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Herbal Remedies and Anaesthesia ۱6 Specialist Registrar Anaesthetics/ITU ‏ع‎ nery

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Contents Background e Extent of use Issues ° Efficacy ° Regulations Common herbal medicines « Effects on anaesthesia Guidelines

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Declaration of Interest: ne Pacific

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Foxglove (Digitalis purpurea)

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Periwinkle

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Purported use of herbal remedies earuaritis 1

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Extent of Use UK ‎of patient use‏ 4.8% و ‎¢ annual expenditure - £1.6 billion America ‎° 12% general surgical ‎* 55% cosmetic surgery ‎٠ 27 billion ‎Europe ‎٠ 40% of breast cancer patients * 20% of lung cancer patients World Health Organisation ‎* 80% of world population

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The Issues ¢ Herbal medicines are ‘safe’ ¢ Natural does not equal safe ° Herbal does not equal benign * 40% of population - “safe” (MORI 2008) * Lack of disclosure/enquiry ° Efficacy and evidence-based practice

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Journal of Clinical Epidemiology ELSEVIER Journal of Clinical Epidemiology 59 (2006) 1134-1149 Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration Joel J. Gagnier*>*, Heather Boon’, Paula Rochon®*, David Moher®**, Joanne Barnes®, Claire Bombardier*", for the CONSORT Group! *Department of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada “Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada “Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada ‘Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada "Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ontawa, Ontario, Canada ‘Department of Epidemiology & Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada *Centre for Pharmacognosy & Phytotherapy, School of Pharmacy, University of London, London, United Kingdom "Institute for Work & Health, Toronto, Ontario, Canada Accepted 16 December 2005

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National Institute of Medical Herbalists HERBAL MEDICIN

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The Issues Herbal medicines are ‘safe’ ° Natural does not equal safe * Herbal does not equal benign ٠» 40% of population - “safe” (MORI 2008) Lack of disclosure/enquiry Efficacy and evidence-based practice Funding/ Product regulation

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0 4 NEWS HeattH eas} Home World UK England N.treand Scotland Wales 6 Home ‘80 April 2041 Last updated at 19:98 Hoss Top Stories Homeop. ۲ Dent woes ‏ما مومت‎ ‏فا‎ ۷ New EU regulations on herbal medicines a Europe new come into force ‏سدم تسس بت هت‎ Postmortem gus on Gadd body ‘Ssimond ising indopondence cll New European Union rules have come into ‏رسد‎ aor foree banning hundreds of traditional herbal MP shared tr i on aang, remedien. ‘The EU law sims to protect consumers from Features & Analysis posi damaging sde-ofects ot versno ‏سك‎ ‏ا اا‎ meses yo ‏سس‎ ‎‘For the first time, new regulations will allow only comets: long-established and quality-controlled = 3 21 — Feeling bleu? ‏یت مود‎ Binet ‏هم مش اب وی‎ ees = ‘World Cup final rugby team ‏اوه‎ | Coons Iman atures fear they coua be forced cu of business Related Stories ‏مورب‎ date, te nds hasbeen covered by tne 1968 Medes ‏هت‎ ‎—_ tp wen ony aan of eral remedies were avalabe and pe umoer Hertel mode ore 5 ‏ماس‎ practioner was very mal Herbal weight oss pil ‘warning Discontent Anglicans say they But surveys show that about a quarter ofall adults inthe UK have used a rave global suppor herbal medicine in the past wo years, moslly bought over the counter in ean food shops and pharmacies. Sern ‏رت‎ New toto ‏که ماع همم و‎ ‏و‎ spending onthe Weatrent a 4m a 1 year hs pays fr our dedicated homeopatic hospi and ‘ Prescriptions Wedding watch Tho ings by GP provokod a bos essence. sooo wat is homeopathy?

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regulation and licensing of herbal products

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regulation and licensing of herbal products ° Lack of international consensus * Herbal products marketed as food supplements or cosmetics ® Medicine Act 1968 ¢ Exemption from statutory control ° EU Medicines Directive 1994 ° Traditional Herbal Medicinal Products Directive (THMPD) 2004

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UK legislation * Unlicensed herbal remedies * Supplied to individual after face to face consultation * Registered traditional herbal medicine (2005) ٠ Specific standards of safety and quality ٠ “Agreed indication based on traditional use” * Licenced Herbal Remedies "When seeking a licence for herbal medicines, many companies have had difficulty meeting conventional requirements to prove efficacy. This was one factor that led to the introduction of the Traditional Herbal Registration Scheme and many products are likely to follow that regulatory route."

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MHRA - Safeguarding public health report => 70 suspected adverse drug reports relating to herbal remedies ° Handful of identified UK deaths ° Steady flow of cases entailing very serious illness e.g. kidney or liver failure ° BUT increasing study and scientific understanding of herbal medicines would be expected to improve safety profile

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BAD MEDICINE - More cases of adverse side effects (The Singapore Straits Times, 11 October 2011) 11 Oct 2011 65211015 6نا08 عكمعلامم « ™Reports received ®@ Where last year’s reports came from 25,000 savage Public 7 ospitals: 20000 —— 39.4% 15000 ‏ل‎ Be Pharmaceutical ‏و و مایت‎ 10,000 3.1 (such tail 25 ۵ ‏یت‎ pharmacies): 1.6% Private clinics hospitals: 1.5% 0 ۷۵۵۲۲۵0 102 ۰۵4 ۰۵6 ‘08 0 Source: Heat Sences Author.

