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EDITORIAL More biological models and randomised clinical trials This issue of Homeopathy concludes our special issue on biological models. Because of the gratifying surfeit of high- quality contributions, we have had to spread the material over two issues; this issue features a further five articles. Some of them focus on less obvious, yet important issues. Similitude The controversial aspect of homeopathy, and the main reason it has been on the receiving end of many attacks, especially in the UK in recent years, is the use of high, ‘ultramolecular’ dilutions. But it is important to remember that the use of ultramolecular dilutions is not a defining characteristic of homeopathy. Many homeopathic medi- cines are not in ultramolecular dilutions. Fred Wiegant’s the team at the University of Utrecht in the Netherlands has conducted a research program on similarity, rather than ultramolecular dilution effects, which they summarise in this special issue. 1 Their model is based on Reuber H35 rat hepatoma cells subjected to heat stress, followed by a low dose, but non- ultramolecular, stimulatory treatment. They conducted both homologous, where the initial harmful and the second- ary stimulatory treatment are the same, differing only in scale, (equivalent to isopathy in clinical homeopathy); and heterologous experiments where the two treatments differ in nature. The heterologous treatments were chemical toxins including arsenite and cadmium. They show effects in terms of cell survival and production of stress proteins. They define objectively the degree of similarity between the two stimuli (in terms of the pattern of stress protein response) and show that the strength of the effect correlates with the degree of similarity. They also demonstrate that the pattern of the response is determined by the second, low dose stimulus. Concepts and reproducibility Leoni Bonamin and Christian Endler critically examine the concepts underlying the design of animal experiments in their systematic review covering the last decade. They identified 33 experiments, most of them randomised, inves- tigating the similia principle. They classify them as based on behaviour, intoxication, inflammation, carcinogenesis, tissue growth and differentiation, and experimental infec- tion. No relationship was found between blindness or kind of control and positive or negative results. The authors note several instances of convergence of results between different models and with clinical homeopathy. They highlight a number of emerging concepts including mathematical modelling of the restoration of sensitised living systems to a stable state and modification of host- parasite relationships. 2 The replicability of experiments is a crucial criterion for their credibility. The multinational group led by Christian Endler and involving coauthors from Austria, Switzerland and Brazil address this issue in their bibliometric study of repetitions of fundamental research models. They found that 24 experimental models have been repeatedly investi- gated, 22 with similar inter-experiment results. They clas- sify repetitions according to whether they came from the same group as the original report, or multicentre or independent work; and results as positive and similar, positive but qualitative different or negative. 3 The most frequently and consistently replicable model is inhibition of basophil activation by high dilutions of histamine. Its originators, Jean Sainte Laudy and Philippe Belon gave a comprehensive account of this work in our last issue. 4 But as Madeleine Ennis shows in her sceptical view of such models, significant methodological issues remain. Methods vary between laboratories, although the same can be said of conventional studies. Several different laboratories have found effects of high dilutions using flow cytometric methods. She suggests that following standardisation another multicentre experiment be performed. 5 The missing link? John Ives and colleagues provide what is, to my knowl- edge, the first empirical evidence in closing an important missing link in the understanding of the biological action of what they call serially succussed and diluted (SSD) so- lutions. There is now a substantial body of evidence that such solutions have biological effects, much of it summar- ised in this and the previous issue of Homeopathy. There is also a significant body of evidence which indicates that the process of production of SSDs induces stable mesoscale structural or coherence effects in liquid water. Colloquially referred to as ‘Memory of Water’ effects, these were reviewed in a previous special issue of Homeopathy. But there is a vital link missing between the presence of struc- tural or coherence effects in water and any biological effects of such preparations. David Anick and John Ives contributed a theoretical paper to our ‘Memory of Water’ special issue outlining the ‘Silica Hypothesis’ for the action of SSDs; prerequisites are the thermodynamic stability of a large number of distinct structures, pattern initiation at low potencies, and maintenance or evolution of these patterns at higher Homeopathy (2010) 99, 1–2 Ó 2009 The Faculty of Homeopathy doi:10.1016/j.homp.2009.11.007, available online at http://www.sciencedirect.com

