Herbal MedicineHerbal Medicine

Penny FranklinPenny FranklinMA Complementary Health StudiesMA Complementary Health Studies

Senior Lecturer Non medical prescribingSenior Lecturer Non medical prescribingUniversity of PlymouthUniversity of Plymouth

May 2005May 2005

Intended presentation outcomesIntended presentation outcomes

Discuss the significance of Complementary Discuss the significance of Complementary and alternative medicine for conventional and alternative medicine for conventional prescribingprescribing

Highlight the difficulties involved in obtaining Highlight the difficulties involved in obtaining reliable information on this topicreliable information on this topic

Discuss significant drug interactions and Discuss significant drug interactions and cautions that relate to different patient groupscautions that relate to different patient groups

HistoryHistory Complementary and alternative medicine (CAM)Complementary and alternative medicine (CAM) Herbal medicine at least 5,000 years oldHerbal medicine at least 5,000 years old CAM interest grown over past two decadesCAM interest grown over past two decades Over 31 million visits to CAM practitioners 1998 Over 31 million visits to CAM practitioners 1998

(Thomas et al, 2001)(Thomas et al, 2001) One in five Britons seeks complementary or One in five Britons seeks complementary or

alternative therapy.alternative therapy. Perceived to be ‘safe’Perceived to be ‘safe’ Research lagging behindResearch lagging behind Health care professionals are thought to knowHealth care professionals are thought to know

What is CAM?What is CAM?

Complementary and alternative medicine. The Complementary and alternative medicine. The treatment of disease using methods other than treatment of disease using methods other than recognised/conventional medicine. recognised/conventional medicine.

Use of homeopathic, herbal, aromatherapy and Use of homeopathic, herbal, aromatherapy and over the counter vitamin supplements to treat over the counter vitamin supplements to treat conditionsconditions

Often not adequately clinically trialledOften not adequately clinically trialled Might not have a product licenceMight not have a product licence

Homeopathic and Herbal medicineHomeopathic and Herbal medicine

Homeopathy: Homeos (Similar) Pathos (disease)Homeopathy: Homeos (Similar) Pathos (disease) Like cures like – remedy mimics symptomsLike cures like – remedy mimics symptoms The greater the dilution – the greater the therapeutic effect The greater the dilution – the greater the therapeutic effect

(serial dilution)- hardly any or no trace of active ingredient(serial dilution)- hardly any or no trace of active ingredient Manufacture controlled by Medicines Act 1968Manufacture controlled by Medicines Act 1968 Medical claims cannot be made for remediesMedical claims cannot be made for remedies However, leaflets can be displayed nearbyHowever, leaflets can be displayed nearby Medical homeopaths (medically qualified and regulated by Medical homeopaths (medically qualified and regulated by

GMC)GMC) Non Medical homeopaths (regulated by different Non Medical homeopaths (regulated by different

bodies/Fellowship of homeopaths etcbodies/Fellowship of homeopaths etc

Effects on patientsEffects on patients

Limited evidence with regard to adverse drug Limited evidence with regard to adverse drug reactionsreactions

Little evidence with regards to drug Little evidence with regards to drug interactionsinteractions

HerbalismHerbalism

National Institute of Medical Herbalists 1864 National Institute of Medical Herbalists 1864 (professional body)(professional body)

Phytotherapy-the science of herbalismPhytotherapy-the science of herbalism

Herbal medicinesHerbal medicines

Plant derived medicines at pharmacological Plant derived medicines at pharmacological doses where effects can be measureddoses where effects can be measured

Symptom based approach to diagnosisSymptom based approach to diagnosis

Commonly used herbal medicinesCommonly used herbal medicines

Glucosamine (not strictly herbal)- For relief of Glucosamine (not strictly herbal)- For relief of joint pain (side effects:mild GI symptoms, joint pain (side effects:mild GI symptoms, rash, drowsiness, headache and insomniarash, drowsiness, headache and insomnia

May alter glucose sensitivityMay alter glucose sensitivity Caution if pregnant or breastfeeding or if Caution if pregnant or breastfeeding or if

allergic to shell fishallergic to shell fish

Saw PalmettoSaw Palmetto

Urogenital conditions – Benign prostatic Urogenital conditions – Benign prostatic hyperplasiahyperplasia

