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Towards the appropriate use of effective and safe TM/CAM therapies of good quality Dr Torkel Falkenberg Leader, Centre for Studies of Complementary Medicine Deputy head, Division of International Health (IHCAR) Lecturer in Complementary Medicine Karolinska Institutet

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Pharmaceutical Sector R&D Laos, Vietnam, Thailand, Boliva, Peru, Uganda, Zambia, Bosnia, WHO & World Bank Complementary Medicine R&D Utilisation Policy development Integrative medicine Education

Traditional and complementary medicine is widely and increasingly used in all regions of the world: 

Traditional and complementary medicine is widely and increasingly used in all regions of the world Sources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001; World Health Organization, 1998; and government reports submitted to WHO.

USA: 

USA 427 million visits 1990 vs 628 million 1997 (385 million visits to primary care physicians) More than 21 billion USD spent on visits 1997 Top four = chiropractic, acupuncture, hypnosis, massage 70% did not inform their doctor about the visit

China: 

China TM hospitals increased from 678 in 1980 to 2522 in 1995 Staff increased from 73458 in 1980 to 353375 in 1995 Approximately 200 miljon patients treated at TM hospitals/wards per year Herbal medicines constitute 30% of total pharma market in 1995

Laos: 

Laos Stratified two-stage sampling procedures were performed for selecting 600 households from one lowland, (Pakse) and one mountainous, (Paksong) district. The number of interviewees that had ever used traditional medicine was 460 (77 %) of which 233 were women. 87 % medicinal plants; 8 % sauna; 3.5 % massage; 2.8 % acupuncture; 16 % other methods.

The herbal medicines market: 

The herbal medicines market Million USD

TM/CAM : 

TM/CAM Increase in utilisation world-wide Consumer movement Lack of regulations Free market situation Unlimited market growth

Common risks associated with TM/CAM where patients may:: 

Common risks associated with TM/CAM where patients may: See unqualified practitioners Risk missed or delayed diagnosis Stop or refuse effective conventional treatment Waste money on ineffective treatments Experience dangerous adverse effects from treatments including unwanted interactions Derived from Zolleman and Vickers, ABC of Complementary Medicine, Brittish Medical Journal Books, 2000

Towards the appropriate use of effective and safe TM/CAM therapies of good quality: 

increase patient saftey affordable alternative to pharmaceuticals improve patient satisfaction provide cost-effective care Developmental goals Towards the appropriate use of effective and safe TM/CAM therapies of good quality

WHO Traditional Medicine Strategy 2002-2005: 

WHO Traditional Medicine Strategy 2002-2005 integrate TM/CAM with national health care systems provide evaluation, guidance and support for effective regulation ensure availability and affordability of TM/CAM, including essential herbal medicines promote therapeutically-sound use of TM/CAM by providers and consumers Policy: Safety, efficacy and quality: Access: Rational use:

Evidence Based Medicine (EBM) Different levels and types of evidence Challenges : 

Evidence Based Medicine (EBM) Different levels and types of evidence Challenges Holistic systems (body, mind, spirit) Commonly many active components and unspecific effects The clinical RCT approach effective in assessing specific effects but limited in assessing unspecific effects

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RCT EVIDENCE Source: Research into complementary/alternative medicine: an attempt to dispel the myths. Ernst E. Int J Clin Pract 2001; 55(6)376-379

RCT COSTS: 

RCT COSTS

Who pays for research?: 

Who pays for research? No industry backing Who will sponsor R&D in the area of acupuncture, massage, reflexology, yoga, etc? Despite popularity only 0.08% of NHS budget in the UK goes to CAM research To support evidence-based CAM it is crucial to find adequate funds for research

RESEARCH ISSUES : 

RESEARCH ISSUES Policy research Setting research outcome priorities cost-effectiveness vs clinical efficacy Selecting and complementing appropriate EBM evaluation designs: circular approach RCT, randomization by group, singel case, qualitative methods, etc Method development Earmarked financing

Towards the appropriate use of effective and safe TM/CAM therapies of good quality: 

Towards the appropriate use of effective and safe TM/CAM therapies of good quality CARING RESEARCH HEALTH SYSTEMS RESEARCH RCT RESEARCH TRIANGULATION

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Bridging gaps between public and traditional health care sectors – testing a model to improve quality of STI/HIV/AIDS care in sub-saharan Africa. Towards integrative medicine – a pilot project exploring a collaborative model between primary health care providers and complementary therapy providers. Best and worst case series: Exploring exceptional experiences of complementary and alternative therapies in patients with cancer. Comparative analysis of national polices for Traditional, Complementary and Alternative Medicine – a global survey. RESEARCH Elisabeth Faxelid, David Finer, Johanna Hök, Jeremy Halpin, Ulf Leander, Marie-Louise Munzing, Suzanne Schönström, Tobias Sundberg, Carol Tishelman, Anders Warenmark

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