Few comments for a better understanding and knowledge in homeopathy research

Few comments for a better understanding and knowledge in homeopathy research

 

Considering some proposals against homeopathy, presented in May 2011, by few English congressmen, then by the federal center for Belgian health care, and certainly by some others tomorrow, an article published few months ago in a weekly journal seemed somewhat “follower”. However, two sentences from that article appear to be an excellent beginning for our remarks.

« …It is funny to see how homeopathy compels itself to provide a lot of pseudo-scientific explanations… water memory, etc… nobody demands…

 … There is a big mystery around homeopathy arithmetic: it is working on a case-by-case basis, but when you sum it up on a population’s scale, it isn’t working at all!”

Dr Elie Arié, Marianne, 19/04/201 0 - Tempête sur l’homéopathie. (“Tempest on Homeopathy”)

Dr Élie Arié & Dr Roland Cash. Les Asclépiades, 2006, 222 pages. (“The Asclepiads”)

We must admit that these are two essential remarks. That’s enough to justify the fairly negative attitude some develop when they consider homeopathy, without being specialists.

We stay away from polemics and understand the pertinence of what homeopaths easily take for, a priori, unfounded attacks, based on their detractors’ ignorance.

 

I- Cutting the matter short with water memory and the ambiguities it has induced

 

The “Water Memory” is a metaphor cleverly chosen for the first time by Dr. Benveniste. John Madox, director of the prestigious scientific journal “Nature”, with its reading committee, demanded with perseverance by Dr. Benveniste, imposed him, between others, to raise a hypothesis on the action mechanisms of the phenomenon he was describing in his future publication. The hypothesis was about the effect of allergen high dilutions, higher to the Avogadro’s number that is to say beyond the original molecules presence, in an immunologic model: the basophiles degranulation.

Let’s remind that the basophiles contain granules rich in high mediators, like histamine. When they are in contact with an allergen they are sensitized to by specific IgE antibodies, they drop their granules and these latest release the enclosed mediators. We are talking of “basophiles degranulation”.

After this publication finally accepted and widely published by the media, the Dr. Benveniste’s experimentations were hardly proved correct by the counting method he developed. The author’s personality, together with tactless methods (allowing a magician to check his work, imposing his assistant as the only capable person to use his own basophiles degranulation tests, etc…) did not make things easier. At first troubled by the Princeps publication, the scientific community turned away from his works and the critics started to appear broadly in the media. That even leads to talk about the “Water Memory History Affair”.

A - The origin of that subject studies

Let’s go back before this publication. Since the middle of the 80s, a lot of researchers have understood the interest of immunologic models in homeopathy experimental research. Scientists have published some significant results on the basophiles degranulation model. Boiron Laboratories director, Dr. Bellon, asked to Dr. Sainte Laudy’s immunology department to investigate the homeopathy remedy, Apis mellifica, used in allergic phenomenon and supposed to inhibit the basophiles degranulation induced by an antigen (producing IgE- specific antibodies).

Apart and simultaneously, Dr. Bernard Poitevin suggested to Dr. Benveniste’s staff to work on the same model. In both laboratories, was observed an inhibition of the basophiles degranulation, that is to say an inhibition of the antigen-antibody reaction, with some Apis specific dilutions.

The work carried out by specialized scientists in universities laboratories and in the CNRS (French National Center of Scientific Research) are far from belonging to a pseudo-scientific process. That leads the Medicine Academy president, Professor Gounelle de Pontanelle to claim:

« These researches are considered as conclusive; however it important to underline the impossibility to extrapolate to a therapeutic activity”.

B - Experimental models evolution. What’s the aim?

Dr. Benveniste took up again his researches and replaced the homeopathy remedy by anti-IgE serum dilutions which inhibit the IgE fixation on specifics receptors without provoking degranulation. So we are not now in homeopathic remedy (Apis) application, used until then.

His goal was to prove, not the homeopathic dilution efficiency, but the activity of immaterial substances - beyond Avogadro’s number limit - that is to say under weight consideration as we already said.

The purpose was to take some distance with homeopathy, judged too sulfurous, to get back to a biological general logic, where the direct effect of biologically active substances is sought at some dilutions where the theoretical molecule is absent. The aim was to enounce a new revolutionary law in the biological physics-chemistry field. Dr Benveniste’s publication has permitted to talk not about homeopathy but to focus only on "High Dilutions" properties study.

Ten years later, in 1995, Dr. Benveniste, who continued his approach with different experimental models, kept on defending his point of view to conclude:

« A water enclosed information that remains after the impregnation solution disappearance does exist… That’s extremely simple. We use the electromagnetical signal of an ovalbumine solution. Let’s remember that this substance induces a coronary flow decrease in a pre-sensitized animal heart. In our experimental model, an electrical circuit connects an ovalbumine solution (at 10-8 M) to a pure water container. By that way, it is truly water saturated by the ovalbumine solution electromagnetical signal, which irrigates the heart and caused the flow decrease. So, we can demonstrate that a biological activity can be obtained without any substance… Indeed, we are walking toward electronic biology, which will drastically change our ordinary life, beginning with the therapeutics”.

