Herbal & Homeopathic Medicines Quiz

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Questions and Answers

What is required for a herbal medicine making a medicinal claim in the UK?

  • It must contain no more than 5 ingredients.
  • It must be registered as a traditional herbal medicine or licensed with marketing authorization. (correct)
  • It must be devoid of traditional use evidence.
  • It must be sold as a dietary supplement only.

Which directive was passed to regulate the use of herbal medicines within the EU?

  • Traditional Herbal Medicinal Products Directive (THMPD)
  • Directive 2004/24/EC (correct)
  • Directive 2006/123/EC
  • Directive 2000/83/EC

What is the minimum duration of evidence required for traditional use of herbal medicines in the EU?

  • A decade or longer of therapeutic success.
  • 5 years of evidence.
  • 30 years of evidence in the EU or 15 years both in the EU and outside. (correct)
  • 15 years of evidence within the EU.

What can unregistered herbal products be marketed as in the UK?

<p>Dietary supplements. (A)</p> Signup and view all the answers

Which of the following statements about herbal medicines regulation is true?

<p>Herbal medicines can be sold without meeting standards if they are safe for consumption. (C)</p> Signup and view all the answers

What percentage of participants did not inform their doctor about their use of herbal medicines?

<p>69% (D)</p> Signup and view all the answers

Which of the following herbal medicines is known for its anti-emetic properties?

<p>Cardamom (D)</p> Signup and view all the answers

What could be a potential interaction when taking St John's Wort with citalopram?

<p>Risk of serotonin syndrome (D)</p> Signup and view all the answers

Which herbal medicine is highlighted for its anticoagulant effect?

<p>Turmeric (B)</p> Signup and view all the answers

What risk is associated with combining garlic and aspirin?

<p>Increased risk of bleeding (C)</p> Signup and view all the answers

Which herbal medicine could decrease the effectiveness of amlodipine?

<p>St John's Wort (C)</p> Signup and view all the answers

What potential effect occurs when herbal medicines and ciclosporin are taken together?

<p>Marked reductions in ciclosporin blood levels (D)</p> Signup and view all the answers

Which of the following herbal products is known for enhancing physical stamina?

<p>Ginseng (C)</p> Signup and view all the answers

What is a disadvantage of herbal medicines?

<p>They have variable dosing not standardized in formulations. (D)</p> Signup and view all the answers

Which statement accurately reflects conventional medicines compared to herbal medicines?

<p>Conventional medicines are regulated and have product licenses. (D)</p> Signup and view all the answers

Which herbal medicine is noted for potentially decreasing the effectiveness of warfarin?

<p>American ginseng (A)</p> Signup and view all the answers

In which decade did the regulation of herbal medicines in the UK begin requiring a product license for medicinal claims?

<p>1970s (A)</p> Signup and view all the answers

What is a common misconception about herbal medicines?

<p>All herbal medicines are safe due to their natural origin. (B)</p> Signup and view all the answers

What is a key characteristic of herbal medicines compared to conventional medicines?

<p>Herbal medicines are often based on long-standing traditional use. (D)</p> Signup and view all the answers

What is the primary purpose of Ayurvedic medicine?

<p>To restore balance in doshas through lifestyle changes (D)</p> Signup and view all the answers

Under the Medicines Act 1968, what allowed a herbal remedy to be exempt from licensing?

<p>If it only contained a single herb without medicinal claims. (B)</p> Signup and view all the answers

What is a misconception regarding the cost of herbal medicines?

<p>Herbal medicines can sometimes be cheaper than conventional medicines. (B)</p> Signup and view all the answers

Which of the following best describes the term 'dosha' in Ayurveda?

<p>A person's life forces influencing health and personality (B)</p> Signup and view all the answers

Which elements correspond to the dosha 'pitta'?

<p>Fire and water (D)</p> Signup and view all the answers

What does the Traditional Herbal Registration Scheme (THR) relate to?

<p>The manufacturing and supply of complementary medicines (A)</p> Signup and view all the answers

Which of the following is NOT a type of therapy included in Complementary and Alternative Medicines (CAM)?

