Zubairi Djoerban MPPK IDI

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1 Zubairi Djoerban MPPK IDI
CAM dan EBM Complementary and Alternative Medicine Evidence Based Medicine Zubairi Djoerban MPPK IDI empati

2 Terima kasih CAMOMILE: Study Shows Chamomile Capsules Ease Anxiety Symptoms

3 Terima kasih Amsterdam 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 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

4 False Claims About Acai Berry
The Federal Trade Commission is requesting federal courts to temporarily halt the allegedly deceptive tactics of 10 operations using fake news websites to market acai berry weight-loss products.  The FTC seeks to permanently stop this misleading practice and has asked courts to freeze the operations’ assets pending trial. The defendants operate websites that are meant to appear as if they belong to legitimate news-gathering organizations, but in reality the sites are simply advertisements aimed at deceptively enticing consumers to buy the featured acai berry weight-loss products from other merchants. The acai palm tree, native to tropical Central and South America, produces a reddish-purple berry that is related to the blueberry and cranberry.

5 Herbal treatment for premenstrual syndrome
Search strategy We searched MEDLINE (January 1950 to December, 2007), EMBASE (January 1980 to December, 2007), Chinese Biomedical Database (CBM) (January 1975 to December, 2007), China National Knowledge Infrastructure (CNKI) (January 1994 to December, 2007), and the VIP Database (January 1989 to December, 2007). Selection criteria RCTs studying the efficacy of traditional Chinese herbal medicine(s) for treatment of the premenstrual syndrome Data collection and analysis: Two review authors telephoned the original authors of the RCTs to confirm the randomisation procedure, extracted and analysed data from the trials Main results: Two RCT considering 549 women were included. One trial which was identified to be of higher methodological quality demonstrated the therapeutic effectiveness of Jingqianping granule. The other study was considered of lower quality due to the inherent risk of various biases in it.

6 Terima kasih Products that have been reviewed and are currently in stock at KPNW pharmacies. The Permanente J. 2008 St John’s wort for symptomatic relief depression Saw palmetto for urinary symptoms related PH Glucosamine sulfate for pain related to osteoarthritis Gingko biloba to improve memory and attention in patients with cognitive impairment Omega-3 fatty acids,11 as in fish oil and flaxseed oil, for high triglyceride levels and secondary prevention of ischemic heart disease Melatonin for jet leg and insomnia.

7 CAM EBM Produk Layanan Kes Sistem High Quality Product Available??
Glucosamin Ginko, Melatonin Omega-3 Lain lain Layanan Kes Sistem Produk CAM

8 Integrating Herbs and Supplements in Managed Care: A Pharmacy Perspective The Permanente Journal Guidelines for Assessing Natural Products, 4 criteria 1. Is there sufficient evidence from randomized controlled trials to suggest efficacy? 2. Are there significant concerns regarding product safety and drug–herb interactions? 3. Is a high-quality product available? 4. Is there sufficient interest in the supplement among patients and/or clinicians?

9 Quality Control and Vendor Selection
US Pharmacopoeia (USP) verification ensures that supplements are tested for the following: 1. The label accurately lists what is in the bottle: all the listed ingredients are present in the declared amount 2. The supplement does not contain harmful levels of contaminants. 3. The supplement will break down and release ingredients in the body. 4. The supplement has been made under acceptable manufacturing practices

10 Complementary and alternative medicine (CAM)
DEFINISI: aneka ragam sistem, produk dan praktek layanan kesehatan dan pengobatan yang saat ini tidak dianggap sebagai pengobatan konvensional. Istilah komplementer dipakai bersama dengan alternatif (menggantikan pengobatan konvensional) Pengobatan konvensional adalah praktek pengobatan yang dilaksanakan oleh dokter, fisioterapis, perawat, psikolog dsb

