CAM dan EBMCAM dan EBM

Complementary and Alternative MedicineComplementary and Alternative Medicine

Evidence Based MedicineEvidence Based Medicine

Zubairi DjoerbanZubairi Djoerban

MPPK IDIMPPK IDI

Terima kasihTerima kasihCAMOMILE: Study Shows Chamomile Capsules Ease Anxiety Symptoms

Terima kasihTerima kasihAmsterdam JD et al. A Randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. J Clinical Psycho pharmacology. 2009 Aug;29(4):378–382

Researchers at the Univ Pennsylvania. For 8 weeks, the 57 participants received either chamomile capsules containing 220 mg Matricaria recutita (German chamomile), standardized to 1.2 percent of the constituent apigenin; or placebo capsules

Compared with placebo, chamomile was associated with a greater reduction in mean HAM-A scores—the study's primary outcome measure. The difference was clinically meaningful and statistically significant

False Claims About Acai BerryFalse Claims About Acai Berry

The Federal Trade Commission is requesting federal courts to The Federal Trade Commission is requesting federal courts to

temporarily halt the allegedly deceptive tactics of 10 operations temporarily halt the allegedly deceptive tactics of 10 operations

using fake news websites to market acai berry weight-loss using fake news websites to market acai berry weight-loss

products.  The FTC seeks to permanently stop this misleading products.  The FTC seeks to permanently stop this misleading

practice and has asked courts to freeze the operations’ assets practice and has asked courts to freeze the operations’ assets

pending trial.pending trial.

The defendants operate websites that are meant to appear as if The defendants operate websites that are meant to appear as if

they belong to legitimate news-gathering organizations, but in they belong to legitimate news-gathering organizations, but in

reality the sites are simply advertisements aimed at deceptively reality the sites are simply advertisements aimed at deceptively

enticing consumers to buy the featured acai berry weight-loss enticing consumers to buy the featured acai berry weight-loss

products from other merchants. The acai palm tree, native to products from other merchants. The acai palm tree, native to

tropical Central and South America, produces a reddish-purple tropical Central and South America, produces a reddish-purple

berry that is related to the blueberry and cranberry. berry that is related to the blueberry and cranberry.

Herbal treatment for premenstrual syndromeHerbal treatment for premenstrual syndrome

Search strategy Search strategy We searched MEDLINE (January 1950 to We searched MEDLINE (January 1950 to December, 2007), EMBASE (January 1980 to December, December, 2007), EMBASE (January 1980 to December, 2007), Chinese Biomedical Database (CBM) (January 1975 to 2007), Chinese Biomedical Database (CBM) (January 1975 to December, 2007), China National Knowledge Infrastructure December, 2007), China National Knowledge Infrastructure (CNKI) (January 1994 to December, 2007), and the VIP (CNKI) (January 1994 to December, 2007), and the VIP Database (January 1989 to December, 2007).Database (January 1989 to December, 2007).

Selection criteria Selection criteria RCTs studying the efficacy of traditional RCTs studying the efficacy of traditional Chinese herbal medicine(s) for treatment of the premenstrual Chinese herbal medicine(s) for treatment of the premenstrual syndromesyndrome

Data collection and analysis: Data collection and analysis: Two review authors telephoned Two review authors telephoned the original authors of the RCTs to confirm the randomisation the original authors of the RCTs to confirm the randomisation procedure, extracted and analysed data from the trialsprocedure, extracted and analysed data from the trials

Main results: Main results: Two RCT considering 549 women were included. Two RCT considering 549 women were included. One trial which was identified to be of higher methodological One trial which was identified to be of higher methodological quality demonstrated the therapeutic effectiveness of quality demonstrated the therapeutic effectiveness of Jingqianping granule. The other study was considered of lower Jingqianping granule. The other study was considered of lower quality due to the inherent risk of various biases in it. quality due to the inherent risk of various biases in it.

St John’s wort for symptomatic relief depressionSt John’s wort for symptomatic relief depression

Saw palmetto for urinary symptoms related PHSaw palmetto for urinary symptoms related PH

Glucosamine sulfate for pain related to osteoarthritisGlucosamine sulfate for pain related to osteoarthritis

Gingko biloba to improve memory and attention in Gingko biloba to improve memory and attention in

patients with cognitive impairmentpatients with cognitive impairment

Omega-3 fatty acids,11 as in fish oil and flaxseed oil, for Omega-3 fatty acids,11 as in fish oil and flaxseed oil, for

high triglyceride levels and secondary prevention of high triglyceride levels and secondary prevention of

ischemic heart diseaseischemic heart disease

Melatonin for jet leg and insomnia.Melatonin for jet leg and insomnia.

