TITLE: PLACEBO

NAME: ABIMANYU
ID:1923504
COURSE: BBA FIB A
 Contents
PLACEBO ........................................................................................................................................... 1
Definitions ............................................................................................................................................... 4
Effects ..................................................................................................................................................... 5
Factors influencing the power of the placebo effect: ............................................................................... 7
CONCERNS .......................................................................................................................................... 7
Symptoms and conditions ...................................................................................................................... 8
Pain ..................................................................................................................................................... 8
Depression .............................................................................................................................................. 9
Chronic fatigue syndrome ..................................................................................................................... 11
Negative effects .................................................................................................................................... 12
Placebos and clinical trials ..................................................................................................................... 13
The placebo effect does not imply an 'imaginary' .................................................................................. 15
illness ................................................................................................................................................ 15
The argument against placebos ......................................................................................................... 16
The ‘nocebo’ effect................................................................................................................................ 16

Figure 1 ................................................................................................................................................... 1
Figure 2 ................................................................................................................................................... 4
Figure 3 ................................................................................................................................................... 6
Figure 4 ................................................................................................................................................... 7

Table 1 12
Table 2 15
 PLACEBO
A placebo is an inert substance or treatment
which is not designed to have a therapeutic1
value. Common placebos include inert tablets
(like sugar pills), inert injections and other
procedures.
In drug testing and medical research (drugs and
research, 2019), a placebo can be made to
Commented [as1]: CONSTANT THERAPY
resemble an active medication or therapy so that
it functions as a control; this is to prevent the
recipient or others from knowing (with
their consent) whether a
treatment is active or inactive,
as expectations
about efficacy can influence
Figure 1 results. In a clinical trial any
change in the placebo arm is
known as the placebo response, and the
difference between this and the result of no
treatment is the placebo effect.

1
relating to the healing of disease.

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A placebo may be given to a person in a clinical
context in order to deceive the recipient into
thinking that it is an active treatment (heavy dose
supply, 2019). The use of placebos as treatment
in clinical medicine is ethically problematic as it
introduces deception and dishonesty into the
doctor–patient relationship.
Even though placebo effects were already
discussed in 18th century psychology, the role of
placebo effects in clinical settings has only been
recognized fully in the 20th century. An influential
1955 study entitled The Powerful Placebo finally
established the idea that placebo effects were
clinically important, and were a result of the
brain's role in physical health, but it did not
Commented [as2]:
account for regression to the mean or other Commented [as3]: TRYING TO DEVELOP FROM THE

factors, and reassessments of the data have LOW STAGE

found no evidence of any placebo

effect Subsequent research has found that
placebos have no impact on diseases; they can
only affect the person's perception of their own
condition. Improvements that patients
experience after being treated with a placebo can
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also be due to unrelated factors, such as a
natural recovery from the illness.
Your mind can be a powerful healing tool when
given the chance. The idea that your brain can
convince your body a fake treatment is the real
thing — the so-called placebo effect — and thus
stimulate healing has been around for
millennia2. Now science has found that under
the right circumstances, a placebo can be just
as effective as traditional treatments.
"The placebo effect is more than positive
thinking — believing a treatment or procedure
will work. It's about creating a stronger
connection between the brain and body and
how they work together," says Professor Ted
Kaptchuk of Harvard-affiliated Beth Israel
Deaconess Medical Center, whose research
focuses on the placebo effect. (harvard, 2019)
Placebos won't lower your cholesterol or shrink
a tumor. Instead, they work on symptoms
modulated by the brain, like the perception of
2
a period of a thousand years, especially when calculated from the traditional date of the birth of Christ.

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pain. "Placebos may make you feel better, but
they will not cure you," says Kaptchuk. "They
have been shown to be most effective for
conditions like pain management, stress-related
insomnia, and cancer treatment side effects like
fatigue and nausea."

