Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PHAR0002 > Clinical Trials, Placebo Effects, Complementary Medicine > Flashcards

Clinical Trials, Placebo Effects, Complementary Medicine Flashcards

1
Q

The placebo effect is particularly profound in clinical trials of which type of drug?

A

Anti-depressants

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What were the conclusions of the House of Commons Science and Technology Committee report on homeopathy in 2010?

A

That it is ‘scientifically implausible’

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What were the advantages in the randomised controlled trial with acupuncture vs. Usual care in treatment for chronic headaches?

A

In those who had received acupuncture:
- there was greater reduction in headache severity at 12 months
- fewer headache days per year
- improved quality of life
- less medication, fewer GP visits, fewer days off
- cost effective; less expensive than Sumatriptan

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What needs to be clearly defined in a clinical trial?

A

The objective needs to be clearly defined

Questions can be prioritised into primary & secondary objectives

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is the possible issue with complementary / alternative medicine?

A

Much of it is not evidence-based and doesn’t stand up to scrutiny

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is the placebo effect

A

Effect of a treatment arising from a patient’s expectations and response to the treatments, excluding the actual action of the treatment

*in medicine - the response observed after inert / inactive treatments

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is the nocebo effect?

A

People reporting adverse side effects after taking a placebo

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is the difference between ‘Superiority’ and ‘Non-inferiority’ in clinical trials?

A

Superiority - designed to show that one treatment is better than the other

Non-inferiority - designed to show that a new treatment is ‘not unacceptably worse’ than the current standard treatment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is the % of complementary medicine that is provided privately?

A

90%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is ‘Superiority’ in treatment comparison?

A

Used to demonstrate that one treatment is better than another

(Needed in placebo trials)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is ‘Non-inferiority’ (in treatment comparison)?

A

The non-inferior margin is the pre-determined margin of difference between new and standard treatments.

It represents how much worse the new treatment can be compared with standard treatment, and yet still be considered ‘similar’ or ‘not worse’ than standard treatment.

Used to evaluate other factors (i.e. cost / side effects)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What is homeopathy?

A

Applied the principle of ‘like cures like’

‘a form of complementary medicine in which ailments are treated by minute doses of natural substances that in larger amounts would produce symptoms of the ailment’

So a substance is highly diluted, effectively a sort of placebo

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What is ‘Equivalence’ (in treatment comparison) ?

A

Used to demonstrate that a treatment is the same - no better or worse, than an existing treatment

Also used to evaluate other factors (i.e. is it better in terms of side effects / cost?)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is considered the ‘gold standard’ for clinical trials?

A

Randomised clinical trials

I.e. randomly allocating treatment to different people / randomly allocating people to different treatment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is an open label clinical trial?

A

Both the clinical / patient know which arm / intervention they are receiving

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is a single blind clinical trial?

A

Patient is unaware of their treatment assignment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What is a randomised clinical trial?

A

Patients are randomly allocated to different arms / treatments in the trial

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What is a placebo controlled clinical trial?

A

Some patients get the ‘active’ therapy and some get a placebo

This has to be at least single-blinded as the patient cannot know whether they are receiving the active or placebo treatment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What is a parallel arm clinical trial?

A

Standard A vs. B
People are randomised
Comparison of 2 interventions / treatments

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What is a multi-arm, multi-stage clinical trial?

A

Enables an undergoing trial to stop or add arms as it continues recruitment, and to evaluate the efficacy of certain arms of the trial

(An arm of a clinical trial is a group of patients receiving a specific treatment, or no treatment)

21
Q

What is a factorial clinical trial?

A

Tests all combinations of 2 or more treatment regimens

E.g.
Testing A vs. B
then A with placebo / B with placebo

This can be done with fewer people

22
Q

What is a double blind clinical trial?

A

Neither the clinician / patient know whether they are receiving the active / placebo treatment

23
Q

What is a cross-over clinical trial?

A

Every patient has both treatments (i.e. A then B or B then A)

24
Q

What is a cluster randomised clinical trial?

A

Participants are randomised by unit (e.g. GP surgery, family, community)

25
Q

What is a clinical trial

A

Scientific investigation that examines and evaluates the SAFETY & EFFICACY of different therapies in HUMAN subject

26
Q

What 5 factors contribute to patients’ response to treatment?

