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HO
35
Memorandum
submitted by the European Central Council of Homeopaths
Introduction to ECCH: The European Central Council of Homeopaths was established in 1990 and
is the professional platform representing the homeopathy profession in Europe. Among its 27 national professional associations
in 23 countries it counts three members in the UK, the Alliance of Registered
Homeopaths, the Homeopathic Medical Association and the Society of Homeopaths.
ECCH's response to the UK House of Commons Science and
Technology Committee Enquiry - Evidence Check Homeopathy
1. Government policy on licensing of homeopathic products
Homeopathic Medicinal
Products (HMPs) are available over the counter (OTC) and on prescription in all EU Member States. They
are an increasingly important part of the European pharmaceutical market. (1)
1.2 HMPs are subject to the provisions of EU Directives on
pharmaceutical products for human use (2,3). As a member of the European Union,
the UK is bound by the provisions of these directives to regulate HMPs on
the UK
market.
1.3 The idea that
because HMPs are diluted they are safe and do not require regulation is a naïve
misconception. HMPs are derived from a
wide range of mineral, plant, zoological and microbial products, many of which
are potentially toxic in their raw state. While the homeopathic manufacturing
process known as 'potentisation' renders all HMPs safe and of no toxic risk
once a certain dilution level has been passed, the fact that some source
materials are of potential risk during the early part of the manufacturing
process means manufacturers' premises and processes have to be strictly
regulated according to standard Good Manufacturing Practice (GMP) in order that there is no risk to workers in
the premises or risk of toxic material remaining in the final product placed on
the market.
1.4 Normal
licensing policy for placing a pharmaceutical product on the market requires
evidence of quality safety and efficacy. Homeopathic treatment using single
HMPs is normally individualised according to
the whole symptom picture of each patient suffering any diagnosed condition.
Consequently, to prove efficacy for any single HMP
for any particular condition as is normally required for conventional
pharmaceuticals is extremely difficult. The current licensing policy of only
requiring proof of safety and quality for single HMPs as outlined in Article 14
of the EU directive 2001/83/EC therefore makes pragmatic sense, particularly
given the low-risk non-toxic state of HMPs once potentised. Evidence for the
range of symptoms that each single HMP
is capable of addressing is available through the extensive 'homeopathic
materia medica' that is available for single HMPs.
1.5 Complex HMPs
and any other HMPs for which manufacturers wish to make therapeutic claims
should be subject to the normal requirements for evidence of proof of efficacy
as for conventional pharmaceuticals as detailed in Article 16 of EU directive
2001/83/EC.
1.6 Within the EU
the UK Medicines and Healthcare products Regulatory Agency (MHRA) is perceived
by homeopathy stakeholders, and other national licensing authorities, to have a
proportionate and pragmatic approach to the licensing of HMPs. We consider it essential that the MHRA
should continue to administer the regulation of HMPs within the UK in the
present manner, not least as an example of best practice for other EU agencies.
References:
1. Homeopathic medicinal products. EU
Commission report to the European Parliament and the Council on the application
of Directives 92/73 and 92/74.
2. Directive 2004/27/EC of the European Parliament and
of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community
code relating to medicinal products for human use
3. Directive 2001/83/EC on the Community code relating
to medicinal products for human use
2. Government policy on
the funding of homeopathy through the NHS
2.1 Homeopathy
has been funded through the NHS from its inception in 1948. Throughout
that time the cost of homeopathic
treatment has been an extremely small percentage of the NHS's overall budget.
Yet, when emerging evidence from recent studies into the provision of
homeopathy in the NHS is taken into account, the benefit to patients who've had
homeopathic treatment would seem to be substantial and worthy of more
consideration than it has received up until now.
2.2 Whether provided by GPs themselves,
through GPs delegating patients for treatment by homeopathic practitioners or
through referral to homeopathic doctors in the outpatient units of the
homeopathic hospitals there is a range of evidence in existence showing that
homeopathy provided through the NHS is effective, highly appreciated by
patients and capable of improving patients health overall. (1,2). There is also
evidence from outside the UK
that homeopathy provided in general practice has short and long-term benefits
on patients' health. A large German cohort study showed sustained improvement
in patients' health over an eight-year period (3).