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Anaesthetic Concerns 1 i “There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don't know. But there are also unknown unknowns. There are things we don't know we don't know.”

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Anaesthetic concerns ° Unknown effects of herbal remedies ¢ Potential interactions with drugs ° Pre-operative ¢ Intra-operative ° Post-operative ° Effects on patient physiology

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most common herbal medicines in the UK Echinacea Ginger St Johns Wort Garlic Saw palmetto Ephedra Ginseng Gingko Valerian Kava Kava

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Echinacea (Echinacea Pururrea) * Uses « Common cold ¢ Wounds/Burns ee UT « 1 ° Possible side effects/interactions ° Hepatotoxicity ° Decrease efficacy of corticosteroids

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St Johns Wort (Hypericum perforatum) Uses ¢ Depression © Anxiety Possible side effects/interaction ٠» Induction of P450 3A4 ¢ Serotonin syndrome ° Decrease efficacy of anti-HIV drugs ٠» Prolong effect of anaesthesia * Organ rejection due to reduce immunosurpressants

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Ephedra (Ephedra Sinica) ° Uses ° Antitussive ° Weight loss supplement * Possible side effects/interactions ¢ Arrhythmias e Enhanced sympathomimetic ¢ MAOI ° Death

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Garlic (Allium sativum) © Uses » Lipid lowering * Blood pressure control ¢ Antiplatelet/Antithrombotic ¢ Antioxidants * Possible side effects/interactions ¢ Potent inhibitor of thromboxane synthetase » Increased bleeding time ¢ Epidural haematoma

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ginseng (panax ginseng) ۶ Uses ° Antioxidants * Energy level enhancer ‎Exam success‏ و ‎ ‎* Possible side effects/interactions * — Ginseng abuse syndrome * sleepiness © hypertonia * oedema * Interactions with antipsychotics ٠ Antiplatelet properties * Increased bleeding * — Hypoglycaemia ° CVS instability

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Canadian Anesthesiologists' Society

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AUSTRALIAN AND NEW ZEALAND COLLEGE OF ANAESTHETISTS Can I take herbal and dietary supplements? The use of herbal medicines is common. Herbal medicine is defined as a plant-derivec product used for medicinal and health purposes; commonly used herbal supplements include echinacea, garlic, ginseng, ginkgo biloba, St John’s wort and valerian. Herbal medicines can have a variety of effects on surgery and interact with anaesthetic drugs. Ginkgo, ginseng and garlic all impair blood clotting and promote excessive bleeding. Prolongation of action of anaesthesia drugs can occur with valerian and St John’s wort. Herbal dietary supplements should be stopped two weeks prior to surgery. Fish oil supplements are also popular as a dietary supplement. They have potential in reducing cholesterol and hence may reduce the risk of heart attack and stroke. They also have anti-inflammatory properties and may be used to treat arthritis. The Therapeutic Goods Administration says that omega 3, which is found in fish oil, has no effect on bleeding and can be continued before surgery.

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American Society of Anesthesiologists 5 ما ‎Physician Series‏ ا 0 ‎What You Should‏ و۱۱ ‎MODERN MEDICINE Know About Your‏ تیان را 0 تا ‎Doo ee eT CEC‏ ‎Other Dietary‏ ‎youu ey ‎ ‎520 N. Northmet Highway + Puck Ridge, IL 60068-2673 American Society or iii ea eee Anesthesiologists “ea

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1 SAMPLE HERBAL AND DIETARY REPLACEMENTS CURRENTLY ON THE MARKET BRAND NAME ‘SCIENTIFIC NAME COMMON USES POSSIBLE SIDE EFFECTS OR DRUG INTERACTIONS lew pect Come, Wand bm cae heaton, epi wel ith ther hp: dp Ley le sehr echelon nice ‏لافطال مؤي‎ ٠.١ ethene dma. Epics Overton Hod, Bite Heat hos balun: comin Guehlietanced ype: eflets Meranda aber (AOI hace Chnwefara ‏هدرن وگ هه شور »سما عمد‎ Fes Fables Midas Day Mignon ‏دسلا وا مه هر انس .متا‎ puna ws oar complet may ehans sg Red ‏ولول سح له 9.1516 مومسم ملي ا لطم‎ ayant patel tt en. ae ee ‏تیه( سیک اس‎ hia Sled pats ‏عقون رمد سل‎ nan, ley raed agp dns ot prone FDA) Ghee A ‘ir pte wei we ened NAP) Maydere catiecene coun ‏هروه وک تسم‎ يملعملا سي عست رن عسات ‎nae chetac ny ured ine Ls whe Ukieg‏ کاخ سا ‎acca aehunic te eae NSAID win oh‏ ۱] ‎Giese Sane (715 elena peti lo, Adie wither ial: uae yee.‏ Moca ‏ما ماه همهم‎ ave mana ۵ ‏نصا و دسر‎ May hae ail popes may iene Beli, td) parton anton edaremioee ge. est aa nse Ove acne ‏اد امه‎ en gue dee (ol ea ot fev). May ea nse pec, ‘Mace sins ‏ماو مت مدا لد معا ساسا طسو‎ nd it nen ceva tes vith edge denn. (lyyhai ain ao ay ce gh bod su, plaka ema Coto ary lo ecco al ‘een pron oan. ‎he‏ مساب ‎eectthaherhomore hae es ih ont ete‏ له مه لا ‎‘Nay dese dense arent vical HN pce hus wa coeur eve tapas whine May ose‏ ‎ucrones PSE SM Nay pkey eens of estes eco nse)‏ سوب ‎oa! eeu doin wake mene‏ ‎‘ills jure bia ‏معط ما‎ pons erin ‏مق اهاط‎ uc en st). ‎ay ict Hk pricy is uct wth aap atic deg. Malt hy ato thre ea tn Mey adres pene in pense ass des ADU pe. ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎

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۳۵۵۸۵ Patient Informatior eg Leaflet The Royal College of Anaesthetists » "It is important for you to bring a list of: ¢ "all the pills, medicines, herbal remedies or supplements you are taking, both prescribed and those that you have purchased over the counter" ¢ "Ifyou are taking medicines, you should continue to take them as usual, unless your anaesthetist or surgeon has asked you not to. For example, if you take drugs to stop you getting blood clots (anticoagulants), aspirin, drugs for diabetes or herbal remedies, you will need specific instructions."

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British association of Day Surgery (ens م8550 ف يي + B 0 ‏مرج‎ ‎% ‎4 < ‏ی‎ 4 a 9 4 4 G 4 su* Excellence in short stay surgery

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british Association of Day Surgery (BADS) Table! Summary of commonly used herbal medicines, known effects and perioperative recommendations as per British Association of Day Surgery guidelines [15] Herbal medicine Known adverse effects Drug interactions Perioperative recommendations [18] Ginseng Hypoglycaomia in type ll OM, Warlarin Stop 1 week before surgery Contral stimulant, Hypartension Garlic Antihypertensive, Hypoglycaarric, Antidiabetic drugs Slop 1 week before surgery Blooding tendency (with NSAIDS/warfarin) Gingko Inhibits platelet activating factor Warfarin, NSAIDS, Stop 1 week before surgery St John’s Wort Enuyme induction, Photosensitvity Immunosuppressants, Stop 1 week before surgery Anticoagulants, Anticonvulsants, HIV protease inhibitors, Digoxin Echinacea Immune modulation, Hepatotoxicity Corticosteroids Continue in most cases. Stop if {with anabolic steroids, amiodarone, immunosuppression required mothotrexate, ketonazole)

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“Current” UK practice * McKenzie and Simpson - Survey of AAGBI members (2005) ‏و‎ 90% - never or seldom asked about herbal medicines * 65% - thought there could be potential harm * 75% - perioperative usage of herbal medicine is important * “Unequivocally’ poor knowledge * Hogg and Foo - Survey of all anaesthetic dept (2010) * 7.3% have perioperative herbal medicine policy * 98.3% did not have specific section documenting herbal medicine use * 15.7% routinely asked about herbal medicine use ٠ Highly variable advice given (not in accordance to existing guidelines)

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Conclusion The use of herbal remedies in patients undergoing anaesthesia is under-reported. Side-effects and herb-drug interactions can be unknown. Elective surgery - all herbal medication should be stopped for between 2 and 3 weeks prior. Emergency surgery - carry on. Improved education and knowledge crucial.

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References . MHRA Public Health Risk with Herbal Medicines: An Overview (2010) . Hogg LA and Foo I. Management of patients taking herbal medcines in the perioperative period: a survey of practice and policies within Anaesthetic Departments in the UK. EJoA 2010; 27: 11-15. . American Society of Anesthesiolgist. What You Should Know About Your Patients’ Use of Herbal Medicines and Other Dietary Supplements (2010). . McKenzie AG and Simpson KR. Current management of patients taking herbal medicines: a survey of anaesthetic practice in the UK. EJoA 2005; 22: 597-602. . Cheng B, Hung CT, Chiu W. Herbal medicine and anaesthesia. HKMJ 2002; 8: 123-130. . Skinner CM and Rangasami J. Preoperative use of herbal medicines: a patient survey. BJA 2002; 89(5): 792- 795. . Batra YK and Rajeev S. Effect of common herbal medicines on patients undergoing anaesthesia. IJoA 2007; 51(3): 184-192. . Hodges PJ and Kam PCA. The peri-operative implications of herbal medicines. Anaesthesia 2002; 57: 889- 899. . Ang-Lee M, Moss J and Yuan CS. Herbal Medicines and Perioperative Care. JAMA 2001; 286: 208-216.

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