Side effects: - dizziness, and GI disturbanceSide effects: - dizziness, and GI disturbance Rare,- mild puritis, headache and hypertensionRare,- mild puritis, headache and hypertension ? Erectile dysfuntion (similar to placebo)? Erectile dysfuntion (similar to placebo) Drug interactions ? Hormonal therapies Drug interactions ? Hormonal therapies

(Contraception and HRT)(Contraception and HRT) Cautions: Pregnancy and breastfeeding, sex Cautions: Pregnancy and breastfeeding, sex

hormone dependent cancershormone dependent cancers

ValerianValerian

InsomniaInsomnia Side effects: headache, drowsiness, (sedation) GI Side effects: headache, drowsiness, (sedation) GI

symptoms, rarely nervousness and excitabilitysymptoms, rarely nervousness and excitability ? Cardiac disturbances rarely on sudden withdrawal ? Cardiac disturbances rarely on sudden withdrawal

(not confirmed)(not confirmed) Precautions: Pregnancy and breastfeeding, before Precautions: Pregnancy and breastfeeding, before

driving or operating heavy machinery, driving or operating heavy machinery, Not to be taken if known hypersensitivityNot to be taken if known hypersensitivity Can cause dependencyCan cause dependency

St John’s WortSt John’s Wort

Mild depression – Mild depression – Caution (Liver enzyme inducer (anti-Caution (Liver enzyme inducer (anti-

epileptics)( theophylline )(the Pill) (SSRI’s), epileptics)( theophylline )(the Pill) (SSRI’s), ( wafarin)( wafarin)

EchinaceaEchinacea Prevention of upper respiratory tract infectionsPrevention of upper respiratory tract infections Side effects: Nausea, dizziness, shortness of breath, burning Side effects: Nausea, dizziness, shortness of breath, burning

and numbing sensation on tongue, dermatitis, hepatitis, puritus and numbing sensation on tongue, dermatitis, hepatitis, puritus and hepatoxicityand hepatoxicity

Drug interactions: Other hepatotoxic drugs e.g anabolic Drug interactions: Other hepatotoxic drugs e.g anabolic steroids, amiodarone, ketoconazole and methotrexate also steroids, amiodarone, ketoconazole and methotrexate also immunosuppressants (might decrease effect)immunosuppressants (might decrease effect)

Cautions: asthma, atopy or allergy, hypersensitivity to Cautions: asthma, atopy or allergy, hypersensitivity to sunflowers, liver dysfunction, TB, diabetes, HIV, MS, SLE sunflowers, liver dysfunction, TB, diabetes, HIV, MS, SLE and other autoimmune diseasesand other autoimmune diseases

Pregnancy and breastfeedingPregnancy and breastfeeding Do not take continuously for more than eight weeks Do not take continuously for more than eight weeks

Regulation of herbal medicinesRegulation of herbal medicines

Licensed: Marketing authorisation (product Licensed: Marketing authorisation (product license) issued by Medicines and Health Care license) issued by Medicines and Health Care products Regulatory Agency (MHRA)products Regulatory Agency (MHRA)

Have to meet safety, quality and efficacy Have to meet safety, quality and efficacy standards similar to conventional drugsstandards similar to conventional drugs

Unlicensed: Exempt from licensing Unlicensed: Exempt from licensing requirements (Section 12 of Medicines act requirements (Section 12 of Medicines act 1968)1968)

Section 12 Medicines Act 1968Section 12 Medicines Act 1968 Section 12 (1) person can make, sell and supply herbal remedy Section 12 (1) person can make, sell and supply herbal remedy

as part of business provided remedy is manufactured on the as part of business provided remedy is manufactured on the premesis and supplied as the consequence of a consultation premesis and supplied as the consequence of a consultation between patient and herbalistbetween patient and herbalist

12(2) allows manufacture and supply where12(2) allows manufacture and supply where Process of manufacture consists of drying, crushing or Process of manufacture consists of drying, crushing or

comminutingcomminuting Remedy sold without any written recommendation as to its useRemedy sold without any written recommendation as to its use Remedy sold under a designation which only specifies the Remedy sold under a designation which only specifies the

plant and the process and does not apply any other name to the plant and the process and does not apply any other name to the remedyremedy

