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Home , Herbal medicine

Alternative

12.

Introduction

 Complementary and alternative medicine (CAM) is a broad term that includes products, nutritional supplements, homeopathic , oils and many other beliefs, and practices (eg yoga, ). In this Tutorial, we shall concentrate on dietary supplements, and herbal and homeopathic medicines.  Alternative medicine is perceived to be ‘safe’ by the general public despite a lack of good- quality evidence to support its efficacy and tolerability. Although some studies have recently been published on the use of selected preparations such as St John’ Wort for depression, and for bone and joint disorders, for most alternative medicines there remains a lack of good quality research-based information.

General Principles

1.  Herbalists use -derived medicines at doses where true pharmacological effects can occur and can be measured. This is in contrast to homeopathic medicine (see below).  Modern herbalists use largely via a symptom-based approach to diagnosis.

2. Homeopathic Medicine  The two main principles of homeopathic medicine are that 1. ‘Like cures like’ – that is that a patient’s symptoms are treated with a medicine that causes the same effects. For example, oral consumption of herbal in significant quantities can cause a reduction in platelet aggregation, which could increase bruising. However homoeopathic doses of Arnica are used to prevent or treat bruising. 2. The more dilute a preparation, the more potent it is.  Plants yield most of the original ingredients in homeopathic medicines. The first step is to prepare a mother with alcohol. Then the tincture undergoes repeated dilution followed by vigorous shaking (succussing).  Two systems of dilution exist for homeopathic remedies: 1. Decimal system is known as ‘x’. These are 1 in 10 dilutions, or a concentration of 1x10-1 eg one part of mother tincture with nine parts of ( or alcohol) = 1x. Then take one part of resulting solution and mix with nine parts of solvent (water or alcohol) = 2x. 2. Centesimal system is known as ‘c’. These are 1 in 100 dilutions or a concentration of 1x10-2 eg one part of mother tincture with 99 parts of solvent (water or alcohol) = 1c.  A range of strengths are available over-the-counter, but strength 6c is common. It is worth noting that dilutions of more than 12c or 24x are unlikely to contain any molecules of the active ingredients.

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3. Dietary Supplements  In the UK, dietary supplements are defined as ‘foods’ in unit dosage form (eg tablets, capsules, ) taken to supplement the diet. Most are products containing nutrients normally present in foods. They are used by the body to develop cells, bone, muscle etc., to replace co-enzymes depleted by infection and illness, and to generally maintain good health.  In addition to and minerals, this definition also includes supplements such as and evening primrose oil.

Regulation

1. Herbal Medicine  The regulation of herbal medicines is complicated. Currently there are three classes: 1. Licensed Herbal Medicines: have a marketing authorisation issued by the Medicines and Healthcare products Regulatory Agency (MHRA). New licences have to meet safety, quality and efficacy criteria in a similar manner to conventional licensed medicines. 2. Unlicensed herbal medicines: these products don’t have to meet specific standards of safety and quality and so standards can vary widely. 3. Registered traditional herbal medicines: A registration scheme for traditional herbal medicines began in 2005 although there is a 7 year transitional period, so it may take some time for registered medicines to appear on the market. Go to the MHRA website for more information.  There are other forms of regulation which restrict use of certain plant species, and some products containing plants are marketed as dietary supplements (see below).  Currently, there is no statutory regulation of herbalists in the UK.

2. Homeopathic Medicine  is practised by two separate groups: 1. Medical homeopaths are medically qualified practitioners regulated by the General Medical Council. 2. Non-medical homeopaths are professionals who use homeopathy only. They are represented by at least four main bodies (eg Society of Homeopaths).  Homeopathic manufacture is controlled by the Medicines Act 1968. With few exceptions, no medical claim can be made for a homeopathic remedy and they can only be promoted generically.

3. Dietary Supplements  In the UK, the majority of dietary supplements are legally classified as foods, and as such are sold under food law. The exceptions include some branded products (eg Maxepa, Pregaday) and some generic and preparations, which are classed as licensed medicines. Supplements that fall under food law do not have to undergo the same rigorous clinical testing as conventional medicines.  Dietary supplements are not allowed to make medicinal claims but can make health claims. For more information refer to Further Reading (Mason – Dietary Supplements).

