EFICACY, SAFETY AND EFICACY, SAFETY AND TOXICITY OF THE TRADITIONAL TOXICITY OF THE TRADITIONAL

MEDICINESMEDICINES

By: By: Prof. Dr. ARMENIA, MS. Apt.Prof. Dr. ARMENIA, MS. Apt.

backgrownbackgrown Most people in non-industrialised countries Most people in non-industrialised countries

(60–80%) receive traditional health care (60–80%) receive traditional health care (THC) for their everyday health care (THC) for their everyday health care needs. (own or in conjunction with modern needs. (own or in conjunction with modern medical care) (WHOmedical care) (WHO

Demand for traditional medicine Demand for traditional medicine ↑ ↑ in many in many countries (Bannerman, 1993). countries (Bannerman, 1993).

Since 1977, Since 1977, traditional healers should traditional healers should be part of the primary health care team be part of the primary health care team (WHO, 1978a). (WHO, 1978a).

The needs for improvement quality and The needs for improvement quality and safety standards safety standards THC as a THC as a complementary therapy. complementary therapy.

LATAR BELAKANGLATAR BELAKANG

OBAT TRADISIONAL PUNYA KERJA OBAT TRADISIONAL PUNYA KERJA FARMAKOLOGI DAN MEMPENGARUHI FARMAKOLOGI DAN MEMPENGARUHI PASIENPASIEN

TIDAK SEMUANYA AMANTIDAK SEMUANYA AMAN DPT BERINTERAKSI DNG OBAT DPT BERINTERAKSI DNG OBAT

MODERNMODERN PERLU DICARI TAHU SEJARAH PERLU DICARI TAHU SEJARAH

PENGOBATAN PASIENPENGOBATAN PASIEN

TRADITIONAL MEDICINETRADITIONAL MEDICINEREASONS FOR RENEWED PUBLIC REASONS FOR RENEWED PUBLIC INTEREST IN COMPLEMENTARY AND INTEREST IN COMPLEMENTARY AND

ALTERNATIVE (TRADITIONAL) ALTERNATIVE (TRADITIONAL) MEDICINES:MEDICINES:

1. increased side effects1. increased side effects2. lack of curative treatment for2. lack of curative treatment for several chronic diseases,several chronic diseases,3. high cost of new drugs3. high cost of new drugs4. microbial resistance 4. microbial resistance 5. emerging diseases5. emerging diseases

OF MODERN OF MODERN MEDICINESMEDICINES

characteristicscharacteristics

CHEAPCHEAP EASY TO OBTAINEASY TO OBTAIN

LOW RISK OF SIDE EFFECT LOW RISK OF SIDE EFFECT (SAFE)(SAFE)

FULFILL MONOSUBSTANCE FULFILL MONOSUBSTANCE MULTYSUBSTANCES MULTYSUBSTANCES

(COMBINATION) THERAPY(COMBINATION) THERAPY PARADIGMPARADIGM

disadvantagesdisadvantages

(1) Language difficulty(1) Language difficulty

it is difficult to translate into modernit is difficult to translate into modern

terminology terminology

(2) imprecision and lack of consistency in(2) imprecision and lack of consistency in

describing the uses of herbs; describing the uses of herbs;

(3) lack of information on chemical (3) lack of information on chemical

constitution,constitution,

(4) difficulties over identification and(4) difficulties over identification and

taxonomic status taxonomic status

SUMBER OBAT TRADISIONALSUMBER OBAT TRADISIONAL

TANAMAN (LAUT/DARAT)TANAMAN (LAUT/DARAT) HEWAN (DARAT/LAUT)HEWAN (DARAT/LAUT) MINERALMINERAL

KATEGORIKATEGORI

PRODUK HERBAL TERDAFTARPRODUK HERBAL TERDAFTAR HERBAL KERING BELUM TERDAFTARHERBAL KERING BELUM TERDAFTAR PRODUK HERBAL YG DIJUAL SEBAGAI PRODUK HERBAL YG DIJUAL SEBAGAI

