When the American Institute of Homeopathy meets in New York City next month to mark its 150th anniversary, spirits are expected to run high. Interest in homeopathy--a form of alternative medicine that uses extremely diluted preparations of natural substances--is growing at a rate unrivaled since the turn of the century. The small number of physicians who practice as homeopaths have waiting lists, and retail sales of homeopathic remedies are rising by about 25 percent a year. Last fall, the National Institutes of Health's fledgling Office of Alternative Medicine approved two grants to researchers studying homeopathy. And the first clinical trial of homeopathy to be accepted by an American peer-reviewed medical journal is scheduled for publication in the May issue of Pediatrics.
These events mark a change in the fortunes of American homeopathy. Despite a strong tradition in Europe, homeopathy in the U.S. has long been the Rodney Dangerfield of medicine. The vast majority of physicians give it no respect; many consider it outright quackery.
For decades, physicians and medical researchers dismissed apparent homeopathic cures as the placebo effect--the benefit a patient gets from simply believing that a treatment will work. That's because homeopathic remedies defy scientific plausibility. Many of them are diluted to such a degree that, in theory, not even a molecule of the active ingredient remains.
Those who paid any attention to homeopathy at all demanded that its practitioners do well-controlled studies to show that their remedies are more than placebos. In recent years, several such studies have been done, have shown positive results, and have been published in European journals of science and medicine.
The situation presents science with a vexing conundrum. If homeopathy is truly effective, then it's time to rethink some basic laws of nature. But if those positive studies are chance occurrences or statistical anomalies, then they raise questions about how published scientific research should be interpreted.
Homeopathy was the brainchild of Samuel Hahnemann, a German physician disillusioned with the prevailing medical practices of the late 1700s. In an era when conventional treatment included extensive bloodletting, blistering, and purging, Hahnemann's interest in less drastic methods led him to do a series of experiments. The first used cinchona bark, which contains quinine, a well-known treatment for malaria. Taking a strong dose himself, Hahnemann experienced headache, thirst, and fever, symptoms typical of malaria. >From this experience he developed the homeopathic "law of similars"--or, put simply, like cures like.
A drug's power to cure a disease, he said, arose from its ability to produce symptoms in a healthy person that were similar to those caused by the disease itself. Hahnemann believed that this process could help the body mount its defenses. He kept testing this theory by giving herbs, minerals, and other substances to himself, his family, and friends in experiments he called "provings."
Unfortunately, some of the substances produced dreadful results. So Hahnemann began doing provings with smaller and smaller doses, trying to see how low a dose would still produce a healing response. Hahnemann came to believe that smaller doses were not only less noxious, but actually more effective than larger ones. Thus, homeopathic remedies are prepared by repeatedly diluting an active ingredient until it virtually disappears from the solution used in treatment. (Often, the treatment is given as a sugar pill that has absorbed the prepared solution.)
A good example is extract of belladonna, derived from a highly poisonous plant also known as deadly nightshade. Conventional physicians prescribe drops of tincture of belladonna for a variety of gastrointestinal problems, but homeopaths use belladonna in vastly smaller amounts. The dosage that homeopathic physicians commonly use for problems such as croup in children or bronchitis in adults is known as 30C; the "C" stands for a one- in-one-hundred dilution. That means one drop of belladonna extract is dissolved in 99 drops of a water/alcohol solution; then one drop of the new solution is further diluted by 99 drops of liquid; and so on, 30 times. After 30 dilutions, the concentration of belladonna would be expressed scientifically as one over 10 to the power of 60. That number--a one followed by 60 zeroes--is virtually beyond imagining. A 30C belladonna solution is about a million billion times more dilute than a solution made from dissolving one molecule of salt in a body of water as large as all the Earth's oceans combined.
At such astronomically high dilutions, of course, the amount of belladonna extract in a homeopathic potion given to a patient with bronchitis would be nil. According to the laws of chemistry and probability, a remedy that has been prepared at a 10 to the power of 24 dilution--that is, a homeopathic dosage of 12C--would theoretically be diluted just past the point where a dose contains a single molecule of the original substance. At greater dilutions, which are often used in homeopathy, the odds that there could be any of the original substance left at all decrease almost to zero.
