Placebo Effect: Is it a Placebo?

eshuster's picture

With vast amounts of research and testing going on all over the world it is important to incorporate some method of control comparison. A placebo, a pharmacologically inert substance distributed in order to observe a medical effect or non at all.[1] A response to the placebo is known as the placebo effect. If a placebo is considered a blank, why are they used? In order to answer this question one must consider the amounts of various tests and experiments currently in progress. There are psychological, neural, social, physical and philosophical tests performed throughout the world. Not only do the types of tests make an impact on the experiment but the subjects themselves; they vary in environmental conditions, financial situation, personality, time and age. [5].With a placebo one can somehow attempt to group the variables because they are already being combined in the experimental group.

In order to create a point of relevance to the subjects being tested, a group of individuals are given a parallel yet false treatment/test. The placebo was first incorporated into testing procedures around 1920 in order to obtain a negative control. The placebo, however, did not always bring about a negative control. When researchers found changes in the placebo group they began to investigate what was occurring. This later led to the discovery of the placebo effect, a positive effect to a pharmacologically inert substance or suggestion. Research was performed to figure out why this change was occurring? How is this possible? Is this experimental error? Are there other factors that led to these results? Is the placebo necessary as a control? Can testing occur with a control group that is not deceived? Is this ethical?

Although several ethical questions have been raised, deceiving the patient and withholding proper treatment, the necessity for placebo groups are essential for proper testing. The placebo group, if no placebo response is observed, gives the researchers a point of reference to compare the experimental drug effects. [5]. If researchers were to control their experiments with a group who was not given any treatment, the subjects would realize they weren’t receiving treatment. This response hurts the experiment. Without a group that is receiving false treatment it would be difficult to tell whether the experimental group is benefiting from their treatment or whether the benefit is manifested. The placebo effect is a phenomenon that will be further explored to gain insight on its cause.

Although several benefits are obtained with a placebo group, ethics should not be ignored. In order to protect patients ethical standards were created by the Canadian Research Ethics Boards (REBS) [5] to insure that patients are not mistreated. Three ethical principles for human experimentation were created: 1-patients are to be respected, 2-researchers must maximize benefit while minimizing risks, and 3- the benefits and harms of research must be distributed equitably.[5]. In order to reduce extensive placebo testing, REB must approve a proposal for this testing and proof must be provided that no “clearly effective therapies” exist for this test. In addition, clear guidelines on the proper use of placeboes are provided by REB in their Code of ethical conduct. Although there are ethical issues, there is a need for placebo testing that can benefit the greater good.

Let’s think about what a placebo effect is and what other factors could elicit a false diagnosis of this effect. In a study of two drugs, a tranquilizer and a stimulant, subjects were given four tablets, both inert, two red and two blue. The subjects were to try the tablets and fill out a questionnaire as to identify the tablet. In the questionnaire, majority of subjects stated that the blue tablets were the tranquilizers and the red tablets were the stimulant [4]. The tablets were designed to elicit a color relation to the effects, which it did. A placebo effect was thereby observed because the subjects responded to the colors of the tablets and not to the pills. We can see this because of the blue/tranquil and red/hot color association.

Another experiment was performed in England where [835 women, who regularly used pain medicine for headaches, were assigned to four groups. One group received aspirin labeled with a common brand name, another group received the same aspirin with no brand name, the third group received a placebo with a brand name label and the last group received a placebo with no brand label. Among 435 headaches reported by group three, 64% improved within one hour of taking the medication while 45% of the 410 headaches improved in the first hour in the fourth group. The study demonstrated that the branded aspirin worked better than the aspirin with no brand and the placebo with a brand name worked better than the other placebo]. [3]. Placebos were present; however, there was no placebo effect because of the brand label effect observed.

Many factors can affect the placebo effect. For this reason, experiments must be performed with caution. In order to test two different groups (one with a drug and the other with a placebo) to look for differences, it is important to replicate the entire procedure perfectly. In order to study the placebo effect, one must study the psychology behind it because the placebo is inert and therefore it is not causing the observed effect. The researcher must express the same amount of emotion, emphasis, logic, body language and interest in both the experimental and placebo groups in order to obtain true experimental data and determine whether a placebo effect occurred. If there were problems with duplicating and repeating the experiment then how would the researcher know if their results and comparisons were accurate? They wouldn’t.

Several theories were discovered to learn the cause of the placebo effect. Many hypotheses exist including the following: the conditioning effect, cognitive theory, motivational/anxiety theory, and response appropriate sensation. The conditioning effect is similar to Pavlov’s dog experiment where a repeated stimulus that leads to a response can be associated with a similar effect if there a false but similar stimulus. [2]. An example of this effect occurs with individuals who commonly take Advil to eliminate headaches. With time and frequent use the individual will develop an association with the shape, color, and taste of the pill and therefore will experience the same effect with a placebo of the same physical appearance.

