Safety studies

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    [post_content] => No medical intervention is risk free, but homeopathy as a treatment option is generally considered to have an excellent safety record1. But what is the evidence supporting this belief?

When assessing the safety of homeopathy, there are three discrete issues to consider:

1)  Safety of homeopathic medicines
One of the main differences between homeopathic medicines and conventional medicines is that the latter can be associated with significant toxicity problems and unwanted side effects known as ‘adverse drug reactions’. The highly-diluted nature of homeopathic medicines means that they are considered to be highly unlikely to lead to this type of toxic side-effect2.

It is the collective experience of homeopaths and patients alike over decades that homeopathic treatment is safe and many patients say that they choose homeopathic treatment rather than conventional treatment because it does not have the side-effects associated with many conventional drugs. However, it must be appreciated that there is a need to continue to carry out formalised research to test the accuracy of these observations; the safety of homeopathic medicines has been identified as a key area for further work by researchers in the field3.

2)  Safety of treatment by a homeopath
Several systematic reviews of the evidence base for homeopathy have been carried out to look at the published rate of adverse events during, but not necessarily caused by, treatment by a homeopath.

The most comprehensive study reviewed the evidence from 1970–1995, including clinical trials, case reports and information provided by manufacturers and regulatory bodies1. Adverse effects reported during clinical trials testing homeopathic medicines were found to be mild and transient e.g. headaches, tiredness, skin eruptions, dizziness and diarrhoea. These adverse effects occurred more often in the groups given a homeopathic medicine than in the control groups given placebo, which is further evidence that homeopathic medicines are different from placebo.

These true side-effects are easy to differentiate from what homeopaths refer to as ‘aggravations’. A homeopathic aggravation is considered to be a brief intensification of pre-existing symptoms that is sometimes seen soon after taking a homeopathic medicine3. When this initial reaction is followed by significant improvement in the patient’s overall sense of wellbeing, it is considered to be part of the healing process and therefore classed as a positive therapeutic outcome4.

A report by the European Council for Clinical Homeopathy reviewed the results of observational studies assessing the safety of homeopathic treatment since 19955. Observational studies are less reliable than randomised clinical trials because they do not attempt to determine precisely what caused any adverse events. However, they provide a useful measurement of what happens in real-life practice which can then be considered alongside RCT results to give the fuller picture. In 20 studies (covering a total of 7,275 patients) the percentage of patients reporting adverse events ranged from 0–11% (including homeopathic aggravations). No cases of serious adverse events or serious adverse drug reactions were found, i.e. no cases were reported resulting in hospitalisation, life-threatening situations, persistent or significant disability/incapacity or congenital anomaly/birth defect.

3)  The appropriateness of homeopathic treatment
It is sometimes stated that homeopathic treatment may carry indirect risks of harm by delaying necessary conventional medical treatment6. However, in practice it is rare for a patient to seek help who has not already tried everything the conventional approach has to offer. Homeopaths also commonly refer patients back to their GP as the in-depth method of consultation by a homeopath can reveal signs and symptoms that the GP may not have had time to uncover.

Risk of harm to the patient in homeopathy may also arise from poorly qualified or unregulated practitioners rather than the practice itself and if homeopathy is used instead of essential conventional medical treatments where it may not be appropriate to do so: not all conditions are appropriate for homeopathic treatment.

Registered members of The Society of Homeopaths (indicated by the letters ‘RSHom’) have met stringent academic requirements, completed a registration process, hold comprehensive insurance and agree to abide by a Code of Ethics & Practice, providing the general public with a guarantee of safety and competence7. It is the Society of Homeopath’s policy to work alongside conventional medicine and to offer an integrated approach to a patient’s health and wellbeing.

In common with other members of the European Central Council of Homeopaths (ECCH), the Society of Homeopaths has a clear and transparent complaints procedure. The ECCH member associations represent over 5,000 practitioners in 24 countries. A recent investigation found that only 10 cases of possible unethical practice or malpractice had been reported against practitioners within this membership over the past decade. Although under-reporting cannot be ruled out, this supports the assertion that homeopathic treatment by well-trained and regulated practitioners is safe.

References
  1. Dantas F, Rampes H. Do homeopathic medicines provoke adverse effects? A systematic review. Br Homeopath J 2000; 89: 535–8
  2. Kirby BJ. Safety of homeopathic products. J Royal Soc Med, 2002; 95:221–2
  3. Endrizzi C. et al. Harm in homeopathy: aggravations, adverse drug events or medication errors? Homeopathy, 2005; 94 (4): 233-40
  4. Thompson et al. A preliminary audit investigating remedy reactions including adverse events in routine homeopathic practice. Homeopathy, 2004; 93: 203-9
  5. The Safety of Homeopathy, European Council for Classical Homeopathy, January 2009.
  6. Sharples F, van Haselen R. Patients’ perspectives on using a complementary medicine approach to their health. A survey at the Royal London Homoeopathic Hospital NHS Trust. London, 1998
  7. Society of Homeopaths, Code of Ethics and Practice 2012 paragraph 2.2
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No medical intervention is risk free, but homeopathy as a treatment option is generally considered to have an excellent safety record1. But what is the evidence supporting this belief?

