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From the Townsend Letter
April 2008

 

A Debate:
Homeopathy – Quackery or a Key to the Future of Medicine?



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University of Connecticut Health Center
Farmington, Connecticut
October 25, 2007

Homeopathy is used by tens of millions of people around the world. On October 25, 2007, six internationally renowned experts examined the basic science as well as the clinical and historical evidence around this 200-year-old system of medicine. Is homeopathy pure quackery, as some contend, or perhaps the future of medicine? What follows is an abridged version of this debate. To watch the full debate, go to www.sonicfoundry.com/uconn.

Participants: Steven Novella, MD (Yale), Rustum Roy, PhD (Penn State),
Donald Marcus, MD (Baylor), Iris Bell, MD, PhD (Arizona), Nadav Davidovitch, MD, MPH, PhD, (Ben Gurion), Andre Saine, ND (Canadian Academy for Homeopathy)

Steven Novella, MD
My task is to cover the scientific plausibility of homeopathy. What basic science underlies this discipline? There are a number of principles of homeopathy – the Law of Similars, the Law of Chronic Disease, and the Law of Infintesimals.

So, let's start with the Law of Similars, or the notion that like cures like. In other words, a substance produces symptoms of illness in a well person when administered in large doses. If we administer the same substance in minute quantities, it will cure the disease in a sick person. Hahnemann, who was the developer of homeopathy, suggested that this is because nature will not allow two similar diseases to exist in the body at the same time. Two hundred years of subsequent scientific development has not discovered any principle in nature or biology that would explain this. Often, there have been modern attempts to explain this apparent effect through an analogy to vaccines, but this is not an apt or a valid analogy.

Hahnemann had a lot of ideas about what illness and disease and health are. In fact, homeopathy is what we call a philosophy-based medicine. It is based upon a philosophy of health and illness. The modern attempts at making it scientific, or evidence-based, in my opinion, have failed.

There are several laws of cure on how homeopathic cures work. The remedy starts at the top of the body and works downward, or works from within the body outward, or symptoms clear in reverse order of appearance. These are fairly superficial observations that do not have any basis in any modern scientific understanding of disease.

Hahnemann had his theory of illness, largely based on the notion of miasms. He thought there were three miasms: psora, syphilitic, and sycotic miasms. Two hundred years of subsequent scientific advance have moved very much away from Hahnemann and his ideas and haven't supported a single one of them.

Let's turn to the Law of Infintesimals. Substances become more potent when diluted. Hahnemann believed that only the desired effects of remedies became more intense with dilution, that the undesirable effects became less potent. There is no notion in chemistry or biology that would explain such an effect. The principle of succussion is basically that the energy or essence of a substance is transferred to a solvent when shaken. Now, Hahnemann formulated his ideas and did not know about Avogadro or Avogadro's number, which is the basis of the dilutional limit. Many of the dilutions that are commonly used in homeopathic preparations are well beyond this limit. A 30C preparation is not uncommon – that means a dilution of 1x1060. Suffice it to say, you are not getting any active ingredient in a 30c homeopathic remedy. So, clearly, that is not how homeopathic remedies could work. They do not work by retaining any active ingredient.

Many contemporary homeopaths argue that homeopathic remedies could work through some property that has to do with either relativity or, more commonly, quantum mechanics or quantum effects. Now, when a theorist invokes quantum mechanics, or quantum theory, to explain a controversial effect that cannot be explainable on the basis of established science, that is a sure sign of abject desperation on their part.

So, we were left with the concept of water memory. Homeopathic qualities are stored in a three-dimensional structure of water molecules, not chemical compounds diluted in it. There is no mechanism for how this structure would survive and actually remember the information in the chemicals that were diluted in it. We have to extend this to also say that the water knows which substances to remember. There is no plausible basis for biological persistence or activity of alleged water memory.