The cognitive theory is one that relies on expectation. Studies have found that instructions determine the effects of the treatment. For example, an individual is participating in a study of cognitive theory using amphetamine. The same individual could be given three different pills of the same amphetamine with three different instructions (stating different effects) and the individual will experience different effects from the same medication. This is a sympathomimetic effect. [2].

Motivational explanations and anxiety theories are also causes of the placebo effect. Motivational explanations are similar to the anxiety theory because they both occur because the individual desires the expected effect. The placebo calms the patient and reduces their anxiety because they feel like they are taking care of their condition/problem. They feel an effect because they want to feel this effect. [2].

The last cause of the placebo effect is called the response-appropriate sensation. This theory is a compilation of the above proposed theories. “[This theory] proposed that expectation-conditioning may represent a factor which determines the appropriate and behavioral repertoire with its associated sensation.”[2]. Although a bit confusing, this theory relies on the expectation of a response to occur because they desire it to occur and this response occurs from an association that already exists. The example in the Benedetti et al. paper discusses an injured soldier. His expectation of death induces a behavioral response for survival while the injury remains inhibited. The pain the soldier experiences seems to disappear when he is moved to a safe place where he will receive treatment. The soldier expects to die, which elicits his survival mechanism, and yet he is preconditioned to believe that at the safe place he will receive treatment and therefore feels no pain only relief because his expectations calm him.

There are several hypotheses as to why or how the Placebo effect works but it does exist and it is important to consider this phenomenon during experimental procedures. In order to create a reference point of the experiment (how would this experiment be without the medical factor?), repetition is necessary while duplicating the same procedures that were given to the experimental group, with the same emotions and emphasis on the experiment while excluding the medication. Also, there are definitely ethical issues that should be addressed when working with a placebo group, however, groups like REB exist to monitor and guide proper placebo use. We have discussed placebos, the placebo effect and the underlying cause of the effect in order to prove that this is a real phenomenon. The placebo effect is not caused by experimental error but without a placebo group the physical effects of consuming small tablets cannot be obtained. This step is one that increases the accuracy of the results. Without this group experiments don’t hold as much validity only a guess with the hope that a placebo effect does not occur.

Reference:

  1. Benedetti F, Mayberg H, Wager T, Stohler C, and J. Zubieta. Neurobiological Mechanisms of the Placebo Effect. The Journal of Neuroscience. 25(45):10390-10402. (2005).
  2. Benedetti F. and M. Amanzio. The neurobiology of Placebo Analgesia from Endogenous opiods to cholecystokinin. Progress in Neurobiology. 52(2): 109-125. (1997).
  3. Moerman D. and W. Jonas. Deconstructing the Placebo Effect and Finding the Meaning Response. Annual Intern. Med. 136:471-476.(2002).
  4. “Placebo Effect: Harnessing Your Mind’s Power to Heal” Mayo Clinic. Science Daily. http://www.sciencedaily.com/releases/2003/12/031231084101.htm (2003).
  5. Placebo Pro & Con. NCEHR Communique CNERH. http://www.ncehr-cnerh.org/english/communique2/Placebo.html. 8(2). (1998).

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eshuster's picture

Are you a Part of the Placebo Effect?

Like this class, we are given lessons but it is our imagination that sorts them. Ideas do nothing for us, mentally; it is what we manifest through them that brings insight to one’s mind. These thoughts are the placebo; they are intellectually inert and yet we believe in them making our reality more wrong. This class’ goal was/is to make us less wrong but how? It is by following the same pattern as conventional classes but telling in advance that we will be wrong. Through the standard method of learning we will always be wrong because we believe what the professor has told us without personally thinking it through. We do not use our brain but perfect our ability to regurgitate.

In this class, I learned I was wrong only after I discovered that the ideas presented to me were to guide me in my own mental journey to be less wrong. This class was about learning how to learn without believing what is presented. I know knowledge will always continue but I found out that the only way to learn the truth is by living the lie (one must participate in the study to learn they are a participant in the placebo group).

This paper demonstrates what a placebo effect is without personality. It is formatted in the same way an average class would be taught. This paper gives you, the reader, ideas of how society teaches people they are wrong, the placebo effect, so that you can learn from these thoughts without absorbing them. Everyone is part of the placebo group because everyone is wrong. It is through one’s personal continuous journey where questions unravel and loops are made that one can end where they first began but this time less wrong.

