Placebo Controlled Trials are incredibly important to the validity of research done in clinical settings. To answer your question of why they are necessary, many subjects in a study would be greatly influenced by the group of the study they are in. For example, the fact that a subject is given a treatment knowing that it is supposed to work, or the fact that they are clearly a control group, and nothing will change would skew results more often than not. For this reason, having a placebo group is essential for determining the real impact of the drug, treatment, device as compared to the control placebo group.
As for your question of whether or not Placebo Controlled Trials are ethical, I don't see a reason as to why it would be considered unethical. It removes all bias from a scientific study, and as long as the placebo group is not given a potentially harmful substance, I think Placebo Controlled Trials are both necessary and ethical.
I feel that a placebo-controlled study is important and valid. The purpose of the study as we know is to understand the effect of treatment that do not depend on the treatment itself. The control group and the group of people receiving the treatment, who do not they are receiving the PCT are evaluated to study the effect of treatment that does not depend on the treatment itself. The motive of the study is to know if patients under the treatment are cured how rapidly,with how much completeness and how frequently as compared to the control group. It helps to identify the efficiency of the treatment. It is ethical in not so severe conditions and would be helpful if it can help without the use of treatment.
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 placebos are important in order to determine a baseline to compare the effects of the actual product against. While some people may argue giving a patient no treatment could serve as the baseline, I think taking the psychological effect into account is absolutely necessary. When people are given actual treatment, not only are they benefiting from the actual effects of the product, but many times, their condition improves simply because their state of mind improves from knowing they got treatment. That is why the "placebo effect" is a very real thing - patient's conditions improve after being administered a placebo solely based on the perception that the drug is working. I think they are ethical as well because the doctor would have made an educated, informed decision to give a patient the actual treatment or a placebo treatment, and at the end of the day, it's the doctor's job to make the patient feel better and cure their condition. If the placebo works, I don't see anything wrong with that.
The mind can have a powerful influence on the body, and in some cases can even help the body heal. The mind can even sometimes trick you into believing that a fake treatment has real therapeutic results, a phenomenon that is known as the placebo effect. In some cases, these placebos can exert an influence powerful enough to mimic the effects of real medical treatments. The placebo effect is very real, so I think in order to know how effective a drug or device is, researchers must also have a good understanding of the impact of the placebo effect on the treatment. So I think placebo-controlled trials are ethical and necessary.
As mentioned by Dr. Simon, a major factor involved in high level clinical tests is the ability to remove any bias that could impact the results of a test. In the case posed in the question here, the bias under examination is that which stems from the individual patients on which a trial is being conducted. For instance, Dr. Simon mentions in his lecture about the relationship present between pain and the mind for some cases where one's level of discomfort can be reduced by convincing them that they have been successfully treated. Therefore, I believe placebo controlled trials are exceedingly important to assess whether the treatment being clinically tested such as a pill was the primary factor that helped bring about the intended result or not. In instances such as this, the patient could simply believe he has been cured because he was given a pill and through the wonders of the mind they would stop feeling the discomfort that was previously present. As a result, I believe placebo controlled trials are ethical because even if they don’t result in any treatment for the patient they aren’t causing any greater risk or discomfort either. Overall, they are necessary to assess whether results being observed are the result of the treatment being tested or the result of other external factors.
I feel Placebo trials are important because it helps us understand the how effective is the drug in curing the disease/ illness. We get to know that how much psychological effect helps by using such trials. I totally feels its ethical if the people are informed that they might receive a placebo as we cannot tell them if they have opted for placebo or not since that may not give good results as the patient already knows that he has received a placebo and it would not work. I totally feel placebo is required since we can deduce the real power of the drug and say how good it is.
I agree with most of these posts in that placebos are both ethical and necessary in testing certain treatments. As long as the patient's safety is not jeopardized, and the signed informed consent form properly details any risks(which must be none to minimal), the experiment should be deemed ethical. Placebos are necessary in ensuring that the other proposed treatment is truly effective in reducing symptoms, and not just a result of the mind convincing the body of the treatment's positive influence. The symptoms being treated must be nonlethal and not detrimental to the subject's health if a placebo is used. For example, placebos can be used in clinical trial that measures a painkiller's ability to alleviate discomfort to mild pain, since pain is linked to the mind's perception(not just physical/bodily). A placebo will also account for other factors, such as environmental factors, that could influence a patient's recovery or severity of symptoms. The experiment must isolate the medication itself as the sole factor in effective treatment. The investigator also informs the subjects that they will be randomly assigned into certain groups, and that there is a possibility that they will be placed in a placebo group. The patient must agree to be subjected to either treatment before participating in the study, so ethics should not be an issue.
If people know that there is a possibility that the device or medication they got is not actual but dummy then there are chances of corrupting the results because if they were given the actual thing and they think its dummy then it will effect the healing process by slowing it down and in some cases completely voiding effects of the medication or device on subject. I believe placebo trails are ethical in single and double blind studies. Because placebo trial will give examiners understanding if what the patients are being treated for actually need medication or they can be cured with out it by knowing the effect of placebo for their trail.
