|
Homeopathic Research
Of all
so-called 'complementary' or
'non-conventional' therapies homeopathy is
probably the one in which there is the
largest established research base of past
and present activity.
National Institutes of Health (NIH):
In the
United States, the National Center for
Complementary and Alternative Medicine (NCCAM)
is 1 of the 27 institutes and centers that
make up the National Institutes of Health
(NIH). The NIH is one of eight agencies
under the Public Health Service (PHS)
in the Department of Health and Human
Services (DHHS). NCCAM is funding and
supporting a number of studies. For example:
-
Homeopathy for physical, mental, and
emotional symptoms of fibromyalgia (a
chronic disorder involving widespread
musculoskeletal pain, multiple tender
points on the body, and fatigue).
-
Homeopathy for brain deterioration and
damage in animal models for stroke and
dementia.
-
The homeopathic remedy cadmium, to find
out whether it can prevent damage to the
cells of the prostate when those cells are
exposed to toxins.
Scientific Findings & Presentations in the
United States
European Union:
In 1997 the Homeopathic Medicine Research
Group, which was established by Directorate
Commission X11 E of the European Union
Commission two years earlier, published a
comprehensive report of its findings into
the status of homeopathic research together
with a Dictionary of Homeopathy and
data-base of homeopathic trials.
The report concluded that there was
sufficient evidence to continue to develop
more effective research into homeopathy and
its effectiveness but that as most of the
trials surveyed were of low methodological
quality much work was needed to improve
trial quality before any truly definitive
statements could be made. This statement
supports the findings of two separate
meta-analyses of homeopathic clinical
research trials in 1992 and 1997 which both
concluded that there is sufficient evidence
to suggest that the effects of homeopathic
treatment cannot be explained by calling
them mere placebo effect but that more
research of greater quality needs to be
carried out before final proof can be
established.
Interesting Facts:
Other Research:
-
Placebo
Effect? Is Homeopathy benefiting from
the placebo effect? Question posed to late Hadhrat Mirza Tahir Ahmad, the fourth
spiritual and administrative leader of the
Ahmadiyya community.
Hadhrat Ahmad was also a renowned
homeopath himself and had delivered many
lectures about specific homeopathic
remedies and treatments. [YouTube]
-
Homeopathy breakthrough?: "homeopathic
solutions proven to carry memory of water
and exhibit biological effects." [click
here] [pdf]
-
Thanks for the memory - "Experiments
have backed what was once a scientific
'heresy', says Lionel Milgrom". [click
here] [pdf]
-
Icy
claim that water has memory - Claims
do not come much more controversial than
the idea that water might retain a memory
of substances once dissolved in it. [click
here] [pdf]
FDA & Homeopathy:
(The following
was published in
FDA Consumer
magazine, December 1996)
Homeopathy:
Real Medicine or Empty Promises?
by
Isadora Stehlin
Some of the
medicines of homeopathy evoke positive
images--chamomile, marigold, daisy, onion.
But even some of Mother Nature's cruelest
creations--poison ivy, mercury, arsenic, pit
viper venom, hemlock--are part of
homeopathic care.
Homeopathy
is a medical theory and practice that
developed in reaction to the bloodletting,
blistering, purging, and other harsh
procedures of conventional medicine as it
was practiced more than 200 years ago.
Remedies made from many sources--including
plants, minerals or animals--are prescribed
based on both a person's symptoms and
personality. Patients receiving homeopathic
care frequently feel worse before they get
better because homeopathic medicines often
stimulate, rather than suppress, symptoms.
This seeming reversal of logic is a relevant
part of homeopathy because symptoms are
viewed as the body's effort to restore
health.
The Food
and Drug Administration regulates
homeopathic remedies under provisions of the
Food, Drug, and Cosmetic Act.
Kinder, Gentler Medicine
In the late
1700s, the most popular therapy for most
ailments was bloodletting. Some doctors had
so much faith in bleeding that they were
willing to remove up to four-fifths of the
patient's blood. Other therapies of choice
included blistering--placing caustic or hot
substances on the skin to draw out
infections--and administering dangerous
chemicals to induce vomiting or purge the
bowels. Massive doses of a
mercury-containing drug called calomel
cleansed the bowels, but at the same time
caused teeth to loosen, hair to fall out,
and other symptoms of acute mercury
poisoning.
Samuel
Hahnemann, a German physician disenchanted
with these methods, began to develop a
theory based on three principles: the law of
similars, the minimum dose, and the single
remedy.
The word
homeopathy is derived from the Greek words
for like (homoios) and suffering (pathos).
With the law of similars, Hahnemann
theorized that if a large amount of a
substance causes certain symptoms in a
healthy person, smaller amounts of the same
substance can treat those symptoms in
someone who is ill. The basis of his theory
took shape after a strong dose of the
malaria treatment quinine caused his healthy
body to develop symptoms similar to ones
caused by the disease. He continued to test
his theory on himself as well as family and
friends with different herbs, minerals and
other substances. He called these
experiments "provings."
