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letter
. 2002 Sep;95(9):474–476. doi: 10.1258/jrsm.95.9.474-b

The safety of homeopathic products

Peter Fisher 1,2,3, Flavio Dantas 1,2,3, Hagen Rampes 1,2,3
PMCID: PMC1280007  PMID: 12205219

It is regrettable that Professor Kirby's editorial (May 2002 JRSM1) did not mention a review of this topic conducted and published by us2. This was a formal systematic review using prospectively defined inclusion and exclusion criteria and data extraction procedures. It comprised a review of English-language publications and enquiries with manufacturers and regulatory agencies.

Table 1 shows a sample of the data: in therapeutic clinical trials (as opposed to healthy-volunteer homeopathic pathogenetic trials) the incidence of reported adverse effects (AEs) is higher in the verum group than in the placebo group (mean incidence 9.4/6.1).

Table 1.

Adverse effects (AEs) of homeopathy reported in therapeutic clinical trials

Trial Medicine Incidence of AEs with homeopathic medicines Incidence of AEs with placebo Reported AEs
Lökken 1995 Arnica D30 (mostly) 5/24 5/24 Non-specific complaints (headache, dizziness)
Reilly 1994 Allergen 30C 1/11 2/13 Aggravation
Reilly 1986 Pollen 30C 11/56 11/52* Aggravation
Reilly 1985 Pollen 30C 1/10 7/25 Aggravation
Labrecque 1992 Thuj. CH30, Ant-c. CH7, Nit-Ac. CH7 2/84 4/87 Stomach ache, loose stools, pimples and tiredness
Attena 1995 Anas Barbariae CH200 77/783 17/790* Aggravation of influenza-like syndrome: myalgia, low-grade fever, rhinorrhoea, headache, rash, itching, earache
Wiesenauer 1995 Galphimia glauca D4 0/64 1/68 Slight nausea in morning
Ernst 1990 Plant complex, Ø to D4 0/31 0/30 None
Jansen 1992 Individualized, 30 to 1000C 0/6 1/4 Repeated aggravations (placebo)
Jacobs 1994 Individualized, 30C 0/43 0/44 None
De Klerk 1994 Individualized D6 to D200 12/86 13/84 Irritability, aggressive behaviour (2), fever, headache, eczema, vomiting, increased perspiration (2), rash (2), hyperactivity, ear discharge, constipation, restlessness, cough, epistaxis, convulsion, albuminuria
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*

Statistically significant

The conclusions were based on these data and reports of apparent AEs from homeopathic pathogenetic trials (provings) and case reports. The main conclusions were:

  • Homeopathic medicines may provoke AEs, but these are generally mild and transient

  • There is under-reporting

  • There are cases of ‘mistaken identity’, where herbal and other medicines were described as homeopathic

  • The main risks associated with homeopathy are indirect, relating to the prescriber rather than the medicine.

Although strictly speaking outside the remit of the editorial, the last point is particularly important. Not only is it the main risk of homeopathy, but it is a topical issue. Medical practice in the UK is currently essentially unregulated; anybody, irrespective of training or registration, can describe themselves as a homeopath. This is the main preventable source of risk. In their evidence to the House of Lords Select Committee on Complementary and Alternative Medicine3, bodies representing non medically qualified acupuncturists and herbalists stated that their professions wished to become statutorily regulated, the Select Committee's report endorsed this view, and the process towards statutory regulation of these professions is now underway.

The non-medical homeopaths, however, indicated that they did not currently wish statutory regulation, despite the view of the Faculty of Homeopathy (doctors and other health professionals practising homeopathy) that homeopathy should be practised only by statutorily registered professionals, and that a new profession should be created if necessary.

References

  • 1.Kirby BJ. Safety of homeopathic products. J R Soc Med 2002;95: 221-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2.Dantas F, Rampes H. Do homeopathic medicines provoke adverse effects? Br Hom J 2000;89:S35-38. [Full text available at www.rihh.org.uk/ conference (Proceedings 2)] [DOI] [PubMed]
  • 3.House of Lords Select Committee on Science and Technology. Complementary and Alternative Medicine. London: Stationery Office, 2000
J R Soc Med. 2002 Sep;95(9):474–476.

Author's reply

Brian J Kirby 1

Dr Fisher and his colleagues' letter, and the article they refer to1, are important in drawing attention to areas I shied away from in my editorial—namely, the paucity and quality of data; and the regulation of homeopaths.

Their survey shows how relatively few adverse events have been reported. As they point out, this might be due to under-reporting; or it might reflect the high dilution of homeopathic remedies. I suspect both explanations are correct. The data on which they based their article and letter illustrate the quality of reports pervading much of the published work on homeopathy: they fail to achieve the standards now expected in pharmacovigilance reporting. In order to gain truly sound, objective, data they need to set up a prospective survey, based on pharmacoepidemiological principles, with sufficient statistical power to yield a useful conclusion. Until this has been done the uncertainty I alluded to in my editorial, and as illustrated by their review, will remain.

They raise the question of regulating homeopathy. This opens an important subject extending beyond the scope of a short editorial. The fact remains that there are non-medical homeopaths in practice many of whom have been through training programmes. For those who have not done so, their detailed knowledge about disease is questionable bringing with it the attendant problem that they may sometimes miss a diagnosis where early intervention by a medical practitioner would reduce suffering or even, on occasion, save a patient's life. The extent of this problem is a matter of conjecture coloured by a small number of adverse experiences; nonetheless, in our increasingly regulated, consumer-conscious society, there can be no doubt that in this discipline, as in all other therapeutic endeavours, there should be an agreed regulatory framework. What this is to be is something homeopaths and the public will need to work out together, taking note of the strengths and weaknesses of the homeopathy as it is currently practised by medical and non-medical homeopaths.

In conclusion, far from refuting my comments their letter goes a long way in confirming my conclusions; thus I am grateful to Dr Fisher and his colleagues for giving me this opportunity to comment further on the subject.

References

  • 1.Dantas F, Rampes H. Do homeopathic medicines provoke adverse effects? Br Hom J 2000;89:535-8 [Full text available at www.rihh.org.uk/ conference (Proceedings 2)] [DOI] [PubMed]

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