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The Placebo Effect

Discussing the ethics behind the contradictory placebo effect.
by

Kana Thompson

on 18 May 2014

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Transcript of The Placebo Effect

Related to Nursing
We as nurses must uphold patient autonomy.
We need to know what patient education to provide.
At any point, they are allowed to withdraw.
Properly educate when there is a possibility to be given a placebo.
As researchers, we need to know how to ethically conduct PCTs
Impact
Dr. Benedetti + Chronic Pain
Morphine every other day, slip in placebo in the other days.
Gradual replacement
Up to 50% reduction

Opens up hope to a future where 100% placebo can replace medicine.

Background
General use of placebos date back to 16th century
The first placebo-controlled trial was probably conducted in 1931
Sanocrysin vs dH2O for treatment of TB
PCTs have been controversial since then.
Especially randomly assigned patients
The Ethics Behind
Population
Background
Through time, placebos have been:
Attacked because:
They are deceptive
There are non-deceptive means to still achieve positive placebo response
Defended on the grounds that:
The deception is illusory
Defended beneficent intentions of the physician justify the deception.
Causes harm to patients in studies by utilizing no interventions when an effective standard treatment.
Focus beyond physical harm
Psychological and social harm should not be dismissed
If ignored, can escalate to suicidal ideation and beyond.
The Placebo Effect
Ethical Significance
In the field of mental health nursing, we see controversial usage of placebos.
Prevalence:
Can be seen in clinical trials, research projects, etc., as the "placebo" or "control" groups.
MDs rumors
Types of Placebos
Pure
No pharmacological effect
Sugar pills
Impure
Pharmacological effect but not on the condition being treated
eg. Antibiotics or vitamins in viral infections
Christina Bedolla-Reyes & Kana Thompson

(Miller, 2000)
(Cadesky, 2001)
http://www.medscape.com/viewarticle/743241
(Abumrad, 2007)
The Ethics of Placebo-Controlled Trials –
A Middle Ground
Are Placebo-Controlled Studies Ethical in Psychiatric Research?
Summary of Articles
Conclusion
Use of Placebo
33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention

and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.


Declaration of Helsinki
A statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data, created by the World Medical Association.
What is the
Declaration of Helsinki?
Strengths
Limitations
Placebos
can
be ethical
Can provide valuable information to researchers & patients
Principles underlying ethical assessment
autonomy
beneficence
paternalism
nonmaleficence
Ethical/scientific benefits of placebo
Proper and ethical use of placebos in research
References
Strengths
Limitations
Strengths
Limitations
Solid definitions of ethical principles
Presents argument/support of both ethical and scientific arguments
Presents solution to unethical studies
"The ethical and scientifically sound placebo-controlled study"
"The ethical and scientifically sound placebo-controlled study"
Patients & families educated before any decisions made
Subjects only if agree to participate
Consent forms blunt & straightforward
Inform patient about disorder, all treatments, risks and benefits from each choice
Placebos never administered without telling subject first that they may be administered one
Not informing violates right to make informed decisions
With psych disorders associated with "perceived loss of control", give more control
Choose whether to take risk of known treatment, one that is potentially better/worse, or nothing.
Researchers should not be involved in subject's clinical treatment
Active placebos only given to subject(s) prepared to experience side effects.
Three-arm trials are ideal
Eric Cadesky, Hons. B.Sc.