An additional step took place, in 1995, when he succeeded in recording this famous molecular signal on a basic computer. In 1996, the recorded signal traveled through thousands of kilometers, between Clamart, near Paris, and Chicago. The electromagnetical signal, received and broadcasted in water, playing the mediator role, induced the same biological reactions as if the emitting molecule was physically present.

Since 2009, Luc Montagnier, physiology and medicine Nobel Prize, and co-discoverer of AIDS virus, began to work on detectable electromagnetical signals in Montagnier’s cells culture. He explains:

« When a mycoplasmas suspension is filtered through porosity filters between 20 and 100 nm (much smaller than the mycoplasmas average size), the obtained filtrate seems to be sterile, when cultivated in a synthetic environment and analyzes by DNA PCR. But if the sterile filtrate is incubated with human T lymphocytes (previously tested as cleared of mycoplasmas infection), after 2 or 3 weeks, we can observe the mycoplasmas come back with all their characteristics, even if the filtrate is brought up to the millionth dilution.”

The phenomenon interpretation proposed by Luc Montagnier is that the nanostructures, enclosed in the substrate, contain each one part of the genetic information: so they rebuild the whole infective genome thanks to the eukaryotes cells.

This hypothesis pushes him into studying the nanostructures type and so leads him to discover another peculiar phenomenon: the production of low frequency electromagnetical waves (between 1.000 and 5.000 Hertz) by virus and bacteria species in appropriate watery dilution. The common pathogenic bacteria, such as Escherichia coli, staphylococcus, streptococcus, mycoplasmas and some virus are the origin of electromagnetic signals emitting structures. All the signals are quite similar, even if a more accurate analysis reveals different species. The plasma of the people chronically infected by the same pathogenic agents radiates identical signals.

 C - Several remarks

1.      It sounds difficult to consider Dr. Benveniste, famous immunologist, as an eccentric and Professor Montagnier, Nobel Prize, as «tired», as insinuated many times.

All this is very “innovating” and disturbing. As said by Dr Benveniste:

« Every researcher who does NOT swear only on the molecular biology is a heretic… »

All these works deserve to be objectively confirmed like any other scientific achievement. But how do they dare talking about pseudo-science, when facing experimental protocols strictly observed by well-known scientists?

Obviously, the “water memory” theory has impressed the minds and a lot of hypothesis and pseudo-scientific works have already been based on what we already defined as metaphor, which may open the door on the “marvelous” that they are fond of! But be careful not to mistake a scientific approach driven by true researchers, with all the pseudo-scientific processes, unfortunately numerous, which may sometimes not be recognized and identified as so or only by a skillful researchers’ minority.

Whatever it may be, we must admit that the Dr Elie Arié first sentence is justified: the works done on the “water memory” are helpless in validating the homeopathy complexity.  At the upmost, they allow affirming that it’s likely that an active molecule may leave a significant and specific print in a solvent, even when this molecule has disappeared.

We are far from homeopathy validation, with indeed, the high dilution notion, but without the whole person and similar law principles… We will go back on it.

Don’t forget that Hahnemann has suggested the high dilutions use in a second time, after having defined the similar law, and considered the patient symptoms as homeopathy fundamental principles.

So we must stop defending homeopathy by referring to the “water memory”! As said byDr Arié, that‘s not what is asked to evaluate homeopathy.

2.      However, we must take into account that many works have been done, until nowadays, on basophiles degranulation phenomenon, with histamine hundredth dilutions, with modern and reliable measuring techniques like the flow cytometry. Significant results have been observed, confirmed by multicentric studies in four different laboratories in four European countries. These works, just like all the researches on homeopathy high dilutions effects, are only published in specialized journals. The whole scientific community has never taken them into consideration. Obviously, due to their rigor, they don’t include in their statement the overmediatised and misunderstood terms of “water memory”…

 

II – Clinical research specifications and epidemiology in homeopathy

 

A – The meta-analysis in homeopathy

That’s a more direct research, targeted on the homeopathy effects on the patient. So it’s logical that it interests firstly the whole medical corporation and each nation decision makers, especially in the European Union.

 The aim is to observe the classical homeopathy treatment efficiency on a patients’ population according to the strictest modern criteria: consideration of the placebo effect, statistical evaluation of the results. It’s a degree matter.

Let us remind the second sentence, quoted in the preamble, and read in an expert report to the English Parliament, criticizing the homeopathy efficiency:

“… There is a big mystery around homeopathy arithmetic: it is working on a case-by-case basis, but when you sum it up on a population’s scale, it isn’t working at all!”