Rustum Roy, PhD
This presentation is based on insights from rudimentary materials science.
Material scientists unequivocally reject, as scientifically absurd, the argument used for decades and centuries against the feasibility of homeopathy: 'A homeopathy remedy cannot have any effect at all because the final water is chemically identical to the water used to make it.' You just heard it from Dr. Novella. Now, this argument has been repeated ad nauseam up to 2007, and it is a totally unscientific basis for any criticism of homeopathy. A typical attitude is shown in the next quote, again from Dr. Novella: 'It is not that we don't know how homeopathy works, it's that homeopathy cannot possibly work. It's just water. There is no possibility within physics – forget biology and medicine – within physics that there could be any therapeutic effect physiologically to homeopathic remedies. ….(Homeopaths) say the water retains memory – but that is functionally the equivalent of saying it is magic because there is no mechanism for what they are saying.'

Let's check out this nonsensical argument about 'it's just water' by looking at what science does know about water. Let's just look at another simple material -- carbon. Graphite is just carbon. The world's softest material is graphite. The world's hardest material is diamond. But in a few nanoseconds, adding absolutely nothing, we can make one into the other. It is just carbon. Yet with zero difference in composition, we can see the magic that structure can perform.

It's true, homeopathic waters really do have identical composition. But composition ain't where it's at. What's different about remedies could scientifically be based on different structures, hence even radically different properties. The first law of material science is, 'properties are controlled mainly by structure, not by composition.'

More specifically, changing liquid water is nothing special. Let me show you much more dramatic changes with no changes in composition reported in a dozen of our papers in the best journals. All the essential solids, in your computer, everything – silicon, the magnets, the dielectrics – can be changed dramatically – structurally – with a tiny microwave field in a few seconds. Why is this 'magic,' or scientific fact, relevant? Such strong, solid materials, some with tetravalent ions, have over an order of magnitude stronger bonds than water; if their structure can be changed easily, surely we can change liquid water with very weak vectors. As a number of very good research studies have shown, the structure of water can be changed easily and retain the new structure for hours and days. The skeptics never point out such facts, possibly because they know so little material science.

Elia and et al. and then Rey have been structuring ultradiluted pure water in the lab explicitly by mimicking the homeopathic process and using standard material science characterization techniques to demonstrate the differences. They were able to change water and demonstrate the changes. At Penn State, we have studied pure water and have done very preliminary work on commercial homeopathic samples of the remedies Natrium muriaticum and Nux Vomica using Raman and UV-Vis spectroscopy. We have found that there are differences between such commercial samples of Nux Vomica and Nat muriaticum and plain water. There are also differences between different potencies – a fact likely tied to the succussion process in the remedy preparation process.

Our work at Penn State provides standard thermodynamic and crystal chemical spectroscopic data first to dispose once and for all the 'anti-science, theological' crowd's 'feasibility' argument against homeopathy. Scientists know that pure water's structure and properties can be changed easily, routinely, outside homeopathy. The key lies in the homeopathic succussing process itself, which introduces three vectors: pressure, epitaxy, and nanobubbles. Each of these things are inherent in remedy preparation. All three of them can change structure.

Donald Marcus, MD
My charge is look at the clinical evidence for homeopathy. In addition to summarizing some of the clinical trials, I'm going to touch on some larger aspects of homeopathy and its relationship to health care.

I will start with a review by Professor Ernst, Chairman of the Department of Complementary and Alternative Medicine at Exeter University in England. Based on over 20 reviews since 1997, he believes there is no evidence homeopathic remedies differ from placebos. Recently the English National Health Service has conducted a review of the evidence supporting the use of homeopathy for the purpose of making recommendations for reimbursing homeopathic care. Their conclusion was that there is insufficient evidence to support the use of homeopathy. In 2005, the Lancet came to the conclusion that there's no point in making further investments in research in clinical trials in homeopathy.

What about safety? Essentially, there is no regulation or inspection of homeopathic medicines by the FDA or any external agency. Another safety concern is that some homeopathic practioners recommend against vaccination. Finally, I am concerned that some people who practice homeopathy are unqualified to perform a general medical evaluation and may miss a serious and treatable condition.

Summarizing the clinical trial data, I believe there is no rigorous evidence to support the efficacy of homeopathy. As a result, I don't think that federal funds should be used to support further clinical trials of homeopathy. A related question, aside from the randomized controlled trials, is does homeopathy help people? I think it's clear that some people who receive treatment feel better. I believe that patients feel better because of their interaction with a supportive and sympathetic practitioner and because of the placebo effect of taking any kind of remedy, homeopathic or conventional.

