NATURAL HEALTH PRODUCTS TO INCLUDE ANIMAL SOURCED MATERIALS

NATURAL HEALTH PRODUCTS TO INCLUDE ANIMAL SOURCED MATERIALS

اسلاید 1: © K Nakatsu, 2005www.tabaye.ir

اسلاید 2: This material is made available through The CAM in UME Digital Resource Repository and is owned and copyrighted by the credited author(s). Materials are provided for educational purposes only. All copied materials must contain clear and proper citation. The CAM in UME Project http://www.caminume.caThe CAM in UME Project does not warrant or assume any legal liability or responsibility for the accuracy, completeness, or usefulness of any information presented herein.HERBAL DRUGS: NATURAL HEALTH PRODUCTS TO INCLUDE ANIMAL SOURCED MATERIALSKanji Nakatsu, PhD Queen’s University March 2005URL: http://www.caminume.ca/drr/resources/00020.ppt33 slides

اسلاید 3: © K Nakatsu, 2005Herbal Drugs Natural Health Products to include animal sourced materials Medical PharmacologyMarch 2005Dr. Kanji Nakatsu

اسلاید 4: © K Nakatsu, 2005OutlineRelevanceDefinitionsRegulation Common Herbals

اسلاید 5: © K Nakatsu, 2005RelevanceOver ¼ (perhaps1/2) of the Canadian adult population have taken a natural health product in the past year.More than 1/2 of Canadians using complementary or alternative medicine did not disclose this to their physicians.Increasing number of natural health products for sale in Canada. Most of these are sold through stores (including mail order) other than pharmaciesEstimated sales >$1 BillionPotential adverse interactions with conventional treatments. The potential for this increases when the doctor does not know that the patient is taking NHP.

اسلاید 6: © K Nakatsu, 2005Why are people using NHPs?Influx of web-based information. As with other topics the quality of the information is uneven, spanning the range from good, useful information to misinformation.Concern over the safety of conventional medicationCost of conventional medicationLack of faith in conventional medicationHope for a cure of incurable/chronic disease- cancer amygdalinBelief that natural is non-toxic

اسلاید 7: © K Nakatsu, 2005DefinitionsDrug (conventional medicine)chemical substance, non-nutritiveTraditional Herbal Medicine (THM)“a finished drug product intended for self-medication that contains, as active principles, herbal ingredients that have received relatively little attention in world scientific literature but for which traditional or folkloric use is well documented in herbal references”

اسلاید 8: © K Nakatsu, 2005DefinitionsNatural Health Product“a plant or its extract, a vitamin, mineral, amino acid, probiotic or essential fatty acid whose purpose is to prevent or treat disease, restore or correct an organic function, or maintain and promote health.Example- St. John’s Wort, chondroitin sulfate

اسلاید 9: © K Nakatsu, 2005Scope of NHPsA plant or a plant material, an alga, a bacterium, a fungus or a non-human animal materialAn extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation Any of the following vitamins: biotin folate niacin pantothenic acid riboflavin thiamine vitamin A vitamin B6 vitamin B12 vitamin C vitamin D vitamin E An amino acidAn essential fatty acidA synthetic duplicate of a substance described in any of items 2 to 5A mineral A probiotic

اسلاید 10: © K Nakatsu, 2005ExclusionsVitamin KFoodsGarlic is used by some people as a herbal remedy but mostly it is used as foodPrescription drugs prepared from natural sourcesProducts made by practitioners, such as naturopathic doctors

اسلاید 11: © K Nakatsu, 2005Spectrum of Responses from Conventional Medicine to Complementary & Alternative Medicine (CAM)Utter disdain, but they still accept that some of their patients are using CAMReluctant acceptanceAcceptance that CAM may have a place, depending on the formParticipation Some doctors do some forms of CAM

اسلاید 12: © K Nakatsu, 2005Natural Health Products, Quackery or QualityAlternative 1- NHPs are dangerous, poisonous, ineffectiveAlternative 2- NHPs are good drugs that just haven’t received formal approvalAlternative 3- between 1 and 2