But, as
might be expected, the intensity of the
symptoms caused by the original proving was
harrowing. So Hahnemann began decreasing the
doses to see how little of a substance could
still produce signs of healing.
With the
minimum dose, or law of infinitesimals,
Hahnemann believed that a substance's
strength and effectiveness increased the
more it was diluted. Minuscule doses were
prepared by repeatedly diluting the active
ingredient by factors of 10. A "6X"
preparation (the X is the Roman numeral for
10) is a 1-to-10 dilution repeated six
times, leaving the active ingredient as one
part per million. Essential to the process
of increasing potency while decreasing the
actual amount of the active ingredient is
vigorous shaking after each dilution.
Some
homeopathic remedies are so dilute, no
molecules of the healing substance remain.
Even with sophisticated technology now
available, analytical chemists may find it
difficult or impossible to identify any
active ingredient. But the homeopathic
belief is that the substance has left its
imprint or a spirit-like essence that
stimulates the body to heal itself.
Finally, a
homeopathic physician generally prescribes
only a single remedy to cover all
symptoms--mental as well as physical--the
patient is experiencing. However, the use of
multi-ingredient remedies is recognized as
part of homeopathic practice.
FDA Regulation
In 1938,
Sen. Royal Copeland of New York, the chief
sponsor of the Food, Drug, and Cosmetic Act
and a homeopathic physician, wrote into the
law a recognition of any product listed in
the Homeopathic Pharmacopeia of the United
States. The Homeopathic Pharmacopeia
includes a compilation of standards for
source, composition and preparation of
homeopathic drugs.
FDA
regulates homeopathic drugs in several
significantly different ways from other
drugs. Manufacturers of homeopathic drugs
are deferred from submitting new drug
applications to FDA. Their products are
exempt from good manufacturing practice
requirements related to expiration dating
and from finished product testing for
identity and strength. Homeopathic drugs in
solid oral dosage form must have an imprint
that identifies the manufacturer and
indicates that the drug is homeopathic. The
imprint on conventional products, unless
specifically exempt, must identify the
active ingredient and dosage strength as
well as the manufacturer.
"The
reasoning behind [the difference] is that
homeopathic products contain little or no
active ingredients," explains Edward Miracco,
a consumer safety officer with FDA's Center
for Drug Evaluation and Research. "From a
toxicity, poison-control standpoint, [the
active ingredient and strength] was deemed
to be unnecessary."
Another
difference involves alcohol. Conventional
drugs for adults can contain no more than 10
percent alcohol, and the amount is even less
for children's medications. But some
homeopathic products contain much higher
amounts because the agency has temporarily
exempted these products from the alcohol
limit rules.
"Alcohol is
an integral part of many homeopathic
products," says Miracco. For this reason,
the agency has decided to delay its decision
concerning alcohol in homeopathic products
while it reviews the necessity of high
levels of alcohol.
"Overall,
the disparate treatment has been primarily
based on the uniqueness of homeopathic
products, the lack of any real concern over
their safety because they have little or no
pharmacologically active ingredients, and
because of agency resources and priorities,"
explains Miracco.
However,
homeopathic products are not exempt from all
FDA regulations. If a homeopathic drug
claims to treat a serious disease such as
cancer it can be sold by prescription only.
Only products sold for so-called
self-limiting conditions--colds, headaches,
and other minor health problems that
eventually go away on their own--can be sold
without a prescription (over-the-counter).
Requirements for nonprescription labeling
include:
- an
ingredients list
-
instructions for safe use
- at least
one major indication
- dilution
(for example 2X for one part per hundred,
3X for one part per thousand).
Over the
past several years, the agency has issued
about 12 warning letters to homeopathic
marketers. The most common infraction was
the sale of prescription homeopathic drugs
over-the-counter. "It's illegal, it's in
violation, and we're going to focus on it,"
says Miracco.
Other
problems include:
- products
promoted as homeopathic that contain
nonhomeopathic active ingredients, such as
vitamins or plants not listed in
homeopathic references
- lack of
tamper-resistant packaging
- lack of
proper labeling
- vague
indications for use that could encompass
serious disease conditions. For example, a
phrase like "treats gastrointestinal
disorders" is too general, explains
Miracco. "This phrase can encompass a wide
variety of conditions, from stomachache or
simple diarrhea to colon cancer," he says.
"Claims need to be specific so the
consumer knows what the product is
intended to treat and the indication does
not encompass serious disease conditions
that would require prescription dispensing
and labeling."
In addition
to enforcement, the agency is also focusing
on preventing problems by educating the
homeopathic industry about FDA regulations.
"Agency representatives continue to meet
with homeopathic trade groups to tell them
about problems we've had, difficulties we've
seen, and trends we've noticed," says
Miracco.
FDA is
aware of a few reports of illness associated
with the use of homeopathic products.
However, agency review of those reported to
FDA discounted the homeopathic product
involved as the cause of the adverse
reaction. In one instance, arsenic, which is
a recognized homeopathic ingredient, was
implicated. But, as would be expected, FDA
analysis revealed the concentration of
arsenic was so minute there wasn't enough to
cause concern, explains Miracco. "It's been
diluted out."