SUPLEMEN, TAK ADA KHASIAT SUPLEMEN, TAK ADA KHASIAT KHUSUS KHUSUS

?? SAFESAFE

TOXIC TOXIC EFFECTIVEEFFECTIVE

PERSPECTIVEPERSPECTIVE EFEKTIVE EFEKTIVE CHEMICAL CONTENTS CHEMICAL CONTENTS TOXICTOXIC YES OR NO YES OR NO

CONTAMINATION (OTHER CONTAMINATION (OTHER CHEMICAL/MICROBES)CHEMICAL/MICROBES)

DOSE AND DURATION OF USINGDOSE AND DURATION OF USING TIME OF HARVESTING TIME OF HARVESTING METHODS OF PREPARATIONMETHODS OF PREPARATION PART OF PLANT USED ETC.PART OF PLANT USED ETC.

SAVETY SAVETY RESTORE THE RESTORE THE BALANCE OF HEALTH BALANCE OF HEALTH (HOMEOPATHIC >< ALLOPATHIC (HOMEOPATHIC >< ALLOPATHIC

adverse events adverse events may be difficult to identify. may be difficult to identify.

First, one often does not have First, one often does not have adequate information about the adequate information about the potential for a specific adverse event. potential for a specific adverse event.

Second,patients who are using Second,patients who are using complementary therapies and their complementary therapies and their providers often fail to report abnormal providers often fail to report abnormal events or symptoms as an adverse events or symptoms as an adverse event (Blendon, DesRoches, Benson, event (Blendon, DesRoches, Benson, Brodie, & Altman, 2001).Brodie, & Altman, 2001).

adverse events (Cont.)adverse events (Cont.)

Third, many experts disagree on Third, many experts disagree on whether an adverse event has whether an adverse event has actually occurred. actually occurred.

Fourth, there is currently no Fourth, there is currently no organized state or national system organized state or national system for reporting adverse effects of for reporting adverse effects of complementary and alternative complementary and alternative therapytherapy

NOTES FOR BOTANICAL MED.NOTES FOR BOTANICAL MED.

SPECIESSPECIES MATERIALS (PART OF PLANTS)MATERIALS (PART OF PLANTS) DOSEDOSE TIME OF USINGTIME OF USING DISEASEDISEASE PREPARATIONPREPARATION INTERACTION WITH OTHER DRUGS!INTERACTION WITH OTHER DRUGS!

MEDICAL TREATMENTMEDICAL TREATMENTEvidence-based medicineEvidence-based medicine (EBM) (EBM)

//Information-based medicineInformation-based medicine (IBM) (IBM)

TM experiential basis >< experimental

basis

OBJECTIVES:OBJECTIVES:The need to achieve The need to achieve optimal efficacyoptimal efficacy

while avoiding adverse drug reactions and while avoiding adverse drug reactions and medical errorsmedical errors..

TM requirementsTM requirements

Consistency AND QualityConsistency AND Quality in composition in composition and biological activity and biological activity FOR safe and FOR safe and effective use of therapeutic agents effective use of therapeutic agents ((botanical medicine).botanical medicine).

Government PoliciesGovernment Policies and regulatory frameworks safety, efficacy and quality access rational use.

WHOWHO

Traditional medicine is based on the needs

of individuals. Different people may receive different treatments even if, according to modern medicine, they suffer from the same disease.