اسلاید 13: © K Nakatsu, 2005Position of NHPsPoisonReal DrugArtemesininSt. John’s WortAristolochic Acid

اسلاید 14: © K Nakatsu, 2005Prescription Drugs from Natural SourcesDigoxin- heart failure- foxgloveAtropine-autonomic-Deadly nightshadeEphedrine- autonomic- EphedraQuinidine- anti-arrhythmic- Cinchona tree barkPenicillin- antibiotic- mold~25% of prescription drugs have botanical roots (no pun intended)

اسلاید 15: © K Nakatsu, 2005Current NHP  Prescription DrugMoss Extract from Traditional Chinese Medicine Huperzia serrata used for improving memoryIdentification of huperzine A as active ingredient Recruiting for phase II clinical trials in USA by NIH for Alzheimer’s Disease http://www.clinicaltrials.gov/show/NCT00083590

اسلاید 16: © K Nakatsu, 2005HuperzineHuperzine AHuperzine R

اسلاید 17: © K Nakatsu, 2005Concerns with NHPsLack of efficacy data; often information is anecdotalLack of safety data- public often assume that they are safe to use because they are “natural”Intentional adulterationRx medications found in NHPs. See Health Canada Warnings; NSAIDS, heavy metals, steroids etcConfusing literatureUnknown active ingredients Marker molecules can be used to standardize products. These are anticipated to either be the active ingredient or associated with the content of active ingredient in the product.

اسلاید 18: © K Nakatsu, 2005Concerns with NHPs (cont’d)Lack of quality control.Unknown active ingredients. Marker molecules can be used to provide some consistency. Poorly designed studiesToxicities poorly defined. Some are mild, but some can be lethal. Aristolochic acid is carcinogenic and nephrotoxicDrug interactions with prescription drugs

اسلاید 19: © K Nakatsu, 2005RegulationLittle attention until 1990sCreation of Natural Health Products Directorate, NHPDNew Regulations- implementation started January 2004.Expect evolution as this is new work for Health CanadaAffect manufacturers, distributors, importers, packagers and labelers All products that fit under the NHP definition must obtain their product licenses by December 31, 2009 Future Regulations:Claims: structure-function, risk-reduction, and treatmentStandards of Evidence: varies with type of claim

اسلاید 20: © K Nakatsu, 2005Application for licenseAn application for a product license must include specific information about the NHP, for example, the quantity of the medicinal ingredients it contains, the specification it complies with, the recommended use or purpose for which the NHP is intended to be sold, and the supporting safety and efficacy data. The NHPD is developing a standards of evidence framework and guidance documents

اسلاید 21: © K Nakatsu, 2005Safety and Efficacyperformance standard, applies to an application which references a monograph in the Compendium of Monographs developed by the NHPD. Medicinal ingredients are the focus of the monographs, and are developed based on public literature. The Compendium of Monographs will ease the administrative burden on industry and ensure more efficient processing of product license applications. Development of single-medicinal ingredient monographs is ongoing. The monographs provide support for the safety and the claim of the NHP, and therefore additional safety and efficacy data are not required in the application for a product license.

اسلاید 22: © K Nakatsu, 2005USA RegulationsCovered by Dietary Supplement Health and Education Act, 1994NHPs are considered to be food supplements and not regulated as drugsAffords less control than Canadian RegulationAndrostendione has just beenruled as not being a food supplement in USAMakes people like baseball players famous

اسلاید 23: © K Nakatsu, 2005NHPs and Health of PopulationInclude consideration of NHPs as part of the drugs that people are taking- interactions & toxicities General knowledge of extent of NHP usageKnowledge of source of information Good reliable web sites and books.Evidence based medicine should be applied to NHPs a challenge because there is so little evidence for the basis of judgment

اسلاید 24: © K Nakatsu, 2005Evidence-based MedicineStandards of evidenceProspective, double-blind controlled trial is desirableNot all current conventional practice is based on such evidenceHormone replacement therapystarted wellcurrently evidence against original

