Here's what the FDA thinks....
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.
