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

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

3. 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

4. Ethiopia Benin Populations using traditional medicine for primary health care India Rwanda Tanzania Uganda Canada Populations in developed countries who have used complementary and alternative medicine at least once Australia France USA Belgium 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.

5. 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

6. 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

7. 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.

8. Million US$ 6 000 5 400 USA 5 000 4 000 3 000 2 400 Japan 2 000 1 000 1 000 UK 860 184 92 0 1990 1991 1994 1996 1997 1998 1999 2000 2002 The herbal medicines market Million USD

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

10. Common risks associated with TM/CAM wherepatients 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

11. 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

13. integrate TM/CAM with national health care systems 1 3 2 4 WHO Traditional Medicine Strategy 2002-2005 Policy: Safety, efficacy and quality: provide evaluation, guidance and support for effective regulation Access: ensure availability and affordability of TM/CAM, including essential herbal medicines Rational use: promote therapeutically-sound use of TM/CAM by providers and consumers

14. Evidence Based Medicine (EBM)Different levels and types of evidenceChallenges • 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

15. Therapy Medical condition Conclusion Acupuncture Dental pain Akupunktur effektivare än ”sham” akupunktur Acupuncture Low back pain Effektivare än diverse andra interventioner Acupuncture /Acupressure Nausea Akupunktur effektivare än ”sham” akupunktur St Johns Wort Mild depression Effektivare än placebo, lika effektiv (och säkrare) som syntetiska antidepressiva läkemedel Ginkgo Biloba Dementia Cerebral funktion förbättrad Kava kava Anxiety Effektivare än placebo Saw Palmetto Prostatit Effektiv för symtomlindring 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

16. RCT COSTS

17. 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

18. 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

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

20. 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