feelings and is activated or not by them to a certain extent.
OK now look at the difference between the plabcebo group and the treated group. THE DIFFERENCE IS ABOUT 5% . It's not a reduciton of "35%" it's only a little tiny bit better than placebo.
if one believed that fish oil would do this for you, you'd get at least as good results, and many do. I have taken stuff like that for years because I think there is good research to support the notion it would be helpful in reducing at least inflammation, but as we've shown in so many threads, imflammation is probably a red herring anyway.
Anyway, I have wanted to post this for some time. We must not overvalue "blind" studies. We need research and people have to do their best to figure out what to treat us with, but equally important is how you react to a given treatment and what other research is out there. Problem is the neuro relies heavily on the blinded group studies and spends much less time reading about the theories behind what's really happening.
It matters that the research here says inflammation is a moot point.
http://www.msif.org/en/research/researc ... on_of.html
It matters that they outline that even severe suppression does not reduce disability.
Yet this kind of thinking based on scientific understanding of how things work is countered with these "blinded" studies. I asked my neuro about the research that Prineas did which showed MS is not autoimmune. He said he did not think anyone seriously thought MS was not autoimmune. His evidence? He cited the fact that CRABS work.