Inclusion of author's opinions.
Potentially biased
Tried to make suggestions for topics with inconclusive past studies.
Mentions of psychiatric disorders limited to schizophrenia & depression
New England Journal of Medicine
Ezekiel J Emanuel, M.D., Ph.D. and Franklin G. Miller, Ph.D.
National Institutes of Health
Thank you!
A review article from September, 20,2001
Summarizes the two schools of thoughts behind the ethics of placebo usage.
Placebo Orthodoxy
"Advocates of placebo-controlled studies argue that it is ethical to conduct such trials even in the case of medical conditions for which there are interventions known to be effective, because of the methodological limitations of trials in which active treatment is used as the control. Sometimes therapies that are known to be effective are no better than placebo in particular populations unpredictable and small effects, and high rates of spontaneous improvement in patients".(Emanuel and Miller, 2001)
Active-Control Orthodoxy
"Proponents of active controls contend that whenever an effective intervention for a condition exists, it must be used in the control group. Furthermore, they argue that placebo controls are inappropriate because the clinically relevant question is not whether a new drug is better than nothing but whether it is better than standard treatments". (Emanuel and Miller, 2001)
Suggest a Middle Ground where both schools of thought meet
"We propose a middle ground in which placebo-controlled trials are permitted but only when the methodological reason for their use are compelling, a strict ethical evaluation has made it clear that patient who receive placebo will not be subject to serious harm, and provisions have been made to minimize the risks associated with receipt of placebo.
Placebos-controlled trials, internal validity, minimizing harm, and informed consent are all vital
Suggest the need to focus on methodological criteria
A strength of this article is an unbiased presentation of two schools of thought
Proposes problems with each school of thought.
The authors propose a new way of approaching this controversial topic
States psychical pain is the most focused on harm, and acknowledges that psychological and social harm needs to be addressed
Abumrad, J. (2007).
Placebo
[Radio series episode].


Brody, H.
The Lie That Heals: The Ethics of Giving


Cadesky, E. Are Placebo-Controlled Studies Ethical in


Declaration of Helsinki - Ethical Principles for '




Emanuel, E. J., & Miller, F. G.
The Ethics of Placebo-


Melamed, Y.
Ethical and Scientific Perspectives of


Miller, F. G.
Placebo-controlled trials in psychiatric
Focuses on chronic stable angina versus other medical conditions
Focuses on physical harm, versus other types of harm
Proposed middle group leaves room for interpretation
Ethics behind placebo usage remains controversial, however has been studied more in depth in regards to patient care
The debate for Scientific Validity remains prevalent
Declaration of Helsinki must be followed if conducting a PCT
Most importantly, if conducting a PCT, informed consent must be received, along with patient education
Placebos can be utilized well
Benefit research and individuals
Different approaches exist
scientific vs. ethical
placebo vs. active control orthodoxy
Schizophrenia has no known cure, PCT are still needed
ensure patient mental status before obtaining consent
Possible to design studies while remaining ethical and still maintain scientific validity.
(Brody, 1982)
("Declaration of Helsinki," 2013)
("Declaration of Helsinki," 2013)
Potential:
Anyone prescribed medications by MDs
Focus:
Participants of Placebo-controlled trials.


In RadioLab. New York City: Jad Abumrad and Robert Krulwich.

Placebos
. Annals of Internal Medicine, 97, 112-118.

in Psychiatric Research?. McGill Journal of Medicine, 6, 56-59.

Medical Research Involving Human Subjects
. (2013, October 1). Retrieved May 5, 2014, from http://www.wma.net/en/30publications/10policies/b3/

Controlled Trials - A Middle Ground
. Sounding Board, 345, 915-919.

Placebo-controlled Trials in Schizophrenia
. Journal of Clinical Medicine Research, 1, 132-136.

research: an ethical perspective
. Biological Psychiatry, 707-716.

McGill University
McGill Journal of Medicine
Ethical and Scientific Perspectives of Placebo-controlled Trials in Schizophrenia
Yueal Melamed, Adiel Doron, Orit Sein-Reisner, and Avi Bleich
Address the Declaration of Helsinki
Details on Informed Consent for a Psychiatric patient
States the Question for PCT
Details the smaller sample size associated with PCT
Supports PCT in Schizophrenia
The difficulty of Placebo usage in Schizophrenia Trials
Stresses importance of follow-up with participants
Details arguments for and against PCT
Highlights the importance of Psychiatrists in PCT
States to train staff well in Ethical Practices
Focuses on acceptance of PCT
Minimal arguments for harm caused to the Placebo-control group
Full transcript