When assessing the safety of homeopathy, there are three discrete issues to consider:

1)  Safety of homeopathic medicines
One of the main differences between homeopathic medicines and conventional medicines is that the latter can be associated with significant toxicity problems and unwanted side effects known as ‘adverse drug reactions’. The highly-diluted nature of homeopathic medicines means that they are considered to be highly unlikely to lead to this type of toxic side-effect2.

It is the collective experience of homeopaths and patients alike over decades that homeopathic treatment is safe and many patients say that they choose homeopathic treatment rather than conventional treatment because it does not have the side-effects associated with many conventional drugs. However, it must be appreciated that there is a need to continue to carry out formalised research to test the accuracy of these observations; the safety of homeopathic medicines has been identified as a key area for further work by researchers in the field3.

2)  Safety of treatment by a homeopath
Several systematic reviews of the evidence base for homeopathy have been carried out to look at the published rate of adverse events during, but not necessarily caused by, treatment by a homeopath.

The most comprehensive study reviewed the evidence from 1970–1995, including clinical trials, case reports and information provided by manufacturers and regulatory bodies1. Adverse effects reported during clinical trials testing homeopathic medicines were found to be mild and transient e.g. headaches, tiredness, skin eruptions, dizziness and diarrhoea. These adverse effects occurred more often in the groups given a homeopathic medicine than in the control groups given placebo, which is further evidence that homeopathic medicines are different from placebo.

These true side-effects are easy to differentiate from what homeopaths refer to as ‘aggravations’. A homeopathic aggravation is considered to be a brief intensification of pre-existing symptoms that is sometimes seen soon after taking a homeopathic medicine3. When this initial reaction is followed by significant improvement in the patient’s overall sense of wellbeing, it is considered to be part of the healing process and therefore classed as a positive therapeutic outcome4.

A report by the European Council for Clinical Homeopathy reviewed the results of observational studies assessing the safety of homeopathic treatment since 19955. Observational studies are less reliable than randomised clinical trials because they do not attempt to determine precisely what caused any adverse events. However, they provide a useful measurement of what happens in real-life practice which can then be considered alongside RCT results to give the fuller picture. In 20 studies (covering a total of 7,275 patients) the percentage of patients reporting adverse events ranged from 0–11% (including homeopathic aggravations). No cases of serious adverse events or serious adverse drug reactions were found, i.e. no cases were reported resulting in hospitalisation, life-threatening situations, persistent or significant disability/incapacity or congenital anomaly/birth defect.

3)  The appropriateness of homeopathic treatment
It is sometimes stated that homeopathic treatment may carry indirect risks of harm by delaying necessary conventional medical treatment6. However, in practice it is rare for a patient to seek help who has not already tried everything the conventional approach has to offer. Homeopaths also commonly refer patients back to their GP as the in-depth method of consultation by a homeopath can reveal signs and symptoms that the GP may not have had time to uncover.

Risk of harm to the patient in homeopathy may also arise from poorly qualified or unregulated practitioners rather than the practice itself and if homeopathy is used instead of essential conventional medical treatments where it may not be appropriate to do so: not all conditions are appropriate for homeopathic treatment.

Registered members of The Society of Homeopaths (indicated by the letters ‘RSHom’) have met stringent academic requirements, completed a registration process, hold comprehensive insurance and agree to abide by a Code of Ethics & Practice, providing the general public with a guarantee of safety and competence7. It is the Society of Homeopath’s policy to work alongside conventional medicine and to offer an integrated approach to a patient’s health and wellbeing.

In common with other members of the European Central Council of Homeopaths (ECCH), the Society of Homeopaths has a clear and transparent complaints procedure. The ECCH member associations represent over 5,000 practitioners in 24 countries. A recent investigation found that only 10 cases of possible unethical practice or malpractice had been reported against practitioners within this membership over the past decade. Although under-reporting cannot be ruled out, this supports the assertion that homeopathic treatment by well-trained and regulated practitioners is safe.

References

  1. Dantas F, Rampes H. Do homeopathic medicines provoke adverse effects? A systematic review. Br Homeopath J 2000; 89: 535–8
  2. Kirby BJ. Safety of homeopathic products. J Royal Soc Med, 2002; 95:221–2
  3. Endrizzi C. et al. Harm in homeopathy: aggravations, adverse drug events or medication errors? Homeopathy, 2005; 94 (4): 233-40
  4. Thompson et al. A preliminary audit investigating remedy reactions including adverse events in routine homeopathic practice. Homeopathy, 2004; 93: 203-9
  5. The Safety of Homeopathy, European Council for Classical Homeopathy, January 2009.
  6. Sharples F, van Haselen R. Patients’ perspectives on using a complementary medicine approach to their health. A survey at the Royal London Homoeopathic Hospital NHS Trust. London, 1998
  7. Society of Homeopaths, Code of Ethics and Practice 2012 paragraph 2.2

 

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