Memorandum submitted by the Society of
Homeopaths (HO23)
1. SUMMARY
1.1 The demand for Evidence Based Practice
in healthcare has led to a stringent examination of evidence for
all types of healthcare interventions. Decisions about what treatments
are offered are informed by the "best" evidence available.
However, there are many other factors that also inform this decision
making process such as cost effectiveness, safety and patient
preference. In addition, policy making in health care has to adhere
to ethical standards. Government policy in health care, as in
all other areas of policy making, cannot be founded upon consideration
of evidence in isolation. In this submission the question of efficacy
is considered within a broader ethical framework. In particular
the issue of decision making in situations where there is debate
about efficacy is addressed.
2. ABOUT THE
SOCIETY OF
HOMEOPATHS
2.1 Established in 1978, the Society of
Homeopaths is the longest standing registering body for professional
homeopaths and is now the largest organisation of its kind in
Europe. The Society, with approximately 2,500 current members,
represents 65% of all registered homeopaths in the UK.
2.2 The Society has long been committed
to the highest standards for homeopathy, having run a voluntary
regulatory system for the last 30 years and a course recognition
process for the last 15 years. Further, it was the first
homeopathy organisation to institute a Code of Ethics & Practice.
Members must meet the stringent standards of competence for clinical
and administrative practice set by the Society. Consequently our
members are trained to very high academic and professional standards.
Our members also hold comprehensive insurance.
2.3 The Society is applying to the Health
Professions Council (HPC) for the statutory regulation of homeopaths,
following a survey in 2006 which showed that 65% of our membership
supported statutory regulation. The application coincides with
the tenth anniversary of the House of Lords' Select Committee
on Science & Technology report into Complementary & Alternative
Medicine (session 1999-2000), which categorised homeopathy as
a "Group One" therapy along with acupuncture, chiropractic,
herbal medicine and osteopathy. This report stated that, "Under
The Society of Homeopaths, the non-medical homeopaths have organised
themselves well and their professional organisation should mean
the transition to statutory regulation does not present too great
an upheaval." [1] The move to statutory regulation is seen
as a natural step forward for both The Society and the profession,
most importantly to offer protection to the public as, under existing
laws, someone without training can currently practise as a homeopath.
3. A FRAMEWORK
FOR DECISION
MAKING
3.1 Traditionally the practice of medicine
has been subject to many pressures, driven not only by developing
scientific knowledge, but also in reaction to social, political
and financial forces. For example, Primary Care Trusts, controlling
80% of the NHS budget, respond to the needs of their local communities
when making decisions about delivery of health care and health
improvements to their local areas. The National Institute for
Clinical Excellence (NICE), responsible for providing national
guidance on the promotion of good health and the prevention and
treatment of ill health, outline key principles underlying NICE
clinical guidelines that incorporates the following factors:
— designed to promote good health and prevent
ill health;
— produced by the people affected by our
work, including health and social care professionals, patients
and the public;
— based on the best evidence;
— transparent in its development, consistent,
reliable and based on a rigorous development process;
— good value for money, weighing up the
cost and benefits of treatments; and
— internationally recognised for its excellence.
[2]
3.2 Government policy in health care, as
in all other areas of policy making, cannot be founded upon consideration
of evidence in isolation. For instance, good value for money has
to be considered within the context of limited resources. Efficacy
plays an important role but cannot be the sole deciding factor.
To do otherwise could exclude a large proportion of conventionally
accepted treatments currently used within the NHS that do not
satisfy the evidence standard. [3]
3.3 In addition, policy making in health
care has to adhere to ethical standards. Current thinking in healthcare
ethics tends to focus upon the four principles outlined by Beauchamp
and Childress [4] as the foundation for ethical professional practice
and these will form the point of reference for this submission.
The four principles are:
The question of efficacy will be considered
within a broader ethical framework that also takes into consideration
the above four principles
3.4 Hence five questions arise from ethical
consideration of the issues to be addressed by
the committee:
(a) Is the intervention effective?
(b) Is the autonomy of the patient respected?
(c) Is there a prospect of benefit?
(d) Is there a risk of harm?
(e) Is the principle of justice respected?
