I disagree with your statement that "placebo treatment is better than no treatment at all". In fact, I think that is the biggest ethical dilemma in utilizing PCTs. Medical professionals have the responsibility to provide optimal medical care to the best of their abilities. Giving placebo treatment is often less than optimal. If a patient requires treatment for a life-threatening condition. they should not be given a placebo
This does not mean that placeboes have no place in clinical trials. If a patient were to receive a placebo, it should not lead to declining health conditions. Placeboes can help determine the legitimacy and efficacy of the treatment, but should not come at the cost of the patient's health or life.
I believe placebo trials are ethical, but not necessary. The ethics behind PCTs are reasonable and do no harm to the subjects. However, the necessity a of placebo is not clearly defined. The advantages are that no one is harmed and there are no risks. The disadvantage is that false positives may skew the data.
The placebo is usually a saline solution. Something that is harmless to inject (and is often used to dilute actual vaccines), but has no medical benefits. Although in some cases an unrelated and already approved vaccine is used as placebo. For example, in one covid-19 vaccine study the placebo group received a meningitis vaccine.
The purpose of using a placebo group in placebo controlled trials is to have a group of people selected based on the same criteria as the group receiving the trial vaccine. Researchers can then compare the incidence of the disease the vaccine is supposed to protect against in the vaccine group with that of the placebo group. If the vaccine is effective, there should be fewer cases of the disease in the vaccine group than in the placebo group.
As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake ultrasound device in a bone healing study.
So, Do you think Placebo-controlled trials: Are they ethical? Are they necessary ? Also, what are the advantages and disadvantages of using PCTs ?
I think PCTs is rarely used in some circumstances like asthma patients for example. The advantage of using PCTs is Zero risk of overdose.Also, Placebos are always better than no treatment.
So, What are your thoughts about placebo controlled trials ?
I think that placebos are necessary for specific clinical trials. Dr. Simon mentioned something known as the placebo effect in his lectures. Even though one is technical with holding treatment from specific participants, it is necessary to combat the placebo effect and get viable data. In most cases, the placebos are not used in high-risk clinical trials where the medication is given may be the last resort for a patient's health.
Hi @llefevre! You've giving a wonderful overview of why placebo is used as well as the fact that it is not harmful in anyway to the patient. Coming from the perspective of the COVID trials, I do think that once the study was completed (or I guess in any trial) that the patients should be informed of which group they were a part of. After having a conversation with a young lady that participated in the COVID trials, she was concerned as whether to get the vaccine or not because she had no idea which group she was a part of despite her trial having been done with months before. This is the only adverse stance I have to using the placebo as a control.
Placebo trials are ethical and necessary in some cases. However, in cases where the placebo can have deadly or negative consequences, I do not believe they should be legal. The placebo is necessary when they test the results on medication that can improve symptoms or cure them; nothing that it not treat can lead to death.
As Dr. Simon discussed in the lecture the mind is a powerful thing and sometimes just believing something is work. I think the placebos are important because it helps scientists by contributing to their research. I believe as long as the patients are aware that they could possibly receive a placebo then it ethical.
A placebo-controlled trial occurs when one group of study participants receives the active treatment, while the other group of study participants receives a placebo. Everything else is held the same between the two groups, so that any difference in their outcome can be attributed to the active treatment. Placebo-controlled trials are ethical and necessary. On average 50 per cent of all questioned physicians acknowledge that they have used placebo medication at least once during the course of a year in their patients (Enck et al. 2011) and mean placebo response rates in antidepressant clinical trials are 30% to 40% (Vellekkarr and Menon 2019). Thus using a placebo in clinical trials will decipher if the new medication actually has an effect on the disease or aliment.
References:
Enck, P., Klosterhalfen, S., Weimer, K., Horing, B., & Zipfel, S. (2011). The placebo response in clinical trials: more questions than answers. Philosophical transactions of the Royal Society of London. Series B, Biological sciences, 366(1572), 1889–1895. https://doi.org/10.1098/rstb.2010.0384
Vellekkatt, F., & Menon, V. (2019). Efficacy of vitamin D supplementation in major depression: A meta-analysis of randomized controlled trials. Journal of postgraduate medicine, 65(2), 74–80.
As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake ultrasound device in a bone healing study.
So, Do you think Placebo-controlled trials: Are they ethical? Are they necessary ? Also, what are the advantages and disadvantages of using PCTs ?
I think PCTs is rarely used in some circumstances like asthma patients for example. The advantage of using PCTs is Zero risk of overdose.Also, Placebos are always better than no treatment.
So, What are your thoughts about placebo controlled trials ?
I think placebo-controlled trials are necessary because they every experiment needs a control. The experiment needs a control to compare the results of the actual device to. They are ethical, because it benefits the research and it is not harming the patient in any way. An advantage of a placebo-controlled trial is that it eliminates the effect that expectations can have on the outcome. A disadvantage is that there can be a higher risk because of non-treatment.
