Are the DBR studies really protected from Placebo effect?

[Spathi]

When in a group of patients half get the drug and half get a placebo, can those on the drug be able to guess that? I mean, if they take an antidepressant for example, then it, being a psychotropic drug, can change the rhythm of their sleep, which will give them the information that it is not a placebo; and further, since people usually believe in medicine, this understanding will have a placebo effect.
Did anyone suggest giving as a placebo not sugar, but a studied ineffective drug?

 

[Bystander]

Did anyone suggest giving as a placebo not sugar, but a studied ineffective drug?

Huh?

 

[Swamp Thing]

I think you are suggesting that maybe such trials should use a placebo that causes the same kind of side effects that most subjects would associate with that class of medicine.

This idea may look good as an ideal principle, but it would be horribly impractical, complicated and expensive apart from legal and ethical aspects.

 

[Spathi]

I think you are suggesting that maybe such trials should use a placebo that causes the same kind of side effects that most subjects would associate with that class of medicine.

Yes.

This idea may look good as an ideal principle, but it would be horribly impractical, complicated and expensive apart from legal and ethical aspects.

Ok, here is one more idea: instead of the placebos the researcher can use well-studied drugs.

 

[pinball1970]

Yes.

Ok, here is one more idea: instead of the placebos the researcher can use well-studied drugs.

That defeats the object. A study is looking at the effects of a drug with everything else being equal. If that is the object, one drug.
So for example male, age range 21-30 no drugs or alcohol in the system, non smokers, no heart, liver, kidney conditions etc.
The guys can help me out a little here but all other conditions are the same for that cohort.
Same time, same venue, same procedure, same duration. 20 individuals, ten have the drug and ten have the placebo.
These trials are usually 'blind' so the volunteers do not know if they had the placebo or not.
"Double blind" the techs and scientists administering the drug/placebo do not know either. This removes bias.
Drugs/placebo administered, results recorded, swap round placebo/drugs repeat.
Same individuals so statistical analyses can be used to see what is significant and what is not.

My experience of drug trials in the late 1980s.

 

[jrmichler]

That's the same as my experience with a drug trial three years ago. After the trial, they informed me that I had received a standard multivitamin and placebo cocoa extract.

 

[Spathi]

After the trial, they informed me that I had received a standard multivitamin and placebo cocoa extract.

Did you guess that before they told you?

 

[berkeman]

That's the same as my experience with a drug trial three years ago. After the trial, they informed me that I had received a standard multivitamin and placebo cocoa extract.

Did you guess that before they told you?

Well, he felt extra healthy and his chocolate craving was satisfied, so yeah, he probably had an idea...

 

[jrmichler]

Must.Correct.Misinformation...

My chocolate craving was NOT satisfied.

 

[jbriggs444]

When in a group of patients half get the drug and half get a placebo, can those on the drug be able to guess that? I mean, if they take an antidepressant for example, then it, being a psychotropic drug, can change the rhythm of their sleep, which will give them the information that it is not a placebo; and further, since people usually believe in medicine, this understanding will have a placebo effect.
Did anyone suggest giving as a placebo not sugar, but a studied ineffective drug?

As I recall, this was a key obstacle to effective testing of DMSO (Dimethyl Sulfoxide). The substance had a distinctive side effect (garlic taste in the mouth when applied to the skin elsewhere).

 

[Vanadium 50]

So put all groups on a high-garlic diet and fix the problem that way. Let their spouses and vampires object.

 

[pinball1970]

Yes.

Ok, here is one more idea: instead of the placebos the researcher can use well-studied drugs.

It makes sense when you think about it. Say you develop a drug for hypertension so you test a group of 20.
You want to make sure that what you measure is not a result of the environment. Say everyone is anxious because of the settings so their BP is elevated anyway?

As I recall, this was a key obstacle to effective testing of DMSO (Dimethyl Sulfoxide). The substance had a distinctive side effect (garlic taste in the mouth when applied to the skin elsewhere).

Volunteers arrive at the facility, 7am check in, bloods and everything else and can only have water and a very light meal at 12pm.
6pm a curry is cooked at the facility, LOTS of garlic.
Garlic bread, garlic and chilli chicken. Then drug/placebo given at 7pm.
Sounds like a dream trial to me. No beer obviously but close.

 

[pinball1970]

So put all groups on a high-garlic diet and fix the problem that way. Let their spouses and vampires object.

No. Has to be in situ.

 

[Vanadium 50]

As a very wise colleague once said of blind analyses "blind doesn't mean stupid". Blind is an important feature in experimental design, but not the only important feature.