As mentioned in this week's lectures, the placebo effect can slightly improve patient outcomes in studies on pain. Dr. Simon mentioned the point that pain is roughly 20% controlled by the brain.
Resnick, Brian. “The Weird Power of the Placebo Effect, Explained.” Vox, Vox, 7 July 2017, https://www.vox.com/science-and-health/2017/7/7/15792188/placebo-effect-explained.
What are some ways that researchers ensure that the placebo effect does not interfere with results? For example, patients may overestimate how much their pain improved after a particular treatment.
In the article titled "The Fascinating Mechanisms and Implications of the Placebo Effect" written by Colloca they stated that when a person expects and experiences a placebo effect, cognitive and emotional circuitries are activated with experience of pain reduction and improvements in other symptoms. Molecular neuro-imaging studies using positron emission tomography and the selective µ-opioid receptor tracer have greatly contributed to current understanding of the neurobiology of the placebo effect.The effect of the placebo effect does not reside in the sham treatment itself; rather, it relies on expectancies that surround the patient and the intervention. Recent findings suggest that patients with impaired cognitive functions may respond to placebos by virtue of implicit cognitive processes that go beyond desire, suggestions, or verbal communication. There are minimum requirements for eliciting placebo effects, both from the view of conscious awareness and from the perspective of brain functionality. Placebo effects are generated primarily to promote adaptation to old and new environments and minimize trials and errors. Placebo effects reflect the ability to merge prior experience and ideas about treatment outcomes with sensory perception reconciling mismatches between what is expected and what is experienced.
Source:
Colloca L. (2018). Preface: The Fascinating Mechanisms and Implications of the Placebo Effect. International review of neurobiology, 138, xv–xx. https://doi.org/10.1016/S0074-7742(18)30027-8
Two (or more) groups are present in a placebo-controlled experiment. One group receives the actual medication, while the other receives a placebo. The other factors are kept constant between the two groups, allowing any variation in their results to be linked to the active therapy. Scientists have to be rather clever to test it against a placebo. A placebo must be an accurate enough replica of the actual therapy for patients to be unable to discern the difference in order to have the desired effect. Researchers may unintentionally offer participants cues about how to act if they anticipate a particular outcome. For the purpose of avoiding bias brought on by demand characteristics or the placebo effect, double-blind trials are very helpful.
Placebos within research and experiments are highly important when testing the efficacy of a new medication or treatment option for an illness. We know the brain has influence over pain detection and severity, as well as with other symptoms and feelings surrounding the effects of an illness. As it pertains to pain-related symptoms and treatments for pain, a placebo group should be present alongside at least one group receiving the medication/treatment. Not having a placebo results in the lack of a control group and, thus, no true baseline to compare the treatment tests and results to.
As we learned in this week's lesson, the placebo effect is the patient's reaction as if the patient had taken the drug, even though the patient was not taking it. In addition, this effect is more evident especially in pain-based diseases. If I'm going to answer your question, I don't know if the placebo effect can be eliminated, but I think the best solution is to increase the number of experiments to reduce the placebo effect.
The placebo effect can be a strong force for some patients. It is something that is built on expectations of the person being tested. In their head, they have conditioned that the placebo means certain results and so psychological they will feel it. And the psychological effects could deter the actual results of the trial being conducted. So one way some researchers could combat the placebo effect is by including a neutral group, one that receives neither the placebo nor the drug being tested. This way there would be a control group that would show the base results versus the placebo group and tested group. The control group could also show a clearer difference between the placebo and tested.
The placebo effect is very interesting to me because just simply thinking that you are getting an effective medication could completely change how you feel, simply due to how our brains impact how much pain we feel. Of course the placebo needs to be well thought out in order to have the participants believing it is effective. If participants have any suspicion that they aren't actually taking a medication, then the placebo won't work. The study I have linked below lists multiple ways in which a placebo treatment can take place in order for it to be deemed effective. They were looking specifically at non-malignant pain due to it being difficult to manage, and they found that there are 5 groups of procedures that clinical studies need to focus on when conducting effective placebo studies: Patient’s beliefs and characteristics, Practitioner’s beliefs and characteristics, Healthcare setting, Treatment characteristics, and Patient–practitioner interaction. By targeting a patients beliefs and characteristics, you could alter a patients response to a placebo. For instance, verbal suggestions could allow the patients to be more keen to see that there are positive changes occurring when taking the placebo. The second group suggests that a highly rated or regarded practitioner might elicit more confidence in the treatment from the patient, essentially receiving more trust in the placebo. Certain environmental conditions, the third group, could affect the comfort level of the patient, and the more comfortable they are the more likely they are to be receptive to the "effects" of the placebo. Treatment characteristics of the placebo need to also be believable and thorough. If the treatment is seem to be "too simple," patients may be not as trusting of its effectiveness but if the treatment is "too complicated," patients may be hesitant in even participating. Of course the last group is important because if there isn't a trusting or good relationship between the patient and practitioner, the patient may not be willing to accept the placebo or the effects of the placebo.