<p>Psychotherapy (A)</p> Signup and view all the answers

How many main doshas are recognized in Ayurvedic medicine?

<p>Three (B)</p> Signup and view all the answers

Which statement accurately represents Ayurveda's approach to health?

<p>It emphasizes a holistic approach considering both body and mind. (C)</p> Signup and view all the answers

Which two elements are combined in the dosha 'kapha'?

<p>Water and earth (A)</p> Signup and view all the answers

Which principle of homeopathy suggests that substances causing symptoms in healthy individuals can be used to treat illnesses?

<p>Law of similar (B)</p> Signup and view all the answers

What is the significance of succussion in the preparation of homeopathic medicines?

<p>It ensures the remedy retains properties of the mother tincture (B)</p> Signup and view all the answers

Which of the following is NOT a source material used in the preparation of homeopathic medicines?

<p>Toxic substances (C)</p> Signup and view all the answers

What method is employed to create potentisation in homeopathic medicine manufacturing?

<p>Serial dilution and succussion (A)</p> Signup and view all the answers

Which of the following preparations is NOT a form of homeopathic medicine?

<p>Chemotherapy drugs (B)</p> Signup and view all the answers

What is typically recommended regarding food intake when administering homeopathic medicines?

<p>A 30-minute gap between food and medication is preferable (A)</p> Signup and view all the answers

Which homeopathic preparation is made from an extraction of fresh, raw plant material?

<p>Mother tincture (A)</p> Signup and view all the answers

Which glass container characteristic is preferred for the storage of homeopathic medicines?

<p>Non-reactive to avoid interactions (C)</p> Signup and view all the answers

What is one of the main disadvantages of homeopathic medicines?

<p>Lack of clinical evidence to prove efficacy (D)</p> Signup and view all the answers

How are homeopathic medicines different from herbal medicines?

<p>Homeopathic medicines use an additional dilution process. (A)</p> Signup and view all the answers

What does the National Rules Scheme (NRS) allow for homeopathic medicines?

<p>Indications for mild, self-limiting conditions. (C)</p> Signup and view all the answers

Which organization’s directive regulates homeopathic medicines in the EU?

<p>European Medicines Agency (EMA) (A)</p> Signup and view all the answers

What is the first dilution required for products to be registered under the Simplified Registration Scheme?

<p>1 in 10,000 dilution (A)</p> Signup and view all the answers

What is a key belief held by homeopaths regarding the potency of their medicines?

<p>The more dilute, the more potent the effect. (A)</p> Signup and view all the answers

What must applications under the National Rules Scheme include?

<p>Dossier of data on quality, safety, efficacy, and labeling. (D)</p> Signup and view all the answers

What does the Product License of Right (PLR) mainly grant?

<p>Permission to market products with therapeutic claims. (B)</p> Signup and view all the answers

Under which regulations must homeopathic medicinal products comply for registration?

<p>Human Medicines Regulation 2012 (A)</p> Signup and view all the answers

Why should NHS doctors avoid referring patients to homeopaths?

<p>There is insufficient evidence to support therapeutic claims. (B)</p> Signup and view all the answers

Flashcards

Ayurveda

A system of medicine that originated in India over 5,000 years ago. Balances the five elements (space, air, fire, water, earth) within the body.

Doshas in Ayurveda

The life forces or energy patterns in Ayurveda. They influence our health and personality.

Vata, Pitta, and Kapha

Ayurveda's three main doshas: Vata, Pitta, and Kapha. Each represents a combination of two elements and controls specific functions.

Vata (Air & Space) Dosha in Ayurveda

Controls movement, such as blood circulation, waste management, and breathing. A combination of air and space elements.

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Pitta (Fire & Water) Dosha in Ayurveda

Controls transformation processes like digestion and metabolism. Combined elements are fire and water.

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Kapha (Water & Earth) Dosha in Ayurveda

Controls lubrication aspects like joints and lungs. Made up of water and earth elements.