4. Is the intervention effective?
4.1 The question of efficacy in homeopathy
often generates a highly charged debate, particularly in the UK,
that has to date not yet been resolved. The following table describes
some of the main issues that are often quoted on either side of
the debate.
| Homeopathy is effective
| Homeopathy is not effective |
| Historical and case-based evidence shows the clinical effectiveness.
| Historical and case-based evidence is not acceptable as proof of efficacy.
|
| Observational studies (of which there are many) consistently report highly positive effects
| Observational studies do not exclude the possibility that homeopathy is no more than placebo
|
| Research methods most highly placed in the evidence hierarchy of Evidence Based Medicine (RCTs and systematic reviews) do not adapt well to complex interventions such as homeopathy
| The only way to thoroughly test an intervention is through a placebo controlled, randomised trial
|
| Inherent bias prevents a fair consideration of evidence such that when positive results from RCTs in homeopathy are published they are dismissed.
| Bias exists on both sides and results can be manipulated or occur by chance
|
| There is a distinct lack of funding available for research in homeopathy
| Research into homeopathy should not be funded as the agents cannot be effective in the dilutions given.
|
| |
4.2 The above two positions cannot be reconciled on the
position of evidence.
If only evidence from RCTs and systematic reviews of RCTs
is considered acceptable proof of efficacy, a substantial proportion
of interventions currently used within the NHS violates the evidence
principle. Estimates vary widely (from 11-70%) as to the exact
proportion of interventions that can be evidence-based in this
manner. [3] In addition, it is accepted that in some areas of
medical practice, for example surgical procedures, most practice
is not evidenced through RCT research as RCTs would be unethical
to conduct. Hence a major challenge for the evidence-based movement
in medicine is that many areas of practice suffer from a paucity
of RCT evidence leading to the conclusion that there is "no
evidence" for the practice on evidence databases such as
Bandolier and The Cochrane Library.
4.3 This demand for RCT evidence also contradicts current
World Health Organisation (WHO) policy to promote and stimulate
research into and use of traditional medicines. [5] For the WHO,
therefore, other types of evidence must carry some value. For
example, The Complementary Medicines Evaluation Committee has
adopted the following definition of "traditional use"
for regulatory purposes:
"Traditional use refers to documentary evidence that
a substance has been used over three or more generations of recorded
use for a specific health related or medicinal purpose".
[6]
4.4 Typically however the greatest debate in homeopathy
centres not on the issue of whether treatment by a homeopath can
have positive benefits, but rather it is rooted in the question
as to whether or not highly diluted remedies can have an effect.
Sceptics variously describe homeopathy as "water", "placebo"
or even "the ultimate fake". [7] To accept that homeopathic
remedies have an effect would entail revision of much of our basic
scientific conception of chemistry and the body. [8] Others point
to a growing number of scientists around the world who are investigating
possible measurable effects of ultra high dilutions. [9-11] These
scientists include well known and respected individuals such as
Luc Montagnier, Nobel Prize winner for discovery of the AIDS virus,
who recently published a paper describing detection of electromagnetic
signals from highly diluted solutions of pathogenic bacteria.
[12] In spite of the opinions of many sceptics scientific investigation
of this nature is being undertaken suggesting that this remains
an unanswered question.
4.5 Philosophers of science might tell us that what we
have here is a state of underdetermination. This thesis states
that any given body of evidence may support numerous, even contradictory
theories, a situation that can be exacerbated when there is disagreement
about what constitutes evidence. Scientific theories are inevitably
underdetermined by data, such that what counts as good scientific
theory depends largely upon other factors: social and political
agendas, preferences, biases and whims—not the evidence
itself. We can find clear examples of underdetermination in homeopathy.
Many people have carried out systematic reviews and meta-analyses
of placebo-controlled homeopathy trials in an attempt to answer
the question of whether or not homeopathy is more effective than
placebo. [13] These studies have been drawing upon the same data
sources, published trials of homeopathy, and yet they come up
with conflicting and contradictory results. The same data can
be used to support either the claim that homeopathy does have
an effect over and above placebo and also that it does not have
an effect over and above placebo. Both theories are underdetermined
by the available data and the data can be used to support either
one.
4.6 Hence the question arises, "what happens when
agreement cannot be reached about efficacy?" Should a practice
continue to be funded or should it be withdrawn? What actually
happens in healthcare is that where there is a lack of RCT based
evidence decisions are made on the basis of other types of evidence
that may include traditional and historical use or advice from
experts etc. The treatments are not simply withdrawn. Evaluation
of existing practice can act as a crucial indicator in this scenario
and results of that evaluation are fundamental for any decision
making. These questions need to be asked: "Have the outcomes
been measured?" "Is there an indication of benefit?"
If the answer is yes then practice should continue but further
research might be needed. Decisions about healthcare should not
and are not based purely upon the issue of "evidence"
in its narrowest sense.
5. Is autonomy of the patient respected?
5.1 Respect for autonomy means respecting the capacity
of an individual to be self-determining, to make decisions for
themselves without undue pressure, coercion or other forms of
persuasion. Paternalism occurs when actions of a health care practitioner
override or do not seek the wishes of the patient, believing that
they are better able to decide what is in the patient's best interests.
Respect for autonomy implies that paternalism should be avoided
as much as possible such that whether or not the doctor knows
best, s/he should respect the patient's own choices and wishes
if possible.