Hahnemann was aware of this enormous theoretical problem, but he believed that the qualities of an active ingredient were somehow retained by the solution itself even when the active ingredient was gone. Hahnemann proposed that vigorously shaking the preparation each time it was diluted could "potentize" the solution. As he put it, the drug's medicinal properties "are excited and enabled to act spiritually (dynamically) upon the vital forces." Modern homeopaths have added some speculative musings about quantum mechanics and the structure of water, but they have not really moved beyond Hahnemann's original explanation.
Homeopathic methods of diagnosis, too, are quite unlike anything in conventional medicine. A patient can spend up to an hour and a half on the initial visit, answering seemingly arcane inquiries as well as standard medical questions: Do you have any problem falling or staying asleep? Are you easily angered? Do you crave sweets or salty foods?
A homeopath will weave all this information into a "symptom picture," focusing on the symptoms that are the most uncommon or peculiar, and choose a remedy from a voluminous "repertory" that matches remedies to combinations of symptoms. (Homeopaths can choose from some 2000 remedies, which they sometimes use in combination.)
Two patients with apparently identical complaints might receive completely different prescriptions if some of their symptoms differ. Patients with flulike symptoms, for example, are often given dilutions of jasmine, hops, or arsenic. But a flu patient who had, say, an unusual craving for fresh air might instead be given carbo vegetabilis, a homeopathic preparation of wood charcoal.
Even by the scientific standards of Hahnemann's day, homeopathy seemed somewhat mystical. But it was an attractive alternative to the torturous and ineffective medical treatments of the time. For that reason, homeopathy flourished in Europe and was introduced to the U.S. in the 1820s. On both continents, homeopathy's apparent successes during cholera epidemics played a major role in attracting converts from orthodox medicine.
Conventional physicians soon began to see homeopaths as competitors; physicians formed the American Medical Association in 1847 partly as an attempt to subdue their rivals. By 1900, there were 22 homeopathic medical schools, more than 100 hospitals, and some 15,000 practitioners in the U.S.
Homeopathy's fortunes began to fade a few decades later, however, as conventional medicine developed effective drugs and therapies and as training programs for physicians became standardized. By the 1920s, most American homeopathic schools had closed, and the ranks of practitioners had dwindled to just a few hundred. Not until the 1970s, when "natural" was in and "chemicals" were out, did homeopathy show signs of reviving. Today, homeopathic remedies promising relief from chronic ills-- allergies, arthritis, premenstrual syndrome--have even moved into chain stores (see "Diluting the Law").
Some statistics suggest that homeopathy is growing rapidly. The National Center for Homeopathy, a promotional organization in Arlington, Va., reports that its membership has increased by more than 50 percent in the past three years. According to the Center's own statistics, almost half of its 6800 members are not health-care professionals but interested lay people. These people meet regularly in semiformal study groups around the country to learn how to use homeopathy on themselves and their families.
The greatest danger in taking any homeopathic remedy is the risk of forgoing effective medical treatment. Many homeopaths have no formal health-care training--a fact that compounds the risk.
There are no uniform training standards for people learning homeopathy. A group of practitioners recently established the Council for Homeopathic Certification, dedicated to ensuring that those who practice homeopathy are well versed in it. But the council has yet to have an impact on homeopathic practice.
Within the past decade, products and practices have appeared that seem dubious even to some homeopaths. Practitioners may use such odd methods of choosing remedies as electrodiagnostic devices--said to measure the body's "electromagnetic energy balance"--and iridology, a system of sizing up a person's health from the irises of the eyes. Unapproved remedies and promotional gimmicks are being marketed, as homeopaths with no training in the health professions are illegally taking on patients.
To practice legally, a homeopath must be licensed by the state as a health-care provider. But even licensed providers who are homeopaths come from widely diverse backgrounds. Edward H. Chapman, a medical doctor who is president of the American Institute of Homeopathy, estimates that about 4000 licensed health-care practitioners now include homeopathy in the treatments they offer. That number consists mostly of chiropractors, dentists, acupuncturists, nurse-practitioners, and naturopaths. (The last group is schooled in a system of treatment that includes homeopathy, herbal medicine, and nutritional therapy.) According to Chapman, only a few hundred American physicians practice homeopathy full-time.