A

Type of procedure
(E.g. it is perceived that surgery > injection > pill)

Previous experiences

Medicines
(E.g. perception that big-branded pills in high quantity > smaller pills in low quantity, colour of pills)

Presentation - by the doctor / advertisements etc.

Individual belief about the treatment

27
Q

What factors can help predict placebo responses?

A

Brain connectivity & structure

Psychological factors
E.g. emotional awareness, capabilities in describing inner experiences, greater openness to experience

28
Q

What example shows how evidence can change between clinical trials?

A

The use of Echinacea for the common cold

29
Q

What does PICO stand for in clinical trials?

A

P - population (patients)

I - intervention

C - comparison (control) group

O - outcome

(T - time)

In [population], what is the effect of [intervention] on [outcome] compared with [comparison group]?

30
Q

What causes the placebo response?

A

The psychological / emotional meaning that defines the response, which can also result in physiological changes

*Not the placebo itself as they are (generally) inert

31
Q

What are the 5 different types of clinical trials?

A
  1. Open label
  2. Placebo controlled
  3. Single blind
  4. Double blind
  5. Randomised
32
Q

What are the 5 different designs of clinical trials?

A
  1. Parallel arm
  2. Cluster randomised
  3. Cross-over
  4. Factorial
  5. Multi-arm, multi-stage
33
Q

What are the (stereotypical) profiles of those who use complementary / alternative medicines?

A

Those with anxiety, depression, long-standing illnesses
Those with poorer mental health and lower levels of perceived social support
More women than men
University educated / in active employment (possibly because it costs money)
Those who appear to pursue healthy lifestyles

34
Q

What are some of the reasons that people choose complementary / alternative medicine ?

A

To cure disease / treat symptoms if standard treatments aren’t working

Side effects of orthodox treatment

‘Holistic approach’

Feeling listened to - given more time & attention (linked to placebo effect)

Feel more in control

35
Q

What are examples of social factors related to Covid that may have influence the placebo effect in clinical trials?

A

High profile in the media
Urgency & societal need

—> could have made people more keen to participate / more worried about adverse effects

36
Q

What are examples of placebo interventions?

A

Inert pills, drugs, injections

Sham surgeries

Inactive medical devices

Non-effective / sham acupuncture

37
Q

What are complementary & alternative medicines?

A

Therapies not taught at medical school or practised within established institutions

38
Q

What % of GP practices offer complementary / alternative medicines?

A

50%

39
Q

Name 5 different types of medical intervention that require trialing

A
  1. Conventional medicine
  2. Complementary medicine
  3. Medical devices
  4. Surgery procedure
  5. Physiotherapy
40
Q

How many phases of clinical trials are there?

A

4

41
Q

How many (%) UK citizens use complementary medicine per year?

A

15-20%

42
Q

How many (%) UK citizens use complementary medicine in their lifetime?

A

50%

43
Q

Give 8 examples of complementary / alternative therapy

A
  1. Massage therapy
  2. Aromatherapy
  3. Acupuncture
  4. Osteopathy
  5. Herbal medicine
  6. Hypnotherapy
  7. Traditional Chinese medicine
  8. Nutritional therapy
44
Q

Describe phase 4 of clinical trials

A

Tends to be after a regulatory authority has approved the drug / treatment
Large-scale = 10,000s of individuals
Adverse event monitoring

45
Q

Describe phase 3 of clinical trials

A

Assesses the risks / benefits of the intervention
Compares the treatment with the current standard (i.e. whether it works / cost effectiveness)
Done in a larger sample of people - 100s-1000s

46
Q

Describe phase 2 of clinical trials

A

Investigates the activity, safety & tolerability of the drug
Carried out in people with the disease
Test group of ~ 80-100 individuals

47
Q

Describe phase 1 of clinical trials

A

Investigates pharmacology & drug safety
Usually done in healthy human volunteers (but sometimes in those with the disease)
Very small group (e.g. 10-20 people)
Very closely monitored

48
Q

Clinical trials need to be properly… (4)

A
  1. Designed
  2. Performed
  3. Analysed
  4. Interpreted
49
Q

Can the placebo effect significantly impact the outcome of clinical studies?

A

Yes

PHAR0002 (20 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions