Evidence Check 2: Homeopathy - Science and Technology Committee Contents


Memorandum submitted by Dr Sara Eames (HO 22)

THE EVIDENCE FOR HOMEOPATHY AND ITS PROVISION WITHIN THE NHS.

  1.   The Faculty of Homeopathy represents over 1000 healthcare professionals in the UK who choose to incorporate homeopathy into their everyday work. Many of these members have become interested in homeopathy because they have seen patients who have been helped by this therapy when conventional treatments have failed.

2.   What is Homeopathy?

  It is well known that the choice of a homeopathic medicine is made by matching the symptoms of a patient with a substance which is known to cause those particular symptoms when taken in larger doses. What is less widely appreciated however is that the whole homeopathic consultation is a complex process and is an ideal way to practice good medicine. It starts with a careful history taking, involving not only the main problem, but also other current problems, past medical, family and social history and factors about the patient's physiology, interests and concerns. It is mandatory to enquire about the patient's lifestyle and identify those factors inhibiting healing and good health. These can include poor diet and lack of or excessive exercise as well as living in difficult emotional situations. The doctor will work with the patient to identify ways in which these blocks may be removed and only then will a homeopathic medicine be prescribed. It thus becomes obvious that when considering the role of homeopathy in the management of patients it is the whole process rather than just the action of the medicine which is to be considered.

3.   What is Evidence?

  3.1.  The concept of evidence is multi-faceted, but in recent years it has become progressively reduced to accepting double blind trials as the gold standard. While these can be useful in assessing the effects of a single intervention on a single symptom or outcome, they are far less suitable when studying the overall effects of a holistic therapy in a complex organism with multiple problems. Notwithstanding this there have been over 100 double blind trials in homeopathy with far more positive than negative outcomes. These are summarised in the submission by my colleague Dr Robert Mathie, on behalf of The British Homeopathic Association.

  3.2.  There are also many other types of evidence for homeopathy:

  Hundreds of thousands of case histories, recording successful cases. (NICE accepts case series as evidence in its review of treatments)

  3.3  Outcome studies from the Homeopathic Hospitals, show consistent results in improving not only the presenting symptoms but also overall well-being and in reducing the use of conventional medicine. [1] The majority of patients in these surveys have chronic conditions, and many have multiple pathologies. All have been referred to the hospitals by their GP or hospital consultants and many have not responded to previous conventional treatment. The outcome studies from the hospitals are discussed in greater detail in the submission by my colleague Dr Hugh Neilsen.

  3.4.  The Department of Health is now advocating the use of patient reported outcome measures (PROMs) as a way of assessing improvements in patients with complex health care needs.

The NHS website requests patient feedback on their hospital experiences and the Royal London Homeopathic Hospital has very positive results.

4.   How Should Evidence be Used in Medicine?

  It is the role of scientists to research and discover new treatments in medicine, but it is the role of the doctor to practice the art of medicine. Pure science and the results of randomised controlled trials (RCTs) are tools in this practice, but should never become the master. A wise physician will use his wisdom and experience to consider a range of treatment options suitable for the individual patient in their particular situation and many conventional doctors find that having homeopathy as an additional tool at their disposal allows them to help more patients in a safe and cost effective way.

5.   The Case for and against Homeopathy.

  5.1  There has been a surprising amount of negative publicity around homeopathy when one considers the tiny proportion of the NHS spending it involves and the fact that it is a remarkably safe therapy which is both popular with and helpful for patients.

There are three main strands to these negative arguments which are the dispute of the evidence from RCTs, the denial of any possibility that an ultra dilute homeopathic medicine can have any action and the publicity given to the few unfortunate cases involving homeopathy where there have been poor outcomes.

  5.2  1.  The consideration of the trial results in homeopathy is fascinating. As stated above in over 100 RCTs there are far more positive than negative results in spite of the fact that in the trials involving classical homeopathy, all trial participants, including those in the placebo group, will have benefited from the homeopathic process as outlined above. This becomes even more compelling in terms of health economics when considering that many of the trial patients will have noticed additional improvements in other health problems which were not recorded as they were not included in the original trial parameters and also that participants suffer from very few, expensive to treat, side effects. All meta-analyses of these trials have been broadly positive, [2,3,4,5] until the last one published by Shang et al in the Lancet [6]. Critics of homeopathy have selectively accepted this outcome as the final word in the argument against homeopathy, but it is worth noting that Shang's work did not include many new trials and was merely a different statistical reworking of the old information. Perhaps the most important conclusion from this is that responsible decision makers should not rely on statistics alone!

  5.3  It is important to note however that the Shang meta-analysis has been widely criticised for not adhering to even the very basic principles of good meta-analysis as outlined in the QUOROM guidelines. [7]

  5.4  Some of the main points of the critique to be aware of include:

  Statisticians involved in a meta-analysis should not have prior knowledge of the subject. At least one of the authors of this study had already critiqued homeopathy although this was not declared in the conflict of interests.

  Enough information about trial selection must be given for the study to be reproducible, yet the article said nothing about the detailed methodology of trial selection and indeed did not even name the trials which had been involved.

The final conclusions of the study were based on the comparison of only eight homeopathy trials, although over 100 had initially been looked at. There is no clear information about how this reduction was done and this number of eight trials was not pre-stated in the methodology as required by QUOROM. One of the chosen homeopathic trials was not even Medline listed, although most of the published homeopathic trials are.

  5.5  At best this is a very poor quality meta-analysis and at worst an example of biased data dredging searching for pre-determined results.

  5.6  2.  The possibility of action of ultra-molecular substances is dismissed as completely implausible by critics of homeopathy, in the face of increasing scientific evidence to the contrary. This evidence has been comprehensively listed and discussed by Dr Peter Fisher in his submission.

  5.7  Some of the more intriguing results include the experiments around the concept of hormesis, where a small dose of a toxic substance will stimulate an organism, even though a larger dose will be toxic. There is also an ever growing group of in-vitro experiments from different centres showing the blocking of basophil activity by highly diluted histamine.

  5.8  It is also fascinating that both plant and animal experiments show how growth can be stimulated or reduced according to the level of dilution of the substance.

  While there is certainly much more to discover about the action of dilute substances, it is no longer scientifically correct to say that they cannot work, with such an increasing body of scientific evidence showing their activity.

  5.9  3.  Individual cases of poor outcomes with homeopathic treatment are obviously to be regretted and may constitute personal tragedy, but they are thankfully rare and usually involve the failure to integrate homeopathy with the best available conventional treatment rather than as an effect of the homeopathic treatment per se.

  It is somewhat surprising that great emphasis and headlines are given to these individual incidents while many thousands of successfully treated patients are dismissed as mere anecdote.

  5.10  There is also a great contrast with the scant publicity given to the side effects of conventional medicine which can produce many serious and expensive to treat complications, but which receive little publicity. The Journal of the American Medical Association (JAMA) has a series of illuminating articles on this subject.

  A study at Toronto University published in 1998 found that over two million hospitalised Americans suffered serious adverse drug reactions during the 12 month period of the study and that 100,000 died as a result of these events. The figures do not include accidental overdoses or errors in administration and they account for more deaths than road traffic accidents each year.

  5.11  A study at John Hopkins School of Hygiene and Public Health two years later found that iatrogenic disease was the third largest killer in the US behind only cancer and cardiovascular disease. It also showed that the largest sub group of these deaths was caused by non-error adverse effects of medication, larger even than deaths caused by hospital acquired infections. [9]

  5.12  It is also important to note that the prescription of multiple conventional drugs concurrently is frequently non-evidence based as little is known about the complicated reactions between them and the effect on patients overall.

6.   The Funding of Homeopathy within the NHS.

  6.1  The two main settings in which homeopathy is used in the NHS are in general practice and at the four homeopathic hospitals.

  6.2  There have been a number of reports of outcomes of GPs prescribing for acute problems and they are all low cost prescribing practices. A recent study published by Robinson showed this and how he was able to use the homeopathic medicines within the context of 10 minute consultations with his patients. [10]

  6.3  It is interesting that some of the positive trials of specific conditions are of great relevance to commonly occurring problems in general practice and include the treatment of allergies, [11] the reduction in duration of influenza symptoms, [12] and a reduction in the duration and severity of childhood diarrhoea when homeopathy is added to conventional treatment. [13]

  6.4  The topic of the Homeopathic Hospitals is discussed in the submission by my colleague Dr Hugh Nielsen, but it is important to stress their unique role and importance within the NHS. They offer an alternative for doctors and their patients when conventional treatments have failed or are contra-indicated and especially when patients suffer from multiple and chronic conditions.

7.  SUMMARY.

  7.1  Homeopathy is a branch of medicine which has an increasing evidence base, both from clinical studies and basic scientific research, which confirms the clinical outcomes reported by practitioners world-wide for over 200 years. There is naturally always scope for further study as suggested by the House of Lords CAM report in 2000.

  7.2  Homeopathy can usefully contribute to care within the NHS both in general practice and the hospital setting. By reducing prescribing costs it will help with the current economic challenges that the health service faces, by reducing not only direct drug costs, but also the number of expensive to treat and sometimes fatal adverse effects of conventional medicine. It is popular with patients and can help with problems that have not responded to conventional treatment including chronic and multiple pathologies.

REFERENCES

1.  Spence D et al Homeopathic Treatment for Chronic Disease: A 6-Year University Hospital based out-patient study. Journal of Alt and Comp Med. 2005; 11; 793-798

2.  Kleijnen J, et al (1991). Clinical trials of homoeopathy British Medical Journal, 302: 316-323.

3.  Boissel JP, et al (1996). Critical literature review on the effectiveness of homoeopathy: overview of data from homoeopathic medicine trials. In: Homoeopathic Medicine Research Group, Report of the Commission of the European Communities, Directorate-General XII—Science, Research and Development, Directorate E—RTD Actions: Life Sciences and Technologies—Medical Research, Brussels, Belgium.

4.  Cucherat M, et al (2000). Evidence of clinical efficacy of homeopathy—A meta-analysis of clinical trials. European Journal of Clinical Pharmacology, 56: 27-33.

5.  Linde K, et al (1997). Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet, 350: 834-84.

6.  Shang A, et al (2005). Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet, 366: 726-732

7.  Lüdtke R, Rutten AL (2008). The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. Journal of Clinical Epidemiology, 61: 1197-1204.

8.  Jason et al (1998) Incidence of adverse drug reactions. Journal of American Medical Association.279(15) 1200-1205.

9.  Starfield B et al (2000) John Hopkins School of Hygiene and Public Health. Journal of American Medical Association . 284(4):483-5.

10.  Robinson TW (2006). Responses to homeopathic treatment in National

Health Service general practice. Homeopathy, 95:9-14.

11.  Taylor MA, et al. Randomised controlled trials of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. British Medical Journal, 2000; 321: 471-476

12.  Vickers A, Smith C. Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes (Cochrane review). In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd. CD001957, 2006

13.  Jacobs J, et al. Homeopathy for childhood diarrohea: combined results and metaanalysis from three randomized, controlled clinical trials. Paediatric Infectious Disease Journal, 2003; 22: 229-234.

DECLARATION OF INTERESTS.

President of the Faculty of Homeopathy and Director of Education and Women's Services at The Royal London Homeopathic Hospital. I have a small private practice.

November 2009





 
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