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Could more than 100 million European citizens be wrong? Developments around the evidence base of homeopathy

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Could more than 100 million European citizens be wrong? Developments around the evidence base of homeopathy Ton Nicolai, MD FFHom (Hon) President – PowerPoint PPT presentation

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Title: Could more than 100 million European citizens be wrong? Developments around the evidence base of 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. gt100 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.
    200117(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 worlds 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
  • WHOs 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?
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