When we mention this sentence in a homeopathy congress, it provokes loud complains among the participants.  These health professionals, used to tangible results in their day-to day practice, consider it as a kind of provocation…

However, this statement doesn’t seem untrue, even when we refer to high quality works, as underlined by Professor Henri Atlan, former member of the medical ethics consultative Committee, at the last Monaco International Talks.

The problem is to determinate if all the recent works in that field are questionable.  Why such a discrepancy between the patients, receiving homeopathy for more than two centuries, and the recent clinical analysis, sampled on more than 1000 subjects? We must admit that, at best, homeopathy doesn’t exceed à 10% deviation compared to the placebo effect.

Hundredth of works have been conducted since the last decade. The obtained results have lead English congressmen to draft a report emphasizing that there’s no need to waste money in such expensive investigations.

These works have been also covered in meta-analysis with results somewhat negative (a meta-analysis is a commented statistical evaluation study of a significant number of clinical tests). In our case, these studies keep the debate alive on the scientists’ ability to evaluate homeopathy, as well as the homeopathic sector willingness to do it. We will for sure establish the limits!

One of the recent meta-analysis, considered as the best and most mediatised, has been selected by EICCAM (European Information Centre on Complementary and Alternative Medicine), after its publication in the «Lancet». This European center has been created to provide and broadcast high quality information, objective and understandable on the non-toxicity, performance and efficiency of the complementary and/or alternative medicines (CAM : Complementary and Alternative Medicine). It really produces meticulous works, on which European politics can based their decisions. That’s why the submitted studies are of major interest.

The only admitted “Research Fact”, we refer to, regarding homeopathy is negative. Lots of scientific commentators have taken this work as the ultimate proof that homeopathy is a placebo-therapy and claim “the homeopathy end”, term logically repeated by some reporters.

Indeed, as this study applies modern statistical techniques and the best analysis methods, we must consider its results as especially valid.

What does this study, published in «The Lancet », prestigious English medical journal, claim?

Swiss researchers have gathered and evaluated data from 110 different studies touching more than 11 000 patients. It compares the homeopathic remedies activity with placebos in the treatment of various illnesses. Most of these studies show that homeopathic medication has a significant activity. But this advantage is wiped off when these high quality studies include a large number of patients. On the other hand, when conventional medicine drugs studies have been identically analyzed, they have given significant results in all cases.

Of course, we must raise some reservation. First of all, we must recognize the difficulty to conduct statistical studies, obviously complex, and by so very fragile. It is impossible in such an article to get into details on a subject that should be treated in a much longer development. To summarize, the applied statistic analysis is by “segmentation”, which gives pertinent information only in case of strict analysis rules. In that case, it appears difficult to apply, distorting the results: it seems impossible to take into account, at the same time, the analyzed works quality criteria, the trial size criteria and the pathologies homogeneity criteria. But we won’t argue on that statistical problem.

Please note that not only the homeopathy partisans doubt the statistics meanings, asking to biomedical statistics professionals to be conscious of the scientific and ethnic responsibilities at that level: If the scientists used the wrong statistical method, you may do just as well believing your horoscope (« The Economist », February 24, 2007, vol 382).

B - Few more detailed remarks on this meta-analysis.

1.      We must mention that, in the homeopathy versus placebo studies, none is testing homeopathy as a complete system but like the isolated effect of a sole homeopathic remedy.

Are excluded some other elements of the homeopathy treatment, such as the time invested to establish the patient’s medical history, or the patient’s specific remedy choice procedure, based on his symptoms. For that reason, that’s not obvious to know if these factors influence or not the individualized medicine efficiency.

2.    Professor Egger’s conclusions, one of the publication co-authors, have been based on a 110 peculiar studies panel, composed of disparate diseases, such as sore throat, cold, hay fever, child diarrhea, post-surgery pain.

This study has been violently criticized,as it seemed to compare apples and oranges, impeding a correct, even impossible, results analysis. For example, homeopathy remedies may work very well for some illnesses but not for some others. If it were true, that would not have been disclosed by Professor Egger’s study. Once again, we do emphasize that homeopathy is more oriented toward patient’s symptoms than to a specific disorder.

Not only, they have mixed various particular diseases but also they have been treated with different homeopathic medications. Moreover, the remedies have been selected after different homeopathy principles. In some studies, the medicines have been specifically chosen according to patients’ individual symptoms (classic homeopathy), but mostly, they have been prescribed as standard formulas (non individualized).