Statutory regulationStatutory regulation

Moves afoot to regulate industryMoves afoot to regulate industry

House of Lords Select Committee House of Lords Select Committee 20002000

Tougher regulation Tougher regulation More rigorous testingMore rigorous testing Greater supervision of practiceGreater supervision of practice Only those with a statutory regulation or Only those with a statutory regulation or

powerful self regulation should be available on powerful self regulation should be available on NHS NHS

Only by referral from GP.Only by referral from GP.

Safety andSafety andRegulation.Regulation.

““We are concerned about the safety We are concerned about the safety implications of an unregulated herbal sector implications of an unregulated herbal sector and we urge that all legislative avenues be and we urge that all legislative avenues be explored to ensure better control of this explored to ensure better control of this unregulated sector in the interests of public unregulated sector in the interests of public health.”health.”

SafetySafety

Lack of dataLack of data ‘‘Natural’ does not always mean safe e.g Natural’ does not always mean safe e.g

digitalisdigitalis Kava Kava hepatotoxicityKava Kava hepatotoxicity

Safety IssuesSafety Issues

Remember herbal remedies are medicinesRemember herbal remedies are medicines Report adverse reactions to doctor or Report adverse reactions to doctor or

pharmacistpharmacist May interact with other medicinesMay interact with other medicines Natural does not mean safeNatural does not mean safe

Duty of Care when prescribingDuty of Care when prescribing

To facilitate full and informed consentTo facilitate full and informed consent To do no harmTo do no harm Negligence – Proven breach of duty of care Negligence – Proven breach of duty of care

and harm to patientand harm to patient

When prescribingWhen prescribing

Always ask the patient what else they are Always ask the patient what else they are takingtaking

Including Over the Counter medication and Including Over the Counter medication and herbal medicinesherbal medicines

Consider potential drug interactionsConsider potential drug interactions BNF (2005) and Stockley (2002)BNF (2005) and Stockley (2002)

AlertAlert

Patients taking drugs with a narrow theraputic Patients taking drugs with a narrow theraputic index e.g wafarin or a drug therapy which is index e.g wafarin or a drug therapy which is considered critical ( e.g insulin) should avoid considered critical ( e.g insulin) should avoid using complementary medicinesusing complementary medicines

Women who are pregnant or breastfeeding Women who are pregnant or breastfeeding should avoid complementary medicinesshould avoid complementary medicines

ProblemsProblems

Poor manufacturing processPoor manufacturing process Adulteration to include toxic substances and Adulteration to include toxic substances and

conventional drugsconventional drugs Misidentification of herbsMisidentification of herbs Substitution of herbsSubstitution of herbs Varying strengths of preparationsVarying strengths of preparations Incomplete labellingIncomplete labelling Incorrect dosage and instructionsIncorrect dosage and instructions

ReportingReporting

To the MHRA using yellow card reportingTo the MHRA using yellow card reporting Important for all drugs especially those less Important for all drugs especially those less

well known.well known.

ReferencesReferences http://http://www.mcs.gov.uk/ourwork/licensingmeds/herbalsafetywww.mcs.gov.uk/ourwork/licensingmeds/herbalsafety Stockley IH (2002) Drug interactions. 6Stockley IH (2002) Drug interactions. 6thth edition. London: edition. London:

Pharmaceutical Press; 2002Pharmaceutical Press; 2002 Thomas, K et al., Use and expenditure on complementary Thomas, K et al., Use and expenditure on complementary

therapies in England: a population based survey. therapies in England: a population based survey. Complementary Therapies in Medicine 2001; 9(1): 2-11Complementary Therapies in Medicine 2001; 9(1): 2-11

Zollman C, Vickers A. ABC of complementary medicine: Zollman C, Vickers A. ABC of complementary medicine: what is complementary medicine? BMJ 1999; 319: 693-696what is complementary medicine? BMJ 1999; 319: 693-696

UKMI Complementary Medicines Summaries December 2002UKMI Complementary Medicines Summaries December 2002