Ethical issues of placebo

treatment

Researcher: Mehrasa Nikandish

Overview
• Introduction
• What is placebo effect?
• how does placebo effect
work?
• Is the use of placebo trials
ethical?
• Ethical issues of placebo
treatment
• PRACTICAL GUIDELINES
Introduction
 A placebo is anything that seems
to be a "real" medical treatment -
but isn't. It could be a pill, a shot,
or some other type of "fake"
treatment. What all placebos have
in common is that they do not
contain an active substance meant
to affect health.
 Researchers use placebos during
studies to help them understand
what effect a new drug or some
other treatment might have on a
particular condition.
 For instance, some people in a study might be
given a new drug to lower cholesterol. Others
would get a placebo. None of the people in the
study will know if they got the real treatment or
the placebo. Researchers then compare the effects
of the drug and the placebo on the people in the
study. That way, they can determine the
effectiveness of the new drug and check for side
effects.
What is placebo effect?

Sometimes a person can have a response to a placebo. The

response can be positive or negative. For instance, the person's
symptoms may improve. Or the person may have what appears
to be side effects from the treatment. These responses are
known as the "placebo effect."

• Depression
There are some conditions in • Pain
which a placebo can produce • Sleep disorders
results even when people know
• Irritable bowel
they are taking a placebo. Studies
syndrome
show that placebos can have an
effect on conditions such as: • Menopause
 How Does the Placebo Effect Work?

Research on the placebo effect has focused on the relationship

of mind and body. One of the most common theories is that the
placebo effect is due to a person's expectations. If a person
expects a pill to do something, then it's possible that the body's
own chemistry can cause effects similar to what
a medication might have caused.

Experts also say that there is a relationship between how

strongly a person expects to have results and whether or not
results occur. The stronger the feeling, the more likely it is that a
person will experience positive effects. There may be a profound
effect due to the interaction between a patient and healthcare
provider.
 Is the use of placebo trials ethical?
 The use of placebo is certainly
unethical
In life treating diseases(and the diseases
which not treating for the duration of the
study might result in irreversible morbidity)
and when an effective proved drug exists,
like a severe infectious disease, myocardial
infarction, pulmonary embolism (unless all
patients receive an efficient treatment and a
new drug or its placebo.
 The use of placebo is ethical
In severe diseases With no efficient drug-
a difference has to be made between an
established but untested drug and a well-
evaluated and efficient drug-in some
severe diseases even when an efficient
standard treatment is available and there
is no irreversible morbidity of placebo
treatment for the duration of the study and
in all moderate and functional diseases.
 Ethical issues of placebo treatment
 Much of the criticism of placebo
controls in clinical research, including
asthma research, has centered on the
contention that placebo controls are
not scientifically necessary. If true, this
is a powerful criticism, because any
clinical research trial without a sound
scientific rationale, whether or not it
included a placebo control, would be
unethical.
 There are, however, at least 5 sound
scientific reasons a placebo arm might
be used, and these are relevant to
controlled trials of asthma
medications.
 Ethical issues of placebo treatment

They are:
 (1) ensuring the scientific validity of the clinical trial (assay
sensitivity),
 (2) evaluating new therapies that are promising but less potent than
the gold standard,
 (3) minimizing the number of patients exposed to potentially
inefficacious or toxic therapy,
 (4) studying common clinical situations in which withdrawal of
therapy might be considered,
 (5) determining the true incidence of adverse events (side effects)
associated with therapy. 
 Ethical issues of placebo treatment
 The ethical problem with placebo
treatment is not that the patient is
receiving an ineffective medicine—the
placebo, as we have claimed, may be
quite effective, just as the standard
medication may prove, in any
particular case, to be useless or even
harmful; furthermore, the placebo will
usually have the advantage of
producing less undesirable side
effects.
 Therefore, the judicious use of the
placebo in a therapeutic context need
not entail automatically a violation of
the doctor’s obligation to heal.
 The ethical problem most frequently
raised regarding the administration
of the placebo is that the doctor is
deceiving the patient. The patient
wants effective treatment; instead he
receives a placebo. On these
grounds, some have maintained that
placebo treatment will always be
unethical, a violation of the patient’s
right to be honestly and fully
informed about treatment.
 PRACTICAL GUIDELINES

The following rules might serve the

physician as guidelines for the justified
use of placebo in clinical practice:

• The intentions of the physician must be
benevolent: her only concern the
wellbeing of the patient. No economical,
professional, or emotional interest
should interfere with her decision.
The placebo, when offered, must be
given in the spirit of assuaging the
patient’s suffering, and not merely
mollifying him, silencing him, or
otherwise failing to address his distress.
 PRACTICAL
GUIDELINES
When proven ineffective the placebo should be immediately
withdrawn. In these circumstances, not only is the placebo
useless, but it also undermines the subsequent effectiveness
of medication by undoing the patient’s conditioned
response and expectation of being helped.

The placebo cannot be given in place of another

medication that the physician reasonably expects to
The physician should not hesitate to
be more effective. Administration of placebo should
respond honestly when asked about
be considered when a patient is refractory to
the nature and anticipated effects of
standard treatment, suffers from its side effects, or
the placebo treatment he is offering.
is in a situation where standard treatment does not
exist.
PRACTICAL GUIDELINES

If the patient is helped by the

placebo, discontinuing the placebo,
in absence of a more effective
treatment, would be unethical.
Thanks for your attention