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Memorandum submitted by the

Prince's Foundation for Integrated Health

 

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

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 30th 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 4th 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