11 Pengobatan Komplementer dan Alternatif
Ruang Lingkup: tumbuhan, ekstrak asal hewan, vitamin, mineral, asam lemak, asam amino, protein, prebiotik, dietary supplement (DS) Bentuk: ekstrak, konsentrat, tablet, kapsul, softgel, bubuk, sirup, cairan Obat harus mengikuti Good Manufacturing Practices DS mengikuti “manufacturing requirements” makanan Obat di approved POM/FDA, harus aman dan efektif DS harus aman DS kemudian menjadi obat: digitalis, kina

12 Pengobatan Komplementer dan Alternatif
JAMA 11 Nop 1998: CAM dipakai 42.1% masy. th 1997. National Health Interview Survey 1999, turun menjadi 28.9% (Med Care 2002) US: Big Business, $ 18.7 billion / tahun While scientific evidence exists regarding some CAM therapies, for many there are key questions that are yet to be answered through well-designed scientific studies, such as whether these therapies are safe and work for the purposes for which they are used. NCCAM's mission is to explore CAM practices using rigorous scientific methods and build an evidence base for the safety and effectiveness of these practices.

13 Apa yang perlu diketahui pasien sebelum memakai CAM ?
Manfaat yang diharapkan ? Risiko ? Manfaat terbukti lebih dari risiko ? Efek samping? Apakah pengobatan dimaksud mengganggu pengobatan konvensional ? Apakah ada uji klinik? Siapa sponsor uji kliniknya?

14 MASALAH Beberapa pasien lupus, kanker dan AIDS menghentikan pengobatan dan menggantinya dg buah merah Pasien2 tsb kemudian meninggal Khasiat buah merah? Terapi urine ? Susu kuda liar ? Kewajiban siapa melindungi masyarakat ? Versus menggali potensi obat nasional ?

15 Pasien penyakit menahun haus harapan sembuh
Dukungan Psikologis Dukungan Klinik Dukungan Sosial Medik Psiko HARAPAN Pasien Penyakit Kronik

16 Khasiat Buah Merah ??? Kanker Kolesterol Asam urat AIDS Hepatitis dll.
Tidak ada bukti manfaat untuk pengobatan

17 Buah Merah Pandanus conoideus Kuansu
Papua, t.u. Jayawijaya, Ayamaru (Sorong) Tumbuh di ketinggian m di atas permukaan laut Panjang s.d 1,5 m Sumber

18 Komposisi Komposisi Kimia Kandungan Karotenoid total 12.000 ppm
antioksidan Tokoferol total ppm Betakaroten 700 ppm Alfa tokoferol 500 ppm Asam oleat 58% asam lemak Asam linoleat 8,8% Asam linolenat 7,8% Dekanoat 2,0%

19 ANTI OKSIDAN Antioksidan melindungi sel dari kerusakan akibat molekul tidak stabil yg disebut radikal bebas Penelitian lab dan binatang menunjukkan antioksidan mencegah kerusakan sel oleh radikal bebas, namun uji klinik tidak konsisten Contoh: beta karoten, lycopene, vitamins C, E, and A Antioksidan terdapat pada makanan yang mengandung sayur dan buah (tomat, mangga, wortel, bayem, jeruk, jambu, semangka, papaya, kacang) Farmakodinamik: efek obat terhadap fisiologi dan biokimia berbagai organ tubuh serta mekanisme kerjanya Farmakokinteik: nasib obat dalam tubuh (absorpsi, distribusi, metabolisme, ekskresi)

20 Beta carotene dan Kanker Paru NEJM, 334: , Effects of a Combination of Beta Carotene and Vitamin A on Lung Cancer and Cardiovascular Disease Kombinasi beta carotene dan vitamin A tidak ada gunanya buat perokok. Bahkan mungkin dapat menyebabkan peningkatan insiden kanker paru dan peningkatan insiden kematian akibat penyakit kardiovaskular dan cardiovascular disease, and any cause in smokers and workers exposed to asbestos

21 Suplementasi antioksidan
Minum beta karoten MENINGKATKAN INSIDENS kanker paru dan MENINGKATKAN MORTALITAS pada PEROKOK. 1a Journal of the National Cancer Institute, Vol. 95, No. 1, Jan 1, 2003

22 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 Jan 4;142(1):37-46.

