Off topic: What is the purpose behind giving placebo in clinical trials? Thread poster: Rajan Chopra
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Rajan Chopra 
India
Local time: 21:00
Member (2008)
English to Hindi
+ ...
Hi friends,
I have translated numerous clinical trials from English into Hindi. Not only this, I have translated a number of such trials back into English, which is perhaps a legal requirement.
I find in nearly all clinical trials that some patients are assigned to group which is to be given placebo or a medicine which does not have any salt or substance which cures a disease. I am just curious to know what is the reason behind giving them such medicine despite the fa... See more Hi friends,
I have translated numerous clinical trials from English into Hindi. Not only this, I have translated a number of such trials back into English, which is perhaps a legal requirement.
I find in nearly all clinical trials that some patients are assigned to group which is to be given placebo or a medicine which does not have any salt or substance which cures a disease. I am just curious to know what is the reason behind giving them such medicine despite the fact that they are already suffering from a severe disease and if they are not given any medicine (placebo does not contain any relieving substance) for some weeks (even months in some cases), their condition may worsen or aggravate.
Do people still participate in such trials despite knowing the fact that their health or life may be jeopardized due to possible intake of fake medicine for some weeks or months?
Regards,
Chopra ▲ Collapse
| | | | Kaspars Melkis
United Kingdom
Local time: 15:30
English to Latvian
+ ...
| It is the only way to discount placebo effect | May 2, 2010 |
Probably people accept the risks with the knowledge that their current sufferings will be offset by the future benefits the new drug might provide to other people? Or maybe sometimes there is no alternative treatment available anyway.
I think that people participate because not receiving the real drug usually does not mean a life threatening outcome. And receiving the drug might be equally dangerous due to not being effective or having unpredictable side effects.
| | | | Erik Freitag
Germany
Local time: 16:30
Member (2006)
Dutch to German
+ ...
| placebo effect | May 2, 2010 |
langclinic wrote:
if they are not given any medicine (placebo does not contain any relieving substance) for some weeks (even months in some cases), their condition may worsen or aggravate.
Their condition may "worsen or aggravate" from taking the medicine as well. And: Taking the placebo may improve their health.
[Bearbeitet am 2010-05-02 07:53 GMT]
| | | | dhsanjeev
India
Local time: 21:00
English to Hindi
+ ...
| Placebo effect | May 2, 2010 |
Ist of all clear this misconception that in a clinical trial placebo medicine has its own importance and point to remember is that patients given placebo drug are not told about this that they are just administered just a powder in form of a drug and not a real drug that is undergoing human trial. Placebo effect is related to the psyche of patients n sometimes only this relief that we re being treated n taking medicindle can cure the disease too as it strengthen the inner power of body . 2nd poi... See more Ist of all clear this misconception that in a clinical trial placebo medicine has its own importance and point to remember is that patients given placebo drug are not told about this that they are just administered just a powder in form of a drug and not a real drug that is undergoing human trial. Placebo effect is related to the psyche of patients n sometimes only this relief that we re being treated n taking medicindle can cure the disease too as it strengthen the inner power of body . 2nd point this way the researcher can very effectively can see the effect of real administered drug and only the pshyshic effects in patients that a certain drug is being given them to treat their disease. If the placebo given patient is known of this then the effects will vanish n there is no use of this placebo trial. Hope it will clear a lot about ur query. ▲ Collapse
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Tina Vonhof (X)
Canada
Local time: 08:30
Dutch to English
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| Reason for placebo group | May 2, 2010 |
The reason for having a placedo group is to provide clear evidence that there is a (statistical) difference between the group undergoing the treatment and the group that does not receive the treatment. Once that clear evidence is available, the treatment can be made available to everyone.
Without a placebo group, improvements could be due to other factors. For example reported improvements could be due to wishful thinking on the part of the patients or on the part of the researchers... See more The reason for having a placedo group is to provide clear evidence that there is a (statistical) difference between the group undergoing the treatment and the group that does not receive the treatment. Once that clear evidence is available, the treatment can be made available to everyone.
Without a placebo group, improvements could be due to other factors. For example reported improvements could be due to wishful thinking on the part of the patients or on the part of the researchers. The evidence is 'anecdotal', i.e. people SAY they are improving but how can you know for sure and how much are they improving? If neither group knows whether they are, or are not, receiving the treatment, wishful thinking is ruled out from the beginning. In a so-called 'double-blind' study the researchers themselves don't even know which group is receiving what.
Clinical trials are carefully scrutinized beforehand by an Ethics committee. The committee will give the go-ahead only if participation is not detrimental to the health of those in the placebo group. Their health is never jeopardized and they will not be worse off than they were before - that would be unethical.
Sometimes it is found early on in a trial that the treatment is indeed very effective and that it would not be justifiable to keep it from the placebo group any longer. In that case the trial is stopped in the middle.
[Edited at 2010-05-02 14:31 GMT] ▲ Collapse
| | | | Andrea Riffo
Chile
Local time: 12:30
English to Spanish
+ ...
| Adding to what Tina has said | May 3, 2010 |
langclinic wrote:
Do people still participate in such trials despite knowing the fact that their health or life may be jeopardized due to possible intake of fake medicine for some weeks or months?
It doesn't happen like this, exactly.
Due to current Ethical guidelines, nowadays if a proven effective treatment for a condition already exists, patients in the trials keep on receiving the existing commercial medicine as background medication, and the experimental drug or its placebo is added on top of that. This is precisely because it is unethical to leave a patient completely untreated if an effective treatment for their condition already exists.
In other words, the patients who are randomized into the placebo group are still receiving medicine for their condition, they are just not receiving the new, experimental drug.
If the experimental drug is the first of its kind (i.e., there's no proven approved treatment for the condition), then the patients in the placebo group are in fact not receiving any medication, but one must remember that the experimental drug's efficacy and safety have not been fully proven yet and, therefore, it may also turn out to be harmful or simply ineffective.
Tina Vonhof wrote:
Sometimes it is found early on in a trial that the treatment is indeed very effective and that it would not be justifiable to keep it from the placebo group any longer. In that case the trial is stopped in the middle.
Likewise, it sometimes happens that it can be seen very early on that there are no significant efficacy differences between the active treatment and placebo groups and, in such cases, this is brought up before the Ethics Committee to consider early suspension of the trial.
Greetings,
Andrea
[Edited at 2010-05-03 04:29 GMT]
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