I think Placebo controlled trials are necessary to the experiment of the drug. In all experiments there’s a need for a baseline to guide as a reference point for understanding. In the last lecture, Dr. Simon expressed, that the more detailed your trial is , the more effective the data will be. Having a placebo shows balance in the experiment. I think trials that do not engage, in a placebo is not effective in the long run.
As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake ultrasound device in a bone healing study.
So, Do you think Placebo-controlled trials: Are they ethical? Are they necessary ? Also, what are the advantages and disadvantages of using PCTs ?
I think PCTs is rarely used in some circumstances like asthma patients for example. The advantage of using PCTs is Zero risk of overdose.Also, Placebos are always better than no treatment.
So, What are your thoughts about placebo controlled trials ?
I believe that they are ethical and necessary because researchers need to need if it actually their medication is causes the positive effects or if it was suggestive thought. The brain is a powerful tool sometimes if you believe something will make you better you will start to feel better.
Placebo-controlled trials are necessary for assessing the overall validity of a medical device or treatment. Without a blind control, experimental results will not be able to make an accurate comparison and which diminishes/exaggerates the study's conclusions. Deciding whether placebo-controlled trials are ethical can not be entirely as black and white. They are presumed ethical because the patient knows beforehand that they may or may not receive the real treatment and are therefore not guaranteed any specific set of results. However, it is certainly unfortunate for the people entering the clinical trial in hopes of a positive outcome when they receive a placebo. It is a strange notion to reduce humans down to test subjects that can randomly be given a life saving treatment. However, it is in my opinion that it is a necessary "con" for the sake of developing medicines/devices for the wider population.
As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake ultrasound device in a bone healing study.
So, Do you think Placebo-controlled trials: Are they ethical? Are they necessary ? Also, what are the advantages and disadvantages of using PCTs ?
I think PCTs is rarely used in some circumstances like asthma patients for example. The advantage of using PCTs is Zero risk of overdose.Also, Placebos are always better than no treatment.
So, What are your thoughts about placebo controlled trials ?
Placebo controlled trials are unfortunately necessary.
During the sophomore year of my undergraduate degree, I was involved in research for children with muscular dystrophy and had the opportunity to attend a conference for an organization called PPMD (Parent Project Muscular Dystrophy). This conference was interesting because unlike most conferences, it was centered around the parents and children of families with Muscular Dystrophy. At this conference I noticed that the primary focus was discussing the advances in trials of experimental medication attempting to "cure" the disease. At every presentation, at least one mother stood up and asked about placebos. Every good parent wants the best for their child and parents of children with disabilities can sometimes feel lost and hopeless, so when they are told they are apart of experimental trials there hopes are raised... until they find out that their child might not actually be getting any treatment.
This experience sticks with me because it showed me the human element of medicine and the unfortunate truth that comes along with experimental science.
As much as it brakes my heart to see parents in tears trying to make sure their child gets medication to possibly help their survival, the scientist in me understands the need for a control/placebo group. This is the price that we pay to make sure we know that the drugs are working and effective. Science and statistics do not take human emotion into account, which is why it is important to have placebo groups and to have blind/double-blind studies. Removing the human removes the chances of emotion and errors biasing the results and inches us closer to the truth.
Does anyone have any similar experiences or thoughts on the unfortunate need of placebo groups in clinical trials (specifically for medication)?
Thanks,
Matt
I think @rachelpatel1796 brings up a good point about the psychological impacts of drugs being taken. While there is a huge chemical component to it, like Dr. Simon mentioned, the human mind can also play a huge role in human treatment. I personally don't think it's unethical especially if it's not treating a life threatening disease and putting the individual at risk. Also like many others have mentioned, patients are usually informed about details of the study including if a placebo is involved and are willingly signing up for the study. While there is a chance the placebo may not work, if it does, we can now save so much time and effort and chemical impacts to the body by focusing energy on creating placebo pills to save future patients which is far less harmful than active ingredients. I think it's definitely necessary to include this in a study design if possible.
Placebo controlled trials are ethical from a bigger picture sense. There is a greater good at hand when conducting them. It is for a good and moral purpose, so therefore, it should not be considered unethical. They are necessary for obtaining the best results for the medical device or drug being tested. The biggest advantage from placebo clinical trials being conducted is that the diversity can be equally spread between the groups. That would also increase the chances that benefits can be observed because of any difference in treatment, instead of differences between the actual patients in each of the groups. A disadvantage for placebo clinical trials, although quite a minor one, is that subjects may experience a negative reaction to the placebo. Although, that is the risk they take as a clinical research study, subject when signing their informed consent for, so in that case, nothing can really be accounted for that.