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Dosha Imbalance in Ayurveda

An imbalance in any of the three doshas can lead to illness. Lifestyle, nutrition, and natural treatments help restore balance.

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Restoring Balance in Ayurveda

Ayurveda suggests that lifestyle changes, nutrition, and natural treatments can help restore balance within the body.

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What are herbal medicines?

A group of plants and their parts used for medicinal purposes.

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What are the types of effects herbal medicines can have?

Herbal medicines can have a range of pharmacological effects, like easing anxiety, regulating blood sugar, or reducing inflammation.

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What are the potential risks of combining herbal medicines with conventional medications?

Herbal medicines can interact with conventional medications, potentially leading to increased risks or decreased effectiveness.

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Why should you be cautious about combining blood thinners with garlic, ginger, or turmeric?

Taking garlic, ginger, or turmeric alongside blood thinners like aspirin or warfarin can increase the risk of bleeding.

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What medications can be affected by St. John's wort?

St. John's wort can reduce the effectiveness of medications like ciclosporin, amlodipine, citalopram, and digoxin.

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What is the potential risk of combining St. John's wort with citalopram?

Taking St. John's wort with citalopram can increase the risk of serotonin syndrome, a serious condition.

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Why does the manufacturer of digoxin advise against using St. John's wort?

The manufacturer of digoxin advises against using St. John's wort because it can decrease the concentration of digoxin in the body.

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What's the most important thing to remember about using herbal medicines?

Always inform your healthcare providers about any herbal medicines you are using to ensure safety and effectiveness.

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Herbal Medicines in Food or Cosmetics

Herbal medicines sold in the UK as food or cosmetics don't need to comply with medicines legislation.

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Medicinal Claim for HM

HM making a medicinal claim needs a Traditional Herbal Medicine Registration (THR) or a Marketing Authorisation (MA).

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Unregistered HM Products

Products without THR or MA can't make therapeutic claims but can be sold as dietary supplements.

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THMPD (Traditional Herbal Medicinal Products Directive)

A directive from the European Parliament and Council of Europe to regulate the use of HMs in Europe.

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HM Marketing Before 2004

Before 2004, HMs could be marketed without a Marketing Authorization (MA) if they met certain quality and safety standards.

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Drug Interactions with Herbal Medicines

Herbal medicines may interact with conventional medications, potentially causing adverse effects. For example, garlic can increase the risk of bleeding when taken with antiplatelet drugs.

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Herbal Medicines: Natural ≠ Safe

Herbal medicines are often marketed as natural and safe, but this doesn't mean they're always harmless. Like conventional medicines, they can have side effects and interact with other substances.

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Regulation of Herbal Medicines

Herbal remedies are often poorly regulated, making their quality and consistency uncertain. This makes it difficult to determine the exact dose or effects of a specific product.

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Advantages of Herbal Medicines

Herbal medicines offer a potential alternative to conventional treatments, particularly for preventative and chronic conditions.

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Herbal vs. Conventional: Source

Herbal medicines are derived from natural sources like plants, while conventional medicines are synthesized in laboratories.

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Herbal vs. Conventional: Evidence Base

Herbal remedies are often based on traditional practices with limited scientific evidence, while conventional medicines rely on rigorous research and clinical trials.

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Herbal vs. Conventional: Cost

Herbal medicines may be less expensive than conventional medications, making them accessible for some individuals.

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Herbal vs. Conventional: System

Herbal medicines are often considered an "alternative" to conventional treatments, while conventional medicines are considered "orthodox" medicine.

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What is Homeopathy?

A system of medicine that uses highly diluted substances, often in a very small dose, to stimulate the body's natural healing response.

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What is the Law of Similars?

The belief that substances causing symptoms in healthy people can be used to treat similar symptoms in ill people.

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What is the principle of Minimal Dose?

The principle that diluting substances to almost imperceptible levels actually increases their therapeutic potency, making them safer and more effective.

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What is Potentisation?

The process of sequentially diluting a substance with alcohol and water, followed by vigorous shaking, to maximize its medicinal potency.

