HMM304 Week 4 Class 11: Placebo effects, complimentary medicine, and regulation

A set of flashcards covering placebo/placebo effects, nocebo, complementary medicines, and regulation (TGA, ARTG) along with basic drug discovery concepts mentioned in Week 4 Class 11 notes.

What is the purpose of using a placebo in a drug trial?

To compare the drug's effect against placebo rather than no treatment.

Define placebo as used in clinical trials.

An identical dosage form to the active treatment but without the active ingredient; delivered the same way; used as a control in blinded trials.

What is the placebo effect?

Improvements in symptoms due to beliefs or expectations about treatment, plus some physiological effects, even if the drug has no pharmacological action.

List key factors that influence the magnitude of the placebo effect.

Conditioning, verbal cues, emotions, expectations, learning, contextual cues, motivation.

How does the clinical setting influence placebo effects compared to home?

Clinical settings tend to elicit greater placebo effects than treatment at home.

How do dose number and invasiveness affect placebo response?

More doses and more invasive treatments (e.g., injections) are associated with stronger placebo effects.

Which types of diseases tend to show stronger placebo responses?

Diseases with strong psychological components or those influenced by brain activity.

How can tablet design influence placebo potency?

The design, color, and packaging of a tablet can affect patient perception and placebo potency; manufacturers exploit this.

Is the placebo effect completely eliminated if the patient knows it is a placebo?

No; some placebo effects remain even when caused to know it is a placebo.

What is the Nocebo effect?

Negative or unwanted effects triggered by a patient's expectations about a treatment, even if inert.

How are health claims for pharmaceutical drugs regulated in Australia?

Claims must be scientifically proven, typically demonstrated in large randomised double-blind placebo-controlled Phase III trials.

How are complementary medicines regulated in Australia?

A two-tier system: lower risk medicines are listed on ARTG (AUST L) and higher risk medicines are registered (AUST R).

What categories fall under 'complementary therapies'?

Herbs, vitamins, minerals, nutritional supplements, and homeopathic treatments, among other non-mainstream products.

When do complementary medicines undergo the same scrutiny as true medicines?

When they are deemed high risk or when properly tested and proven to be effective.

What triggers the Nocebo effect?

The psychology and expectations of the patient that lead to negative or worsened symptoms from an inert treatment.

Give historical examples illustrating placebo-like marketing.

Snake oil liniment and Perkins tractors advertisements marketed as cures despite lack of evidence.

What are complementary therapies according to the notes?

Treatments not part of consensus Western medical practice, which may or may not be evidence-based and can include placebos.

What is the difference between 'complementary' and 'alternative' therapies?

Complementary therapies are used alongside conventional medicine; alternative therapies are not part of standard practice and may be untested.

What does ARTG stand for?

Australian Register of Therapeutic Goods.

What do AUST L and AUST R denote in ARTG listings?

AUST L indicates listed medicines (lower risk); AUST R indicates registered medicines (higher risk).

What types of products are regulated by the TGA?

Medicines, including herbs, vitamins, minerals, nutritional supplements, and homeopathic treatments.

Why are some complementary medicines considered cost concerns?

They can be costly and may be subsidized by private insurance or taxpayer rebates, potentially delaying proven medicines.

What is the role of target validation in drug discovery?

To confirm that a biological target is involved in disease and can be modulated to achieve a therapeutic effect.

What is a lead compound in drug discovery?

A chemical with potential therapeutic activity that serves as the starting point for optimization.