Ton Nicolai, MD FFHom (Hon) President European Committee for Homeopathy

1. Could more than 100 million European citizens be wrong?Developments around the evidence base of homeopathy Ton Nicolai, MD FFHom (Hon) President European Committee for Homeopathy

2. Definition of CAM Complementary and Alternative Medicine (CAM) is a broad domain of healing resources that encompasses all health systems, modalities, practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period (definition by Cochrane Collaboration)

3. Prevalence of use of CAM • CAM is increasingly used, up to 65% of the population have used CAM (WHO, 2004) • Yearly number of visits to CAM practitioners greatly exceeds those to conventional primary care physicians in the USA • Also increasing interest in CAM among physicians:in the UK 18% of GPs practise CAM (mostly without training), 38% of GPs endorse CAM treatments, 30-40% refer for them, 62% report that their patients had successful results from CAM treatments • 50,000 CAM practitioners in the UK, 10,000 conventional healthcare professionals practise CAM

4. Commonly used CAM therapies • homeopathy • acupuncture • manual therapies (osteopathy, chiropractic) • herbal medicine (phytotherapy) • anthroposophic medicine • naturopathy • traditional Chinese medicine

5. Prevalence of use of homeopathy • 3 Europeans out of 4 know about homeopathy and 29% of these use it for their health care (European Commission, 1996), i.e. >100 million citizens • 15,000 doctors, veterinarians and dentists trained in homeopathy (European Union) • 4,000 non-medical homeopathic practitioners (European Union) • 7% of all GPs in the UK prescribe homeopathy, 18% refer to homeopathic doctors, 7% recommend homeopathy (2000)

6. Reasons for using CAM • Dissatisfaction with conventional treatment, which is viewed as (Jonas, JAMA, 1998) • Being ineffective, esp. in chronic disease • Having too many adverse side effects • Being impersonal, too technologically oriented • Need for personal control • CAM is less authoritarian, more personal autonomy and control • Philosophical congruence • CAM is more compatible with patients’ values/world-view/philosophy

7. CAM as holistic medicine • Holistic or biopsychosocial model of medicine(Engel, George L. The need for a new medical model, Science, 1977) • An individual is a living system that is self-healing, self-renewing, homeostatic and adaptive • Disease is a result of psychosocial and pathogenic factors, along with constitutional susceptibilities; a failure of adaptive response, resulting in disruption of the overall equilibrium of the system • The aim of the treatment is to restore all of the patients’ own natural systems for fighting disease to optimum efficiency • The value of this model is corroborated by recent scientific developments, notably in complexity science and psychoneuroimmunology

8. CAM as holistic medicine - 2 • All the major CAM systems approach illness first by trying to support and induce the self-healing process of the person • If recovery can occur from this, the need for high-impact, high-tech and high-cost intervention is reduced • It is this orientation towards self-healing and health promotion –improving health rather than defeating disease – that makes CAM approaches especially appropriate

9. When CAM is inappropriate • a degree of irreversible tissue damage or constitutional imbalance, whether from a disease, genetic cause or injury • any life threatening condition

10. CAM safety • Risks are very low in comparison with conventional prescription drugs, but vary from one CAM therapy to the other • Especially homeopathy and acupuncture are very safe (hardly any adverse effects, cases of mistaken identity in homeopathy) • Indirect risks: lack of practitioners’ training

11. CAM research • Widespread use of CAM among European citizens, but a negligible amount of funding for research in this area by the EU Member States • Research in CAM has been seriously hampered by • lack of research infrastructure and funding • lack of research expertise among CAM practitioners • lack of appropriate research models and strategies • the scepticism of the scientific community • To date, CAM research has mainly been “justification” research, i.e. to show to the sceptic scientific community that a specific CAM therapy is better than placebo

12. CAM research - 2 • The sceptic scientific community argue that on theoretical grounds homeopathy could not possibly be effective, so any positive trial result must be due to bias (the mindset of a sceptic: “I cannot understand how it works, so it cannot possibly work”) • Recent Lancet article is a case in point: The authors have no homeopathic expertise, the leading author is known as a fierce opponent of homeopathy. They believe that the effects in randomized clinical trials (RCTs) of homeopathy can only be attributed to bias. And, lo and behold, after selecting 8 secret studies out of 110 they have found the ”evidence”. In another group of 8 trials of homeopathy in acute respiratory tract infections no bias has been found, but the authors do not believe these results, because this group of trials is “too small”. This is not science, but prejudice in scientific disguise. • Conclusion: more RCTs do not help convince the sceptics.