Some of the few American physicians who have turned to homeopathy seem to have been drawn to it, as Hahnemann was, by disillusionment with conventional medicine. Dr. Jennifer Jacobs, a clinical assistant professor of epidemiology at the University of Washington in Seattle, also runs a homeopathic family practice in suburban Edmonds, Wash. She recalls her disappointment after medical school when she discovered that many of the therapies she had been taught were of limited value. "Often a drug would simply cover up symptoms rather than cure the condition, and sometimes side effects would require additional medication," she says. "Soon the patient was taking three or four different prescription drugs without really becoming any healthier."
Physicians who practice homeopathy often say they give conventional medicine its due, and will begin by diagnosing patients to see whether their condition needs conventional treatment. Certain conditions, such as severe infections, surgical emergencies, and serious injuries, obviously require immediate medical care. Homeopathy can't replace the insulin needed by diabetics or repair a liver damaged by cirrhosis. Many homeopaths--though not all--also steer away from serious disorders such as cancer and advanced heart disease.
Nevertheless, Jacobs and many other homeopaths maintain that 95 percent of the problems seen in general practice can be successfully treated with homeopathy. Homeopaths also claim that their treatments can relieve or even cure such chronic conditions as allergies, arthritis, asthma, and migraine.
Some homeopathic practitioners go further. One naturopath practicing in Westport, Conn., recently told the audience at a public lecture that "There is no illness known to man that homeopathy can't cure in certain individuals," including cancer. He also disparaged the widespread practice of immunization against infectious disease.
Physicians and public-health experts are alarmed by such claims; they worry that some people practicing various forms of "natural medicine," including homeopathy, could divert patients from immunization and effective medical treatment. Joe Sanders, executive director of the American Academy of Pediatrics, raises a special warning about the treatment of children, who are too young to make an informed decision about forgoing conventional medical care. "If there's a well-documented standard therapy for a particular problem, withholding it from a child would be wrong," he says.
Homeopathic theory is at least as puzzling to conventional scientists as homeopathic practice. Beyond partial analogies and speculation, no one has come up with an explanation of how homeopathy might fit into a modern scientific model.
Proponents often point to immunization and allergy treatment as two conventional practices that work according to the law of similars, but the analogy is flawed. Those treatments use substances that are similar, or identical, to disease-causing agents. Homeopathic remedies use substances that are usually different from those that cause disease; their similarity is supposed to be in the symptoms they provoke. In addition, homeopathic remedies aren't targeted at the immune system, as immunization and allergy treatment are, but rather at something broader and undefined. Hahnemann called it the vital force. Dr. Chapman of the American Institute of Homeopathy calls it a "subtle, integrating principle in the body that coordinates all its functions; whatever it is that distinguishes a living person from a dead one."
For scientists accustomed to understanding drug action at the molecular level, that kind of vagueness is irksome enough. But the toughest issue is the remedies' infinitesimal doses.
The most popular theory for how such a dilution can possibly have a biological effect is that somehow the water retains a "memory" of the active molecules that were once in it. Some researchers speculate that the vigorous shaking between each dilution induces water molecules to line up according to the structure of the active molecules, much like iron filings that line up when shaken and placed near a magnet. So arranged, the water molecules could carry on the information.
Even within the alternative-medicine community, this theory has its critics. One is Beverly Rubik, the director of the Center for Frontier Sciences at Temple University, which publishes research on homeopathy. She rejects the idea of rearranged water molecules because each shaking, she says, would just break up the new structures.
But Rubik's view of the phenomenon is even more elusive: Homeopathy, she believes, works by "some subtle informational signal" whose nature is undefined. "I don't think there's a good theory yet," she says. "We need to rethink the properties of matter. It's that deep."