Traditional medicine is based on a belief that each individual has his or her own constitution and social circumstances which result in different reactions to “causes of disease” and treatment.”

national policy national policy

• • to promote public awareness of and to promote public awareness of and access to traditional medicine;access to traditional medicine;

• • to evaluate the economic potential of to evaluate the economic potential of traditional medicine;traditional medicine;

• • to establish appropriate standards to establish appropriate standards for traditional medicine;for traditional medicine;

national policy national policy

• • to encourage and strengthen to encourage and strengthen research into evidence-based research into evidence-based practice of traditional medicine;practice of traditional medicine;

• • to foster respect for the cultural to foster respect for the cultural integrity of traditional medicine; andintegrity of traditional medicine; and

• • to formulate policies on the to formulate policies on the protection and conservation of health protection and conservation of health resources.resources.

Beberapa obat dari tanaman Beberapa obat dari tanaman

Obat Obat Kegunaan klinik Kegunaan klinik Spesies Spesies Aspirin Aspirin Analgetik, antiinflamsi Analgetik, antiinflamsi Filipendula ulmaria Atropin Filipendula ulmaria Atropin

Dilator pupil Dilator pupil Atropa belladonna Dikumarol Atropa belladonna Dikumarol Antitrombosit Antitrombosit Melilotus officinalis Digoksin Melilotus officinalis Digoksin Gagaljantung Gagaljantung Digitalis purpurea Digitoksin Digitalis purpurea Digitoksin Gagaljantung Gagaljantung D. purpurea D. purpurea

Ipratropium Bronkodilator Ipratropium Bronkodilator H. niger H. niger Quinidin Quinidin Antiaritmia Antiaritmia C. pubescens C. pubescens Reserpin Reserpin Antihipertensi Antihipertensi Rauvolfia canescens Rauvolfia canescens

Emetin Emetin Antiamuba Antiamuba Psychotria pecacuantha Psychotria pecacuantha Efedrin Efedrin Bronkodilator Bronkodilator Ephedra sinica Ephedra sinica

Hiosiamin Hiosiamin Antikolinergik Antikolinergik Hyoscyamus niger Hyoscyamus niger IpecacIpecac Emetik Emetik P. ipecacuantha P. ipecacuantha Vinkristin Vinkristin Leukaemia Leukaemia Catharanthus roseusCatharanthus roseus

Formulation Means of Preparation

Infusion Near-boiling water poured on herb for 5–10 minutes

Tea (tisane) Infusion of aromatic herbs Decoction Simmer herb for 15 minutes, then strain Maceration Steep herb in room-temperature water Tincture Steep herb in ethyl alcohol and water Fluid extract 1 part herb to 1 part ethyl alcohol Glycerin extract Steep herb in glycerin–water mix Juice Juice expressed by crushing herb Inhalation Breathe in vapor from heated herb mix Oil Steep herb in olive or other plant oil

Formulation Means of Preparation

Ointment Herb salve made with lanolin or beeswax Lozenge Herb preparation that dissolves in the

mouth Powder Dried powdered herb Tablet Compressed herb material in pill form Capsule Encapsulated herbal material Syrup Concentrated sugar solution to preserve

infusion Compress Cloth soaked in herbal solution Poultice Application of moist herbal paste

Herbal Preparation Type of Toxicity

Aristolochia Nephrotoxicity Bloodroot General toxicity Chaparral tea Liver toxicity Coltsfoot tea Possible carcinogen, liver

toxicity Comfrey tea Liver toxicity Ephedra (ma huang) Arrhythmias, stroke,

elevated blood pressure Lobelia Nervous system toxicity,

respiratory paralysis Pennyroyal CNS stimulation Sassafras (safrole) tea Carcinogen Yohimbe CNS stimulation,

psychosis

Plants That Can Be Used for Plants That Can Be Used for Common Ailments Common Ailments

ActionActionBotanical NameBotanical Name

AnalgesicsAnalgesics Datura suaveolen, Albizia sp., Cannabis Datura suaveolen, Albizia sp., Cannabis sativa, sativa, Papaver Papaver somniferumsomniferum