2.3 GPs are the recognised gatekeepers to NHS
services and it is they who should continue to decide whether to refer patients
for homeopathic treatment. They make their decisions on the basis of perceived
patient need, within the constraints of their practice budget and, hopefully,
in consultation with their patients. The element of therapeutic choice is an
important priority in current NHS policy and the maintenance of homeopathy as a
viable treatment option for patents and GPs is an important example of this
principle being maintained and developed. There are a range of 'effectiveness
gaps' involving conditions where conventional approaches are either relatively
ineffective or simply do not exist and where homeopathy has been shown to be
effective. (4-13)
2.4 The
National Institute for Health and Clinical Excellence (NICE)
recently published guidance on the treatment of low back pain that recommended
consideration among other interventions of the use of acupuncture and
manipulative therapies.(14) This landmark recommendation was based on the fact
that conventional medicine has a limited potential for intervention in this
condition and there is a range of
evidence, including but not totally reliant on RCTs, to support the use of
the therapies such as acupuncture, osteopathy and chiropractic as effective
interventions before considering more drug and surgical intervention. This
pragmatic approach to the evaluation of evidence is one we consider should be
applied to the consideration of homeopathic treatment where the range evidence available, including
RCTs, presents a far more convincing case for its use than the simplistic
criteria of whether sufficient RCTs alone exist to support it. (15)
References:
1. Spence DS, Thompson EA, Barron SJ. Homeopathic Treatment for
Chronic Disease: A 6-Year, University-Hospital
Outpatient Observational Study. The Journal of
Alternative and Complementary Medicine. Volume
11, Number 5, 2005, pp. 793-798.
2. Northern Ireland Department
of Health, Social Services and Public Safety: Independent
Evaluation Report into Departmental CAM Pilot (PDF 950KB)
http://www.dhsspsni.gov.uk/complementary-alternative-medicine
3. Witt CM, Lüdtke R, Baur R, Willich SN.
Homeopathic medical practice: Long-term results
of a cohort study with 3 981 patients. BMC Public Health 2005, 5:115
doi:10.1186/1471- 2458-5-115
4. Weatherley-Jones E, Nicholl JP,
Thomas KJ, Parry GJ, McKendrik MW, Green ST,
Stanley
PJ, Lynch SPJ. A randomised, controlled, triple-blind trial of the efficacy of
homeopathic
treatment for chronic fatique syndrome. Journal of Psychosomatic
Research
56 (2004) 189-197.
5. Balzarini A,
Felisi E, Martini A, De Conno F. Efficacy of homeopathic treatment of skin
reactions during radiotherapy for breast cancer: a
randomised, double-blind trial. Br Homeopath J. 2000,
89(1), 8-12.
6. Kassab S, Cummings M, Berkovitz S, van Haselen
R, Fisher P. Homeopathic medicines
for adverse effects of cancer treatments.
Cochrane Database of Systematic Reviews
2009, Issue 2. Art. No.: CD004845. DOI:
10.1002/14651858.CD004845.pub2.
7. Witt CM, Lüdtke R, Willich SN. Homeopathic
treatment of children with atopic eczema: a
prospective observational study with 2 years follow-up. Acta
Dermato-Venerologica 2009;89:182-183.
8. Witt CM, Lüdtke R, Willich SN. Homeopathic
treatment of patients with psoriasis. A prospective
observational study with 2 years follow-up. Journal of the European
Academy
of Dermatology &
Venerology 2009;23:538-543.
9. Witt CM, Lüdtke R, Willich SN. Homeopathic
treatment of patients with dysmenorrhea - a prospective
observational study with 2 years follow - up. Archives of Gynecology and
Obstetrics 2009;280:603-611.
10.
Witt CM, Luedtke R, Willich SN. Homeopathic treatment of patients with chronic
low back pain - a prospective observational
study with 2 years follow - up. Clin J Pain
2009;25:334- 339.
11. Witt CM, Lüdtke R, Willich SN. Homöopathische
Behandlung von chronischem
Kopfschmerz (ICD-9: 784.0) - eine
prospective Beobachtungsstudie mit 2-Jahres- Follow- Up.
Forsch Komplementärmed Klass Naturheikd 2009;16:227-235.
12.
Witt CM, Lüdtke R, Willich SN. Homeopathic treatment in patients with chronic
sinusitis: a prospective
observational study with 8 years follow-up. BMC
Ear, Nose and Throat Disorders
2009;9:7.
13. Witt CM, Lüdtke R, Willich SN: Homeopathic
treatment of patients with migraine. A
prospective observational study with
a 2 year follow-up period. J Altern Complement
Med 2009, accepted for publication.