"Giving people more choice is a priority of the modern
NHS. This is because research in the UK and overseas has shown
that treatments are more effective if patients choose, understand
and control their care." [14]
5.2 The United Kingdom is a nation of well-educated individuals
who are capable of making decisions about their own healthcare
and it is clear that there is much choice available to them. Many
studies show that homeopathy is one of the most popular forms
of complementary and alternative medicine (CAM) in Europe, being
practised in 41 out of 42 European countries. [15] Homeopathy
is the most frequently used CAM therapy in five out of 16 surveyed
countries in Europe and among the three most frequently used in
11 out of 16 surveyed countries. [16] If people are
choosing to use homeopathy then the more information that is available
to them to help inform decision making the better.
5.3 The labelling of the most commonly used over the
counter homeopathic medications could inform decision making for
individuals ensuring responsible usage of these medications. Thus
labelling of a limited range of products should be acceptable
if it does not contravene other ethical principles.
5.4 Autonomy of patient and patient choice in healthcare
must be considered within light of other ethical principles such
that welfare is protected.
6. Is there a prospect of benefit?
6.1 Results from many studies, including an evaluation
of service by practitioners registered with the Society of Homeopaths,
show that many patients seek homeopathic treatment for conditions
for which there is either no conventional alternative or for whom
the conventional treatment is not acceptable. [17] For example
many people seek help for conditions such as Chronic Fatigue for
which there is no clear conventional treatment. Women for whom
Hormone Replacement Therapy is contraindicated might come with
symptoms associated with the menopause. The majority of patients
that seek homeopathic treatment have tried conventional approaches
first. [18] The provision of homeopathy is therefore meeting the
needs of a patient population who are not having those needs met
elsewhere.
6.2 The results from numerous large scale observational
studies around the globe demonstrate that homeopathic treatment
evaluates very well. The largest in the UK to date was conducted
at the Bristol Homeopathic Hospital [18]. In this observational
study of 6,544 consecutive patients during a six-year period,
and over 23,000 consultations, results showed that 70.7 %
reported positive health changes, with 50.7 % recording their
improvement as better (+2) or much better (+3). Of the 1270 children
that were treated 80.5 % had some improvement, and 65.8 %
were better (+2) or much better (+3).
6.3 Who decides whether homeopathy is of benefit? Should
this be the homeopath, the doctor, the politician, the sceptic?
Clearly those patients who seek homeopathic treatment on a regular
basis believe that they benefit from this intervention.
7. Is there a risk of harm?
7.1 The World Health Organisation acknowledge that, "in
general, traditional procedure-based therapies are relatively
safe, if they are performed properly by well-trained practitioners"
[5] In particular studies show a very good safety record for homeopathy
with little risk of harm from the remedies. [19] In contrast the
number of adverse drug reactions from conventional medicines reported
in 2005 in the UK was 21,234, of which 5% were fatal. The
NHS spends £466 million/year treating adverse effects
from conventional medicines. [20]
7.2 Risk of harm to the patient in homeopathy arises
from poorly qualified or regulated practitioners rather than the
practice itself. Registered members of The Society of Homeopaths
have met stringent academic requirements, completed a registration
process, hold comprehensive insurance and agreed to abide by a
Code of Ethics & Practice, providing the general public with
a guarantee of safety and competence. [21]
7.3 The best way to ensure patient safety is to continue
to offer homeopathy within the NHS and to properly regulate those
practitioners who work in private practice.
7.4 It is sometimes stated that patients are put at risk
of harm when seeking help from CAM practitioners because this
might delay them seeking help from conventional medicine. [22]
In practice it is rare for a patient to seek help who has not
already tried the conventional approach. In addition it is not
uncommon for a homeopath to refer a patient back to their GP.
The in-depth method of consultation by a homeopath can reveal
signs and symptoms that the GP may not have had time to uncover
and hence treatment can act as an extra safety net rather than
a potential risk. The Society of Homeopaths has a clear and transparent
complaints procedure and registered practitioners have agreed
to abide by a strict code of ethics and practice.
8. Is the principle of justice respected?
8.1 The principle of justice requires that we do what
we can to ensure that costs and benefits are fairly distributed.
In the UK homeopathy is mostly delivered in the private sector
and therefore not easily accessible to those who cannot afford
to pay for treatment. Patient choice here is affected by affordability
and those with less money have less choice. However, homeopathic
treatment is available via the NHS in some parts of the country
such that patient choice for individuals in these locations is
increased in this regard.
8.2 In considering the justice of offering homeopathic
treatment by the NHS the relative cost of this provision must
be weighed against the relative benefits to the patients. In addition
the issue of whether the money that is used to provide this service
could bring a greater amount of benefit to a greater number of
people if used otherwise needs to be considered.