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What is a Mother Tincture?

The starting point for the dilution process in homeopathy, created by extracting the medicinal substance with mixtures of alcohol and water.

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What is the Principle of Single Medicine?

Homeopathy uses only one remedy at a time for a particular condition.

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What is Succussion?

The process of vigorously shaking a diluted substance to retain and enhance its properties for therapeutic use.

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What is the Holistic Approach in Homeopathy?

The idea that homeopathic treatments address the individual as a whole, taking into account their unique physical, mental, and emotional characteristics.

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Distinguish homeopathy from herbal medicines.

Homeopathic medicines are often mistaken for herbal medicines. While herbal medicines use plant extracts, homeopathic medicines are prepared by serial dilution and succussion (shaking).

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How are homeopathic medicines prepared?

Homeopathic preparations involve serial dilutions, meaning the concentration of the original substance decreases with each dilution. Homeopaths believe the more diluted a substance becomes, the more potent its effect. However, this concept is not supported by scientific evidence.

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Is there scientific evidence for homeopathy?

Homeopathy lacks strong scientific evidence to support its effectiveness. Trials have shown its effects to be comparable to a placebo effect, meaning the perceived benefits are due to the expectation of improvement rather than an actual therapeutic effect.

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How are homeopathic medicines regulated in the UK?

Homeopathic medicines are registered under the UK's Medicines Act 1968, with specific regulations governing their production and marketing.

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What is the Simplified Registration Scheme (SRS)?

The Simplified Registration Scheme (SRS) for homeopathic medicines focuses on ensuring product safety and quality. Products must be diluted to a specific level, ensuring safety, but they cannot make claims that are medicinal in nature.

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What is the National Rules Scheme (NRS)?

The National Rules Scheme (NRS) allows for the registration of homeopathic products with indications for mild conditions. However, products cannot be registered for serious conditions. Registration requires thorough documentation, including data on quality, safety, and efficacy.

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What regulations govern the registration of homeopathic products?

The Human Medicines Regulation 2012 sets out the conditions for registering homeopathic products in the UK, including application requirements, fees, and information to be provided.

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How are homeopathic products classified?

Homeopathic products are classified based on their intended use and potential risks. This classification helps determine the appropriate regulation and marketing requirements of the product.

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Study Notes

Herbal & Homeopathic Medicines

  • Herbal and homeopathic medicines are used alongside conventional medicine
  • Current legislation and professional issues concerning the manufacturing and supply of complementary and alternative medicines (CAM) are important - including Traditional Herbal Registration Scheme (THR)
  • Herbal and Homeopathic medicines need to be differentiated
  • CAM covers over 700 types of therapies, including acupuncture, Ayurveda, chiropractic, diet/dietary supplements, herbal medicines, homeopathy, massage, osteopathy, reflexology, reiki, traditional Chinese medicine (TCM) and yoga
  • Ayurveda is a holistic, natural system of medicine that originated in India over 5,000 years ago. The name comes from Sanskrit words ayur (life) and veda (knowledge)
  • Five elements make up Ayurveda's view of the world - space (ether), air, fire, water and earth
  • Doshas (vata, pitta, and kapha) are life forces that influence health and personality and are assessed via physical and mental characteristics
  • Ayurvedic medicine suggests imbalances in doshas can lead to illness and lifestyle changes, nutrition, and natural treatments can help restore balance
  • Traditional Chinese Medicine (TCM) includes acupuncture, herbal medicine, moxibustion, cupping therapy, Tui Na, Qi Gong, Tai Chi, and dietary therapy
  • Chi is regarded as a vital life force permeating the body. Balanced chi is indicative of health and vitality.
  • A study by Royal Marsden (2004) found 50% of participants did not tell their doctor about using herbal medicines
  • A study by Bhamra et al. (2017) found 69% of participants did not tell their doctor about using herbal medicines, and even more didn't tell their pharmacist

