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.
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