13. CAM research - 3 • “Critics of complementary medicine often seem to operate a double standard, being far more assiduous in their attempts to outlaw unevaluated complementary medical practices than unevaluated orthodox practices.” “These double standards might be acceptable if orthodox medicine was based solely on practices which had been shown to do more good than harm, and if the mechanisms through which their beneficial elements had their effects were understood, but neither of these conditions applies.” (quotations from Dr Ian Chalmers, the director of the UK Cochrane Centre, 1998) • Why should homeopathy be placed in the straitjacket of RCTs while the efficacy of most conventional treatments has not been demonstrated by RCTs and RCTs are no longer necessarily put at the top of the pyramid in conventional medicine either? (Ezzo J, et al Reviewing the reviews. How strong is the evidence? How clear are the conclusions? Int J Technol Assess Health Care. 2001;17(4):457-66) (Horton R. The clinical trial: deceitful, disputable, unbelievable, unhelpful, and shameful--what next? Control Clin Trials. 2001; 22(6):593-604)

14. CAM research - 4 • Long-term outcome studies including many thousands of patients have shown that the effectiveness of homeopathy is high and at least as high as that of conventional medicine • Most patients who see homeopathic (CAM) doctors have found out that conventional medicine failed in providing a solution for their health problems and that homeopathy (CAM) subsequently worked • If, as the sceptics believe, these effects are solely due to context effects, it would be imperative for the medical/scientific world to investigate these effects and use them for the benefit of all citizens

15. CAM research - 5 • Rather than focusing on more RCTs to prove that CAM is more than placebo, research should address: • role of CAM in wellness and health promotion • deeper understanding of health, illness/disease and healing, e.g. mechanisms facilitating self-healing, factors contributing to ‘spontaneous remissions’ • mechanisms of action of individual CAM therapies, including patterns of response to treatment • improvement of effectiveness of individual CAM therapies • role of context effects, patient-doctor relationship, optimal therapeutic environment • development of appropriate methodologies, e.g. quasi-experimental and observational (QEO) studies, cohort studies, active comparator RCTs that assess a new method against the best current methods (in line with latest revision of the Declaration of Helsinki), etc.

16. CAM research - 6 • Currently CAM research proposals can hardly compete against other bids for funds. Research development pump priming funds are needed to build up research capacity in CAM(report by House of Lords Select Committee on Science and Technology, 2000) • Without the development of a research infrastructure which reflects the actual prevalence and relevance of CAM in Europe, an adequate evaluation of this huge field is not possible • Incorporation into 7th EU RTD Framework Programme with a separate budget line is highly recommended

17. Position of WHO • Two-thirds of world’s population seek health care from sources other than (Western) biomedicine • Traditional medicine (TM) remains widespread in developing countries, CAM is increasing rapidly in developed countries • WHO’s role in TM/CAM: policy, safety, efficacy, quality, access and rational use

18. WHO Traditional Medicine Strategy 2002-2005 • Integrating TM/CAM with national health care systems • Promoting the safety, efficacy and quality of TM/CAM • Increasing the availability and affordability of TM/CAM • Promoting therapeutically sound use of appropriate TM/CAM

19. WHO publications on TM/CAM • Traditional Medicine Strategy 2002-2005 • Legal Status of TM/CAM: a worldwide review (2001) • Global Atlas of TM/CAM: a means of sharing information on the current state of TM/CAM (2005) • Guidelines on developing consumer information on proper use of TM/CAM (2004) • General Guidelines for methodologies on research and evaluation of TM (2000)

20. WHO publications on TM/CAM -2 • On acupuncture • Several guidelines, e.g. for clinical research, basic training, safety, terminology, nomenclature, etc. • Review and analysis of reports on controlled clinical trials • On herbal medicine • Several guidelines, e.g. for safety, efficacy, quality control, conservation, appropriate use, etc.