Herbal Medicines

  • A herbal medicinal product is a medicinal product whose only active ingredients are herbal substances or herbal preparations (HMR 2012)
  • Herbal substances are mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen, in unprocessed/usually dried, form but sometimes fresh
  • Herbal preparations are obtained by subjecting herbal substances to treatments like extraction, distillation, expression, fractionation, purification, concentration or fermentation (Directive 2004/24/EC)
  • In the UK, 20% of adults use herbal medicines
  • The use of CAM in cancer patients is high
  • There is a potential risk of adverse effects if herbal and conventional medicines are taken together
  • Examples of potential drug interactions include garlic, ginger, turmeric, aspirin, Clopidogrel, Warfarin. This can result in an increased risk of bleeding
  • There are other herb-conventional medicine interactions: St. John's wort with Ciclosporin, Amlodipine, Citalopram,and Digoxin; Garlic with Antiplatelet drugs and Warfarin; and Ginseng with Warfarin
  • Herbal medicines, while having advantages such as being effective for health conditions, being natural, and potentially cheaper than conventional medicines, have disadvantages such as not being well-regulated, variable dosing, lack of clinical evidence.

Homeopathic Medicines

  • Homeopathy is a complementary discipline based on the law of similars, involving administration of ultra-dilute medicines prepared according to methods specified in homeopathic pharmacopoeias, aiming at stimulating a person's own healing capacity.
  • Homeopathic medicinal product is a medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure.
  • Homeopathic medicines are based on the principles of "like cures like," minimal dose, and single medicine
  • Developed by German doctor Samuel Hahnemann in the 1700s.
  • Homeopathic medicines are prepared from various sources like plants, animals/insects, biological material, and chemical material.
  • Mother tinctures are made from extracting the source material (plant or herb) in alcohol and water.
  • Homeopathic medicines are often diluted using a serial dilution and succussion method
  • Formulations of homeopathic medicine include oral preparations (tablets, pills, granules, powders), liquid preparations (drops), topical preparations (cream, gel, ointment, paste)
  • Absorption may be affected by food (usually a 30-minute gap is recommended)
  • Patients should avoid smoking or strongly flavoured products (e.g. peppermint toothpaste) and not touch the product with their hands
  • Homeopathic medicines can be supplied on the NHS or via a private prescription.
  • There are disadvantages of homeopathic medicines including lack of clinical evidence, effects compared to a placebo effect, and that they are not always evidence based.

Legislation

  • Regulation of herbal medicines in the UK passed through several phases, with early 1970s requirements for a product license for medicinal claims.
  • Section 12.2 of the 1968 Medicines Act allowed exemption from licensing for herbal remedies that contained only herbal substances and no medicinal claims.
  • Human Medicines Regulations (HMRs) 2012 requires that herbal medicines making a medicinal claim either be registered under the Traditional Herbal Registration Scheme (THR) or licensed with marketing authorisation.
  • Unregistered products cannot make any therapeutic claim.
  • Traditional Herbal Medicinal Products Directive (THMPD) was passed in 2004 to regulate the use of HMs.
  • The legislation required herbal medicinal products to have at least 30 years of evidence of traditional use in the EU, or 15 years within the EU and 15 years elsewhere.
  • Safety data, quality, and pharmacovigilance were also required.
  • There are various details about registrations, validity, and conditions for homeopathic medicines which were granted by the MHRA

Risk of Buying Herbal Medicines Online

  • Fake, substandard, unlicensed contaminated or adulterated products may contain banned ingredients or substances.
  • Products may be made in unlicensed factories with no Quality Assurance
  • Claims such as "100% safe," "Safe because they are natural," and "Has no side effects" should be avoided.

Herbal Medicines vs. Conventional Medicines

  • Herbal medicines are alternative, with a poor evidence base, and are natural. Traditional use is not well documented
  • Herbal medicines are not well regulated, marketing authorisation is not always necessary, and there is a lack of clinical evidence that proves their efficiency
  • Conventional medicines are conventional, evidence based, synthetic/manufactured/purified and regulated which has well established use. Necessary product licenses or marketing authorisation is required.

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