Most homeopathic practitioners are willing to overlook the lack of a suitable theory, but that deficiency incenses traditional scientists. The animosity between the two camps was played out several years ago in an unprecedented public slugfest between the journal Nature--one of the world's most respected scientific publications--and a French research team. In June 1988, Nature published a report by the team showing that dilutions up to 10 to the power of 120 of an antibody--a substance produced by the immune system in response to infection --could evoke a reaction from a certain type of white blood cell. The research had been confirmed in other laboratories, and Nature's reviewers had been unable to find a flaw that would invalidate the startling results. Still, the editors felt compelled to add an editorial "reservation," assuring readers of their "incredulity."
The following month the journal dispatched three observers to investigate the research first-hand: Nature editor John Maddox; fraud-hunter Walter Stewart of the National Institutes of Health; and magician James "The Amazing" Randi, famous for debunking claims of telepathic powers and other paranormal phenomena. They declared the results "a delusion," charging that the experiments were poorly designed, that unsatisfactory measurements were discounted, and that the experimenter's bias had probably influenced the interpretation of results.
In response, immunologist Jacques Benveniste, head of the French team, called the investigation "a mockery" and compared it with the Salem witch hunts. Among other things, he pointed out that none of the debunkers were trained in immunology, and he questioned their competence to judge an immunological experiment.
Benveniste subsequently repeated his research with what he said were better controls and achieved the same results. But last December, British scientists reported that they had used Benveniste's methods and had not confirmed his findings.
"Given that homeopathy has been around since the 1800s and has so little scientific support, I'd say that almost certainly it's a placebo treatment," says Arthur Shapiro, clinical professor of psychiatry at Mount Sinai School of Medicine in New York City.
Numerous studies have documented the placebo effect--the power of a patient's beliefs to influence treatment results. In one study that is now classic, Dr. Shapiro gave pregnant women ipecac, which usually induces vomiting, and told them it would cure their nausea; most of the time, it did. Because the impact of belief is so strong, well-designed clinical trials typically test a new drug against a placebo, a lookalike dummy medication. The best studies are "double-blind": Subjects are randomly assigned to receive either the drug or the placebo, and neither subject nor investigator knows which is which, so neither person's expectations can influence the outcome.
By the most common estimate, about one-third of patients in a study will improve when they are given a placebo. But sometimes the placebo effect is even stronger. Placebos can be so potent, Dr. Shapiro notes, that he'd sooner bet homeopathy works than invest in the stock market.
In fact, homeopathic treatment almost seems designed to evoke the placebo response. The time spent in close collaboration with a helpful professional, the attention paid to the mental, emotional, and physical aspects of an individual, and the prospect of being given just the right remedy all heighten the expectation that relief is at hand. And because homeopathic theory holds that treatments will often make symptoms worsen before they get better, even someone who stays sick for days or weeks but eventually recovers could maintain the faith that the treatment itself had worked.
Not surprisingly, homeopaths bristle at the notion that their medicines are nothing more than sugar pills. "You can't be educated about homeopathy and think it's just the placebo effect," says Dana Ullman, a layman trained in homeopathy and president of the Foundation for Homeopathic Education and Research.
As part of the argument, Ullman and others point to homeopathy's apparent effectiveness in infants and animals. Since babies and dogs can't understand what a homeopath is trying to do, the argument goes, their expectations can't affect the success of the treatment. But Frederick J. Evans, a psychologist in Belle Mead, N.J., who has extensively researched the placebo effect notes that even infants and animals respond differently to stress in the presence of a comforting person. The attention they receive in homeopathic treatment, he says, might be enough to trigger the placebo effect.
Homeopaths also point out that their remedies can produce long-lasting results, while the placebo effect tends to be transient. But there are documented examples of long-lasting placebos. In one study, drug addicts who unknowingly used a placebo substitute for morphine over the course of several years showed chronic dependence and even withdrawal symptoms, just as they would have with the real drug.
Until fairly recently, homeopaths answered their critics by pointing to two centuries of clinical experience and the thousands of cases in which their treatments appeared to have worked. Modern homeopaths, however, have realized that they must conduct well-controlled clinical trials in order to be taken seriously. Now they have, and several published studies offer an argument for doing further research.
In 1986, the British journal The Lancet published a study of homeopathy that followed the rules of proper clinical research. It compared hay-fever sufferers given a homeopathic remedy of mixed grass pollens with similar patients given a dummy pill. Symptoms improved significantly more in the treatment group, and by the end of the study that group used half as much antihistamine as the controls. Yet the remedy they had taken was so greatly diluted that none of the original material should have remained.