14. Low back
pain: early management of persistent non-specific low back pain Full
guideline May 2009 National Collaborating Centre for Primary
Care
15. DE TESTIMONIO On the evidence for decisions
about the use of therapeutic
interventions THE HARVEIAN ORATION
Delivered before the Fellows of The Royal
College of Physicians of London on Thursday 16
October 2008 by Professor Sir Michael David
Rawlins MD FRCP FFPM FMedSci
3. The evidence
base on homeopathic products and services
3.1 The evidence for the therapeutic action of homeopathic products The central controversy surrounding HMPs, and the one that has dogged homeopathy for two hundred years, relates to whether a) HMPs have an action and b) what the nature of that action is. Mathematically HMPs potentised above a level of dilution synonymous with Avogadro's Number do not contain any molecules of the source material of the medicine i.e. they are not having a molecular action in the way conventional pharmaceuticals do. Yet potentised HMPs above this dilution are commonly used with apparent effect in homeopathic practice and have been used in research trials that have produced results indicating a positive action. Furthermore, there is an accumulating body of evidence from a variety of research areas within and outwith homeopathy that high dilutions of source materials appear to have a measurable effect (1 - 14). While we may therefore actually be approaching a point where it can be established that potentised medicines have an action, the mechanism of action may take a little longer to elucidate. 3.2 The efficacy of homeopathic treatmentThe efficacy of homeopathy has been considered through a large number of clinical trials of varying methodological quality. The overall results of these trials have been evaluated in a number of literature reviews and meta-analyses (15-22). Seven out of eight of these reviews/analyses found results in favour of homeopath. The eighth study which did not find an effect in favour of homeopathy, Shang et al., (22), has since been severely criticised by scientists and researchers around the world for its poor methodology. The authors first claimed that their conclusions were based on 110 homeopathy trials compared to 110 trials of conventional medicine. It was subsequently shown that they had based their conclusions on just 8 homeopathy trials compared with 6 conventional trials only. When re-analysing the data of this study, researchers found that homeopathy had a significant effect beyond placebo, and the conclusions drawn by the original authors were highly influenced by one single trial (23). Moreover, the researchers found that the overall quality of homeopathy trials was significantly higher than in the conventional trials (24). (Note: It is interesting to note that a number of critics of homeopathy have particularly referred to the Shang trial to support their position, where, if they had they taken a more objective viewpoint they should have spotted these methodological faults themselves.) 3.3 The effectiveness of homeopathic treatmentThe effectiveness of homeopathy has been considered in a number of observational studies, including a six year study of over 6 500 patients treated in a University Hospital Outpatient clinic in the UK, with over 23 000 consultations, where over 70 % of patients reported positive health changes, and more than 80 % of 1 270 children experienced an improvement (25) In another study of almost 4 000 patients treated by 103 primary care practitioners, 97 % suffered from chronic complaints lasting an average of 8.8 years (26). Significant improvement in most complaints was recorded, as well as improvement in patients' quality of life. 3.4 The cost-effectiveness of homeopathy
The issue of
the cost-effectiveness of homeopathic treatment can be addressed through
comparing the direct costs of the treatment itself with conventional treatments
and through calculating savings in potential future other care. A number of
studies have demonstrated the cost effectiveness of homeopathy. There is enough
evidence from these studies to show that homeopathy does offer potential real
cost savings in spending on conventional medicines, referrals to consultants
and GP consultation time. (27 -37)
3.5 The safety of homeopathy
Homeopathy is a safe treatment (40).
The potentisation (serial dilution and succussion) of HMPs means that beyond 4
dilution stages of 1:10 their source materials are rendered safe without risk
of toxic side effects to patients. This is recognised by the EU directive 2004/27/EC
that permits simple registration for single HMPS diluted one part in 10,000 or
more. The only possible toxic risk would come
from the use of certain source materials in tinctures and dilutions below one
part in 10,000 or from poor manufacturing procedures leaving toxic residues in
potentised medicines.
The other element of safety relates to
the appropriate education and professional regulation of those who practise
homeopathy. As with all healthcare professions, the education and regulation of
those practising homeopathy should convey a clear awareness of the boundaries
of competence and responsibility surrounding their practice. Anyone offering
any form healthcare must be appropriately educated and submit to professional
regulation through registration with a recognised professional association.
3.6 The use of homeopathy
Homeopathy is practised throughout Europe (41) Homeopathy is the most frequently used CAM therapy in 5 out of 14 countries in Europe, and
one of three CAM therapies most
frequently used in 11 out of 14 countries (42, 43). According to the World
Health Organization homeopathy is practised worldwide and it is provided within
national healthcare systems in several countries. (44, 45)
As an example a poll carried out in Norway in 2001 showed that 52 % of the population were of the opinion that homeopathy should be a part of the public health service there (46) Half of all Norwegian nurses think homeopathy should have a place within the public health service (47) and half of all medical doctors are willing to recommend patients to a homeopath (48)
3.7 Meeting the costs of homeopathic treatment
Expenses for CAM therapies including homeopathy are currently reimbursed through the national healthcare service in eight countries in Europe. Expenses are reimbursed through private insurance companies in 12 countries. (49)
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Stephen Gordon
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November 2009
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