Definitions
The word "placebo", Latin for "I will please", dates
back to a Latin translation of the Bible by St
Jerome. (historical data,
2019)
The American Society of
Pain Management
Nursing define a
Figure 2
placebo as "any sham
medication or procedure designed to be void of
any known therapeutic value".
In a clinical trial, a placebo response is the
measured response of subjects to a placebo;
the placebo effect is the difference between that

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response, and no treatment. It is also part of the
recorded response to any active medical
intervention.
Any measurable placebo effect is termed
either objective (e.g. lowered blood pressure)
or subjective (e.g. a lowered perception of pain).
Effects
Placebos can improve patient-reported
outcomes such as pain and nausea. This effect
is unpredictable and hard to measure, even in the
best conducted trials. For example, if used to
treat insomnia, placebos can cause patients to
perceive that they are sleeping better, but do not
improve objective measurements of sleep onset
latency. A 2001 Cochrane Collaboration meta-
analysis of the placebo effect looked at trials in 40
different medical conditions, and concluded the
only one where it had been shown to have a
significant effect was for pain (recovery option,
2019).
Measuring the extent of the placebo effect is
difficult due to confounding factors. By contrast,
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placebos do not appear to affect the
actual diseases. For example, a patient may feel
better after taking a placebo due to regression to
the mean (i.e. a natural recovery or change in
symptoms). It is harder still to tell the difference
between the placebo effect and the effects
of response bias, observer bias and other flaws
in trial methodology, as a trial comparing placebo
treatment and no treatment will not be a blinded
experiment. In their 2010 meta-analysis of the
placebo
effect, Asbjørn

Figure 3

Hróbjartsson and Peter C. Gøtzsche argue that

"even if there were no true effect of placebo, one
would expect to record differences between
placebo and no-treatment groups due to bias
associated with lack of blinding."
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Hróbjartsson and Gøtzsche concluded that their
study "did not find that placebo interventions have
important clinical effects in general.Jeremy
Howick has argued that combining so many
varied studies to produce a single average might
obscure that "some placebos for some things
could be quite effective." To demonstrate this, he
participated in a systematic review comparing
active treatments and placebos using a similar
method, which generated a clearly misleading
conclusion that there is "no difference between
treatment and placebo effects".

Factors influencing the power of the placebo

effect:
CONCERNS

A review published
in JAMA Psychiatry found
that, in trials of
antipsychotic medications,
Figure 4

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the change in response to receiving a placebo
had increased significantly between 1960 and
2013. The review's authors identified several
factors that could be responsible for this change,
including inflation of baseline scores and
enrollment of fewer severely ill patients. Another
analysis published in Pain in 2015 found that
placebo responses had increased considerably
in neuropathic pain clinical trials conducted in the
United States from 1990 to 2013. The
researchers suggested that this may be because
such trials have "increased in study size and
length" during this time period.
Children seem to have greater response
than adults to placebos.

Symptoms and conditions

A 2010 Cochrane review suggests that placebo
effects are only apparent in subjective,
continuous measures, and in the treatment of
pain and related conditions.
Pain
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Placebos are believed to be capable of altering a
person's perception of pain. "A person might
reinterpret a sharp pain as uncomfortable
tingling."
One way in which the magnitude of placebo
analgesia3 can be measured is by conducting
"open/hidden" studies, in which some patients
receive an analgesic and are informed that they
will be receiving it (open), while others are
administered the same drug without their
knowledge (hidden). Such studies have found
Commented [as4]:
that analgesics are considerably more effective
when the patient knows they are receiving them.

Depression
In 2008, a controversial meta-analysis led by
psychologist Irving Kirsch, analyzing data from
the FDA, concluded that 82% of the response to
antidepressants was accounted for by
placebos. However, there are serious doubts
about the used methods and the interpretation of
3
medication that acts to relieve pain

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the results, especially the use of 0.5 as cut-off
point for the effect-size A complete reanalysis
and recalculation based on the same FDA data
discovered that the Kirsch study suffered from
"important flaws in the calculations". The authors
concluded that although a large percentage of
the placebo response was due to expectancy,
this was not true for the active drug. Besides
confirming drug effectiveness, they found that the
drug effect was not related to depression
severity.
Another meta-analysis found that 79% of
depressed patients receiving placebo remained
well (for 12 weeks after an initial 6–8 weeks of
successful therapy) compared to 93% of those
receiving antidepressants. In the continuation
phase however, patients on placebo relapsed
significantly more often than patients on
antidepressants.

