Real Medicine or Empty Promises?
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
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.
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
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.
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
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.
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
"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."
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
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.
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
nonprescription labeling include:
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.
- an ingredients list
- instructions for safe
- at least one major
- dilution (for example
2X for one part per hundred, 3X for one part per thousand).
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.
- products promoted as
homeopathic that contain nonhomeopathic active ingredients, such as
vitamins or plants not listed in homeopathic references
- lack of
- lack of proper
- 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
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."
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."
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
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.
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.
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
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
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."
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.
Stehlin is a member of FDA's public affairs staff.