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Page 1: Thesis106

Homeopathy (2010) 99, 1–2� 2009 The Faculty of Homeopathy

doi:10.1016/j.homp.2009.11.007, available online at http://www.sciencedirect.com

EDITORIAL

More biological models and randomised clinical trials

This issue of Homeopathy concludes our special issue onbiological models. Because of the gratifying surfeit of high-quality contributions, we have had to spread the materialover two issues; this issue features a further five articles.Some of them focus on less obvious, yet important issues.

SimilitudeThe controversial aspect of homeopathy, and the main

reason it has been on the receiving end of many attacks,especially in the UK in recent years, is the use of high,‘ultramolecular’ dilutions. But it is important to rememberthat the use of ultramolecular dilutions is not a definingcharacteristic of homeopathy. Many homeopathic medi-cines are not in ultramolecular dilutions. Fred Wiegant’sthe team at the University of Utrecht in the Netherlandshas conducted a research program on similarity, ratherthan ultramolecular dilution effects, which they summarisein this special issue.1

Their model is based on Reuber H35 rat hepatoma cellssubjected to heat stress, followed by a low dose, but non-ultramolecular, stimulatory treatment. They conductedboth homologous, where the initial harmful and the second-ary stimulatory treatment are the same, differing only inscale, (equivalent to isopathy in clinical homeopathy); andheterologous experiments where the two treatments differin nature. The heterologous treatments were chemicaltoxins including arsenite and cadmium. They show effectsin terms of cell survival and production of stress proteins.They define objectively the degree of similarity betweenthe two stimuli (in terms of the pattern of stress proteinresponse) and show that the strength of the effect correlateswith the degree of similarity. They also demonstrate that thepattern of the response is determined by the second, lowdose stimulus.

ConceptsandreproducibilityLeoni Bonamin and Christian Endler critically examine

the concepts underlying the design of animal experimentsin their systematic review covering the last decade. Theyidentified 33 experiments, most of them randomised, inves-tigating the similia principle. They classify them as basedon behaviour, intoxication, inflammation, carcinogenesis,tissue growth and differentiation, and experimental infec-tion. No relationship was found between blindness orkind of control and positive or negative results. The authorsnote several instances of convergence of results betweendifferent models and with clinical homeopathy. Theyhighlight a number of emerging concepts including

mathematical modelling of the restoration of sensitisedliving systems to a stable state and modification of host-parasite relationships.2

The replicability of experiments is a crucial criterion fortheir credibility. The multinational group led by ChristianEndler and involving coauthors from Austria, Switzerlandand Brazil address this issue in their bibliometric study ofrepetitions of fundamental research models. They foundthat 24 experimental models have been repeatedly investi-gated, 22 with similar inter-experiment results. They clas-sify repetitions according to whether they came from thesame group as the original report, or multicentre orindependent work; and results as positive and similar,positive but qualitative different or negative.3

The most frequently and consistently replicable modelis inhibition of basophil activation by high dilutions ofhistamine. Its originators, Jean Sainte Laudy and PhilippeBelon gave a comprehensive account of this work in ourlast issue.4 But as Madeleine Ennis shows in her scepticalview of such models, significant methodological issuesremain. Methods vary between laboratories, although thesame can be said of conventional studies. Several differentlaboratories have found effects of high dilutions usingflow cytometric methods. She suggests that followingstandardisation another multicentre experiment beperformed.5

Themissinglink?John Ives and colleagues provide what is, to my knowl-

edge, the first empirical evidence in closing an importantmissing link in the understanding of the biological actionof what they call serially succussed and diluted (SSD) so-lutions. There is now a substantial body of evidence thatsuch solutions have biological effects, much of it summar-ised in this and the previous issue of Homeopathy. There isalso a significant body of evidence which indicates that theprocess of production of SSDs induces stable mesoscalestructural or coherence effects in liquid water. Colloquiallyreferred to as ‘Memory of Water’ effects, these werereviewed in a previous special issue of Homeopathy. Butthere is a vital link missing between the presence of struc-tural or coherence effects in water and any biological effectsof such preparations.