Intrigued by these findings, a team of Dutch epidemiologists scoured the homeopathic and conventional medical literature for other controlled clinical trials. Their analysis of 107 studies, published in 1991 in the British Medical Journal, sent a wave of satisfaction through the homeopathic community. Of 105 studies with interpretable results, 81 appeared to show that homeopathy was effective. But many of the studies were seriously flawed: Patients weren't assigned randomly to receive a treatment or placebo, or knew which they were getting. More than half the trials had too few subjects to allow confident conclusions.
The Dutch researchers scored the different studies according to their scientific validity--and when they looked at the 23 best, they found that 15 showed positive results. "Based on this evidence," they wrote, "we would be ready to accept that homeopathy can be efficacious, if only the mechanism of action were more plausible." They concluded that the evidence wasn't definitive, but that it did justify further study.
We asked two scientists well versed in study design to comment on the review, the hay-fever study, and two other studies that homeopaths often cite as examples of good research. In one, patients with flu symptoms who received a common homeopathic flu remedy recovered faster than those who took a placebo. In the other, patients with rheumatoid arthritis were given homeopathic remedies based on their individual "symptom picture," and those who received the homeopathic treatment showed significantly reduced pain and better functioning than those on placebo.
Thomas Chalmers, adjunct professor of medicine at Tufts and Dartmouth Universities, took issue with the Dutch review on two counts. The evaluators, he said, should have been "blind" as to the origin and results of each study to avoid potential bias in scoring the study's design. More important, studies in which subjects weren't randomly assigned to the treatment or control groups should have been dropped from the review rather than just given a lower score. Until homeopathic research is evaluated by such standards, says Dr. Chalmers, it's hard to say whether additional studies are worthwhile. (In the Dutch review, only eight of the high-scoring studies were randomized and double- blind. Results were positive in seven of those eight--but given the diversity of the studies, that is too few studies on which to base a conclusion.)
Chalmers is a strong advocate of meta-analysis, a technique of combining the results of several studies to draw more meaningful conclusions. He pointed out some of the pitfalls of looking at evidence one study at a time--pitfalls that apply to studies of conventional medical treatments as well. When the outcome of a clinical trial is "statistically significant," the accepted criterion for success, it means there's less than a 5 percent probability that the results happened by chance. But 5 percent is not zero, and occasionally what looks like a positive result will actually be a chance outcome. Then there's the problem of "publication bias": Researchers are less likely to submit studies with negative outcomes, and journals are less likely to publish them.
Our other reviewer was Dr. Paul Marantz, associate professor of medicine and epidemiology at Albert Einstein College of Medicine in New York. He found the arthritis study flawed because subjects weren't assigned to groups strictly at random. But the flu and hay-fever studies were "impressive," he said. "These papers used orthodox research methods to show effectiveness, and demonstrated it soundly."
In that case, would he prescribe these remedies for patients with hay fever or flu? Without hesitation, he answered no. "Ultimately, it gets to the issue of plausibility and how well it fits into your scientific view of the world," he said. "This doesn't fit."
Few people would claim that there is sufficient scientific evidence to prove that homeopathy is effective. A single study showing that a remedy seems to help a problem is not reason enough to use the remedy widely, or, for that matter, to accept an entire system like homeopathy.
The very existence of any well-designed positive studies of homeopathy is a surprise, and one the scientific community has not yet been able to explain or dismiss. But the claims of homeopathy are truly extraordinary, and they demand extraordinary proof to back them up.
Because homeopathic medicines are usually prescribed on the basis of an individual's physical, mental, and emotional symptoms, it's difficult to study specific remedies as treatments for specific problems. However, it is possible to design studies to examine homeopathic remedies in the context in which they are prescribed. At the minimum, the few well-controlled studies that have been done need to be repeated, and the results--positive or negative--need to be published. That is the basic standard applied to conventional drug research.
Homeopaths and their critics agree on one point: Homeopathic remedies themselves are probably harmless, even though they have not been tested for safety.
