Seems like you can’t watch an hour of television these days without seeing at least one commercial for a new drug, designed to alleviate anything from allergies to social anxiety.
In many of these spots, after they run down the list of all the atrocious side-effects (May include diahrrea, vomiting, swollen eyeballs, etc… etc…), the announcer says something to the effect of, “Incidents of side-effects were about the same as with a sugar pill.”
I’m wondering to what this refers. During these clinical studies, do they give a certain test group sugar pills as a “control”? And if this is the case, does this mean that just as many people who took the sugar pills complained of swollen eyeballs? After hearing of all the terrible ways your body might react to this medication, I find it hard to believe that participants given inert pills managed to psych themselves into experiencing side effects.
If this is what they’re telling me, it would seem that any random group of people will complain about unprovoked ailments regardless of what you hand them to swallow. What gives?
You’re partially correct. The sugar pill is given to the control group to test for the “placebo effect.” They scientists monitor the occurrence of side effects in the placebo group (who should, in theory, have none) and the number who took the actual drug. This shows what side effects they should warn against, based on the results. The placebo effect is, essentially, what causes people taking the sugar pill to experience these side effects. Convincing oneself that you are ailing is apparently strong enough to require a test.
Now to answer your other question. If the commercial does warn you about something like diarrhea, then it was more prevalent in the group with the actual drug, at least enough so to be statistically noted. Sometimes only a slightly greater amount of real drug users will experience side effects, and it can be deemed a statistical error.
During clinical trials, drug companies frequently perform double-blind studies where the doctors who administer the drug do not actually know whether they are administering the real drug or the placebo, and neither does the patient.
The placebo’s use extends beyond side-effects due to the fact that the placebo also helps people get better! Therefore, if a drug company wants to prove that CancerAway 2.0 is effective in curing cancer, they have to show that the remission rate in patients taking the drug is higher than in patients who are taking placebos. No one is really quite sure why people who take placebos get better faster than those who take nothing at all, but presumably it has something to do with the inner workings of the brain and its control over the immune system.
Clinical trials are conducted in a ‘double blind’ fashion. That is, neither the doctor, nor the patient knows who is getting the experiental drug, and who is getting a placebo compound/ solution of the same physical consistency/ appearance. Only the trial coordinators know, and who got what is only revealed at the end
A ‘sugar tablet’ or pill that looks the same as the test pill but is inert is typically used for oral medications, or for IV, a saline solution. What will probably happen during the course of the trial is that someone (possibly on the real drug) will get diarrhea. The doctor may then unwittingly ask another patient (who is on the placebo) “have you had any bowel problems?”, the patient may respond “Why yes, I have diarrhea”, at which point the doctor may re-enforce this by saying “Oh, we’ve been seeing a lot of it”. Of course, the placebo patient neglects to tell the doctor he ate 10 Taco Bell bean burritos followed by a Metamucil chaser, and suddenly when he has a regular meal, he starts getting diarrhea too. Welcome to the nocebo effect which Cecil has lovely addressed…