21. WHO tasks in field of homeopathy • Harmonizing definitions of homeopathic products and practices in order to allow classification and identification of homeopathic products at national level • Establishing recommendations for safe degrees of dilutions of homeopathic preparations • Promoting the exchange of information on homeopathic medicines, including official pharmacopoeias • Developing systems to collect and provide information to consumers on the safe use of homeopathic medicines • Providing guidance to governments and NGOs for training of homeopathic medicine providers Recommendations by 10th International Conference of Drug Regulatory Authorities (ICDRA) in 2002

22. European Union policy on CAM • Homeopathic medicinal products and herbal medicinal products are legally recognized • All EU Member States are obliged to register homeopathic medicines pursuant to Directive 2001/82/EC (veterinary use) and 2001/83/EC (human use) on the Community Code relating to medicinal products. • Homeopathic medicines must be prepared in accordance with manufacturing procedures in the French, German, and increasingly, the European Pharmacopoeia (under jurisdiction of the Council of Europe)

23. European Union policy on CAM-2 • European Parliament resolution (1997) called on the Commission to • carry out studies into the safety, efficacy, and use of CAM and to draw up a comparative study of the various national legal models to which CAM practitioners are subject • launch a process of recognizing CAM • encourage the development of research programmes in the field of CAM • create a directive on food supplements • A Directive on food supplements is the only concrete response from the Commission and Council so far

24. European Union policy on CAM-3 • COST B4 report (1999) • called on the Commission to establish an independent ‘European Healthcare Office’ in collaboration with experts from biomedicine and CAM • to recommend guidelines for CAM research • to consider a pan-European strategy to help training of researchers • called on the Commission to establish a ‘pan-European advisory group on healthcare options in CAM’ • to provide reliable scientific information • to offer practical research and education advice • recommended the development and funding of new CAM research programmes • No concrete response from the Commission so far

25. CAM Developments in USA • National Center for Complementary and Alternative Medicine since 1998, is charged to “conduct basic and applied research, research training, and disseminate health information and other programmes with respect to identifying, investigating, and validating CAM treatments, diagnostic and prevention modalities, disciplines and systems”. • Annual budget US$ 123 million in 2005 • NCCAM shows that, if dedicated funds are there, experienced researchers will apply for them, and with sufficient investment high-quality CAM research can be achieved.

26. CAM Developments in USA -2 • White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) established in 2000 • It provides recommendations to the US government for ensuring that public policy maximizes the potential benefits of CAM therapies to consumers, and to address • education and training of health care practitioners in CAM • coordination of research to increase knowledge about CAM products • provision of reliable and useful information on CAM to health care professions • provision of guidance on the appropriate access to and delivery of CAM

27. CAM Developments in UK • House of Lords Select Committee on Science and Technology report (2000) concluded: • public satisfaction with CAM is high and use of CAM is increasing • in the interests of public safety the complementary medicine sector should be properly regulated • training for CAM professionals should be standardized and independently accredited • registered conventional health professionals should become more familiar with CAM • the most effective therapies should be integrated into the NHS • funding research should be boosted (‘pump-priming’) in order to create a few centres of excellence for conducting CAM research, integrated with research into conventional healthcare

28. CAM Developments in UK -2 • The UK government is “committed to developing a NHS which is responsive to the needs and wishes of patients and which enables patients to play an active role in managing their health conditions. Complementary therapies are clearly attractive to a number of patients and so could in principle feature in a range of services that local NHS organisations provide, if they agree that it would be a clinically and cost effective use of resources and be in line with locally agreed health priorities”. • The UK government granted £1.3 m (€1.9 m) for research projects in CAM • Herbal medicine and acupuncture are currently working towards statutory regulation, homeopathy will follow suit

29. CAM in other EU Member States • In many Member States the practice of CAM is not legally recognized or defined, its regulation varies from jurisdiction to jurisdiction, and hardly any funding for research in this area is provided • In spite of the WHO General Assembly resolution on TM/CAM (2003) that urges the member states to • integrate CAM with national health care systems • promote the safety, efficacy and quality of CAM • increase the availability and affordability of CAM • promote therapeutically sound use of appropriate CAM • establish legislation and regulation for CAM medicines and practice as well as education, training and licensing of practitioners • promote and create funds for research in CAM(this would also mean opting for a separate budget for CAM research in the 7th RTD EU Framework programme!)

30. Conclusion • The WHO, the USA, the UK and Lombardy all take the public demand for CAM seriously and have been acting upon it • Is not it about time for the rest of Europe, the European Commission and the Council of Ministers to respond likewise to the demand of more than 100 million European citizens?