What is the rationale for homeopathy? One claim made by advocates for homeopathy and other alterative therapies is that biomedicine is mechanistic, reductionist, and unaware of mind-body interactions. Contemporary medicine taught in this medical school, and all medical schools, is not reductionistic. It's based broadly on biochemical, physical, and behavioral sciences, and there is a great deal of research on mind-body interactions.

Another claim is that quantum physics and the Heisenberg Uncertainty Principle have overturned our view of the world and that biomedical science is merely a cultural construct that has no greater validity than other systems of health care. The Heisenberg principle concerns atomic and subatomic particles, and it does not invalidate Newtonian physics. There is no justification for taking this concept from physics and applying it to humanities, social sciences, or health care.

Finally, I'd like to consider the role of homeopathy in health care. From the perspective of an academic medical center, homeopathy should be evaluated by the same standard of evidence used for all therapies. Patients should be informed that there is no rigorous evidence for the health claims made for homeopathic remedies. Advocacy of homeopathy by some academic integrative medicine programs undermines scientific and scholarly standards. On the other hand, homeopathy is a belief system and not a science. I believe it will persist in the community because its practitioners and adherents will ignore the negative data from clinical trials.

Iris Bell, MD, PhD
I cover three main points: pre-clinical and clinical studies demonstrate biological effects of homeopathic remedies; multiple observational studies on thousands of patients are overwhelmingly positive for homeopathic treatment in real world clinical practice; and randomized controlled trials and the meta-analyses based on them show mixed findings, but raise significant methodologic concerns, especially regarding external validity.

First, biological effects. To address the most controversial laboratory work, i.e., Benveniste et al., skeptical European scientists in 2004 (Belon et al.) published a multi-center study involving four different laboratories, showing, with more objective measurement techniques, that dilutions of histamine, including those below Avogadro's number, do modulate basophil activation in a non-linear manner. In a thrombogenesis model, other investigators used ultra-high dilutions of aspirin prepared homeopathically and showed an objective, measurable non-linear dose-response relationship for actives versus controls. These findings have precedent in the phenomenon of hormesis within the field of toxicology, involving bidirectional and non-linear dose-response relationships.

In animal research ranging from experimentally induced paw edema through experimental stroke, arsenic poisoning, chemically induced liver cancer, and changes in normal physiology, such as EEG sleep stages, researchers have repeatedly demonstrated objectively that homeopathic remedies have biological activity not seen with placebo. To my knowledge, there have been no negative studies to countervene – but skeptics choose to ignore this entire body of literature.

In my laboratory, we performed a double-blind, placebo-controlled, randomized trial of individualized homeopathy in people with fibromyalgia, including a sub-study involving quantitative EEG recordings. We found that alpha EEG frequency magnitude increased over time in people who received active remedies, but decreased in people who received placebo. Skeptics have not published any data to counter these findings.

What about observational evidence? Multiple peer-reviewed observational research studies on thousands of homeopathic patients (see bibliography) demonstrate an average rate of 70-80% favorable outcomes and excellent safety profiles in real-world practice. Although skeptics dismiss observational studies, papers in respected conventional medical journals, such as the New England Journal of Medicine, have shown that well-designed cohort or case-controlled observational studies do not overestimate treatment effect sizes. There are no negative observational studies of homeopathy.

Finally, what about the randomized control trial data and the meta-analyses of homeopathy that derive from individual studies? Linde et al.'s famous positive meta-analysis, published in Lancet in 1997, has been vigorously attacked over time. That study concluded that while the evidence was insufficient to recommend homeopathy for any one conventional condition, the data suggested an overall effect different from placebo. However, an important problem with both the Linde et al. positive meta-analysis and the recent negative meta-analysis by Shang, et al, published by Lancet is the pooling of studies of all types of practice involving homeopathic remedies across all types of clinical conditions. For instance, only 16% of the sampled Shang et al. studies involved individual remedies prescribed by classical homeopathic principles. In addition, Shang et al. started with 110 pairs of conventional and homeopathic studies, but then disrupted their own pairing when they boiled their sample down to eight of one system and six of the other to reach their negative conclusions about homeopathy. Experts on meta-analysis state that such pooling of heterogeneous practices across heterogeneous patient populations and unpairing the studies sampled methodologically weaken the conclusions drawn.