8.3 The total amount that is spent on homeopathy in the
NHS is approximately £4 million per year representing
just 0.0004% of the total NHS budget. [23] What we have here is
a situation where a comparatively small amount of money is being
used to generate a very high level of patient satisfaction.
8.4 0.0004% of the total NHS budget is being spent on
a service for patients for whom conventional approaches are either
not suitable or desirable. The patients choose this service, they
feel benefit from the service and there is no evidence of harm
resulting from that use. It could be claimed here that adherence
to the principle of justice leads to the conclusion that homeopathic
provision should be vastly increased on the NHS to ensure
that benefits are available to all.
9. RECOMMENDATIONS
9.1 When reviewing the evidence for traditional medicines
such as homeopathy that consideration be paid to a variety of
different types of evidence as recommended by the WHO. [5]
9.2 When reviewing the provision of homeopathy by the
NHS due consideration be paid to ethical issues such as patient
autonomy, safety, benefit and cost-effectiveness and not simply
the notion of evidence in its narrowest sense.
9.3 When considering policy on the licensing of homeopathic
products that again due consideration be paid to the ethical concerns
described.
CONFLICT OF
INTERESTS
The Society of Homeopaths is a registering body for professional
homeopaths in the UK.
REFERENCES
1. House of Lords. Select Committee on Science & Technology,
Session 1999-2000, p52
2. National Institute for Health and Clinical Evidence. Our
Guidance. Cited 11-09. Available at:
http://www.nice.org.uk/guidance/index.jsp
3. Booth A. What proportion of healthcare is evidence based?
Resource Guide. Cited 11-09. Available at: http://www.shef.ac.uk/scharr/ir/percent.htm1£genmed
4. Beauchamp T & Childress J. Principles of Biomedical
Ethics (4th edition). Oxford, Oxford University Press; 1994
5. WHO General Guidelines for Methodologies on Research
and Evaluation of Traditional Medicine, 2000. Available at:
http://apps.who.int/medicinedocs/en/d/Jwhozip42e/14.1.html
6. Ibid. p41
7. Barrett S. Homeopathy: The Ultimate Fake. Cited
10-09. Available at:
http://www.quackwatch.com/01QuackeryRelatedTopics/homeo.html
8. Sehon S R & Stanley D E. A philosophical analysis of
the evidence-based medicine debate BMC Health Serv Res
2003;3:14-24
9. Samal S, Geckler R E. Unexpected solute aggregation in
water on dilution. Chem Commun 2001;21:2224-2225.
10. Rey L. Thermoluminescence of ultra-high dilutions of
lithium chloride and sodium chloride. Physica A 2003;323:67-74.
11. Jonas W B, Ives J A, Rollwagen F, et al. Can specific
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12. Montagnier L et al. Electromagnetic signals are
produced by aqueous nanostructures derived from bacterial DNA
sequences' Interdiscip Sci Comput Life Sci, 2009;1:81-90
13. NHS Centre for Reviews and Dissemination. Homeopathy.
Effective Health Care Bulletin 2002;7(3): 1-12.
14. NHS All about Choice Cited 11-09. Available at:
http://www.nhs.uk/choiceintheNHS/Yourchoices/allaboutchoice/Pages/Allaboutchoice.aspx
15. World Health Organisation. Legal Status of Traditional
Medicine and Complementary/Alternative Medicine: A Worldwide Review,
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16. Norges offentlige utredninger, NOU Alternativ
medisin. 1998:21 (Official report published by the Norwegian
Department of Health. Cited 06-08. Available at:
http://odin.dep.no/hd/norsk/publ/utredninger/NOU/030005-020019/index-ved005-b-n-a.html
17. Relton C, Chatfield K, Partington H, Foulkes L Patients
treated by homeopaths registered with the Society of Homeopaths:
a pilot study. Homeopathy 2007; 96:87-89
18. Spence D S, Thompson E A, Barron S J. Homeopathic treatment
for chronic disease: a 6-year, university-hospital outpatient
observational study. J Alt Comp Med 2005; 11:793-798
19. Kirby B J. Safety of homeopathic products. J Royal
Soc Med 2002;95:221-222
20. Hitchen L. Adverse drug reactions result in 250 000 UK
admissions a year BMJ 2006;332:1109
21. Society of Homeopaths, Code of Ethics and Practice 2004 paragraph
2.2
22. Markman M, Safety Issues in Using Complementary and Alternative
Medicine JCO 2002;20:39-41
23. British Homeopathic Association. An overview of NHS
homeopathy Cited 11-09. Available at:
http://www.britishhomeopathic.org/what_you_can_do/campaign_for_homeopathy/nhs_homeopathy_overview.html
November 2009
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