General Question

crazyguy's avatar

Do side effects reduce the double blind aspects of a medical study?

Asked by crazyguy (2014points) 1 month ago

The most beneficial studies of the effects of a new medicine or vaccine are generally placebo-controlled double-blind. What double-blind means is that neither the doctor or the patient knows whether s/he was injected with a placebo or the drug. However, if the drug causes readily observable side effects such as “injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site”, while the placebo obviously does not, don’t the doctor and patient know what the patient got?

Does this knowledge possibly influence a patient’s actions?

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34 Answers

Zaku's avatar

What sort of actions are you worried about?

You might be surprised about the range of placebo effects and how strong they can be. They also don’t exclude side-effects.

Hamb's avatar

I don’t think you understand what the placebo effect is.

@crazyguy: “However, if the drug causes readily observable side effects such as “injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site”, while the placebo obviously does not, don’t the doctor and patient know what the patient got?”

As @Zaku mentions, all of these are completely possible via placebo effect.

crazyguy's avatar

@Zaku If you notice that was the second part of my question. There is a reason why double-blinding is preferred. So my first question is basically whether side effects compromise that.

The second question relates to the actions of a patient who knows s/he received the experimental drug. In the case of the covid vaccine, does the recipient of the vaccine take a few extra chances because s/he knows that the real drug is in his/her body?

Hamb's avatar

@crazyguy: “In the case of the covid vaccine, does the recipient of the vaccine take a few extra chances because s/he knows that the real drug is in his/her body?”

Any good study takes something like exposure level into consideration. But I think you’re again jumping here. How does the recipient know that s/he has the real drug if it’s not possible to know?

LuckyGuy's avatar

No, The dose administered might be the test medicine, a half (or some other fraction) dose of the medicine, or a placebo that might be something innocuous – maybe a salt solution or even a vitamin.
Look at virtually every drug you find – go ahead, I’ll wait… The side effects include: pain, fatigue, myalgia, arthralgia, headache, nausea, constipation, diarrhea… death. But most of the time there is no effect.
Any injection – even sugar water can be painful or not. But most of the time the effect is small.
Double blind is the best way to run the test. No one can tell if the juice is “Live or Memorex.” (Folks over 60 will remember that ad.)

JLeslie's avatar

Sometimes trials are done with totally inert ingredients like sugar pills or saline water, and sometimes tests are done against another drug.

Even if it’s a true placebo trial, people will still have reactions and symptoms. Some might be psychosomatic, but others very real. In every day life people get headaches, nausea, tired, and it’s all recorded during the testing time. If symptoms happen while taking the drug it is counted as a side effect during trials, even if it might have been unrelated, we can’t know if it was related or not, so it’s counted.

Sometimes doctors do have a guess who is receiving the drug, but the patients wouldn’t know as easily. The patients don’t know how other people in the test trial are doing.

Regarding covid I don’t see the justification for double blind vaccination for efficacy, and possibly it’s unethical. The entire population is exposed to covid right now, the community is basically the placebo for efficacy.

zenvelo's avatar

@JLeslie I know of a Covid vaccine study in West Virginia (the Sawbones podcast people are part of it) where 25% get a placebo; the other quartiles get different vaccine doses.

crazyguy's avatar

@Hamb I guess what I was missing is that the placebo can not only confer a beneficial impact because the patient believes s/he has the drug, but also the unpleasant side effects.

So the patient does not know.

crazyguy's avatar

@Hamb You say in your professorial tone:

“Any good study takes something like exposure level into consideration. ” Given the fact that there are over 30,000 volunteers, I beg to differ. There is no fucking way!

crazyguy's avatar

@canidmajor Which is it: No, the doctor and patient don’t know.

Or No, this knowledge does not influence a patient’s actions.

JLeslie's avatar

@zenvelo I heard of covid vaccine studies with similar ratios. A while back one being discussed was 50/50, I don’t know which one.

The vaccine efficacy is questionable also, because they are just looking at how many people caught covid, but are the people being careful not to expose themselves to covid?

One study I heard about in another country they purposely were exposing the vaccinated people to covid. I wish I remembered the exact details.

crazyguy's avatar

@LuckyGuy LOL I do remember the “Is it live?...or is it Memorex?” ad. Thanks for the education.

crazyguy's avatar

@JLeslie Thanks for a thorough answer. I understand your point about the control group. The only rationale I can offer is the regularity and frequency of testing. If testing is as random as it tends to be for the general population, I do not see the need for a control group.

JLeslie's avatar

@crazyguy Testing? You mean testing to see if the participants are positive for covid?