23 Pengembangan dan Penilaian Obat
Senyawa baru (hasil isolasi / sintesis). Uji praklinik : pada organ terpisah atau hewan coba Melihat farmakodinamik, farmakokinetik, toksisitas pada hewan coba Uji Klinik : Manusia Fase I-IV Memastikan efektivitas, keamanan, efek samping Farmakodinamik: efek obat terhadap fisiologi dan biokimia berbagai organ tubuh serta mekanisme kerjanya Farmakokinteik: nasib obat dalam tubuh (absorpsi, distribusi, metabolisme, ekskresi)

24 Uji Klinik Fase I Fase II Fase III :
Orang sehat (20-50 orang) Menguji keamanan, bukan efektivitas Fase II Pasien ( org), seleksi ketat Dibandingkan dg. plasebo atau obat standar Fase III : Pasien (min. 500 org), seleksi lebih longgar Efektif  dipasarkan Fase IV : post-marketing drug surveillance

25 Kesimpulan Perjalanan suatu calon obat untuk diakui sebagai obat yang efektif mengobati penyakit tertentu sangat panjang, membutuhkan biaya besar. Buah merah sebagai obat HIV : Harus diketahui zat aktif yang spesifik berefek thd HIV Harus melalui serangkaian penelitian, binatang, uji klinik Penelitian harus memenuhi standar metode yang baik, agar tidak bias

26 Evidence-based Medicine

27 Pencegahan Penyakit Pasien bertanya setelah melihat dan membaca Iklan di TV v/s Surat Pembaca Kompas, Apakah benar untuk hidup sehat harus makan sayur 5x/hari dan buah 5x/hari Jika tidak bisa, haruskah makan suplemen serat

28 Telusuri Internet (Cochrane, Bandolier, dll)

29 AS: Healthy People 2010 Buah Sayuran
: 28% , 2 porsi buah / hari Target 2010: 75% penduduk makan buah 2 porsi sehari. Sayuran : hanya 3% , 3 porsi sayur / hari Target 2010: 50% makan sayur 3 kali sehari minimal 1/3 sayur berwarna hijau tua atau oranye.

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31 TV - TIMUN

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33 Level of Evidence I Evidence from at least 1 properly randomized
controlled trial (RCT). II-1 Evidence from well-designed controlled trials without randomization. II-2 Evidence from well-designed cohort or case-control analytic studies, preferably from more than 1 centre or research group. II-3 Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments could also be included here. III Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert

34 Kesimpulan Buah bermanfaat buat kesehatan: tomat, papaya, jeruk, buah merah dll. Makan buah setiap hari mencegah kanker, stroke dan penyakit jantung koroner Buah merah, tomat dsb tidak ada bukti shahih/valid untuk dapat mengobati lupus, kanker, AIDS, hepatitis B, hep-C Jangan menghentikan pengobatan lupus dan mengganti dg obat komplementer Silahkan makan buah merah untuk melengkapi nutrisi

35 Kesimpulan Buah merah belum siap untuk masuk uji klinik RCT
Dasar ilmiah dan bukti lemah bahwa buah merah memulihkan kekebalan Anjuran untuk yang promosi buah merah Terbitkan dalam jurnal ilmiah yang peer reviewed Bekerjasama dg peneliti untuk penelitian pada binatang

36 Agar uji klinik shahih Jumlah sampel Desain penelitian Dosis Blinding
Objective Standar Data absorpsi Metabolisme Ekskresi Penyimpanan Zat kompleks vs tunggal (Zn)

37 "...neither rejects conventional medicine, nor embraces alternative practices uncritically."[32] (Andrew Weil)

38  Thankyou