Ethical and legally ok to this in a study?

[Carn]

In a article a homeopath complains,(http://www.sciencedirect.com
click "journal", then "h", then "homeopathy", volume 93, issue 4, page 186-189)
that in that the practioners taking part in a trial are hindered in their performance by the uncertainess, whether the "medicine" had not the expected effect due to choosing the worng remedy or due to being in the placebo group. He thinks, that this hinders further treament decisions seriously and therefore might reduce the positive effects of homeopathy(of course continously assuming some are there). This he offers as a possible explanation, why homeopathy fairs so bad in DBPC.

Now, i don't want to discuss whether the argument is actually a good one, but i had an idea for a simple solution of this problem:
Don't tell the practioner, that he has a patient from a DBPC.

This of course has some problems,e.g. the patient could simply let it slip, that he is part of a DBPC, but apart from the technical problems, would it be moraly and legaly ok to send the test subjects to some unknowing doc?

The blinding of the patients would of course require, that they do not take any medicine, that was given directly to them by the doc(it's pretty hard to copy the way small packages are deformed in my pockets), and instead send them the medicine, but if patients are already motivated to keep it from the doc, that they are part of a DBPC, this should be possible.

It would be a DBPC, where one part is truly blinded.

Carn

 

[Quasi]

Hi,

The article is a glaring example of how little homeopaths understand science. It is very easy to setup a double blind trial of individualized hpathy. Just draw up all blanks and all homeopathic remedies, prepared in a widely recognized method (Boiron, or the German socialized medicine procedures.) Then setup say six hpaths, three will be given only placebo, and three the Boiron solutions. Patients will then be treated individually, either all placebo or all hpath. This way, the two groups can be compared directly. Quite simple really. This paper essentially used a collection of logical fallacies, such as no true scottsman (the trials that failed were not real homeopathy) to straight out rediculous statements. However, they should also know that even a trial such as I have proposed, they can claim the preparation was also not "real homeopathy." There are simply no standards whatsoever in the field. They also actually claim that it is important to un-blind CAM trials because when you remove self deception and fraud, there are no positive results and it should be taken apriori that homeopathy works, despite the fact that in the introduction they admit it has not been proven. Terrible paper. Nothing to see here, move along.

 

[Carn]

Hi,

The article is a glaring example of how little homeopaths understand science. It is very easy to setup a double blind trial of individualized hpathy. Just draw up all blanks and all homeopathic remedies, prepared in a widely recognized method (Boiron, or the German socialized medicine procedures.)

I do not think that the author of the article realy thought about whether his arguments are correct or not, he just grabbed something that looked like it supports his believes and doesn't think about what it realy means.

Most importantly i think he is correct, that homeopaths might perform worse in a DBPC than in normal practice, because the added pressure and the uncertainity, whether the changes in patients could be from remedy(which they can't be in case of placebo) makes decisions for them harder.
My personal less euphemistic description of this is:
"we are in a test, we are in a test, help"
and
"oh ****, i fail to delude myself any longer, that all changes i notice in patient are due to remedy, now i start thinking how to recognize placebo effects and it is so difficult and complicated, nearly as i had to face, wait how is it called, ... reality?"

Obviously those problems might interfere with homeopathic practices even if there is something working about it, but it is their problem if they have no nerves to stand testing.

But the other complaint i think is in a very, very weak effecting DBPC:
Assuming that patients and practioners know, that a DBPC is performed and all believe that the medicine is effective and the medicine is realy very effective, then the following is possible:

Some docs and patients in the placebo group consciously or subconsioucsly notice there is no real positive effect. The docs let themselve hang a bit because "well i'm giving placebo anyway, so it is a waste of time", while the noticing patients subocnsciously think "damn, i'm getting only placebo". Both attitudes can affect the strength of the placebo effect, as the placebo effect is strongest, when both patient and docs believe the treatment is effective.
OTOH, any doubt about in which group they are can cause similar, though weaker attitudes, which then are diminished in the verum group, because both some docs and patients might notice that they are in the verum group.

From my description you see, that i think the homeopath in his article made the big mistake not to think about how strong this add on effect would be and in which direction it would effect the results. Afaik it would be a slight change to the strength of the placebo effects in both groups, so is not relevant, when studying something as fantastically effective as homeopathy.
But furthermore, even if it causes a relevant change, that change would increase the verum group performance, and decrease the placebo group performance, so would make the difference between the groups even bigger.

Nonetheless, whether this thoughts are right or wrong, i'm just thinking, that in principle the optimal test is always, that no participant knows that a test is going on. Since that is illegal, i'd like to know, whether it is legal, that at least the docs do not know what is happening?

