Placebo effect-a modern phenomenon first introduced by Mark Twain in the 1950’s. He claimed: “”The power which a man’s imagination has over his body to heal it or make it sick is a force which none of us are born without. The first man had it; the last one will possess it.”1 Though the definition is ambiguous, it can be described as an elusive ‘treatment’ caused by the administering of treatment that has no intrinsic therapeutic value in the healing process. As a clinical phenomenon, it is distinguished as symbolising the interpersonal constituent of healing, discrete from spontaneous natural healing dependent on physiologically active pharmaceuticals or procedures. Over the years, the astounding advancements in medicine and effective procedures have enhanced the longevity of lives. Many researchers claim that part of this improvement stems from placebo effect, and many studies reveal that a degree of plasticity of the human brain.
My research in this area stems from an interest in the neurobiological implications of such studies with a desire towards understanding the psychological vs. physiological aspects of the brain-body relationship. In this paper, I will investigate the placebo effect while outlining the research done by researchers in the past. The placebo treatment is often utilised to test a myriad of new drugs or medication, and examine the effect it might have on a patient with a particular condition. For example, in a study with a group of people with the same disease, a test of the effectiveness of the new drug is carried out. In the group of people, some people will be given a placebo, and others will be given the new drug. The researchers who carry out this experiment then dictate how valuable the drug is, considering its side effects as well as effectiveness of the drug on the disease itself. The placebo effect is known as the response the patient has towards the placebo treatment.
The response is often unpredictable and unclear for every patient, it can vary from positive responses such as the reduction of symptoms in the patient or negative responses such as an exacerbation of the disease. Research illustrates the the treatment has also caused a plethora of symptoms such as depression, pain, sleep disorders, irritable bowel syndrome and menopause to certain patients. However, placebo treatments has increased the mental health of certain patients, allowing them to entertain a more positive mindset. Often, the latter can be hoped for but not predicted. A case study example of the placebo effect includes a study involving asthma.
In this study, people with asthma were given a placebo inhaler. They were given breathing tests whilst they were stationary and after they inhaled from the placebo inhaler, the results did not improve. However, when they were asked about how they felt, their response reported that the placebo inhaler imparted alleviation. Research into the placebo effect is still ongoing. It is said to focus on the ‘relationship of mind and body’. There are many theories formed regarding this effect as there is still no definite answer toward this unexplained phenomenon.
One of the most common theories of this effect is one’s presumptions of the effects of the treatment, if the patient believes certain effects will happen, then it is plausible that it can happen through the biochemical actions of the body. Although the placebo treatment is intriguing, it portrays an extremely complicated effect. In recent studies regarding this unexplained effect, a large amount of attention has been paid to neurobiological mechanisms, in order to completely develop an extensive theory for this treatment and its effect. There are studies which suggest that the placebo effect operates mainly by producing relief of illness, eg pain and fatigues, rather than by modifying the pathophysiology of disease as a hypothesis for the effects of this treatment. There are experimental research which can form evidence for the placebo effect theory, including randomised placebo- controlled clinical trials of drugs and procedures as well as laboratory investigations to evaluate the placebo effect. Significant improvement was shown in the results of randomised clinical trials involving patients in the placebo segment in comparison to their pretrial baseline. However, this experiment is limited since there is the possibility that the patient improved due to natural history of their condition or regression rather than the placebo treatment itself.
Therefore, as a conclusion for this type of experimental research, a placebo effect is unable to be demonstrated without a comparison with a placebo group with a no treatment control group, which is not usually considered in a randomised trial. Despite this, even when no treatment control groups are included, these randomised clinical trials still have particular restrictions when establishing the placebo effect. This is due to how these investigations are normally designed to evaluate treatment efficacy, the trialists tend to express more interest in minimising the placebo effects.
During these trials, the patients are told that they may either get a drug or a placebo masked to appear indistinguishable, creating a double- blind design. However, this fabricates a lower beneficial effect compared to when placebos are portrayed deceptively to be known as a beneficial treatment. In September 1992, a placebo controlled trial was carried out to evaluate the efficiency of the ursodeoxycholic acid for treatment of primary sclerosing cholangitis. To assess and analyse the efficiency of ursodeoxycholic acid for the treatment of primary sclerosing cholangitis, a stochastic, presumptive placebo controlled trial took place. It was done using a double-blind design technique, commonly used when assessing recently developed or newly discovered remedies. The experiment consisted of fourteen patients with primary sclerosing cholangitis documented by cholestatic serum enzyme pattern, liver histological appearance and endoscopic retrograde cholangiography.
After a randomised selection for patients involved to receive either the ursodeoxycholic acid or a placebo, six patients were presented with the ursodeoxycholic acid and eight were presented with a placebo. In the experiment, two patients were removed from the study due to the aggravation of the disease whilst the placebo treatment was carried out, and the other due to UDCA- related diarrhea. The results of the experiment after one year favoured the patients in the ursodeoxycholic acid group as most involved presumed. The patients in this group were in ameliorated situations during the year of treatment with respect to serum levels of bilirubin, alkaline phosphatase, y- glutamyltransferase, AST and ALT in comparison to the placebo group. However, not in respect to serum levels of hydrophobic bile acids. As analysed by multiparametric scores, histopathological features were also enhanced. Doctors involved concluded that ursodeoxycholic acid involved in the experiment is of benefits to patients with primary sclerosing cholangitis.