Terima kasihTerima kasihProducts that have been reviewed and are currently in stock at KPNW pharmacies. The Permanente J. 2008

EBM

High QualityProduct

Available??

GlucosaminGinko, Melatonin

Omega-3

Lain lainL

aya

nan

Ke

sS

iste

m

Produk

CAM

Integrating Herbs and Supplements in Managed Integrating Herbs and Supplements in Managed Care: A Pharmacy Perspective Care: A Pharmacy Perspective The Permanente Journal 2008.12.3The Permanente Journal 2008.12.3

Guidelines for Assessing Natural ProductsGuidelines for Assessing Natural Products, 4, 4 criteria criteria

1. Is there sufficient evidence from randomized 1. Is there sufficient evidence from randomized

controlled trials to suggest efficacy?controlled trials to suggest efficacy?

2. Are there significant concerns regarding product 2. Are there significant concerns regarding product

safety and drug–herb interactions?safety and drug–herb interactions?

3. Is a high-quality product available?3. Is a high-quality product available?

4. Is there sufficient interest in the supplement among 4. Is there sufficient interest in the supplement among

patients and/or clinicians?patients and/or clinicians?

1. The label accurately lists what is in the bottle: all the 1. The label accurately lists what is in the bottle: all the

listed ingredients are present in the declared amountlisted ingredients are present in the declared amount

2. The supplement does not contain harmful levels of 2. The supplement does not contain harmful levels of

contaminants.contaminants.

3. The supplement will break down and release 3. The supplement will break down and release

ingredients in the body.ingredients in the body.

4. The supplement has been made under acceptable 4. The supplement has been made under acceptable

manufacturing practicesmanufacturing practices

Quality Control and Vendor SelectionUS Pharmacopoeia (USP) verification ensures that supplements are tested for the following:

Complementary and alternative Complementary and alternative medicine (CAM)medicine (CAM)

DEFINISI: aneka ragam sistem, produk dan praktek DEFINISI: aneka ragam sistem, produk dan praktek

layanan kesehatan dan pengobatan yang saat ini layanan kesehatan dan pengobatan yang saat ini

tidak dianggap sebagai pengobatan konvensional. tidak dianggap sebagai pengobatan konvensional.

Istilah komplementer dipakai bersama dengan Istilah komplementer dipakai bersama dengan

alternatif (menggantikan pengobatan konvensional)alternatif (menggantikan pengobatan konvensional)

Pengobatan konvensional adalah praktek Pengobatan konvensional adalah praktek

pengobatan yang dilaksanakan oleh dokter, pengobatan yang dilaksanakan oleh dokter,

fisioterapis, perawat, psikolog dsbfisioterapis, perawat, psikolog dsb

Pengobatan Komplementer dan Alternatif Pengobatan Komplementer dan Alternatif

– Ruang Lingkup: tumbuhan, ekstrak asal hewan, Ruang Lingkup: tumbuhan, ekstrak asal hewan,

vitamin, mineral, asam lemak, asam amino, protein, vitamin, mineral, asam lemak, asam amino, protein,

prebiotik, dietary supplement (DS)prebiotik, dietary supplement (DS)

– Bentuk: ekstrak, konsentrat, tablet, kapsul, softgel, Bentuk: ekstrak, konsentrat, tablet, kapsul, softgel,

bubuk, sirup, cairanbubuk, sirup, cairan

– Obat harus mengikuti Good Manufacturing PracticesObat harus mengikuti Good Manufacturing Practices

– DS mengikuti “manufacturing requirements” makananDS mengikuti “manufacturing requirements” makanan

– Obat di approved POM/FDA, harus aman dan efektifObat di approved POM/FDA, harus aman dan efektif

– DS harus amanDS harus aman

– DS kemudian menjadi obat: digitalis, kinaDS kemudian menjadi obat: digitalis, kina

Pengobatan Komplementer dan Alternatif Pengobatan Komplementer dan Alternatif – JAMA 11 Nop 1998: CAM dipakai 42.1% masy. th 1997. JAMA 11 Nop 1998: CAM dipakai 42.1% masy. th 1997.

