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 per cent 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 per cent 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

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:

Respect for autonomy

Beneficence

Non-maleficence

Justice

The question of efficacy will be considered within a broader ethical framework that also takes into consideration the above four principles

 

3.4 Hence 5 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 5 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 6544 consecutive patients during a 6-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 466m/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.html#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 SR & Stanley DE. A philosophical analysis of the evidence-based medicine debate BMC Health Serv Res 2003;3:14-24

9. Samal S, Geckler RE. 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 WB, Ives JA, Rollwagen F, et al. Can specific biological signals be digitized? FASEB J 2006;20:23-28.

 

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, 2001.

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 DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Alt Comp Med 2005; 11:793-798

 

19. Kirby BJ. 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