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Safety Issues

1. Herbal Medicine  Many patients perceive herbal medicines as ‘safe’ because they occur naturally. However, some herbal medicines can be potentially dangerous, at therapeutic doses, eg kava, now withdrawn from UK, can cause ; St John’s wort can interact with many conventional medicines.  In addition, there is no standardisation at present for herbal medicines. Therefore potential sources of problems include: – Failure of good manufacturing practice. – Adulteration (eg inclusion of toxic metals or conventional pharmaceuticals). – Misidentification of . – Substitution (ie different used to that which is supposed to be in the preparation). – Varying strengths of active ingredient (eg for St. John’s Wort preparations). – Incomplete labelling. – Incorrect dosage or instructions.  The amount of information available about herbal medicines is very limited. This lack of data makes it difficult to provide information about common enquiries, eg drug-herbal interactions, adverse effects and use in special patient groups.  In order to answer questions about interactions involving conventional medicines and herbal products it is necessary to exercise some lateral thinking, since there are rarely any systematic or high quality studies. It is helpful to look for herbal side effects that might be additive to those of the medicine or, conversely, may oppose its therapeutic action.  As the use of herbal medicines increases, the risk of adverse reactions will increase. Currently, the main method for reporting adverse reactions due to herbal medicines in the is to the Committee on Safety of Medicines (CSM) through the yellow card reporting scheme. MI pharmacists should encourage reporting of herbal side effects to the CSM.

2. Homeopathic Medicine  Homeopathic medicines are designed to be used for self-limiting conditions only. Patients should be discouraged from repeatedly self-treating the same condition without medical advice.  There is very limited information about adverse effects of homeopathic remedies, although in theory these are most unlikely to exist. In about 10% of patients with chronic conditions, their illness may be aggravated within 2-5 days of taking a remedy. If this occurs, the patient may be advised by their homeopath to stop taking the remedy until symptoms subside. The remedy should then be recommenced at a lower frequency or lower potency.  There is no evidence that homeopathic medicines interact with conventional . In practice, if a homeopathic medicine is from a reputable source and the strength is stated, it is generally accepted that no interaction with conventional medicines, or any adverse effects, based on conventional beliefs would be anticipated. High concentration or unknown dilution products may, theoretically, contain active ingredient and could potentially interact with conventional medicines. Such situations should be treated as if dealing with a herbal product.

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3. Dietary Supplements  Dietary supplements also have the potential to cause adverse effects and to interact with conventional and alternative medicines.  Dietary supplements containing levels of vitamins in excess of those in prescription-only medicines are available to the public. However, the Department of Health is setting maximum limits of intake for vitamins and minerals to reduce the use of these ‘mega- dose’ products (eg vitamin B6).

Questions to Ask an Enquirer

 Is the patient already taking the alternative medicine or do they want to start taking it?  Identify the alternative medicine, indication, route, strength, dose and frequency. If applicable, how long has it been taken for?  Has the patient self-diagnosed the condition that they are seeking to treat? If they have, perhaps they should consider speaking to a healthcare professional first.  Does the patient take any conventional ? Is there any history of adverse drug reactions or allergies?  Check relevant past and present medical history.

Example Sources to Use in Answering Enquiries

The sources used to answer alternative medicine enquiries will depend on the of the enquiry (eg interactions, adverse effects, general reviews).  AltMedex (http://www.thomsonhc.com/home/dispatch) – part of the Micromedex Series (subscription needed) provides evaluated information in a monograph style.  Longwood Herbal Task Force (http://www.longwoodherbal.org) – useful for patient information leaflets and detailed scientific information.  Herbal Companion to AHFS DI, 2001 – a book providing information in a monograph style.  Barnes J et al. Herbal Medicines. 2nd edition. London: Pharmaceutical Press; 2002.– useful for scientific evidence, adverse effects and contraindications.  Mason P. Dietary Supplements. Pharmaceutical Press, London 2nd edition, 2001. This is a very useful resource that summarises available evidence on efficacy, adverse effects, interactions and dose.  The Natural Medicines Database at www.naturaldatabase.com. This site requires a subscription. It is incredibly comprehensive and very useful. If your local MI centre does not have it your regional centre should have access.  Baxter K. Stockley’s Drug Interactions. 7th edition. London: Pharmaceutical Press; 2006 – some herbal medicines are listed that interact with conventional medicines (eg garlic).  Bandolier (http://www.jr2.ox.ac.uk/bandolier/) – provides evidence-based information.  A general internet search via the Google search engine can help.  Embase, Medline and Cochrane Database.  The MHRA website at www.mhra.gov.uk has some useful information on the regulation and safety of alternative medicines.

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Further Reading

 Barnes J. An introduction to herbal medicinal products. Pharm J, 2002; 268: 804-806.  Complementary Therapies for Pharmacists (Kayne) – provides good background information.  British Homeopathic Association FAQs http://www.trusthomeopathy.org/trust/tru_faq.html

Exercises  Have a go at the questions on page 12.6 (‘Test Yourself!’). Answers at the back of this book.  There is an example enquiry with a model answer on page 12.8.  Page 12.9 has some real enquiries that you might like to tackle with your MI tutor.  If you have the MiCAL programme, have a go at question nos. 12 and 15, which are about complementary therapies.

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Test Yourself!

