Publlished: Duckworth J, Partington H (2009) Provings: the research and ethical context The Homeopath Autumn 2009 pp43-45

Provings: the research and ethical context By Jean Duckworth and Hazel Partington
The proving of homeopathic remedies in order to identify their potential medicinal uses has been a cornerstone of homeopathic theory and practice since the first proving of China by Hahnemann in 17901. You should choose medicines for the symptoms they produce in healthy individuals bodies, as witnessed by repeated observation. Use these medicines in a case of disease which manifests a group of symptoms that are part of the series of symptoms produced by a substance itself. And you will surely cure the disease; you will cure it easily. 2 Information gained from provings forms the majority of our homeopathy canon i.e. repertories and materia medica. While several authors have written about the methodology of proving3 4, little consideration has been given to examining provings within the context of modern research and research ethics. Defining terms The original term for what we now call a proving as used by Hahnemann was the German Pr!fung, which can be translated as test in English 5. Dantas6 and Kaptchuk7 have suggested using the term Homoeopathic Pathogenetic Trial (HPT) for Hahnemanns Pr!fung rather than proving which has other connotations in modern English. Dantas6 goes on to define an HPT as an experimental trial using homoeopathic medicines in non-patient volunteers and compares the homeopathic proving

(HPT) with Phase 1 research trials as currently outlined by the United States and European Union. Phase 1 clinical trials use normal volunteers to assess tolerance of a new drug and to obtain basic pharmacokinetic data. Are HPTs research? Similarities between HPTs and Phase 1 trials include the use of non-patient volunteers, the observation of subjective and objective changes produced in the volunteers by the medicines, both include multiple or more specific end-points, both are controlled, both are a necessary phase for future drug or medicine prescription by doctors and both tend to use a relatively small number of participants6 . However HPTs and Phase 1 trials are not identical in their scope and nature, the primary difference being HPTs use of ultra- high dilutions of substances, which may ordinarily be considered toxic or pathogenic. There is an expectation that the participant will experience a range of symptoms. Participants are expected to provide subjective and objective reporting of each symptom experienced. Typical reactions during HPTs tend to be transitory, unpredictable and idiosyncratic reactions. In contrast Phase 1 trials are the first test of new drugs in human subjects, designed primarily to reduce the risk of serious toxicity and avoid confounding pharmacologic and disease effects and obtain basic pharmacokinetic data. The monitoring of participants is used to assess the objective changes. A positive outcome for a Phase 1 trial is the generation of as few symptoms as possible. Furthermore there is a different emphasis in the recording of symptoms, with a greater level of detail of the idiosyncratic symptoms required for a homeopathy proving. Phase 1 trials generally produce symptoms or reactions that are dose related common symptoms to the drug, in contrast to the reactions generated by the ultra-high dilutions used in HPTs.

Given the differences are HPTs still research? If we accept the definition of research as the creation of new knowledge through investigation89 then logically HPTs would be classified as research on the basis that participants are given substances with the intention to produce symptoms in the participant, such symptoms are then recorded and used to provide information for the use of the substance on future patients. Without provings the homeopathy profession would lose a valuable tool, which is intended to provide homeopaths with new or deeper knowledge about the nature and role of the remedies they use10. Ethical concerns Traditionally, the literature relating to homeopathic provings has focussed on the establishment of an appropriate methodology, designed to ensure the generation of clear and reliable information to add our materia medica and repertories3. Little attention is paid to ethical concerns such as informed consent and protection of the participants. Fisher and Dantas, writing in the British Homeopathic journal highlight ...serious methodological deficiencies The main weaknesses were: inadequate or absent placebo control, low ethical standards, inadequate description of volunteer characteristics or definition of healthy. Indeed many provings are carried out by colleges of homeopathy with the participation of volunteer students11 This is of some concern as students may feel under pressure fellow students to participate, or may participate from a desire to please their lecturers rather than from their own wish to experience a proving. In addition they may have completely unrealistic expectations of the process and which may be compounded by a lack of adequate information12 A brief examination of research ethics will provide context here. Kent13states in the Journal of Medical Ethics, that it can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties- potential research

participants, society and researchers Fisher suggests that this balance is not always achieved in homeopathy provings. A pragmatic approach to ethical principles, necessarily leads us to a consideration of respect for autonomy, non-maleficence, beneficence and justice 9. In respect to the issue of participant safety, the literature is fairly clear that long term adverse effects do not happen with provings however this does not mean that they are impossible, just that they have not yet been observed 14 15. Rights of participants Although there is relatively low risk to participants in homeopathic provings from the medicinal effects of the remedy, we would suggest that the primary reason that participants in HPTs should be the recipients of ethical consideration is a rights based one. A rights based deontological approach would enable us to ask, What is the right way to treat a participant in a Homeopathic Pathogenetic Trial? Kants approach would be to argue that if participants in a trial are rational beings then they should always be used as ends in themselves and not as a means to someone elses end. Using this approach means that it is the prior existence of autonomous reason in a rational being that insists that we should treat participants as ends in themselves 12 . The adoption of a rights-based approach to participants in provings would be congruent with prevailing views in homeopathy on the empowerment of patients. From this it follows that we should seek to place HPT participants in the same position. Rights derive from basic human rights not just those that are codified such as The Nuremberg Code, The Declaration of Helsinki and the International Declaration of Human Rights but also the inchoate rights, which are the product of reasoned moral analysis12.