The ideas are the placebo, empty. They are pharmacologically and intellectually inert. The knowledge I obtained in this class was neither through lectures nor through the ideas presented to me but by questioning these ideas to prove to myself I was becoming less wrong. The only way to be more right is to question what is wrong. It is at the end of the study that the individuals find out they belonged to the placebo group and they realize they manifested the symptoms and effects they were told to expect. They had no medical treatment and yet they believed they were cured.

It is like a conventional high school class, students are presented with ideas and asked to regurgitate them create an illusion that the students are learning. It is like AP exams, the class is taught the material present on the AP exam so that the ideas can be regurgitated as a false sense of gaining knowledge. Isn’t this the same as a placebo effect? This paper unlike others begins by telling the reader to challenge oneself and question the ideas presented. It will give you the research of the placebo effect; however, you must answer the question, do you know you’re part of the placebo group?

THE PLACEBO EFFECT IS IT A PLACEBO?

With vast amounts of research and testing all over the world it is important to incorporate some method of control comparison. A placebo, a pharmacologically inert substance distributed in order to observe a medical effect or non at all.[1] A response to the placebo is known as the placebo effect. If a placebo is considered a blank, why are they used? In order to answer this question one must consider the amounts of various tests and experiments currently in progress. There are psychological, neural, social, physical and philosophical tests performed throughout the world. Not only do the types of tests make an impact on the experiment but the subjects themselves; they vary in environmental conditions, financial situation, personality, time and age. [5].With a placebo one can somehow attempt to group the variables as they are already pooled in the experimental group. In order to create a point of relevance to the subjects being tested, a group of individuals are given a parallel yet false treatment/test.

The placebo does not always bring about a negative control. When researchers found changes in the placebo group they began to investigate what occurred. This later led to the discovery of the placebo effect, a positive effect to a pharmacologically inert substance or suggestion. Research was performed to figure out why this change was occurring? How is this possible? Are there other factors that led to these results? Is the placebo necessary as a control? Can testing occur with a control group that is not deceived? Is this ethical?

Although several ethical questions have been raised, deceiving the patient and withholding proper treatment, the necessity for placebo groups are essential for proper testing. The placebo group, if no placebo response is observed, gives the researchers a point of reference to compare the experimental drug effects. [5]. If researchers were to control their experiments with a group who was not given any treatment, the subjects would realize they weren’t receiving treatment. This response hurts the experiment. Without a group that is receiving false treatment it would be difficult to tell whether the experimental group is benefiting from their treatment or whether the benefit is manifested. The placebo effect is a phenomenon that will be further explored to gain insight on its cause.

Although several benefits are obtained with a placebo group, ethics should not be ignored. In order to protect patients ethical standards were created by the Canadian Research Ethics Boards (REBS) [5] to insure that patients are not mistreated. Three ethical principles for human experimentation were created: 1-patients are to be respected, 2-researchers must maximize benefit while minimizing risks, and 3- the benefits and harms of research must be distributed equitably.[5].

In order to reduce extensive placebo testing, REB must approve a proposal for this testing and proof must be provided that no “clearly effective therapies” exist for this test. In addition, clear guidelines on the proper use of placeboes are provided by REB in their Code of ethical conduct. Although there are ethical issues, there is a need for placebo testing that can benefit the greater good.

Let’s think about what a placebo effect is and what other factors could elicit a false diagnosis of this effect. In a study of two drugs, a tranquilizer and a stimulant, subjects were given four tablets, both inert, two red and two blue. The subjects were to try the tablets and fill out a questionnaire as to identify the tablet. In the questionnaire, majority of subjects stated that the blue tablets were the tranquilizers and the red tablets were the stimulant [4]. The tablets were designed to elicit a color relation to the effects, which it did. A placebo effect was thereby observed because the subjects responded to the colors of the tablets and not to the pills. We can see this because of the blue/tranquil and red/hot color association.

Another experiment was performed in England where [835 women, who regularly used pain medicine for headaches, were assigned to four groups. One group received aspirin labeled with a common brand name, another group received the same aspirin with no brand name, the third group received a placebo with a brand name label and the last group received a placebo with no brand label. Among 435 headaches reported by group three, 64% improved within one hour of taking the medication while 45% of the 410 headaches improved in the first hour in the fourth group. The study demonstrated that the branded aspirin worked better than the aspirin with no brand and the placebo with a brand name worked better than the other placebo]. [3]. Placebos were present; however, there was no placebo effect because of the brand label effect observed.

Many factors can affect the placebo effect. For this reason, experiments must be performed with caution. In order to test two different groups (one with a drug and the other with a placebo) to look for differences, it is important to replicate the entire procedure perfectly. In order to study the placebo effect, one must study the psychology behind it because the placebo is inert and therefore it is not causing the observed effect. The researcher must express the same amount of emotion, emphasis, logic, body language and interest in both the experimental and placebo groups in order to obtain true experimental data and determine whether a placebo effect occurred. If there were problems with duplicating and repeating the experiment then how would the researcher know if their results and comparisons were accurate? They wouldn’t.