SedativesSedatives Rauwolfia vomitoria, Datura stramoniumRauwolfia vomitoria, Datura stramoniumOpportunistic Opportunistic Allium sativa (Garlic), Cannabis sativaAllium sativa (Garlic), Cannabis sativainfections/symptomsinfections/symptomsImmunomodulatorsImmunomodulators Withania somnifera, Aloe sp., Loranthus Withania somnifera, Aloe sp., Loranthus

(Mistletoe)(Mistletoe)AntibioticsAntibiotics Leonotis nepetifolia, Albizia Leonotis nepetifolia, Albizia

sp.,Erythrina sp.,Erythrina abyssinica, Aristolochia elegansabyssinica, Aristolochia elegans

AntiviralsAntivirals Withania somnifera, Aspilia africana Withania somnifera, Aspilia africana /pluriseta /pluriseta

Antipyretics (fevers)Antipyretics (fevers) Entanda abyssinica, Boerhavia repens, Entanda abyssinica, Boerhavia repens, Albizia sp.Albizia sp.

Plants That Can Be Used for Plants That Can Be Used for Common Ailments Common Ailments

ActionAction Botanical Botanical NameName

Antipyretics (fevers)Antipyretics (fevers) Entanda abyssinica, Boerhavia Entanda abyssinica, Boerhavia repens, Albizia sp.repens, Albizia sp.

Neuralgia Neuralgia Securinega virosa, Cucurbita Securinega virosa, Cucurbita maxima maxima

EnteritisEnteritis Abrus precatoriousAbrus precatoriousAnti-diarrhoeaAnti-diarrhoea Paullinia pinnata, Priva cordifolia Paullinia pinnata, Priva cordifolia Anti-emeticsAnti-emetics Ambrosia maritime, Erythrina Ambrosia maritime, Erythrina

abyssinicaabyssinicaAnti-fungalAnti-fungal Cassia alata, Bridelia Cassia alata, Bridelia

ferruginea, ferruginea, Dracaena manniDracaena manniPruritusPruritus Clerodendrum rotundifoliaClerodendrum rotundifoliaAppetiteAppetite Cannabis sativaCannabis sativa

WHO Expected outcomes

➤ Increased government support for TM/CAM, through comprehensive nationalpolicies on TM/CAM.➤ Relevant TM/CAM integrated intonational health care system services.➤ Increased recording and preservation ofindigenous knowledge of TM, includingdevelopment of digital TM libraries

Safety, efficacy and quality

➤ Evidence-base for TM/CAM. (emphasis on priority health problems such as malaria and HIV/AIDS).

➤ Regulation of herbal medicines. ( for registration and quality assurance of herbal medicines).

➤ Guidelines on safety, efficacy and quality. Develop and support implementation of technical guidelines for ensuring the safety, efficacy and quality control of herbal medicines and other TM/CAM products and therapies.

Tradisional Tradisional medicationmedication

VIRGIN COCONUT OIL, Obat VIRGIN COCONUT OIL, Obat mujarap segala penyakit ?.mujarap segala penyakit ?.

1. Batuk pilek, 3 kali sehari satu sendok makan, 1. Batuk pilek, 3 kali sehari satu sendok makan, paling cepat 3 hari hari sembuh.paling cepat 3 hari hari sembuh.

2. Luka luka kecil/ baret2/ luka jahitan, di olesi 2. Luka luka kecil/ baret2/ luka jahitan, di olesi dan di kompres dengan kapas, ganti pagi-sore. dan di kompres dengan kapas, ganti pagi-sore.

Barengi juga dengan diminum satu sendok Barengi juga dengan diminum satu sendok makan 3 kali sehari.makan 3 kali sehari.

3. Bisul, jerawat, biang keringat, boleh di olesi 3. Bisul, jerawat, biang keringat, boleh di olesi sampai di kompress dengan kapas. Barengi juga sampai di kompress dengan kapas. Barengi juga

dengan diminum 2 kali sehari satu sendol dengan diminum 2 kali sehari satu sendol makan.makan.