In discussing research on the placebo effect in psychotherapy, Bootzin and Bailey wrote, in 1995, that the theory of how a treatment produces change predicts when to label effects 'specific' versus 'non-specific' (e.g., 'placebo'). Homeopathic theory predicts patterns of multiple changes across the patient as a whole over time, not by disease or diagnosis, but Shang et al. randomly chose only one outcome from multiple reported outcomes in each study, thus damaging external validity for homeopathic studies. Conventional experts in meta-analysis consider the Shang et al. paper heavily flawed methodologically for multiple reasons. Relying on mainstream criteria for judging internal validity leads researchers to ignore important external validity issues.

A fairer test of homeopathy needs to consider that homeopaths claim to alter the long-term trajectory of the person's illness process toward fewer, shorter, and less severe illness flares and delayed complications, not necessarily to suppress symptomatic manifestations of a specific disease at a given point in time. High-quality clinical trials should measure not only the short-term disease endpoints and quality of life as required for conventional medical research, but also overall health trajectory outcomes across diagnoses for a given individual over time as predicted for homeopathic clinical research.
In summary, homeopathic remedies exhibit biological activity across multiple in vitro and and in vivo models. Observational studies consistently show real-world effectiveness of individualized homeopathic treatment across multiple conditions, especially with long-term follow-up. Randomized controlled trials and meta-analyses to date have major methodologic limitations, positive or negative in conclusions.

Nadav Davidovitch, MD, MPH, PhD
Contemporary discussions of the alternative vs. orthodox medicine debate are steered almost immediately in the direction of randomized controlled clinical trial (RCT). While the claim that the successes of alternative treatment originate in the placebo effect is old, the steering of the debate towards the methodology of statistical research is relatively new. At the beginning of the century, it was alternative medicine, particularly homeopathy, that attempted to use statistics and the placebo effect to prove its claims, encountering a skeptical orthodox medical profession hostile to the use of statistics and the placebo effect within the realm of the clinical encounter.

A deeper, more historical look at the various contexts in which the placebo is present in the medical debate enables questions such as: What is scientific medicine? What is considered acceptable proof in the clinical world? Who should judge what treatments are considered to be effective, and, generally, what treatments 'deserve' to be available to the public. The dominant policy at the end of the nineteenth century of extensive use of the placebo, while denying the attendant ethical problem, actually prevailed until the middle of the twentieth century. Paternalism, being entrenched so deeply in the medical profession at the turn of the twentieth century, and the common practice of what was termed as 'benevolent deception' were central factors in the establishment of this approach. However, what is equally interesting is the phenomenon of the extensive use of the placebo by homeopaths in this period in their medical practice but notably also for research purposes.

The turning point in this approach was after the World War II. The world of clinical research also underwent a transformation in these years, symbolized by the research into penicillin and streptomycin, research that, in fact, laid the practical and theoretical foundations for the image of RCT as we know it today. The flag bearers of this revolution were no longer the laboratory men, but the clinicians, the epidemiologists, and the statisticians. At the time, the objective was not how to harness what is called in the medical school world the 'basic sciences' for the good of clinical diagnosis but to turn the treatment interaction into one that could be scientifically tested. The development of the methodologies of clinical research, with RCT at the top of the pyramid, was the primary concern of those people who sought to make the clinic scientific. At this point, the placebo came into action – not the placebo that served mainly in the treatment interaction, but a placebo that could help in clinical medical research. From the 1980s, research that was not RCT had very little chance of being published in a leading medical journal.

Without dwelling excessively on the way the alternative doctors and therapists conducted the debate between themselves and orthodox medicine, their response can be divided in two possible categories. One possibility is to accept the rules of the language of the hegemony and attempt to answer the RCT challenge by means of monitored research that demonstrates the superiority of alternative treatments over dispensing placebos. Another possibility is a refusal to accept the rules of the game, especially in the light of the claim that the basic assumptions of monitored research inherently contradict the holistic, individual perception of alternative medicine. This question is closely aligned to the question of how various unconventional doctors see themselves in relation to orthodox medicine. Is unconventional medicine complementary to orthodox medicine, constituting an answer at the point from which orthodox medicine does not have answers, or is it alternative medicine, which should, therefore, serve as a radical alternative to the bankrupt bio-medical paradigm?