Several theories were discovered to learn the cause of the placebo effect. Many hypotheses exist including the following: the conditioning effect, cognitive theory, motivational/anxiety theory, and response appropriate sensation. The conditioning effect is similar to Pavlov’s dog experiment where a repeated stimulus that leads to a response can be associated with a similar effect if there a false but similar stimulus. [2]. An example of this effect occurs with individuals who commonly take Advil to eliminate headaches. With time and frequent use the individual will develop an association with the shape, color, and taste of the pill and therefore will experience the same effect with a placebo of the same physical appearance.

The cognitive theory is one that relies on expectation. Studies have found that instructions determine the effects of the treatment. For example, an individual is participating in a study of cognitive theory using amphetamine. The same individual could be given three different pills of the same amphetamine with three different instructions (stating different effects) and the individual will experience different effects from the same medication. This is a sympathomimetic effect. [2].

Motivational explanations and anxiety theories are also causes of the placebo effect. Motivational explanations are similar to the anxiety theory because they both occur because the individual desires the expected effect. The placebo calms the patient and reduces their anxiety because they feel like they are taking care of their condition/problem. They feel an effect because they want to feel this effect. [2].

The last cause of the placebo effect is called the response-appropriate sensation. This theory is a compilation of the above proposed theories. “[This theory] proposed that expectation-conditioning may represent a factor which determines the appropriate and behavioral repertoire with its associated sensation.”[2]. Although slightly confusing, this theory relies on the expectation of a response to occur because of a desire to occur from a previously established association that already exists.

The example in the Benedetti et al. paper discusses an injured soldier. His expectation of death induces a behavioral response for survival while the injury remains inhibited. The pain the soldier experiences seems to disappear when he is moved to a safe place where he will receive treatment. The soldier expects to die, which elicits his survival mechanism, and yet he is preconditioned to believe that at the safe place he will receive treatment and therefore feels no pain only relief because his expectations calm him.

There are several hypotheses as to why or how the Placebo effect works but it does exist and is important to consider experimental procedures. In order to create a reference point of the experiment (how would this experiment be without the medical factor?), repetition is necessary while duplicating the same procedures that were given to the experimental group, with the same emotions and emphasis on the experiment while excluding the medication.

Also, there are definitely ethical issues that should be addressed when working with a placebo group, however, groups like REB exist to monitor and guide proper placebo use. We have discussed placebos, the placebo effect and the underlying cause of the effect in order to prove that this is a real phenomenon. The placebo effect is not caused by experimental error but without a placebo group the physical effects of consuming small tablets cannot be obtained. This step is one that increases the accuracy of the results. Without this group experiments don’t hold as much validity only a guess with the hope that a placebo effect does not occur.

OVERALL

As the reader you have been exposed to background, cases, theories, ethics, and examples of the placebo effect. It is the reader’s personal journey through their lifetime while reading the facts/ideas of the placebo effect that will determine whether they are part of this effect. Society’s education system is one that plays on the principles of the placebo effect. Children are given ideas that influence their beliefs (given brain medicine to believe they are socially treated and educated) and taught to regurgitate. This logic, like the placebo effect, provided intellectually empty material to resemble the ability of one’s mind to think and discover without influence from society.

Have we learned anything or are we given the idea that through regurgitation we gain knowledge? It is only through one’s continual mental journey that one can embark on ideas and values that are individual and progressively less wrong. Think about the information presented about the placebo effect and how much regurgitation is actually present in today’s educational system. What do you think? Regurgitate?

THIS IS THE PLACEBO EFFECT, but don’t let this paper tell you what to think.

 

Reference:

  1. Benedetti F, Mayberg H, Wager T, Stohler C, and J. Zubieta. Neurobiological Mechanisms of the Placebo Effect. The Journal of Neuroscience. 25(45):10390-10402. (2005).
  2. Benedetti F. and M. Amanzio. The neurobiology of Placebo Analgesia from Endogenous opiods to cholecystokinin. Progress in Neurobiology. 52(2): 109-125. (1997).
  3. Moerman D. and W. Jonas. Deconstructing the Placebo Effect and Finding the Meaning Response. Annual Intern. Med. 136:471-476.(2002).
  4. “Placebo Effect: Harnessing Your Mind’s Power to Heal” Mayo Clinic. Science Daily. http://www.sciencedaily.com/releases/2003/12/031231084101.htm (2003).
  5. Placebo Pro & Con. NCEHR Communique CNERH. http://www.ncehr-cnerh.org/english/communique2/Placebo.html. 8(2). (1998).

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