As it is now practiced, however, homeopathy does pose one clear risk: that of seeing a practitioner who will ignore or misdiagnose early symptoms of a serious disease that needs medical or surgical treatment. Many homeopaths practice out of the medical mainstream or even in direct opposition to it. They may advise patients to avoid appropriate medical care and may prescribe unproven treatments in addition to homeopathic remedies.
Finally, while these risks are real, there is still no logical scientific case to be made for homeopathy's benefits. The theoretical basis of homeopathy is highly implausible, and what experimental evidence exists is preliminary at best.
Thanks to good friends in high places, homeopathic remedies have been legally recognized as drugs for half a century. In 1938 U.S. Senator Royal Copeland, who was also a homeopathic physician, saw to it that the new Federal Food, Drug, and Cosmetic Act included a special provision for homeopathic remedies. As a result, all substances listed in the Homeopathic Pharmacopeia of the United States have been exempt from the safety and efficacy testing legally required for other drugs.
The status of homeopathic remedies gives them a marketing edge over herbal products and dietary supplements, which are under increasing U.S. Food and Drug Administration scrutiny. That's one reason homeopathy has had a high profile in health- food stores in recent years, says Margot Murphy Moore of Luyties Pharmacal, the nation's oldest manufacturer of homeopathic remedies. Aggressive advertising by well-financed European companies has also increased homeopathy's visibility. Remedies for cough, colds, muscle soreness, insomnia, and other ills are appearing on the shelves of discount chains such as K Mart, PayLess, RiteAid, Giant, and Osco, and also in independent pharmacies. You can even get next-day delivery from Homeopathy Overnight, an Ohio company. In all, the market for homeopathic remedies is estimated at $250-million.
But the homeopathy boom has also produced products that are questionable even by homeopathic standards, and possibly illegal. These products have come from both established companies and upstarts.
Approximately 95 percent of homeopathic medicines are classified as over-the-counter drugs, which means they are limited by law to acute conditions that usually resolve without treatment and don't require a doctor's diagnosis. (Because every remedy has multiple uses, virtually all have at least one use that meets the criteria for OTC drugs.) But an informal survey of natural-food stores in New York and Connecticut turned up over- the-counter products being sold for disorders that are usually chronic or that require medical monitoring. Natra-Bio's Bladder Irritation Relief, for instance, listed symptoms typical of a bladder infection. If not effectively treated, a bladder infection can progress to a kidney infection and may ultimately result in a life-threatening bacterial infection of the bloodstream. The warning on the box--to consult a health-care professional "if symptoms worsen or do not improve after 10 days" --is insufficient, according to CU's medical consultants, because a bladder infection can significantly worsen in less time than that.
Other remedies we found promise symptom relief for asthma and arthritis, conditions that are typically chronic in nature and should be medically monitored. These claims may be fraudulent, says FDA spokesman Mike Shaffer, but he doesn't expect the agency to act against the companies making them. "Homeopathic products are not a high priority for the FDA," he says. "It's too bad if they don't work, but people aren't likely to be harmed by them."
Occasionally a product appears on the market that offends even homeopathic manufacturers. Late last year an article in Body Mind & Spirit magazine touted the Medipatch Homeopathic Remedy Kit, which features a "digitally encoded homeopathic magnetic strip" that attaches to a Velcro bracelet. Worn on the wrist or ankle, the bracelet is said to "interface with the 12 acupuncture meridian pulse points, strengthen the body's electromagnetic field (verifiable by Kirlian photography), and enhance the output of the chakral energy system." The article on Medipatch raised the hackles of the homeopathic trade association, according to Jay Bourneman, vice-president of Standard Homeopathic Inc., who says that, in general, the industry tries "to be good citizens." Transdermal delivery isn't even an approved form of administering homeopathic drugs.
A bigger issue than obvious frauds, however, is the fact that homeopathic remedies have been exempt from the safety and efficacy testing required of other drugs. CU believes that these remedies deserve a closer look. Congress should remove the blanket exemption from drug laws enjoyed by homeopathic remedies. In particular, remedies being marketed as treatments for specific illnesses should be removed from drugstore shelves unless and until they are tested and shown to be safe and effective.
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