1. Homeopathic remedies are produced by serial dilutions. State the number of dilutions and the concentration for 6c.

2. What are the two general principles on which homeopathic medicine is based?

3. Are all herbal medicines unlicensed? What law allows unlicensed products to be supplied?

4. What problems did kava-kava cause which brought it to the attention of the MHRA? What did the MHRA do as a result?

5. How should a suspected adverse drug reaction to a herbal medicine be reported?

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6. What questions would you ask an enquirer when handling a drug-herbal interaction enquiry?

7. A community pharmacist would like to know whether he is able to dispense a prescription presented to him for glucosamine 500mg tablets. What sources would you use to answer this question?

8. List three conventional medicines that can interact with St. John’s Wort and the potential result of this interaction.

9. Can warfarin interact with alternative medicines? By what mechanisms might they interact? What effect could garlic have in patients taking warfarin?

10. Can be used to treat a common cold in a patient taking long-term prednisolone?

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Example Enquiry

Below is an example of an HHM enquiry. Think about how you would have answered it.

From: Skywalker, Luke To: Medicines Information Date: 4.5.2002 Re: Herbal Medicine Interactions

Dear Han, Re: Mr O W Kenobi DoB 16/12/1925

I wonder if you could help me with this rather curious man who came to see me yesterday afternoon. He wanted to know whether he could take vera orally with his normal medication. He suffers from AF and hypertension, and currently takes digoxin 250 micrograms daily; warfarin 3mg daily; bendroflumethiazide 2.5mg daily; and ramipril 5mg daily. He also uses Human Mixtard. I note his midichlorian levels are quite high. (See: www.theforce.net/midichlorians/)

I don’t think there should be a problem but would be most grateful if you could check for me.

I look forward to hearing from you.

Dr. Luke Skywalker A Practice Far, Far Away

From: Medicines Information To: Skywalker, Luke Date: 4.5.2002 Re: Herbal Medicine Interactions

Dear Luke, Re: O W Kenobi DoB 16/12/1925

Thank you for your enquiry. You asked whether this patient could take with his current medication. Published data on interactions involving herbal products are very incomplete.

There doesn’t appear to be any published interactions between aloe vera and the prescribed medication. However, aloe vera can sometimes decrease levels and this can be more profound when patients are taking thiazides, as here (1). This could be a problem since hypokalaemia can sensitise the myocardium to the effects of digoxin, and I note that the dose of digoxin is high. You might like to review this in light of the potential effects of aloe vera, particularly since he will be prone to digoxin accumulation due to the deterioration in renal function which occurs with age.

Since this gentleman is using insulin, please note that a small study in 5 patients with NIDDM has shown that certain aloe can significantly lower blood sugar (2). This effect has also been confirmed in animal studies (2,3). Therefore, if aloe vera is taken, blood sugar should be monitored carefully and insulin dose adjusted as necessary.

I would suggest that there is a potential for harm here if your patient does decide to take aloe vera. If you can let me know why he wants to take it, I would be happy to send you any evidence for effectiveness which may help you both come to a decision.

Finally, you may wish to know that the local PCT has just opened a ‘Midichlorian Walk- in Centre’ run by a small green hairy doctor on Lightsabre Avenue. I hope this information is helpful. Please contact me again if I may assist you further.

Han Solo MRPharmS Medicines Information Pharmacist

(1) Forget L et al (eds). Herbal Companion to AHFS Drug Information. USA (Bethesda): American Society of Health-System Pharmacists; 2001 p.4. (2) Ghannam N et al. Hormone Research. Vol 24(4) (pp 288-294), 1986. (3) Rajasekaran S. et al. Biomedicine. Vol 21(4) (pp 40-45), 2001.

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Real Enquiries

Below are given the details of three real enquiries received by a regional MI centre. Decide with your tutor which of these enquiries to do. Then for each one describe: (a) Any further questions you would like to ask the enquirer. (b) The top sources that you would use to answer the enquiry. If you like, research a full answer using your local enquiry answering form to document it and discuss this with your tutor.

1. Identification of a herbal preparation A community pharmacist phones to ask about Antistax. What is it?

Further questions for enquirer Sources to use

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2. St. John’s Wort A patient phones wanting some advice. She has been feeling depressed recently and decided to start taking St. John’s Wort because she “doesn’t like taking medicines from the doctor”. She wants to know how long it takes for St. John’s Wort to start working. She also tells you she takes oral contraceptives.

Further questions for enquirer Sources to use

3. Agnus castus interactions A district nurse phones you. She has just visited a patient who has recently started taking some agnus castus because the health shop said it was good for preventing pre- menstrual symptoms. The patient also takes regular paracetamol, digoxin, furosemide, enalapril and warfarin. Are there any interactions between the agnus castus and these conventional medicines?

Further questions for enquirer Sources to use

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