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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)  

References

 

1. Chaplin M. Water structure and science. http://www1.lsbu.ac.uk/water/index2.html (last      accessed 22.08.2009)

 

2. Brooks M. Homeopathy. It's patently absurd, so why won't it go away? In: 13 things that     don't make sense. The most intriguing scientific mysteries of our times. Profile books.      2009.

 

3. Rey L. Thermoluminescence of ultra-high dilutions of lithium, chloride and sodium     chloride. Physica A, 2003, 323, 67-74.

 

4. Roy R, Tiller WA, Bell I, Hoover MR: The structure of liquid water; novel insights from     materials research; Potential relevance to homeopathy. Mat Res Innovat     2005;9:577-608.

 

5. Rao ML, Roy R, Bell IR, Hoover R: The defining role of structure (including epitaxy) in the      plausibility of homeopathy. Homeopathy 2007;96:175-182.

 

6. Samal S, Geckler KE: Unexpected solute aggregation in water on dilution. Chem     Commun     2001;21: 2224-2225.

 

7. van Wijk R, Bosman S, van Wijk EP: Thermoluminescence in ultra-high dilution research.        J     Altern Complement Med 2006;12:437-443.

 

8. Elia V, Elia L, Cacace P, Napoli E, Niccoli M, Savarese F: Extremely diluted solutions as     multivariable systems: a study of calorimetric and conductimetric behaviour as functions      of  the parameter time. J Therm Anal Calorim 2006;84:317-323.

 

9. Arani R, Bono I, Del Guidice E, Preparata G: QED coherence and the thermodynamics of     water. Int J Mod Phys B 1995;9:1813-1841.

 

10. Demangeat JL. NMR water proton relaxation in unheated and heated ultrahigh aqueous        dilutions of histamine: Evidence for an air-dependent supramolecular organization of        Mol. Liquids, 144 (2009), 32-39.

 

11. Belon P, Cumps J, Ennis M, Mannaioni PF, Sainte-Laudy J, Roberfroid M, Wiegant         FAC. Inhibition of human basophil degranulation by successive histamine dilutions:          Results of a  European multi-centre trial. Inflamm. Res., 48, Suppl.1, 1999, 17-18.

 

12. Belon P, Cumps J, Ennis M, Mannaioni PF, Robertfroid M, Sainte-Laudy J, Wiegant         FAC. Histamine dilutions modulate basophil activation, Inflamm. Res., 53 2004, 181-       188.

 

13. Sainte-Laudy J, Belon P. Use of four different flow cytometric protocols for the analysis         of human basophil activation. Application to the study of the biological activity of high         dilutions of histamine, Inflamm. Res., 55, Suppl. 1, 2006, 23-24.

 

14. Montagnier L, Aanissa J, Ferris S, Montagnier J-L, Lavallee C, Electromagnetic       Signals Are Produced by Aqueous Nanostructures Derived from Bacterial DNA       Sequences  Interdiscip Sci Comput Life Sci (2009) 1: 81-90

 

15. Jonas, W. B., Kaptchuk, T. J., & Linde, K. 2003b, "A critical overview of homeopathy",        Ann.Intern.Med., vol. 138, no. 5, pp. 393-399.

 

16. Cucherat, M., Haugh, M. C., Gooch, M., & Boissel, J. P. 2000, "Evidence of clinical        efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic       Medicines Research Advisory Group", Eur.J.Clin.Pharmacol., vol.. 56, no. 1, pp. 27-33.

 

17. Linde K, Clausius N, Ramirez G, et al. Are the clinical effects of homoeopathy placebo        effects? A meta-analysis of placebo-controlled trials. Lancet 1997;350:834-43.

 

18. Report to the European Commission directorate general XII: science, research and        development. Vol 1 (short version). Brussels: European Commission, 1996:16-7.

 

19.  Kleijnen J, Knipschild P, Ter Riet G. Clinical trials of homoeopathy. British Medical        Journal. 1991b;302:316-23.

 

20. Linde K. Jonas WB, Melchart D, Worku F, Wagner H, Eital F. Critical Review and Meta-       Analysis of Serial Agitated Dilutions in Experimental Toxicology. Human and        Experimental Toxicology. 1994;13:481-492.

 

21. Reilly D, Taylor MA, Beattie NGM, Campbell JH, McSharry C, Aitchison TC, Carter       R,  Stevenson RD. Is evidence for homoeopathy reproducible? Lancet.       1994;344:1601-1606.