– National Health Interview Survey 1999, turun menjadi 28.9% National Health Interview Survey 1999, turun menjadi 28.9%

(Med Care 2002) (Med Care 2002)

– US: Big Business, $ 18.7 billion / tahunUS: Big Business, $ 18.7 billion / tahun

– While scientific evidence exists regarding some CAM therapies, While scientific evidence exists regarding some CAM therapies,

for many there are key questions that are yet to be answered for many there are key questions that are yet to be answered

through well-designed scientific studies, such as whether these through well-designed scientific studies, such as whether these

therapies are safe and work for the purposes for which they are therapies are safe and work for the purposes for which they are

usedused. NCCAM's mission is to explore CAM practices using . NCCAM's mission is to explore CAM practices using

rigorous scientific methods and build an evidence base for the rigorous scientific methods and build an evidence base for the

safety and effectiveness of these practices.safety and effectiveness of these practices.

Apa yang perlu diketahui pasien Apa yang perlu diketahui pasien sebelum memakai CAM ?sebelum memakai CAM ?

Manfaat yang diharapkan ? Manfaat yang diharapkan ?

Risiko ? Risiko ?

Manfaat terbukti lebih dari risiko ? Manfaat terbukti lebih dari risiko ?

Efek samping? Efek samping?

Apakah pengobatan dimaksud mengganggu Apakah pengobatan dimaksud mengganggu

pengobatan konvensional ? pengobatan konvensional ?

Apakah ada uji klinik? Siapa sponsor uji kliniknya? Apakah ada uji klinik? Siapa sponsor uji kliniknya?

MASALAHMASALAH

– Beberapa pasien lupus, kanker dan AIDS Beberapa pasien lupus, kanker dan AIDS

menghentikan pengobatan dan menggantinya dg buah menghentikan pengobatan dan menggantinya dg buah

merahmerah

– Pasien2 tsb kemudian meninggal Pasien2 tsb kemudian meninggal

– Khasiat buah merah?Khasiat buah merah?

– Terapi urine ? Susu kuda liar ?Terapi urine ? Susu kuda liar ?

– Kewajiban siapa melindungi masyarakat ?Kewajiban siapa melindungi masyarakat ?

– Versus menggali potensi obat nasional ?Versus menggali potensi obat nasional ?

Pasien penyakit menahun haus harapan sembuhPasien penyakit menahun haus harapan sembuh

Dukungan Psikologis

Dukungan Klinik

DukunganSosial

Medik

So

sial

Ps

iko

HARAPAN

PasienPenyakitKronik

Khasiat Buah Khasiat Buah Merah ???Merah ???

KankerKanker

Kolesterol Kolesterol

Asam urat Asam urat

AIDSAIDS

HepatitisHepatitis

dll.dll.

Tidak ada bukti manfaat untuk pengobatanTidak ada bukti manfaat untuk pengobatan

Buah MerahBuah MerahPandanusPandanus conoideusconoideus

KuansuKuansu

Papua, t.u. Jayawijaya, Ayamaru (Sorong)Papua, t.u. Jayawijaya, Ayamaru (Sorong)

Tumbuh di ketinggian 1000-3000 m di atas Tumbuh di ketinggian 1000-3000 m di atas

permukaan lautpermukaan laut

Panjang s.d 1,5 mPanjang s.d 1,5 m

Sumber http://www.westpapua.org/images/bua_merah.jpg

KomposisiKomposisiKomposisi Kimia Kandungan

Karotenoid total 12.000 ppm

antioksidanTokoferol total 11.000 ppm

Betakaroten 700 ppm

Alfa tokoferol 500 ppm

Asam oleat 58%

asam lemakAsam linoleat 8,8%

Asam linolenat 7,8%

Dekanoat 2,0%

ANTI OKSIDANANTI OKSIDAN

Antioksidan melindungi sel dari kerusakan akibat molekul Antioksidan melindungi sel dari kerusakan akibat molekul

tidak stabil yg disebut radikal bebastidak stabil yg disebut radikal bebas

Penelitian lab dan binatang menunjukkan antioksidan Penelitian lab dan binatang menunjukkan antioksidan

mencegah kerusakan sel oleh radikal bebas, namun uji mencegah kerusakan sel oleh radikal bebas, namun uji

klinik tidak konsistenklinik tidak konsisten

Contoh: beta karoten, lycopene, vitamins C, E, and A Contoh: beta karoten, lycopene, vitamins C, E, and A

Antioksidan terdapat pada makanan yang mengandung Antioksidan terdapat pada makanan yang mengandung

sayur dan buah (tomat, mangga, wortel, bayem, jeruk, sayur dan buah (tomat, mangga, wortel, bayem, jeruk,

jambu, semangka, papaya, kacang)jambu, semangka, papaya, kacang)

Beta carotene dan Kanker ParuBeta carotene dan Kanker ParuNEJM, 334:1150-1155, 1996 ENEJM, 334:1150-1155, 1996 Effects of a Combination of Beta Carotene and Vitamin A ffects of a Combination of Beta Carotene and Vitamin A

on Lung Cancer and Cardiovascular Diseaseon Lung Cancer and Cardiovascular Disease

Kombinasi beta carotene dan vitamin A tidak ada Kombinasi beta carotene dan vitamin A tidak ada

gunanya buat perokok.gunanya buat perokok.