The changing role of the placebo reflects historical shifts within the medical discourse. The current tendency to differentiate between the deceitful 'clinical placebo' and the unbiased 'research placebo' erects a wall of silence regarding serious ethical drawbacks in contemporary medical research practices. The ethical debates concerning the information/deception aspects of placebo use in clinical practice cannot remove us from other pressing questions of using placebos in the context of clinical trials as a substitute for the best established therapy, both in conventional and complementary medicine. Both problematic dichotomies, the clinical vs. research placebo and physician as caretaker vs. researcher, need a thorough historical evaluation in order to assist our analysis of ethical issues in present experimental medicine.

André Saine, ND
With more than 25,000 volumes, the homeopathic literature is very rich in reports about the results obtained by homeopathy during epidemics. Results obtained by homeopathy during epidemics reveal a very important and clear constancy – namely, a very low mortality rate. This constancy remains, regardless of the physician, institution, time, place, or type of epidemical disease, including diseases carrying a very high mortality rate, such as cholera, smallpox, diphtheria, typhoid fever, yellow fever, and pneumonia. This low mortality rate is always superior to the results obtained by the allopathy practiced at that particular time and, as a rule, the allopathy of today. Despite well-documented and official reports, the results obtained by homeopathy have been almost completely ignored by the scientific and medical communities, as if they had occurred in a void of time and space.

I will now give five examples to illustrate these results:
When cholera first invaded Europe in 1831, the mortality throughout Europe was generally between 40-60%. To the surprise of many, mortality rates reported by homeopathic physicians was generally below ten percent and, commonly, under four percent.

I will now present two typical cholera reports, which have an official stamp to them. The first one comes from the territory of Raab in Hungary where, in 1831, a Dr. Joseph Bakody treated 223 patients with mild-to-severe cholera, 14 of whom were in the collapse state. He lost a total of eight patients, a mortality of 3.6%.

A similar situation occurred in Cincinnati in 1849. The Board of Health issued an order calling for physicians to report all cases of cholera. The Board received reports of a high mortality rate from the city hospital and allopathic physicians. However, six homeopathic physicians attracted national attention when they reported not one single death out of their first 350 cases of cholera. Two of these homeopathic physicians, Dr. Pulte and Ehrmann would eventually report treating 2,646 cases with 35 deaths, or a mortality rate of 1.3%. Allopaths reported fatal outcomes in 50% of their cases.

Now, let's move on and look at pneumonia, whose incidence and virulence has remained quite uniform throughout time. Before the era of antibiotics, the average death rate from pneumonia was 30%. Since the introduction of antibiotics, the death rate has only gone down to 18%. On the other hand, the death rate under genuine homeopathic treatment has always been less than one to three percent, even in patients suffering from the most fulminate type of pneumonia.

Let's push our inquiry a bit further and look at the most fatal of all infectious diseases, rabies. I have been able to document more than a dozen well-described cases with unmistakable, fully developed clinical rabies that had uneventful recoveries under homeopathy without any prophylaxis whatsoever to assuage the virulence of the disease.

This small sample of reports should be sufficient to illustrate the potential of homeopathy and incite real scientists, honest physicians, and intelligent people to examine homeopathy more seriously. Such extraordinary outcomes are not an exception in homeopathy but are the rule for all 33 infectious diseases I have so far investigated, which include typhus, malignant scarlet fever, meningitis, tetanus, anthrax, septicemia, and malaria.

What you have seen today makes it clear – homeopathy is very plausible, and there is both ample clinical and epidemiological evidence that it works. Homeopathy will become an integral part of medicine despite the paradoxical nature of its remedies and all other prejudices against it, simply because homeopathy is safe, efficacious, and cost-effective.

Correspondence:
Peter W. Gold,
172 West Main Street, Avon, CT 06001

 


 

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