 

22. Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JAC, Pewsner D,       Egger M. Are the clinical effects of homeopathy placebo effects? Comparative study       of controlled trials of homeopathy and allopathy. Lancet 2005; 366: 726-32.

 

23.  Lüdtke R, Rutten ALB. The conclusions on the effectiveness of homeopathy highly        depend on the set of analyzed trials. Journal of Clinical Epidemiology. 2008, 61(12),        1197-204.

 

24. Rutten ALB, Stolper CF. The 2005 meta-analysis of homeopathy: the importance of        post- publication data. Homeopathy, 2008, 97, 169-177.

 

25.  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.

 

26.  Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: Long-term        results of ß a cohort study with 3 981 patients. BMC Public Health 2005, 5:115        doi:10.1186/1471-2458-      5-115

 

27.  Swayne J. The cost and effectiveness of homoeopathy. Br Homeopath J        (1992) 81:       148-50.

 

28. Feldhaus HW. Cost-effectiveness of homoeopathic treatment in a dental        practice.       British Homeopathic Journal (1993); 82: 22-8.

 

29. Jain A. Does homeopathy reduce the cost of conventional drug prescribing?        A       study of comparative prescribing costs in general practice. British        Homeopathic       Journal (2003)  92: 71-6

30. French Government Report: Social Security Statistics, CNAM (National Inter-       Regulations       System) (1991)61

31.  Witt et al Outcome and costs of homoeopathic and conventional treatment        strategies:         AComparative cohort study in patients with chronic disorders        Complementary         Therapies in  Medicine (2005) 13. 79 -86

32. Trichard, Chaufferin et al. Effectiveness, Quality of Life, and Cost of Caring        for        Children   in France with Recurrent Acute Rhinopharyngitis Managed by       Homeopathic        or Non- Homeopathic General Practitioners Dis Manage       Health       Outcomes (2004)        12 (6): 419- 4271173-8790/04/0006-0419/$31.00/0

33. M Van Wassenhoven and G Ives An observational study of patients         receiving        Homeopathic treatment. Homeopathy (2004) 93, 3-11.

34. Dempster, A Homeopathy within the NHS; Evaluation of homeopathic treatment of       common mental health problem 1995- 1997.(1988) Society of Homeopaths

 

35. Ward A and Christie Dr E Report on NHS practice based homeopathy project       (1996)          Society of Homeopaths,

 

36. Slade et al, Evaluation of a GP practice based homeopathy service.      Homeopathy       (2004)       93, 67-70

 

37. Sharples F, van Haselen, R, Patients perspective on using a          complementary        medicine     approach to their health: a survey at the Royal         London Homoeopathic        Hospital NHS     Trust (1998).

 

38. L. Hektoen DVM1 The Veterinary Record, Vol 155, Issue 22, 701-707

 

39. Hollinghurst, Shaw and Thompson, Capturing the value of complementary        and       alternative medicine: Including patient preferences in economic        evaluation . Science        Direct (2007)

40. The safety of homeopathy. An ECCH report. January 2009. European Central Council       of  Homeopaths (ECCH) Available at: www.homeopathye-ecch.eu

41. The Legal Situation for the Practice of Homeopathy in Europe, An ECCH Report,         Revised Edition March 2009. European Central Council of Homeopaths (ECCH)         www.homeopathy-ecch.eu

 

42. Norges offentlige utredninger, NOU 1998:21 Alternativ medisin. (Official report         published by the Norwegian Department of Health. Available at:

http://odin.dep.no/hd/norsk/publ/utredninger/NOU/030005-020019/index-ved005-b-n-        a.html)

 

43. Ot.prp. nr. 27 (2002-2003). Om lov om alternativ behandling av sykdom mv.

 

44. WHO Global Atlas of Traditional Complementary and Alternative Medicine. Ong CK,        Bodeker G, Grundy C, Burford G, Shein K. 2005, Kobe Japan.

 

45. Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A         Worldwide Review. 2001. World Health Organization (WHO).

 

46. Kjennskap og holdninger til homeopati. Opinion, Norway, 2001.

 

47. Sykepleiere sier ja til alternativ behandling. Tidsskriftet sykepleien nr.17 - 1998.

 

48. Pedersen EJ, Norheim AJ, Fønnebø V. Norske legers holdninger til homøopati.        Tidsskrift for Den Norske Lægeforening, 1996, 116: 2186-9.

 

49. Reimbursement of Expenses for Homeopathic Treatment in Europe, An ECCH Report,        European Central Council of Homeopaths April 2008

 

 

Stephen Gordon

General Secretary

European Central Council of Homeopaths

 

 

November 2009