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.
U.S. Food and Drug Administration
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