Bahkan mungkin dapat menyebabkan peningkatan Bahkan mungkin dapat menyebabkan peningkatan

insiden kanker paru dan peningkatan insiden insiden kanker paru dan peningkatan insiden

kematian akibat penyakit kardiovaskular dan kematian akibat penyakit kardiovaskular dan

cardiovascularcardiovascular disease, and any cause in smokers disease, and any cause in smokers

and workers exposed to asbestosand workers exposed to asbestos

Suplementasi antioksidanSuplementasi antioksidan

Minum beta karoten MENINGKATKAN Minum beta karoten MENINGKATKAN

INSIDENS kanker paru dan INSIDENS kanker paru dan

MENINGKATKAN MORTALITAS pada MENINGKATKAN MORTALITAS pada

PEROKOK. PEROKOK. 1a1a

Journal of the National Cancer Institute, Vol. 95, No. 1, Jan 1, Journal of the National Cancer Institute, Vol. 95, No. 1, Jan 1,

20032003

Tidak boleh lagi memberikan Vitamin E 400 IU sehari

Meta-analisis mengenai konsumsi vitamin E yang

menyatakan bahwa konsumsi vitamin E dosis

tinggi (>400 International Unit) per hari akan

meningkatkan risiko kematian sehingga harus

dihindari.

Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E.

Meta-analysis: high-dosage vitamin E supplementation may increase all-cause

mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46.

Pengembangan dan Pengembangan dan Penilaian ObatPenilaian Obat

Senyawa baru (hasil isolasi / sintesis).Senyawa baru (hasil isolasi / sintesis).

Uji praklinik : Uji praklinik : – pada organ terpisah atau hewan cobapada organ terpisah atau hewan coba– Melihat farmakodinamik, farmakokinetik, toksisitas Melihat farmakodinamik, farmakokinetik, toksisitas

pada hewan cobapada hewan coba

Uji Klinik :Uji Klinik :– ManusiaManusia– Fase I-IVFase I-IV– Memastikan efektivitas, keamanan, efek sampingMemastikan efektivitas, keamanan, efek samping

Uji KlinikUji KlinikFase IFase I– Orang sehat (20-50 orang)Orang sehat (20-50 orang)– Menguji keamanan, bukan efektivitasMenguji keamanan, bukan efektivitas

Fase IIFase II– Pasien (100-200 org), seleksi ketatPasien (100-200 org), seleksi ketat– Dibandingkan dg. plasebo atau obat standarDibandingkan dg. plasebo atau obat standar

Fase III :Fase III :– Pasien (min. 500 org), seleksi lebih longgarPasien (min. 500 org), seleksi lebih longgar– Efektif Efektif dipasarkan dipasarkan

Fase IV : post-marketing drug surveillanceFase IV : post-marketing drug surveillance

KesimpulanKesimpulanPerjalanan suatu calon obat untuk diakui sebagai obat Perjalanan suatu calon obat untuk diakui sebagai obat

yang efektif mengobati penyakit tertentu sangat yang efektif mengobati penyakit tertentu sangat

panjang, membutuhkan biaya besar.panjang, membutuhkan biaya besar.

Buah merah sebagai obat HIV :Buah merah sebagai obat HIV :– Harus diketahui zat aktif yang spesifik berefek thd HIVHarus diketahui zat aktif yang spesifik berefek thd HIV– Harus melalui serangkaian penelitian, binatang, uji klinikHarus melalui serangkaian penelitian, binatang, uji klinik– Penelitian harus memenuhi standar metode yang baik, agar Penelitian harus memenuhi standar metode yang baik, agar

tidak bias tidak bias

Evidence-based Evidence-based MedicineMedicine

Pencegahan PenyakitPencegahan Penyakit

Pasien bertanya setelah melihat dan membaca Iklan Pasien bertanya setelah melihat dan membaca Iklan

di TV v/s Surat Pembaca Kompas, 11-8-2001di TV v/s Surat Pembaca Kompas, 11-8-2001

