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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