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CAM dan EBM Complementary and Alternative Medicine Evidence Based Medicine

empati. CAM dan EBM Complementary and Alternative Medicine Evidence Based Medicine. Zubairi Djoerban MPPK IDI. Terima kasih. CAMOMILE: Study Shows Chamomile Capsules Ease Anxiety Symptoms. Terima kasih.

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CAM dan EBM Complementary and Alternative Medicine Evidence Based Medicine

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  1. empati CAM dan EBMComplementary and Alternative MedicineEvidence Based Medicine ZubairiDjoerban MPPK IDI

  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. 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

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

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

  8. Integrating Herbs and Supplements in Managed Care: A Pharmacy Perspective The Permanente Journal 2008.12.3 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. 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 Quality Control and Vendor Selection US Pharmacopoeia (USP) verification ensures that supplements are tested for the following:

  10. Complementary and alternative medicine (CAM) DEFINISI: anekaragamsistem, produkdanprakteklayanankesehatandanpengobatan yang saatinitidakdianggapsebagaipengobatankonvensional. Istilahkomplementerdipakaibersamadenganalternatif (menggantikanpengobatankonvensional) Pengobatankonvensionaladalahpraktekpengobatan yang dilaksanakanolehdokter, fisioterapis, perawat, psikologdsb

  11. PengobatanKomplementerdanAlternatif • RuangLingkup: tumbuhan, ekstrakasalhewan, vitamin, mineral, asamlemak, asam amino, protein, prebiotik, dietary supplement (DS) • Bentuk: ekstrak, konsentrat, tablet, kapsul, softgel, bubuk, sirup, cairan • Obatharusmengikuti Good Manufacturing Practices • DS mengikuti “manufacturing requirements” makanan • Obatdi approved POM/FDA, harusamandanefektif • DS harusaman • DS kemudianmenjadiobat: digitalis, kina

  12. PengobatanKomplementerdanAlternatif • JAMA 11 Nop 1998: CAM dipakai 42.1% masy. th 1997. • National Health Interview Survey 1999, turunmenjadi 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 ? • Manfaatterbuktilebihdaririsiko ? • Efeksamping? • Apakahpengobatandimaksudmengganggupengobatankonvensional ? • Apakahadaujiklinik? Siapa sponsor ujikliniknya?

  14. MASALAH • Beberapapasien lupus, kankerdan AIDS menghentikanpengobatandanmenggantinya dg buahmerah • Pasien2 tsbkemudianmeninggal • Khasiatbuahmerah? • Terapi urine ? Susukuda liar ? • Kewajibansiapamelindungimasyarakat ? • Versus menggalipotensiobatnasional ?

  15. HARAPAN Psiko Sosial Medik Dukungan Psikologis Pasien Penyakit Kronik DukunganKlinik Dukungan Sosial Pasienpenyakitmenahunhausharapansembuh

  16. Khasiat Buah Merah ??? • Kanker • Kolesterol • Asamurat • AIDS • Hepatitis • dll. • Tidakadabuktimanfaatuntukpengobatan

  17. BuahMerah • Pandanusconoideus • Kuansu • Papua, t.u. Jayawijaya, Ayamaru (Sorong) • Tumbuhdiketinggian 1000-3000 m diataspermukaanlaut • Panjangs.d 1,5 m Sumber http://www.westpapua.org/images/bua_merah.jpg

  18. Komposisi

  19. ANTI OKSIDAN • Antioksidanmelindungiseldarikerusakanakibatmolekultidakstabilygdisebutradikalbebas • Penelitian lab danbinatangmenunjukkanantioksidanmencegahkerusakanselolehradikalbebas, namunujikliniktidakkonsisten • Contoh: beta karoten, lycopene, vitamins C, E, and A • Antioksidanterdapatpadamakanan yang mengandungsayurdanbuah (tomat, mangga, wortel, bayem, jeruk, jambu, semangka, papaya, kacang)