Placebo is being used extensively in the field of pharmaceutical clinical trials. It is important to acknowledge that the extent of how the human mind places a role in affecting the human body both positively and negatively. And the only way to do this is by using placebos. According to an article published in health Harvard( https://www.health.harvard.edu/mental-health/the-power-of-the-placebo-effect ). It explains that there have been numerous studies done which proves that placebo can be as effective as traditional treatments espscially for "pain management, stress-related insomnia, and cancer treatment side effects like fatigue and nausea." Therefore placebo should be tested so that the placebo effect is accounted for to determine the success rate of specific drugs or devices.
For PCT I would say it depends upon the type of trial being under consideration I think they are pretty good to go with in terms are being ethical, as there is low risk and patients might get cured on an effective way.
I believe placebo-controlled trials are necessary and can be done ethically, since previous studies have shown the placebo-effect to be apparent in a wide range of fields. The mechanism behind the placebo-effect is still not quite fully understood, but multiple mind-brain processes seem to mediate the placebo effect, including learning, expectation, and social cognition. Due to individual susceptibilities to the placebo effect, it is necessary to include them in clinical trials. This can be done ethically by telling the patients beforehand that they will receive two drugs (or more) and one will be a placebo, but of course, the patient doesn't know which is which. The placebo drug is typically chosen so that there is minimal risk to the patient. For example, in the case of diabetes, one would not use a sugar pill as the placebo pill, since it could possibly be dangerous for the diabetic patients. Therefore, choosing the correct placebo drug is just as important as including a placebo drug in the studies. In another case where a patient is in need of the experimental drug immediately, it is not ethical to perform placebo trials on the patient first, since the delay of the experimental drug could be costly.
References: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6013051/
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 ?
The common belief is that placebo is a sugar pill; thus, it is not ethical. Although there are certainly advantages, and they are the only option in some cases (so this makes them necessary), some patients would rather know the truth instead of using a fake pill that potentially will do nothing. Placebo-controlled trials are permissible. The ethical issue here is the cases when no treatment can cause more damage than the actual drug. 4 cases can be used according to the international ethical guidance permits. These are:
1) When there is no treatment for the condition
2) When mo treatment causes minimal damage to the patient
3) when there are good reasons to use a placebo, and again no treatment wouldn't cause serious damage to the patient
4) There are good reasons to use a placebo for research, and no treatment is necessary for the patients to begin with.
Other than research purposes best advantage of the placebo-controlled treatment is that by tricking the patient psychologically, the patient might get better. The brain controls the body, and although there are different views on this, I believe that by manipulating the brain in a good direction, the patient's condition may improve.
I agree with @maniakberk. If the inclusion of a placebo does not harm the patient, I think it would be better to include placebos as well. They also mentioned how they believed a placebo-controlled trial could positively affect the patient psychologically, which in turn would improve the patients’ condition. I agree with this point as well and I know that there are papers that discuss the positive effects of a placebo-controlled trial. According to a study I found, placebos can cause neurological changes in patients which can result in them feeling less pain or fewer symptoms. [1] From an ethical standpoint, it would be important to report if there were any placebo effect-based circumstances. This would be more troublesome since it raises the question of whether a treatment is as successful as it was found to be or if the success could be partially attributed to psychological beliefs. Obviously, this would not apply to all clinical trials but can still make a difference in those that it does apply too. All in all, I think placebos are necessary, if they do not harm the patient, and believe that they play an important role within the clinical trial.
The original post mentions that "Placebo is better than no treatment" however I believe placebo means no treatment is actually given. For example a placebo for an injectable drug could be a saline injection. I do see the ethical dilemmas that come with offering a placebo medication. Patients who are very sick might not be getting a potentially effective medication, resulting in worsening of their condition. This however is explained to them and when accepting to be part of the trial the patient consents to this. A control/placebo group is necessary in order to attribute any changes seen in the experimental group to the actual medicine being given.
I have an experience where I have suspected to be part of a control group though I did not suspect at the time. It was for an eye therapy aimed to improve your vision. I felt like over time the treatment was aiding me in being able to converge images more. The treatment itself felt strenuous enough that I thought it was the experimental. After the trial ended, I spoke with a friend who was part of the same trial and he had received a much more strenuous treatment which led me to believe his was the real one. I certainly think there is a possibility that I experienced a placebo effect.
I understand that placebo studies may provide the necessary research in order to advance technology and healthcare, however I believe they can sometimes be unethical. For example, if a patient is battling a vigorous disease and they believe they are receiving the best possible treatment for said disease, it would be disappointing to learn that after 5 weeks of treatment that it was just a placebo treatment. In this time, the disease can easily worsen and potentially become irreversible. When thinking back upon the placebo treatment, the patient may have wished that they received the actual treatment rather than just the placebo. In this particular circumstance, I believe the placebo controlled trials can be unethical.