Carn

 

[geni]

Don't tell the practioner, that he has a patient from a DBPC.

This of course has some problems,e.g. the patient could simply let it slip, that he is part of a DBPC, but apart from the technical problems, would it be moraly and legaly ok to send the test subjects to some unknowing doc?

I think I can safetly say the odds of you getting this past an ethics committee are pretty much zilch.

 

[Quasi]

It sounds like you are claiming that the homeopathic solutions do, in fact have an effect. This has been disproven for highly potent solutions. No one on earth using any method at all can tell the hpathic from the stock when the "real" homeopathic solution bottle is randomiyed with bottles of non. Taking this into account, any trial based on highly potent hpathic solutions is a sham, and all groups are placebo. I agree that many "low potency" hpathic solutions contain active chemicals, but I would dispute their therapeutic value (mercury, nightshade, etc.)
Taking this information into account, and in light of the discussion, I would still say it is quite possible to do the DRPC trial. Even with your concerns, a pharmacist could give either placebo or "real" on a patient by patient basis using a random schedule for several homeopaths. This would eliminate groups of placebo and groups of "real" treatment which should further strengthen the study. Again, the hpaths actually doling out the solutions will not know which patient is receiving real or sham.
I have reviewed several hpathic trials, and they are similar in that they deliberately avoid the real, direct, straightforward test. Not that any of this really matters. Even if the test was negative for any effects, another group of hpaths would claim that the clinical trial was not "real" homeopathy. The first thing hpaths need to do is to agree how to prepare the solutions, and how to properly diagnose. This is so controversial there are almost as many forms of hpathy as hpaths. So in reality, there can be no proper testing of homeopathy until there is a common practice to test. All trials done before that are just wasted resources.

 

[Carn]

It sounds like you are claiming that the homeopathic solutions do, in fact have an effect.

If you want to think about whether a DBPC can detect, that a homeopathic remedy, then you have to turn your head slightly by 180 degree and look if from that direction, there are any problems to be seen in a DBPC.
If you want to discuss, whether our radar and so on should be able to detect the hordes of abducting aliens, that are supposed land here day and night, you have to assume for a moment, how they and their space ships look like to conclude, that you would detect them, if they'd be here.

This has been disproven for highly potent solutions.

Not exactly correct, you can only prove that their maximum effect is smaller than the detection efficiency. If a treatment improves survival from a normal 51.433% to 51.434%, it has an effect, but likely we'll miss it.
But we can argue that our detection efficiency is so good, that anything we do not detect is not worth notice, e.g. a increase from 51.433% survival rate to 51.434% is irrelevant unless its for free without any work.
The clever homeopaths try to hide beneath the detection efficiency, but they know that it is pretty ridiculous as long as our detection efficiency seems to be so good, therefore they come up with such thoughts as in the article to assure themselves, that the detection efficiency is not that good and that their hiding beneath it is not ridiculous.
But it still is and sceptics have to show it to.
For that it is useful to understand their argument.

Taking this information into account, and in light of the discussion, I would still say it is quite possible to do the DRPC trial. Even with your concerns, a pharmacist could give either placebo or "real" on a patient by patient basis using a random schedule for several homeopaths.

You mean, that a patient would receive during a trial e.g. p,v,p,p,v,p,v,v,p,v,v,... totally randomly?
While i have no problem with that idea, i guess homeopaths would tell you, that homeopathy then cannot work. Yes you know that, but they would say that it can only work with v,v,v,v,v,v,v,v,...

This would eliminate groups of placebo and groups of "real" treatment which should further strengthen the study. Again, the hpaths actually doling out the solutions will not know which patient is receiving real or sham.
I have reviewed several hpathic trials, and they are similar in that they deliberately avoid the real, direct, straightforward test.

Could you explain?
I mean what is the difference between what the hpathy trials do and the straightforward test?
Isn't it both something like one bunch of people get placebo, the other bunch get "verum" and there got to be a statistical significant difference between the 2?
Or do you mean, that the homeopaths are brave enough to say what conditions should be get better by administration of one remedy?

All trials done before that are just wasted resources.

I don't think so, because in some areas the homeopaths indirectly admit, that they can do nothing, that might keep some patients from running to them. These are especially the areas, where test are beyond doubt, e.g. curing speed of wounds.
I think they can be chased back to the position, that they can only treat chronic diseases on a long term basis with extensive case taking, that would keep people from trying to help their child, when it has 40 degree fever, with homeopathy as they read it in a small book bought at supermarket.

Carn