4. Berat badan saya yang overweight juga jadi 4. Berat badan saya yang overweight juga jadi berkurang meskipun tanpa diet makan dan berkurang meskipun tanpa diet makan dan

kurang olahraga.kurang olahraga.5. Stamina saya juga stabil, tidak lekas capai. 5. Stamina saya juga stabil, tidak lekas capai. Dari bangun pagi sampai mau tidur. Dan tidur Dari bangun pagi sampai mau tidur. Dan tidur

pun lebih pulas.pun lebih pulas.

Resep Tradisional untuk Resep Tradisional untuk Radang Usus.Radang Usus.

Bahan :Bahan :- 7 lembar daun kumis kucing- 7 lembar daun kumis kucing- 3 lembar daun imbau- 3 lembar daun imbau- 1 ruas dlingo bengkle / lengkuas- 1 ruas dlingo bengkle / lengkuas

Cara Mengolah :Cara Mengolah :bahan2 tersebut dikeringkan diatas api ( tidak boleh dikeringkan di sinar bahan2 tersebut dikeringkan diatas api ( tidak boleh dikeringkan di sinar matahari), setelah itu di tumbuk jadi satu. Tumbukkan dari bahan-bahan matahari), setelah itu di tumbuk jadi satu. Tumbukkan dari bahan-bahan ini berwarna hitam seperti serbuk arang.ini berwarna hitam seperti serbuk arang.campur bahan yg telah di tumbuk dgn sebutir telor ayam kampung dan campur bahan yg telah di tumbuk dgn sebutir telor ayam kampung dan beri madu.beri madu.Aduk rata dan jika pengadukan benar maka bau amisnya akan berkurang.Aduk rata dan jika pengadukan benar maka bau amisnya akan berkurang.

Dosis :Dosis :1 x sehari selama 3 hari berturut-turut. Kemudian tunggu dan jangan di 1 x sehari selama 3 hari berturut-turut. Kemudian tunggu dan jangan di minum lagi. Proses penyembuhannya memang agak lambat tapi manjur minum lagi. Proses penyembuhannya memang agak lambat tapi manjur dan alami. Jika terasa masih sakit. Ramuan ini bisa di ulang setelah 2 dan alami. Jika terasa masih sakit. Ramuan ini bisa di ulang setelah 2 minggu. dan untuk waktu penggunaan 3 hari saja.minggu. dan untuk waktu penggunaan 3 hari saja.

Biasanya orang tuaku membuat ramuan bubuk itu sekaligus dan bisa di Biasanya orang tuaku membuat ramuan bubuk itu sekaligus dan bisa di simpan untuk waktu yang lama asalkan di bungkus dalam bungkus kertas simpan untuk waktu yang lama asalkan di bungkus dalam bungkus kertas bersih dan dimasukkan dalam toples. Sehingga sewaktu-waktu bersih dan dimasukkan dalam toples. Sehingga sewaktu-waktu memerlukan dapat langsung digunakan. memerlukan dapat langsung digunakan.

CONCLUSIONS ?CONCLUSIONS ?

PLEASE WRITE DOWN YOUR PLEASE WRITE DOWN YOUR CONCLUSIONS !CONCLUSIONS !

THANK YOUTHANK YOU

EBM><IBM (CONT.)EBM><IBM (CONT.)

EBM: EBM: evidence gained from the gained from the scientific method conscientious, explicit and judicious use of current best conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual evidence in making decisions about the care of individual patients.“patients.“

IBM: A model of individualized healthcare whereby patients IBM: A model of individualized healthcare whereby patients receive personalized, targeted treatment solutions specific receive personalized, targeted treatment solutions specific for their individual disease states as well as their individual for their individual disease states as well as their individual genetic and metabolic parameters genetic and metabolic parameters Information Based Information Based Medicine is about providing the right information in the Medicine is about providing the right information in the right format to the right individual at the right timeright format to the right individual at the right time