3.      The study conclusions were based on a very small number of peculiar observations. Even if, in a first time, 110 studies were examined, the main analysis only included a total of 8 high quality works, on a large scale. Once again, unfortunately, the researches were dealing with homeopathic remedies used more to prevent than to cure the disease (even if there’s an open debate to establish if homeopathy can be used in prevention in all the cases). Therefore, Professor Egger’s results should accentuate a kind of homeopathy inefficiency in some observations, more that its overall inadequacy.

In fact, the true reason for not considering a meta-analysis as the ultimate in scientific works approval, is not only dealing with homeopathy. Its limits are proven. At this level, we can analyze methodological criteria, but not therapeutic… so we may stay very cautious about the obtained results and widely disclose it!  This problem has been frequently discussed when the meta-analysis took as comparison element, the choice between chemotherapy and surgery acts, for cancer affected patients.

As asked by some, the problem is to establish if other clinical and epidemiological studies, similar to the ones conducted until now, are useful.

Our opinion agrees with other observers who have written relevant reports:it’s seems not! It may sound surprising when homeopathy future must be promoted in the medical field. We must explain our conviction.

C - Making some new recommendations

The clinical Research validation process is the same everywhere and obviously has been established according to the conventional medicine criteria. To be validated, each modern work must follow the randomized double blind against placebo tests. This method consists in selecting at random patients; neither the individuals (first blind) nor the researchers (second blind) know who will take the remedy or the placebo.

Non-homeopaths hardly understand why it’s a major problem.

The homeopathic prescription is complex and must consider several parameters. We are not talking about “one remedy-one illness” but taking into account the way the patient expresses his own disease, not a disease, and how he is going to react to successive homeopathic medications.

Taking into account the patient’s overall symptoms is essential in homeopathy. The similar law principle doesn’t rest only on the link between pathology and a remedy. It’s based on the pathology expression (the symptoms), reflecting the body impossibility for self-healing. This differs with allopathic medicine, which only considers biologic parameters alterations.

A so-called “specific therapeutic approach” clinical test should take all this into account. Only therapeutic strategies should be compared, not medicines, in a comparative perspective.

The patients having received the homeopathic treatment should be followed by skillful homeopaths, in a clearly defined context and with their habitual practices. The medication choice will be individualized, preferably without constraint. Unfortunately, actually, the official authorities, which estimate that only randomized double-blind works must be retained,do not accept it.

There would be a lot to say but that would overpass this article limit. A book would be necessary. As for example,the randomization, that is to say the patients random drawing at the experiment beginning, is hardly compatible with similar law principle application, based on the analysis of the patient specific symptoms and not on the illness ones.

So, if we don’t admit the whole individual characteristics Natrum mur, we cannot conduct a randomized double blind against placebo test, pretending that the personality signs represent a conventional medicine diagnostic…

D - Classical medical Research Structures and its suitability with homeopathy

Once again, a sole book shouldn’t be sufficient to deal with that subject. The complexity degree is unquestionable. So some references are indicated… for the enthusiasts…

In medicine, exist different types of studies from the case study to randomized double blind against placebo controlled tests, considered as the most significant, with a pledge of besides similar studies.(http://www.ebm.lib.ulg.ac.be/prostate/typ_etud.htm)

Some studies levels are compatible with the homeopathy specificity, as the statistical studies based on Bayes’s theorem (Elsevier, Homeopathy, volume 98, number 2, 2009, http://www.chups.jussieu.fr/polys/biostats/poly/stats.pdf).

This subject has been debated for several years in the Monaco International Talks and in the GIRI meetings (www.giriweb.com) and some solutions exist. Indeed, the debate is possible with the most eminent specialists as long as we are rigorous, avoiding the pseudo-science.

In spite of what some may believe, there’s a major subject to discuss, not specific to homeopathy: the most conventional scientists claim for the need to evaluate the paradigms (i.e. accepting new matrices for a better understanding of different way of looking at things)… They deeply need it in various fields that have nothing to do with homeopathy.

Nowadays, it is essential to obtain the scientific field trust and to impose a research adapted to the homeopathy specificity (as well as for other complementary medicines).

Otherwise, we should admit that all the concessions have been done; that homeopathy identity was close to its limits when observed in some very simplistic studies… It would be useless to keep on going this way. That why we agree, in that sense, with the so-called homeopathy detractors who suggest that sufficient works have been conducted and that we won’t gain more...

Homeopathy researchers must fight for their approach. But not only them… These scientists sometimes stay too close to their works and don’t act as their best “advocates”. They never reach the media… But, it’s a medical and health problem, concerning the whole population.For that reason, the homeopaths’ role, but also the consumers’ associations’ (too sparse and lacking of means), is essential. A country like France is not well organized from that point of view. That’s regrettable and must imperatively change… Within several European countries, only the attacks against homeopathy, fought by professionals or by cohesive consumers’ associations, well informed and organized, have been defeated…

Dr René-Philippe Halm

Monaco Talks General Secretary

GIRI Chairman