Homeopathic Treatment
Homeopathy
consists of highly individualized treatments
based on a person's genetic history,
personal health history, body type, and
present status of all physical, emotional
and mental symptoms.
Jennifer
Jacobs, M.D., who has a family practice and
is licensed to practice homeopathy in
Washington state, spends at least an hour
and a half with each new patient. "What I do
is review the lifetime history of the
patient's health," she explains. "Also I ask
a lot of questions about certain general
symptoms such as food preferences and sleep
patterns that usually aren't seen as
important in conventional medicine. In
looking to make the match between the person
and the remedy, I need to have all of this
sort of information."
Why does
someone trained in conventional medicine
turn to homeopathy? "With chronic illnesses
such as arthritis and allergies,
conventional medicine has solutions that
help control the symptoms but you don't
really see the patients getting better,"
says Jacobs. "What I have seen in my
homeopathic work is that it really does seem
to help people get better. I'm not saying I
can cure everyone but I do see where
people's overall health is improved over the
course of treatment."
Jacobs'
hasn't abandoned conventional medicine
completely. "My daughter is 17 and she's
never taken antibiotics, but I would have no
hesitation to use antibiotics if she had
pneumonia, or meningitis, or a kidney
infection," says Jacobs.
About a
third of Jacobs' practice is children, and
ear infections are one of the most common
problems she treats. "Ear infections are
something that seems to respond well to
homeopathy," she says. "Of course, if a
child is not better within two or three
days, or if the child develops a high fever,
or if I feel that there's a serious
complication setting in, then of course I
will use antibiotics. But I find that in the
majority of cases, ear infections do resolve
without antibiotics."
In addition
to treating patients, Jacobs has conducted a
clinical trial the results of which suggest
that homeopathic treatment might be useful
in the treatment of acute childhood
diarrhea. The results were published in the
May 1994 issue of Pediatrics. In the
article, Jacobs concluded that further
studies should be conducted to determine
whether her findings were accurate. A
subsequent article appearing in the November
1995 issue of Pediatrics indicated that
Jacobs' study was flawed in several ways.
Although
Pediatrics is published by the American
Academy of Pediatrics, Jacobs' study and
several others published in such journals as
The Lancet and the British Medical Journal
are considered "scanty at best" by the
academy. "Given the plethora of studies that
are published [on other topics] in
scientific journals, I wouldn't say there
are a lot of articles coming out," says Joe
M. Sanders Jr., M.D., the executive director
of the academy. "Just because an article
appears in a scientific journal does not
mean that it's absolute fact and should be
immediately incorporated into therapeutic
regimens. It just means that the study is
[published] for critique and review and
hopefully people will use that as a stepping
stone for further research."
More
studies are under way. For example, the
Office of Alternative Medicine at the
National Institutes of Health has awarded a
grant for a clinical trial of the effects of
homeopathic treatment on mild traumatic
brain injury.
Even with
the dearth of clinical research,
homeopathy's popularity in the United States
is growing. The 1995 retail sales of
homeopathic medicines in the United States
were estimated at $201 million and growing
at a rate of 20 percent a year, according to
the American Homeopathic Pharmaceutical
Association. The number of homeopathic
practitioners in the United States has
increased from fewer than 200 in the 1970s
to approximately 3,000 in 1996.
When
looking for a homeopathic practitioner, it's
important to find someone who is licensed,
according to the National Center for
Homeopathy. Each state has its own licensing
requirements. "Whether that person is a
medical doctor or a physician's assistant or
a naturopathic physician, I feel that anyone
who's treating people who are sick needs to
have medical training," says Jacobs.
Real Medicine or Wishful Thinking?
Many who
don't believe in homeopathy's effectiveness
say any successful treatments are due to the
placebo effect, or, in other words, positive
thinking.
But
homeopathy's supporters counter that their
medicine works in groups like infants and
even animals that can't be influenced by a
pep talk. Jacobs adds that sometimes she
mistakenly gives a patient the wrong remedy
and he or she doesn't get better. "Then I
give the right remedy, and the person does
get better," she says. "So it's not like
everybody gets better because it's all in
their head. I think it's only because we
don't understand the mechanism of action of
homeopathy that so many people have trouble
accepting it."
The
American Medical Association does not accept
homeopathy, but it doesn't reject it either.
"The AMA encourages doctors to become aware
of alternative therapies and use them when
and where appropriate," says AMA spokesman
Jim Fox.
Similarly,
the American Academy of Pediatrics has no
specific policy on homeopathy. If an adult
asked the academy's Sanders about
homeopathy, he would tell that person to "do
your own investigation. I don't personally
prescribe homeopathic remedies, but I would
be open-minded."
That
open-mindedness applies only to adults,
however. "I would have problems with
somebody imposing other than conventional
medicine onto a child who's incapable of
making that decision," he says.
Even
professionals who practice homeopathy warn
that nothing in medicine--either
conventional or alternative--is absolute.
"I'm not saying we can cure everyone [with
homeopathy]," says Jacobs.
Isadora
Stehlin is a member of FDA's public affairs
staff.
|
