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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