اسلاید 25: © K Nakatsu, 2005Where to find information Natural Health Products Directoratehttp://www.hc-sc.gc.ca/hpb/onhp This is anticipated to be a stable site with valuable information.Camlinewww.camline.org. This site has valuable information but its stability is uncertain. Much depends on whether good people continue to develop and maintain it.Chandler, F. Herbs: Everyday Reference for Health Professionals. Ottawa: CPhA & CMA, 2000. This is a very useful reference with credible sponsors. It is limited in its coverage. Its continuing value will depend on regular revisions.National Centre for Complementary and Alternative Medicinehttp://nccam.nih.gov This anticipated to be a stable site with valuable informtion.Bracken Library- Natural Standard

اسلاید 26: © K Nakatsu, 2005Common HerbalsGlucosamineBlack CohoshGarlicSt. John’s WortEchinaceaGinsingGinkgo Biloba

اسلاید 27: © K Nakatsu, 2005Glucosamine-collagen componentUses: osteoarthritis, prevent inflammationC/I-none knownA/E-mild GI, drowsiness, h/aDosage: 1500mg po div TID, or 400 mg IM/IV (caution in diabetics)

اسلاید 28: © K Nakatsu, 2005GlucosamineGlucosamine- amino-monosaccharide produced in humans. Used in biosynthesis articular cartilage components, such as glycosaminoglycans, proteoglycans, and hyaluronic acid. Reduces pain in humans, increases joint space in ratsEvidence indicates efficacy in osteoarthritis of the knee

اسلاید 29: © K Nakatsu, 2005Black CohoshEstrogen-like activity?Uses: menopausal symptoms, PMS, dysmenorrheaC/I: preg/lact, estrogen dependent tumours, estrogen receptor activity?.A/E: h/a, GIDosage: dried extract equivalent to 160 mg of dried root or rhizome per day

اسلاید 30: © K Nakatsu, 2005GarlicAllicin, diallyl sulfide, ajoene (sulfur based compounds)Uses: hyperlipidemia- some evidence of mild effect-immune enhancer etc no evidenceC/I: none knownA/E: odour,  bleeding timeDosage: fresh garlic 1-5 cloves/day, oil 0.25mg/kgIntxns: anticoagulants

اسلاید 31: © K Nakatsu, 2005St. John’s WortHypericin, hyperforinUses: depression (comparable to TCAs and SSRIs, SAD, anxiety)Evidence of effectiveness in mild-moderate depression, but not severe depressionC/I: noneA/E: photosensitivity, restlessnessIntxns: theophylline, warfarin, indinavir,cyclosporine, SSRIsInduces Cytochrome P4503A4

اسلاید 32: © K Nakatsu, 2005EchinaceaE. angustifolia (N.A.), E. purpurea (Germany)Uses: immune stimulation, cold, flu, prevent of yeast infectionsTreatment of upper respiratory tract infections in adults- some evidenceC/I:autoimmune diseases A/E: hepatotoxicity,  sperm ability to penetrate eggIntxns: cancer chemo, immunosuppressants, warfarin

اسلاید 33: © K Nakatsu, 2005GinsengPanax quinquefolius (N.A.), Panax ginseng (Oriental); white vs. red ginseng, do not confuse with Siberian Ginseng (Eleuthero)Uses: stress, impotence, BPProbably useful for improving mental performance and type 2 diabetes.C/I: preg/lact, hyperactive childrenA/E: HTN, diarrhea, insomnia, mastalgia, vaginal bleedingIntxns:warfarin, BP meds, estrogen, hypoglycemics, MAOIs, caffeine, psychotherapeutics

اسلاید 34: © K Nakatsu, 2005Ginkgo BilobaUses: ischemia assoc with periph arterial disease, dementiaC/I: caution in pts on meds affecting hemostasisA/E:  risk of bleeds, GI upset, h/aIntxns: anticoagulants, NSAIDs

اسلاید 35: © K Nakatsu, 2005Important issues regarding NHPsWide use in CanadaPossibilities of useful therapiesPossibilities of harmful effects and interactionsEvolving regulationQuality control