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Placebo-controlled trials: Are they ethical? Are they necessary ?

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ama224
(@ama224)
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In terms of the ethicality of placebos, I believe they are very ethical because you aren't actually doing anything to the patient. In terms of necessity, I believe they are very necessary. I'm a firm believer in medicine when treating someone you always want to avoid what you don't need, or if there is a natural way to go about then that's the route you should take. With placebo's the power is in the anticipation. Essentially the person is no longer feeling as much pain because they think they took something to relieve the pain. As Dr. Simon mentioned the majority of feeling pain is mental, depending on the condition of course. So I personally believe placebo trials should be conducted before more experimental trials to see if they're even necessary.  

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Posted : 24/10/2021 11:33 am
Naglaa Hemida
(@naglaa-hemida)
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Placebo trials are essential because they provide a data point that may be compared to the findings of other experiments. A placebo study can be likened to a control experiment in terms of setup. This guarantees that there is a trial that is not anticipated to change and that the different factors that are being altered can be monitored and quantified using a reference.
To be ethical, I believe that integrating a placebo-controlled trial in testing is not unethical. I feel that because participants are just required to report the impacts they are having, the experiment will have no negative consequences.

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Posted : 24/10/2021 7:51 pm
cb447
(@cb447)
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Placebo-controlled trials are an important part of clinical studies because they provide a comparison to new therapies. Placebo-controlled trials also help investigators determine the percent effective their drug or new therapy is, as well as help determine whether or not a therapy is truly safe and effective (and not just working by chance). However despite these benefits, placebo-controlled trials are highly debated and some argue that is actually unethical for a patient to receive a placebo if a proven therapy is available during the investigation. Additionally, it is argued that such placebo treatments actually hinder results and lack scientific research/merit. In addition to the ethical concern, some say that the placebo effect can actually cause unwarranted side effects such as drowsiness and rashes. I am wondering, would you feel comfortable participating in a clinical study if you knew there was a chance you could receive a placebo therapy? Are there some trials where a placebo study might be acceptable but not in others depending on the severity of the condition being investigated? Where is the line drawn and who should be the primary party responsible for making that decision?

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Posted : 24/10/2021 8:33 pm
mcr29
(@mrela13)
Eminent Member Registered

Yes, I believe that placebo controlled trials are ethical and are very necessary to ensure that drugs and treatments are both effective and not creating fake results. This may seem like it is cruel, because some people are signing up for these trials hoping for one last miracle cure, but may receive a sugar pill that does not do anything. Especially if the drug ends up working and helping those who are taking, it may be too late for some individuals who were not given the actual treatment. While these may seem like problems, this process allows for the drugs to be tested properly and helps get the drug passed for release. Also, this is not unethical because patients are informed when they enter the study that they may be given the actual drug or a water/sugar pill that does not affect them. It is not like the group running the trial is trying to sneak this past the patients so they aren't aware of the situation at all. Unfortunately, this is a necessary test for most trials and can help hundreds of thousands of people by hurting a small few.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5918690/

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Posted : 10/12/2021 8:38 pm
JustinMB
(@justinmb)
Eminent Member Registered

I believe the use of PCTs are ethical as well as necessary. Placebos allow studies to have a control they can test against the baseline of a patient/participant. Thanks to placebos we can see if a change in participant or patients behavior is due to the medicine or in their heads. There are also cases to where people who do not have illness and believe they do being prescribed a placebo and they claim they are healed. I believe it is necessary to help establish a balance and find out if a drug really works and if it really affects the patient as well as in what ways.

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Posted : 28/03/2022 3:53 pm
Alexia Coffer
(@alexia-coffer)
Eminent Member Registered

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial cases. To be ethical, clinical research requires balancing rigorous science with the protection of human subjects. Most people accept the use of placebo controls in trials for conditions with no effective treatment. However, PCTs raise ethical concerns when a proven effective treatment exists, since randomizing subjects to a placebo exposes them to the potential harms of non-treatment. First, PCTs are acceptable when there is no proven effective intervention for the condition under study, or when placebo is compared against an investigational treatment added on to established treatment. This includes trials of treatments shown to be efficacious in some populations but where the data cannot be extrapolated to the population of interest. Use of placebo in this case is typically not ethically controversial. A second justification is sometimes invoked to justify placebo controls in trials of new treatments for conditions whose response to both established treatments and placebo is highly variable. For example, depression has fluctuating symptoms and a high placebo response rate. It is not uncommon to have inconsistent evidence of the efficacy of approved anti-depressants, showing superiority to placebo on some endpoints in some trials but not others. Demonstrating equivalence or non-inferiority of an investigational compared to an approved anti-depressant treatment may mean that the new drug is as efficacious as the established anti-depressant or that neither the established nor the investigational drug performed better than placebo in this trial. Similar phenomena can arise with anti-psychotics, treatments for mania, and analgesics. In such cases a placebo control may be necessary in order to establish the efficacy of a new treatment.

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Posted : 02/04/2022 10:55 am
Ayomide.O
(@ayomide-o)
Eminent Member Registered

I believe placebo-controlled trials are very important and necessary in the clinical trial process. By using a placebo, researchers are able to ensure that none of the changes that occurred to the subjects happened by chance, through the placebo effect, and actually resulted from the treatment. This is extremely important to know in order to determine whether the treatment is actually effective. The use of placebo-controlled trials has garnered much controversy. I do understand how it can be seen as unethical that a placebo is being used when there is an effective treatment available. It is also seen as unethical in terms of clinical professionals, such as physicians, who have the obligation to offer optimal medical health. In the case of a clinical trial where there is no current effective treatment for the condition being studied, I think it is ethical to use a placebo. This means that giving the participants the placebo does not deter them from being any more healthy. I do not see any disadvantages to using placebos and think they are very beneficial to a study. 

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Posted : 03/04/2022 1:31 am
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