2- Ulrich Beuers M.D., Ulrich Spengler, Wolfgang Kruis, ülker Aydemir, Baldur Wiebecke, Walter Heldwein, Marlene Weinzierl, Gerd R.
Pape, Tilman Sauerbruch, Gustav Paumgartner- 1992 Prior to discussing the ethicality of the placebo treatment, it is equitable to discuss the theories of the said phenomenal theory in order to achieve a greater comprehension of the topic as a whole. How exactly do specialised individuals explain placebo effects on autonomic functions? Due to the vast amount of research accomplished, researchers have deduced three methods to explain this intricate yet unexplained discovery. The first explanation considers an individual’s lowering of blood pressure by pharmacological conditioning. This is when the repeated pairing of a treatment’s vehicle is involved as accompanied with its pharmacological effect which has potential to conduct to a conditioned effect of the identical classification, despite the fact the drug is substituted with another without pharmacological activity. Nonetheless, this particular mechanism is inapplicable to participants without the history of having taken a hypotensive drug. The second feasible interpretation presents a more typical approach of justifying the placebo treatment.
This examines the participants expectation of the hypotensive drug effect, which inclines the patient’s brain-body relationship to cooperate, resulting in the placebo effect. Kirsch 3- Kirsch I. 1999 was amongst the earliest to prioritise the role of expectancy as a cognitive mediating variable for placebo effects. It was assumed that verbal suggestions, for instance ‘this pill will lower your blood pressure’ coinciding with drug administration would express information about a non-volitional response. Kirsch used ‘response expectancies’ to exhibit the existence of non-volitional responses.
He presented a thesis suggesting humans could be ‘hard-wired in such a way that expecting a subjective experience produces that experience, in the same way that deciding to emit a voluntary act (eg lifting one’s arm) produced that act’ 3. Therefore, the expectancy theory maintains a sentiently attainable symbolism of the repercussion. That is, the expectation can be triggered consciously when directed with attention 4- Kirsch I. 2001. The more modern, newly discovered theory of the placebo effect was recently presented by Frenkel.
5- Frenkel O. 2008. An accomplished philosopher by the name Maurice Merleau- Ponty one affirmed that ‘the understanding of the world that informs skilful, unreflective actions is not the same as, nor can it be reduced to, the understanding of the world that informs my reflective or cognitive acts’. Frenkel states that when there is a lack of prior bodily engagement in an activity, accompanied with the lack of lived experience, it is then impossible to represent it. As stated by this argument, a cognizant depiction of the result should not be required for prompting a physiological placebo response.
A patient necessitates the perception in which his/her response is relevant to the circumstance and verbal suggestion provided. Consequently, the degree of the companionship between the knowledge and affordance of the situation will determine the practical importance afforded by a placebo 5. Affordances have been described as all ‘action possibilities’ latent in the environment. 6- Gibson J.
J. 1977.To speak in more specific terms, in relation to the case of our patient, the verbal proposition of a hypotensive drug effect could have caused the activation of association regions that accumulate memories of bodily and/or mental activities which typically induce alterations in blood pressure. This is reasonable as most of the world’s population have, to an extent, general knowledge regarding the connection between intensified bodily and/ or mental activity and increased blood pressure. In this case, consuming the pill may have resulted in associating the lowering of blood pressure with a condition of reduced bodily or mental activity. For that reason, with the lack of an explicit understanding of blood pressure regulation or expectation of the how the drop of blood pressure should feel, it is possible for the patient to respond in the appropriate bodily way. Based on this opinion, the placebo effects are the outcome of the implicit affordance of the treatment situation to react in a particular manner. The word ‘implicit’ is reference to how the patient is not ordered to reduce the level of his/her blood pressure through cognitive means.
With significant distinction to the conditioning hypothesis which necessitates drug exposure beforehand, as well as the expectancy model which builds upon awareness of the accessible representations of the result, this affordance model can include physiological placebo effects in a parsimonious way to a greater extent, unaccompanied by the strain of bridging the gap between a conscious expectation and a non-volitional response, for instance the example used previously- the drop in blood pressure. 5 During the discussion of ethicality referring to the placebo treatment, we must appraise the essential ethical conditions when a placebo treatment is being contemplated over. A crucial ethical condition regarding a randomised clinical trial comparing two treatments with the intention to cure a disease includes how there should not be a valid justification as to assume one treatment is of better quality in comparison to the other. 7- Angell M and 8- Freedman B Typically, doctors carrying out the treatment yearn or expect a particular drug to be more effective than the other, despite this, it is only considered unethical to most if there is no cogent evidence one way or the other. However, if there is verification as to a certain drug consisting of more benefits, in addition to the trial being scientifically redundant, the doctors would have to plead guilty in providing inferior treatment to certain partakers in the investigation.
This expected behaviour for the doctors to perpetually be in this state of equipoise 9- Helsinki IV 1989 is also relevant to placebo- controlled trials.