David Anick and John Ives contributed a theoreticalpaper to our ‘Memory of Water’ special issue outliningthe ‘Silica Hypothesis’ for the action of SSDs; prerequisitesare the thermodynamic stability of a large number ofdistinct structures, pattern initiation at low potencies, andmaintenance or evolution of these patterns at higher

Page 2: Thesis106

EditorialP Fisher

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Homeop

dilutions.6 They proposed laboratory experiments thatmight confirm or refute this hypothesis, and in this issue re-port the results of several such experiments. They show thatthe stability of enzymes is enhanced in SSD solutionsprepared in glass, compared to plastic. Analysis of SSDwater prepared in glass detected boron, silicon, and sodiumat micromolar concentrations. Silicates have biologicalactivity, but the concentrations in these SSDs were toolow to account for any in vivo effects, but the enzyme-stabilising effect may be relevant to in-vitro biologicalassays reporting homeopathic effects.7

.andrandomisedclinical trialsAlso in this issue, we report two randomised clinical tri-

als reflecting widely divergent prescribing strategies andclinical applications of homeopathy. Irene Camerlink andcolleagues from the Biological Farming Systems Group,Wageningen University in the Netherlands compared theeffects of a standard homeopathic nosode/biotherapy on di-arrhoea in over 500 piglets. Piglets of the homeopathicgroup had highly significantly less E. coli diarrhoea thanthose receiving placebo.8

In another trial featuring in this issue, by David Naudeand collaborators of Durban University of Technology,South Africa is also of randomised placebo-controlleddesign. But it contrasts in most other respects: prescribingstrategy (individualised), pathology (chronic primaryinsomnia), scale (30 subjects) and indeed species (human).Again the results, as measured standard instruments, arepositive.9 Both of these trials represent important findingsand should be repeated.

athy

All in all, these are exciting times for research inhomeopathy!

References

1 Wiegant FAC, van Wijk R. The similia principle; results obtained in

a cellular model system. Homp 2010; 99: 3–14.

2 Bonamin L, Endler PC. Animal models for studying homeopathy and

high dilutions: conceptual critical review. Homp 2009; 98: 37–50.

3 Endler PC, Thieves K, Frass M, Bonamin L, Scherr C,

Baumgartner S. Repetitions of fundamental research models for

homeopathically prepared dilutions beyond 10�23: a bibliometric

study. Homp 2010; 99: 25–36.

4 Ste Laudy J, Belon P. Inhibition of basophil activation by histamine:

A sensitive and reproducible model for study of biological activity of

high dilutions. Homp 2009; 98: 186–197.

5 Ennis M. Basophil models of homeopathy: a sceptical view. Homp2010; 99: 51–56.

6 Anick DJ, Ives JA. The silica hypothesis for homeopathy: physical

chemistry. Homp 2007; 96: 189–195.

7 Ives J, Moffett JR, Arun P, et al. Enzyme Stabilization by Glass-

Derived Silicates in Glass-Exposed Aqueous Solutions. Homp2010; 99: 15–24.

8 Camerlink I, Ellinger L, Bakker EJ, Lantinga EA. Homeopathy as

replacement to antibiotics in the case of Escherichia coli diarrhoea

in neonatal piglets. Homp 2010; 99: 57–62.

9 Naude DF, Couchman IM, Maharaj A. Chronic primary insomnia:

efficacy of homeopathic simillimum. Homp 2010; 99: 63–68.

Peter FisherFaculty of Homeopathy, Hahnemann House,

29 Park Street West, Luton LU1 3BE,United Kingdom

E-mail: [email protected]