Hamb's avatar

@crazyguy: “You say in your professorial tone:

“Any good study takes something like exposure level into consideration. ” Given the fact that there are over 30,000 volunteers, I beg to differ. There is no fucking way!”

Is “There is no fucking way!” to be interpreted as, “there is no way to create a study that targets certain variables while minimizing the influence of others”? Should we not bother with trials?

And to circle back (in a professorial tone) – you’ve already ceded the point that the participants do not know if they have the real thing, so your theoretical concerns are irrelevant.

canidmajor's avatar

@crazyguy No, side effects do not reduce the double blind aspects of a medical study. These studies tend to have tens of thousands of subjects, the percentage experiencing significant side effects are likely few enough to not even register on the meter, and can often be attributed to other causes anyway.
The folks that have been designing and executing these methods of determination have been doing so for a very long time, and are likely waaaaay the hell more educated in the levels of statistical probabilities of anomalous outcomes than you are.
I know some of these people, we talk about this stuff, it has been covered.

crazyguy's avatar

@canidmajor Thanks for the complement!

crazyguy's avatar

@Hamb My comment was geared only to your comment: “Any good study takes something like exposure level into consideration. ” If you think about analyzing exposure levels of 30,000+ people you know I was right.

crazyguy's avatar

@JLeslie What I meant was that the reason to not use the general population as the control group is the lack of knowledge of them. For instance, you do not know when any particular individual got tested and whether a person already had antibodies or not.

Hamb's avatar

@Hamb – You didn’t answer the question.

Let’s cut to the chase here. Is there a specialty that you don’t know better than than those who study and dedicate their lives to? I get the suspicion that you feel that you’ve figured out major limitations that researchers just haven’t thought of. You also appear to have an expertise in medicine that surpasses physicians and the medical community. And if I’m not mistaken, you likely understand climate science better than climate scientists.

Is it possible that your shower thoughts are merely those of a layperson rather than some kind of omniscient being?

crazyguy's avatar

@Hamb You are obviously one of those people who would rather lash out than admit s/he may be wrong. Good luck, my friend.

Hamb's avatar

^ At least you admit it.

LostInParadise's avatar

Lack of symptoms may reduce the placebo effect, which would be a good thing. If the placebo control group is less inclined to believe that they got the real thing due to lack of side effects then they are less likely to to get any benefits from taking the placebo, which would mean that the placebo effect can be discounted for those given the vaccine. Any benefits they get are more likely to be due to the actual effects of the vaccine.

crazyguy's avatar

@LostInParadise Thanks for a great answer. But, do you mean “Lack of side effects…”?

LostInParadise's avatar

Not sure what you are asking. If someone given the placebo knows that there are likely to be side effects then not having side effects would suggest that they were given a placebo.

canidmajor's avatar

@LostInParadise He wants you to use the words that he wants you to use.

Hamb's avatar

@LostInParadise: “Not sure what you are asking. If someone given the placebo knows that there are likely to be side effects then not having side effects would suggest that they were given a placebo.”

He didn’t understand what placebo meant. Once he understood that placebo effects are real and therefore a participant can’t know if s/he was part of the control group or not, his premise was gone. However, he continued on without it, completely ignoring what he had just conceded.

He is now vaguely claiming to be a clinical researcher who has figured out that clinical research is useless. His position now appears to be…

“Everyone is wrong in thinking it’s worthwhile to run clinical double-blind trials. Why? Because I said so.”

JLeslie's avatar

People aren’t told they are likely to have side effects, they are told to record what they experience.

jca2's avatar

@Hamb: @crazyguy also indicated he doesn’t understand how these studies work when he wrote ”What I meant was that the reason to not use the general population as the control group is the lack of knowledge of them. For instance, you do not know when any particular individual got tested and whether a person already had antibodies or not.

Of course if someone is participating in a study like that, their medical history would be an open book, before they went receiving shots of any kind.

JLeslie's avatar

Here is the information on the vaccine trial that includes purposefully exposing participants to covid. https://www.nature.com/articles/d41586-020-02821-4

crazyguy's avatar

@LostInParadise What I meant was that your answer should begin with “Lack of side effects..” instead of “Lack of symptoms”. You answered my question.

crazyguy's avatar

@Hamb Talking about somebody in the third person even though s/he is very much present is considered insulting in some societies. However, on this board, I have become immune to insults.

I am not a medical doctor or a researcher. However, I do know what a placebo controlled, double blind study is. What I had not realized, and I have zero hesitation in admitting it, is that side effects can be part of the “placebo effect”.

crazyguy's avatar

@jca2 I stand by what I wrote and suggest that you have no idea what you are talking about.

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