Liberty is a primary human right; implicit in this important right is a right to self-determination so participants as rational beings can make autonomous decisions. If we give these rights to participants then this acts as a check on the research researchers must take account of the rights of the participant. This respect for autonomy is paramount. The rights of participants should include the right to be consulted, as one of those most affected by researchers actions and the right to have their confidentiality respected. The relative lack of significant risk to participants in an HPT should not preclude the respect for these fundamental rights when designing an HPT, researchers should ensure that as far as is reasonably practicable that the participant is not going to be subject to harm. These criteria may be met sufficiently by assessing and accounting for risk in a trial or HPT, and providing participants with adequate information. Informed consent If consent (to respect autonomy) is to be valid, it must be given by a competent person, who is adequately informed, and consenting voluntarily. There is some consideration of inclusion/exclusion criteria for HPTs in the literature. Sherr3 suggests that provers are over 18 and in good health. Pregnant women are also excluded. Walach16 suggests that: Provers should not be affiliated to homeopathy, but willing to take part in the study. They should be over 18, trustworthy, in good health, not currently involved in major life events Dantas11 proposes that volunteers (aged 18-70) should be in good health with no active illness, mentally competent with no major life events planned. Both Walach and Dantas suggest payment for volunteers. Although such inclusion criteria by default offer some protection to participants this is tacit rather than explicit. It would appear

that the primary aim of current inclusion criteria is to ensure good research subjects rather than recognising the rights of the participants, as the majority of HPTs stand they are putting the end result ahead of the participants rights and not treating the participants as ends in themselves by fully respecting their autonomy. Confidentiality Researchers should also respect confidentiality; this has implications for the subsequent uses and dissemination of the data generated. One of the features of homeopathic provings or HPTs is that by their nature they seek to isolate the individual or idiosyncratic reactions in the participant rather than the dose related, common reactions6. The valid and useful data not only concerns the objective data from participants but the subjective changes. Therefore the researcher needs to ensure that participants are fully aware of the uses of the data generated and the mechanisms by which that data will be disseminated to the profession. This may seem to promote a more goal-orientated agenda but we would argue that as long as the participants are aware before the outset of a trial how information will be disseminated and used, that the fundamental right to liberty is upheld. Wieland10 would not support this view; he clearly states, we must not forget the true goal of homoeopathic drug provings, which is to find medicines that cure. The methods of the investigation must serve and not hinder this goal. We cannot agree with this on the basis that the superior consideration must be the rights of the individual to self-determination and that it is this that should be paramount. Conclusion In summary, the researcher is looking for a goal and an outcome in the case of homeopathy provings to the compilation of the proving symptoms into the language and form needed for

prescription to patients. HPTs can be seen as ethically weak in the way they are currently conducted, and attention needs to be paid to the development of an ethical framework for their operation. We argue that a combination of a Kantian approach and the adoption of choice theory would enable a framework for beginning to consider the approach to ethics in HPTs. What this approach fails to do though is to take full account of the researchers role in research, it relies on the participants having adequate knowledge but also the ability to refuse or withdraw from participation. In our opinion this is particularly apposite in provings managed by course providers. This is not to suggest that students are forced to participate in proving, but if we take a rights-based approach, students can be seen as being the weaker party. As Dantas has stated, proving participants should be not be subservient. We should like to see the national and international development of ethical guidelines for the operation of Homeopathic Pathogenetic Trials or Provings. (1853 words)

Bibiography 1 Bayr G (1989) Hahnemanns Selbstversuch mit der Chinarinde im Jahre 1790 Heidelberg: Haug Belon P (1995) Provings: Concept and methodology British Homoeopathic Journal, 84: 213-7
2

Sherr J (1994) Dynamics and Methodology of Homoeopathic Provings Malvern: Dynamis Books
3 4

European Committee of Homeopathy (2004) Homeopathic Drug ProvingGuidelineshttp://www.homeopathyeurope.org/pdf/ECH_Provin g_Guidelines_v1.pdf [accessed 5.3.09].

Kotok A (2009) The history of homeopathy in the Russian Empire until World War I, as compared with other European countries and the USA: similarities and differences. http//www.homeoint.org/books4/kotok/founder.htm [accessed 12.4.09)
6

Dantas F (1996) How can we get more reliable information from homeoeopathic pathogenetic trials? A critique of provings British Homoeopathic Journal, 85: 230-236
7

Kaptchuk T (1996) When does unbiased become biased? The dilemma of homoeopathic provings and modern research methods British Homoeopathic Journal, 85: 237-247

Universities Scotland What is research? [online] www.universitiesscotland.ac.uk accessed 4 January 2007

8 9

Sutton C (2006) When? How? What? Making those applications Notes from University of Central Lancashire Research Presentation December 2006 Wieland F (1997) Good homoeopathic provings British Homoeopathic Journal, 86: 229-234 Fisher P, Dantas F (2001) Homeopathic pathogenetic trails of Acidum malicum and Acidum ascorbicum British Homeopathic Journal, 90: 118-125
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10

Foster C (2001) Ethics of Medical Research on Humans Cambridge: Cambridge University Press
12

Kent G (1997) The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs Journal of Medical Ethics, 23:3: 186190
13

14

Chatfield K (2006) In Pursuit of Evidence The Homeopath Winter 2006, 25:3 78-82 Ernst E (1995) The safety of homoeopathy British Homoeopathic Journal, 84: 193-4
15

Walach H (1997) The pillar of homoeopathy: Homoeopathic drug provings in a scientific framework British Homoeopathic Journal, 86: 219-224
16