I don’t think it’s possible to eliminate the placebo effect, especially in studies that rely on patient-reported data such as pain level. But as jdfoster01 mentioned above, the placebo effect can be accounted for in a clinical study by having a placebo group and double-blind trials. This way, neither the subject nor the administrator of the treatment is aware of which group each subject belongs to. However, to manage the placebo effect even further, it may be beneficial to use a triple-blind study where the scientist analyzing the results is also blind to the subjects’ groups. This helps control any potential bias from the scientist if there is some subjectivity in the data collected. Additionally, the trial should make sure to use a large enough sample size and randomize which subjects end up in which group. These are good practices for clinical trials in general, but they also help with controlling the placebo effect because some people respond very strongly to placebos while others may report no difference in symptoms at all. Thus, you want to make sure you also account for variability in the placebo effect between individuals in the population.
The dialogue under this post has shared a lot of great information. One of the most effective ways I believe researchers can try to make sure the placebo effect does not interfere with the results is by double-blind study method. Double-blind study method is a type of clinical trial where neither the researcher nor participants know which treatment is given until after the trial.
In order to eliminate the placebo effect, researchers have to ensure that both products look as close to identical as possible. For example, if a clinical trial is being conducted using auto-injectors and syringes, with the placebo being water-filled syringes in comparison to drug-filled syringes, some people may be able to identify the differences between both. For example, if the drug product has a large viscosity, the drug product may stick more to the walls of the syringe, which is typically not the case with a low-viscosity liquid such as water. Additionally, the injection time between the water syringes and the drug syringes could be a significant difference in the auto-injectors, depending on the viscosity of the drug. Researchers should also try to avoid speaking about the potential benefits of the drug at great length in order to avoid the participants from having extremely high expectations. Also, researchers can increase the time between checking in with the participant to allow for them to actually observe the effects of the drug, rather than having their judgment affected by the placebo effect.
Blinding is a very useful method for researchers to minimize the placebo effect in clinical trials. In single blinding, participants do not know whether they are receiving the active treatment or a placebo. In double blinding, neither the participants nor the researchers know who is receiving which treatment. To reduce the placebo effect, I think double blinding is the best method because it eliminates bias in reporting and assessment. Randomization also helps, as it evenly distributes potential placebo effects across both the treatment and control groups. Using objective measures of outcomes, such as biomarkers or diagnostic tests, rather than relying solely on self-reported data, can further reduce the influence of the placebo effect.
This is a very interesting topic because controlling the placebo effect in clinical research is critical to the success and accuracy of a trial, especially in studies in which the patient's perception of pain can heavily influence the results. While there are several strategies used to minimize the impact of a placebo effect, one of the most widely used methods that has proven to be among the most effective is blinding. This method withholds information about treatment assignments from certain people, so that individuals own beliefs about the treatment don't influence the results. When using blinding in clinical research, there are two different methods, single-blind and double-blind studies. A single-blind study is when the patients are the only ones blind to the treatment. This can be useful when researchers need to oversee aspects of the treatment for further safety or technical reasons. On the other hand, a double-blind study is when neither the patients or researchers know who is receiving which treatment. This reduces biases from both patients and researchers that could inadvertently influence outcomes.
Aside from the different types of trials researchers can conduct to reduce the effects of a placebo effect, researchers sometimes manage patient's expectations by providing balanced information about the study's goals and potential outcomes. By carefully framing the treatment’s expected effects, they avoid creating unrealistic expectations that could amplify the placebo response. For example, a patient might be told by the researcher that the treatment may or may not improve their condition. This helps them to remain open to a range of outcomes which, in turn, reduces the potential for expectation-driven placebo responses. In summary, these methods, from blinding to setting expectation for the patients, are crucial for ensuring that the placebo effect does not skew the results of a clinical research study.
I have always been fascinated by the concept of placebo. The fact that it is possible for the brain to allow suffering of healing, based on itself, is almost mind boggling. There are attempts to minimize the effects of placebo, however, it cannot be fully eliminated. For example blinding, double blinding, and random assignments have been proven to be effective in minimize the effects of the minds of both the patients and researchers. However, as Dr. Simon alluded to, pain and emotion are subjective to each patient. These symptoms can be felt differently by each person, and based on how the person believes in the treatment they are receiving, the results will vary. This is the first of many effects that the patient's placebo has, despite the attempts to minimize it. Another example is that the patients can report pain differently based on their perception of what the treatment is doing and their hope for it to yield positive results. In order to avoid this, researchers and physicians can rely on data from tests, rather than self reporting.
I believe the placebo effect will vary a lot within the group of test patients who are have placebo treatment. This can be one sign because as said in the lecture, it really depends on the patients' expectancy and I believe it will not be consistent through out the study group. Another thing is the biological tests. I strongly believe that the placebo cannot result in the same statistics of biological response in the placebo group. This can be one of the key thing the researchers can count on to distinguish real effects of the drug versus the placebo effect.