  20. Beta carotene dan Kanker ParuNEJM, 334:1150-1155, 1996 Effects of a Combination of Beta Carotene and Vitamin A on Lung Cancer and Cardiovascular Disease • Kombinasi beta carotene dan vitamin A tidakadagunanyabuatperokok. • Bahkanmungkindapatmenyebabkanpeningkataninsidenkankerparudanpeningkataninsidenkematianakibatpenyakitkardiovaskulardan cardiovasculardisease, and any cause in smokers and workers exposed to asbestos

  21. Suplementasi antioksidan • Minum beta karoten MENINGKATKAN INSIDENS kankerparudan 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. 2005 Jan 4;142(1):37-46.

  23. Pengembangan dan Penilaian Obat • Senyawabaru (hasilisolasi / sintesis). • Ujipraklinik : • pada organ terpisahatauhewancoba • Melihatfarmakodinamik, farmakokinetik, toksisitaspadahewancoba • UjiKlinik : • Manusia • Fase I-IV • Memastikanefektivitas, keamanan, efeksamping

  24. UjiKlinik • Fase I • Orangsehat (20-50 orang) • Mengujikeamanan, bukanefektivitas • Fase II • Pasien (100-200 org), seleksiketat • Dibandingkan dg. plaseboatauobatstandar • Fase III : • Pasien (min. 500 org), seleksilebihlonggar • Efektif dipasarkan • Fase IV : post-marketing drug surveillance

  25. Kesimpulan • Perjalanansuatucalonobatuntukdiakuisebagaiobat yang efektifmengobatipenyakittertentusangatpanjang, membutuhkanbiayabesar. • Buahmerahsebagaiobat HIV : • Harusdiketahuizataktif yang spesifikberefekthd HIV • Harusmelaluiserangkaianpenelitian, binatang, ujiklinik • Penelitianharusmemenuhistandarmetode yang baik, agar tidak bias

  26. Evidence-based Medicine

  27. PencegahanPenyakit • PasienbertanyasetelahmelihatdanmembacaIklandi TV v/s SuratPembacaKompas, 11-8-2001 • Apakahbenaruntukhidupsehatharusmakan sayur 5x/haridanbuah 5x/hari • Jikatidakbisa, haruskahmakansuplemenserat

  28. Telusuri Internet(Cochrane, Bandolier, dll)

  29. AS: Healthy People 2010 • Buah • 1994-1996: 28% , 2 porsi buah / hari • Target 2010: 75% penduduk makan buah 2 porsi sehari. • Sayuran • 1994-1996 : hanya 3% , 3 porsi sayur / hari • Target 2010: 50% makan sayur 3 kali sehari minimal 1/3 sayur berwarna hijau tua atau oranye.

  30. TV - TIMUN

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

  32. Kesimpulan • Buahbermanfaatbuatkesehatan: tomat, papaya, jeruk, buahmerahdll. • Makanbuahsetiapharimencegahkanker, stroke danpenyakitjantungkoroner • Buahmerah, tomatdsbtidakadabuktishahih/valid untukdapatmengobati lupus, kanker, AIDS, hepatitis B, hep-C • Janganmenghentikanpengobatan lupus danmengganti dg obatkomplementer • Silahkanmakanbuahmerahuntukmelengkapinutrisi

  33. Kesimpulan • Buahmerahbelumsiapuntukmasukujiklinik RCT • Dasarilmiahdanbuktilemahbahwabuahmerahmemulihkankekebalan • Anjuranuntuk yang promosibuahmerah • Terbitkandalamjurnalilmiah yang peer reviewed • Bekerjasama dg penelitiuntukpenelitianpadabinatang

  34. Agar uji klinik shahih • JumlahsampelDesainpenelitian • Dosis Blinding • Objective Standar • Data absorpsiMetabolisme • EkskresiPenyimpanan • Zatkompleksvstunggal (Zn)

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

  36. Thankyou

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