– Apakah benar untuk hidup sehat harus makanApakah benar untuk hidup sehat harus makan

sayur 5x/hari dan buah 5x/harisayur 5x/hari dan buah 5x/hari

– Jika tidak bisa, haruskah makan suplemen serat Jika tidak bisa, haruskah makan suplemen serat

Telusuri InternetTelusuri Internet

(Cochrane, Bandolier, dll)(Cochrane, Bandolier, dll)

AS: Healthy People 2010AS: Healthy People 2010

BuahBuah– 1994-1996: 1994-1996: 2828% , 2 porsi buah / hari% , 2 porsi buah / hari– Target 2010: Target 2010: 7575% penduduk makan buah 2 porsi sehari. % penduduk makan buah 2 porsi sehari.

SayuranSayuran– 1994-1996 : hanya 1994-1996 : hanya 33% , 3 porsi sayur / hari% , 3 porsi sayur / hari– Target 2010: Target 2010: 5050% makan sayur 3 kali sehari% makan sayur 3 kali sehari

minimal 1/3 sayur berwarna hijau tua atau minimal 1/3 sayur berwarna hijau tua atau oranye.oranye.

TV - TIMUN

Level of EvidenceLevel of EvidenceII Evidence from at least 1 properly randomized Evidence from at least 1 properly randomized

controlled trial (RCT). controlled trial (RCT). II-1II-1 Evidence from well-designed controlled trials without Evidence from well-designed controlled trials without

randomization. randomization. II-2II-2 Evidence from well-designed cohort or case-control Evidence from well-designed cohort or case-control

analytic studies, preferably from more than 1 centre or analytic studies, preferably from more than 1 centre or research group. research group.

II-3II-3 Evidence from comparisons between times or places Evidence from comparisons between times or places with or without the intervention. Dramatic results in with or without the intervention. Dramatic results in uncontrolled experiments could also be included here. uncontrolled experiments could also be included here.

IIIIII Opinions of respected authorities, based on clinical Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert experience, descriptive studies or reports of expert

KesimpulanKesimpulan– Buah bermanfaat buat kesehatan: tomat, papaya, Buah bermanfaat buat kesehatan: tomat, papaya,

jeruk, buah merah dll.jeruk, buah merah dll.

– Makan buah setiap hari mencegah kanker, stroke dan Makan buah setiap hari mencegah kanker, stroke dan

penyakit jantung koronerpenyakit jantung koroner

– Buah merah, tomat dsb tidak ada bukti shahih/valid Buah merah, tomat dsb tidak ada bukti shahih/valid

untuk dapat mengobati lupus, kanker, AIDS, hepatitis untuk dapat mengobati lupus, kanker, AIDS, hepatitis

B, hep-CB, hep-C

– Jangan menghentikan pengobatan lupus dan Jangan menghentikan pengobatan lupus dan

mengganti dg obat komplementermengganti dg obat komplementer

– Silahkan makan buah merah untuk melengkapi nutrisiSilahkan makan buah merah untuk melengkapi nutrisi

KesimpulanKesimpulan

– Buah merah belum siap untuk masuk uji klinik RCTBuah merah belum siap untuk masuk uji klinik RCT

– Dasar ilmiah dan bukti lemah bahwa buah merah Dasar ilmiah dan bukti lemah bahwa buah merah

memulihkan kekebalanmemulihkan kekebalan

– Anjuran untuk yang promosi buah merahAnjuran untuk yang promosi buah merah

Terbitkan dalam jurnal ilmiah yang peer reviewedTerbitkan dalam jurnal ilmiah yang peer reviewed

Bekerjasama dg peneliti untuk penelitian pada binatang Bekerjasama dg peneliti untuk penelitian pada binatang

Agar uji klinik shahihAgar uji klinik shahih

– Jumlah sampel Jumlah sampel Desain penelitianDesain penelitian

– DosisDosis BlindingBlinding

– ObjectiveObjective StandarStandar

– Data absorpsiData absorpsi MetabolismeMetabolisme

– EkskresiEkskresi PenyimpananPenyimpanan

– Zat kompleks vs tunggal (Zn)Zat kompleks vs tunggal (Zn)

"...neither rejects conventional "...neither rejects conventional

medicine, nor embraces alternative medicine, nor embraces alternative

practices uncritically."practices uncritically."[32] (Andrew (Andrew

Weil)Weil)

ThankyouThankyou