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Chronic fatigue syndrome
It was previously assumed that placebo
response rates in patients with chronic fatigue
syndrome (CFS) are unusually high, "at least
30% to 50%", because of the subjective reporting
Commented [as5]: CHANGES OCCURING DURING A
of symptoms and the fluctuating nature of the PERIOD OF TIME

condition. According to a meta-analysis and

contrary to conventional wisdom, the pooled
response rate in the placebo group was 19.6%,
even lower than in some other medical
conditions. The authors offer possible
explanations for this result (placebo drama,
2019): CFS is widely understood to be difficult to
treat, which could reduce expectations of
improvement. In context of evidence showing
placebos do not have powerful clinical effects
when compared to no treatment, a low rate of
spontaneous remission in CFS could contribute
to reduced improvement rates in the placebo
group. Intervention type also contributed to the
heterogeneity of the response. Low patient and
provider expectations regarding psychological

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treatment may explain particularly low placebo
responses to psychiatric treatments.
Table 1

Negative effects
A phenomenon opposite to the placebo effect
has also been observed. When an inactive
substance or treatment is administered to a
recipient who has an expectation of it having
a negative impact, this intervention is known as
a nocebo (Latin nocebo = "I shall
harm"). A nocebo effect occurs when the
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recipient of an inert substance reports a negative
effect or a worsening of symptoms, with the
outcome resulting not from the substance itself,
but from negative expectations about the
treatment.
Another negative consequence is that placebos
can cause side-effects associated with real
treatment.
Withdrawal symptoms can also occur after
placebo treatment. This was found, for example,
after the discontinuation of the Women's Health
Initiative study of hormone replacement
therapy for menopause4. Women had been on
placebo for an average of 5.7 years. Moderate or
severe withdrawal symptoms were reported by
4.8% of those on placebo compared to 21.3% of
those on hormone replacement.

Placebos and clinical trials

Placebos have been used in clinical trials for a
long time, and are an essential part of research
4
the ceasing of menstruation.

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into new treatments. They are used to help test
the effectiveness of a new health care
treatment, such as a medication. For ethical
(moral) reasons, people participating in clinical
trials are told that they may be given a 'dummy'
treatment.
Usually, one group of people takes the
medication while another group (control goup,
2019) takes the placebo. The placebo may be a
sugar pill. In some cases, none of the
participants know whether the (free mind,
2019)y are taking the active or inactive (placebo)
substance. Sometimes, not even the
researchers know (this is called a double-blind
test).
Comparing the results from both groups should
show the effects of the medication.
Around one third of people taking placebos for
health complaints (including pain, headache and
seasickness) will experience relief from
symptoms. To show that a new treatment is
more effective than can just be explained by the
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placebo effect, the results from the people taking
the new treatment are compared with the results
from the people taking a placebo.

The placebo effect does not imply an 'imaginary'

illness

If a person's symptoms are relieved by

taking a placebo or undergoing a ‘dummy
procedure’, it may seem logical to assume
that their illness must have been imaginary.
This is not the case. Table 2

Medical research
has shown that state
of mind plays an
important role in the
development of
disease. For
example, stress is
known to increase blood pressure (free
mind, 2019), which in turn is a risk factor for
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 heart disease. So, just as the mind can
contribute to a physical disorder, it can also
contribute to its cure.
The argument against placebos

Arguments against the use of placebos,

include:
 Placebos have the power to cause
unwanted side effects. Nausea, drowsiness
and allergic reactions, such as skin rashes,
have been reported as negative placebo
effects – also known as nocebo effects (see
below).
 Deceiving people is wrong, even if it helps
someone’s symptoms to go away.
The ‘nocebo’ effect

The nocebo effect is a negative effect (such

as pain or nausea) brought on by the
expectation of experiencing that negative
effect after taking a placebo. (pain and
caution, 2019)

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This expectation of negative effects from
placebo may be triggered when the patient
is told which adverse effects they might
experience before starting treatment.
CONCLUSION
In summary, it is often unclear in the clinical
setting as to what is a placebo intervention. This
does not apply to the intentional use of pure
placebos, but such interventions are infrequently
used (although the total number of such uses on
a population level still might be a cause for
concern). Pseudo-treatments, dispro
(methodlogy, 2019)ven or non-indicated
treatments are used much more frequently, but
whether they are considered placebos is often a
matter of perspective. What are summarized
under the term placebo effects are highly
heterogeneous phenomena related to the overall
context of healthcare interventions. (various
meassures, 2019) Calling context effects
associated with the application of active
interventions placebo effects leads to confusion
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and should be, in our opinion, avoided. We do
not know how large placebo effects actually are
in clinical practice, but the available evidence
suggests that, on average, they are often small.
Because of the professional ideal that all
treatments used should be specific in action and
used when only necessary (precise and safe,
2019), the use of placebo interventions is
problematic, while harnessing context effects is
clearly legitimate when the treatment is active.

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