Research in hom eopathy, a UK perspective

RONALD W. DAVEY, MB, BS, MFHOM, AKC

Is research in homceopathy really necessary, or is it merely an academic pursuit which satisfies those of us who are a little bit more than curious. Or is it something which is going to be vital for the continuance of hom~eopathy? In my opinion there can be no doubt whatsoever: research is vital, and I am going to give you very briefly some of the reasons why.

Alan Warren has just told us about the Committee for the Review of Medicines and this date of 1990, which is hovering on the horizon. The facts are that homceopathy is allegedly exempt from this review until 1990, by which time all the existing licences will have been reviewed by this Committee. I have been informed by a member of the Committee that they will be turning their attention to homceopathic medicines after 1990. So it does not matter which side of the divide we fall as homoeopathic practitioners, we have got to have half an eye on the Committee for the Review of Medicines and how it is going to evaluate homoeopa- thy. The Committee comprises 14 doctors and 4 pharmacists, and none of them to my current knowledge has any real understanding of homceopathy. So, how can you get a reasonable review of our own particular discipline?

Another reason why I would suggest that research is vital is that the Research Council for Complementary Medicine is receiving growing numbers of applications for funding from orthodox practitioners and orthodox academic researchers who are often uninformed in the sense of the special requirements for research into hom~eopathy. There are obvious dangers if such people perform inadequate work and publish negative trials. I am aware of polytechnic departments of pharmacy who have students pressing for research projects, and one polytechnic in particular has students carrying out projects in homceopathy as part of their dissertations for their degrees. Professor D'Arcy, Professor of Pharmacology at Queen's University, Belfast, has been pressing to investigate homoeopathy for some time and is deeply committed in a political sense in the Northern Ireland National Assembly to see hom~eopathy researched.

The colloquia or meetings at the Royal Society of Medicine between complemen- tary and orthodox medicine are now pressing more and more for research. There is growing demand on the part of the orthodox fraternity that we justify the claims we make if there is going to be a continuing dialogue between us.

The BMA report on alternative medicine is due out quite shortly and is going to do quite a panning job for all complementary therapies, but in particular homceopa- thy, which will generate its own backlash. No doubt it will demand that we put our house in order and perform research and demonstrate the claims we make in a clinical context.

And so I could go on. There are all these political, medical, academic pressures

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upon us now, with time factors possibly in and around 1990, which are pressing us to do research, to demonstrate our case and not specially plead that research is inappropriate to homo~opathic clinical practice. So, research will happen, whether we like it or not; it could happen more from those outside homo~opathy, and the results could be counterproductive if it is ill-informed research and lacks any homeopathic oversight, interpretation or direction. That is my answer to the question: is research necessary?

Alan Warren has already pointed out the requirements in the UK for phar- macological preparations. In my mind they fall into three specific categories. Efficacy is the first one--does it actually work? Is hom~eopathy something which actually has a therapeutic effect, or is it merely a placebo? You may well have your answer very readily, but in a research context you must not assume that answer.

Secondly, is homeopa thy safe? The safety factor. Again, you may be thoroughly convinced in your own mind that it is perfectly safe. But the question must be raised because of existing legislation: does homceopathy ever do harm? Let me pose a simple question: are you always certain in your own mind, being honest, that the aggravations which you see are always beneficial? I think that is a reasonable question.

Thirdly, quality control the actual product we prescribe. In the early stages of my association with research in hommopathy, I was quite shattered to discover that in reality there are no standards. I mean by this, that if you were to take Arsenicum album 30c off the shelf in one pharmacy or from one manufacturer, can you be absolutely certain that Arsenicum album 30c taken from other sources is exactly the same? Can you be absolutely certain that the named product is exactly what it says it is? Does this lack of either quality controls or standards account perhaps for the varying therapeutic response some of us see? Does it account for the frequent reports that some homeopathic research is non-repeatable? I would say it could well do, if we are not using exactly the same source materials.

Hommopathy uses the term 'drug pictures'; it is inevitable that at some stage they will be subjected to pharmacological assessment. In fact, it is already happening. If homeopathy can be prescribed from mother tinctures right up to 10M, CM and beyond, then you have material doses at the mother tincture end of the scale and non-material doses of the high potencies at the other end. In research terms this can be reduced to two simple areas: one is pharmacological and the other is phe- nomenological. If you examine homeopa thy along pharmacological lines, then there are existing well defined research tools to hand and there is an argument for applying these to mother tinctures and low potencies. However, if you are to examine homceopathy under a phenomenological regime, then you probably need to consider new methodologies and new paradigms, and some of us have high hopes that David Reilly will be giving some of his time to this in the future. There are still plenty of standard approaches to assess outcome studies, phenomenological hap- penings, within homeopathy. Double-blind clinical trials can be used in assessing certain aspects of treatment and outcome. However, it is true to say that certain new methodological approaches will need to be worked out for many areas of homo~opathic prescribing.

