Memorandum submitted by the Prince's Foundation
for Integrated Health (HO 41)
INTRODUCTION
1. The Prince's Foundation for Integrated
Health was founded in 1993 at the personal initiative of
HRH The Prince of Wales to promote integrated healthcare for all.
HRH remains its President but has no direct involvement in the
Foundation's day to day operations. It is a registered Charity
and has no commercial, financial or other vested interests in
complementary or alternative products or services.
2. Integrated healthcare encompasses two
concepts. First, it means treating patients as whole human beings
with bodies, minds and spirit, and understanding that whatever
affects one part affects all three. Secondly, it is about integrating
those complementary and traditional modalities which have evidence
of clinical effectiveness with conventional healthcare, providing
that is in the patient's best interests. The Foundation does not
suggest that is necessarily the case for all medical conditions
or for all patients.
3. The Foundation is clinically led by a
group of Fellows and Clinical Leads. They include medical scientists
and scientists from related fields together with practising clinicians
from a number of healthcare professions including medicine, pharmacy,
nursing and physiotherapy. Some Fellows are also researchers and
practitioners of complementary medicine. This document reflects
their advice.
4. The Foundation's interest in homeopathy
is focused on the question of clinical and cost effectiveness:
whether or not it provides any benefit to patients and, if can
be established that it does, for which conditions and which patient
groups at what cost.
GOVERNMENT POLICY
ON LICENSING
HOMEOPATHIC PRODUCTS
5. The licensing of homeopathic products
in the UK is governed by the Medicines Act (1968) and by European
legislation, in particular EU Directive (2001/83/EC)/
6. The task of implementation is carried
out by the Medicines and Healthcare products Regulatory Agency
(MHRA) for whose expertise the Foundation has the highest respect.
Currently the rules provide two ways in which homeopathic products
may be registered. The Simplified Scheme in which no medical claims
or indications for the product are permitted although the safety
and quality of the product must be demonstrated. The National
Rules Scheme, introduced in 2006, does allow homeopathic medicinal
products to be registered with indications for the relief or treatment
of minor and self-limiting conditions, with full information on
safety and quality together with appropriate product labelling
and product literature. In accordance with current pharmaceutical
legislation, evidence must be provided that the product is used
as a homeopathic treatment for the indications identified.
7. The Foundation has complete confidence
in the judgement of the MHRA as to the benefits for public information
and safety of the current system.
THE EVIDENCE
BASE
8. Homeopathy is a system of medicine, developed
in Germany in the late eighteenth century, that is based on the
idea that "like treats like": a substance taken in small
quantities will cure the symptoms it would cause in large quantities.
In homeopathy, the idea of the small quantity has resulted in
extreme dilutions of the substance. In some homeopathic products,
not even a single molecule of the original substance remains in
the diluted medicine prescribed to the patient. These concepts
are not supported by modern science and, indeed, run counter to
it.
9. Unlike much pharmaceutically based conventional
medicine, treatment is individualised so that patients presenting
with the same diagnosis may be prescribed different medicines
depending on their personal histories, diet, and other factors.
Homeopathy rejects the notion that mind and body are separate
(a concept that was also developed in the eighteenth century)
and insists that there is continual interaction between them.
In this at least, modern science would tend to agree.
10. Homeopathy is highly controversial.
From our current understanding of the physical and biological
sciences, any specific mechanism of action based on extreme dilution
is implausible and regarded as unsupportable by the majority of
scientists working in this field, although a small number disagree.
The evidence from randomised controlled trials (RTCs) is less
than convincing.
11. Nevertheless, there is some evidence
of clinical effectiveness of the whole homeopathic package: that
is, the consultation and the medicine combined. As a consequence
the Foundation finds it difficult to dismiss the experience of
patients who say they have benefited from homeopathic treatment.
Providing it is delivered by trained and statutorily regulated
health professionals such as doctors, homeopathy is safe and low
cost. However, there are anxieties about the safety of practice
by unregulated, non-medically trained homeopaths.
NHS FUNDING OF
HOMEOPATHY
12. Homeopathy is one of a number of complementary
therapies that are provided by the NHS as an adjunct to treatment
in palliative care and for a range of chronic, benign conditions.
A significant number of patients report that they benefit from
homeopathy. However there is a need for controlled research studies
to establish:
— whether and what benefit is provided;
— the extent of that benefit, if any;
— how the risk/benefit evaluates against
conventional medical interventions; and
— the mechanism of action that produces
benefit, if any.
13. It would then be for the National Institute
of Clinical Excellence (NICE) to evaluate the evidence and reach
a decision as to whether the NHS should continue to fund homeopathy
treatments.
IN CONCLUSION
14. The Foundation wholeheartedly supports
evidence based practice (and, indeed, practice based evidence).
That should include evidence, where possible, of the efficacy
of a treatment as well as evidence of its clinical and cost effectiveness
and safety.
15. We are mindful that many patients who
are treated with homeopathy are those for whom no effective evidence
based disease specific treatment is available. That may be because
no such treatment exists or is provided by the NHS for their condition,
for example fibromyalgia and some forms of arthritis, or because
the recommended treatment is contra-indicated, for example, the
patient is a pregnant woman or there is a risk of drug interactions
in cases of multiple morbidities. The health service should not
abandon these patients but rather support research into how to
improve their management.
EVIDENCE CHECK:
HOMEOPATHY
The Prince's Foundation for Integrated Health
is grateful to the Committee for the opportunity to provide the
attached submission for its Evidence Check into homeopathy.
The Committee may be interested to know of two
publications from the USA Institute of Medicine (IoM) that may
relate to its discussion of homeopathy and, in particular, to
the Foundation's evidence:
— Initial National Priorities for Comparative
Effectiveness Research was published 30 June 2009. The
US Congress has committed £1.1 billion dollars for comparative
effectiveness research (CER) and tasked the IoM to recommend national
priorities for research questions to be addressed.
— Integrative Medicine and the Health
of the Public was released 4 November 2009 and provides
a summary of the IoM/Bravewell Collaborative summit on integrative
medicine, held in February this year. This included thorough discussion
of evidence for integrative medicine.
November 2009
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