What research has been done in the UK along these two lines? Taking phar-

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macology research in the broad sense of bio-assay systems, there are a number of papers: Keysell et al. from Portsmouth Polytechnic using Arnica and Hypericum as a pain-controlling drug; 1 the work of Peter Fisher; 2 and W. E. Boyd's excellent work,3 which historically stands the test of time. Pelikan and Unger the experiments on plant growth; 4 Jones and Jenkins' work on wheat and yeast cultures; 5 Steffen's work on yeast cultures, 6 but without the same results. There is unpublished work by Grange and others using a bacteriological assay system which very excitingly has discovered new antibiotic activities amongst homceopathic preparations. 7

In terms of phenomenological studies there are several interesting trials, for example, Gibsons' trials on rheumatoid arthritis, 8,9 and the trial by Shipley et al. using Rhus.Tox. TM There is Day's report of his treatment of stillbirths in pigs. u Further, a dental trial using Arnica has recently been published in the B H R G Communications. 12 There is the well-known work of David and Morag Taylor Reilly, whose pilot study has been published.i3 Their second trial is in preparation TM

and I consider it will be a very far-reaching potency versus placebo trial. Finally, there is work repeating Barnard's research on testing the hypothesis that hom0eopathic remedies produce macromolecules in solution, a5 These phe- nomenological studies are based upon the null hypothesis that homceopathic remedies are inherently ineffective, and were designed to demonstrate whether that was true or otherwise.

I can report that there is other research in the pipeline, ranging from anti- mutogenic effects through to the effect of homeeopathy on the common cold. Having demonstrated pharmacological and phenomenological effects or otherwise of homceopathy, we then have to address the very difficult question: how does it work? However I am not even going to speculate in that particular area!

REFERENCES 1 Keysell GR, winiamson KL, Tolman BD. An investigation into the analgesic activity of two hom0eopathic

preparations Arnica and Hypericum. Communications (British Homoeopathy Research Group) 1984; 11: 32-42.

2 Fisher P. The treatment of experimental lead intoxication in rats by penicillamine and Plumbum metallicum. Proc 35 Int Horn Congress 1982: 320--332.

3 Boyd WE. Biochemical and biological evidence of the activity of high potencies. Br Horn J 1954; 44: 6-44. 4 Pelikan W, Unger G. The activity of potentized substances. Experiments on plant growth and statistical

evaluation. Br Horn J 1971; 60: 233-66. 5 Jones RL, Jenkins MD. Comparison of wheat and yeast as in vitro models for investigating homeeopathic

medicines. Br Horn J 1983; 72: 143-47. 6 Steffen WA. Growth of yeast cultures as in vitro model for investigating homceopathic medicines. Br Horn J

1984; 73: 198-210. 7 Grange J, Davey RW, Jonas S. Antibiotic activity in folklore medicine. (In press) 8 Gibson RG, Gibson SLM, MacNeill AD etal. Salicylates and hom0eopathy in rheumatoid arthritis: prelimin-

ary observations. B r J Clin Pharmacol 1978; 6: 391-395. 9 Gibson RG, Gibson SLM, MacNeill AD et al. Hom0eopathic therapy in rheumatoid arthritis: evaluation by

double blind clinical therapeutic trial. Br J Clin Pharmacol 1980; 9: 453-59. 10 Shipley M, Berry H, Broster Get aL Controlled trial of homeeopathic treatment of arthritis. Lancet 1983; i:

97-98. 11 Day CEI. Control of stillbirths in pigs using hom0eopathy. The Veterinary Record 1984; 114: 216. 12 Pinsent RJFH. Does Arnica reduce pain and bleeding after denal extraction. Communications 1986; 15:

3-11.

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13 Reilly DT, Taylor MA. Potent placebo or potency? A proposed study model with initial findings u~sing hom~eopathically prepared pollens in hay fever. Br Hom J 1985; 74: 65-75.

14 Reilly DT, Taylor MA, McSharry C, Aitchinson T. Is homceopathy a placebo response? A controlled trial of a homceopathic potency using oral mixed grass pollens 30c in hay fever as a model. (Submitted for publication.)

15 Davey R. Viscometric studies of hom~eopathic potencies. (In press)

Report from the working party on research

The group asked the fundamental question of research: whom are we really trying to please? Is it our fellow practitioners in homceopathy, or is it the big world outside? Our peers in orthodoxy and the scientists? Or is it even the Committee for the Review of Medicines? The question is: are we really trying to do research for the wrong reasons? Whatever the reasons, we agree that it has to be done. It was thought that there is a lot of scientific work, basic scientific methodologies, which exist today and which still need to be considered. Homo~opathy cannot, as yet, get into the position of specially pleading its case and going for new methodologies. There is still plenty of scope within the accepted scientific framework for investiga- tion for hom~eopathy to demonstrate its case.

However, politically, the most interesting point of the discussion was a proposal, which was formally adopted by our group and is now laid before the whole meeting, that there should be a Hom~eopathic Research Council. This would involve all the working groups, all the research groups in the UK that are known to us, beavering away in various ways, including the Faculty, the Research Council for Complemen- tary Medicine, the British Homoeopathy Research Group and the Blackie Foun- dation. They should put up members for this Council, maybe even unite resources and personnel, to produce an officially recognized body, hopefully gaining status from government, and hopefully gaining funding from the DHSS. It is all very possible. We should speak with a united voice and develop our research using the limited resources available to all these individual units. We could unite these resources to use them in the best possible way, so that we have a well defined scientific research strategy which wilt begin to answer the many questions which are facing us.

This is one of the priority aims which we lay before this meeting and before the greater constituency of the Faculty itself.

A further very interesting point was raised. There is, as many of you are aware, a journal called Communica t ions , the official organ of the British Homoeopathy Research Group, which has been going in its own right for some years. It was put to the meeting: why does it not combine with t h e British Hom~eopathic Journa l - -perhaps , to begin with, as a supplement, and maybe as a form of combina- tion later on, depending how things develop? All this would be in order to give the

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