Are Homeopathic Treatments Safe?
For more than 200 years, homeopathy operated under the radar of mainstream medicine, dispensing natural "remedies" that critics claim are based on wishful thinking or, worse, pseudoscience. But the practice hasn't been considered deadly or even dangerous—until now. Stories of homeopathic harm have surfaced recently, propelling the Food and Drug Administration to take a serious look at these alternative treatments.Preventiondelves underneath the latest news to examine the story of homeopathy.
1. What propelled homeopathy into the limelight?
Over a 7-year period starting in 2010, 10 babies died while using homeopathic teething tablets containing belladonna, a toxic substance. In 2019, FDA lab results showed that Hyland's Teething Tablets had levels of belladonna far beyond the amount indicated on the label. (Hyland disputes the FDA's findings, claiming that the evidence showed the medicines are "well within the margin of safety," according to a company representative.) Hyland withdrew its product from the market, and in April voluntarily recalled any remaining products on store shelves. Raritan, another manufacturer of homeopathic teething products containing belladonna, recalled its products in November.
Since 2010, when the agency issued its first warning about these products, the FDA's drug-safety monitoring system has received more than 400 reports of adverse reactions to using homeopathic teething products. In addition to the 10 deaths, "most [reports] were very serious, including. . .seizures," says FDA spokesperson Lyndsay Meyer. (Take a look at these 8 natural alternatives to Tylenol.)
Back in 2009, the FDA warned that three different nasal gels and swabs for cold symptoms marketed as homeopathic by manufacturer Zicam had measurable amounts of zinc (homeopathic remedies are made to have negligible amounts of active ingredients). That warning came after 130 people claimed the cold remedies had caused them to lose their sense of smell, perhaps permanently. (Zicam has consistently disputed the claims and settled lawsuits without acknowledging responsibility. The FDA concedes it's nearly impossible to prove cause and effect in most of these situations.)
MORE:23 Remedies For The Common Cold
2. What is homeopathy exactly?
Homeopathy was developed by an 18th-century German physician as a gentler alternative to medical treatments of the day such as bloodletting using leeches. Made from plants and other natural substances, these remedies were supposed to cure a wide range of ailments without side effects. Today, an estimated 5 million adults and 1 million children use homeopathic remedies each year in the US. And it's big business: Americans pay an estimated .9 billion annually for these products, which are sold in mainstream supermarkets and pharmacies as well as health food stores.
3. How are the remedies believed to work?
Homeopathic therapies come from plants, minerals, even animals and include a wide variety of substances, including red onion, crushed bees, and white arsenic. One main principle behind homeopathy is that "like cures like"—in other words, substances that produce symptoms mirroring those of a sick person can help cure those symptoms by stimulating the immune system. A treatment for blistering skin rashes, for example, might be an extremely small dose of the irritating chemical in poison ivy.
Through rigorous dilution as part of creating homeopathic remedies, toxins are rendered safe, according to homeopathic practitioners, who also believe that the healing power of these substances is actually increased through their dilution. (This thinking explains why toxic belladonna can be an ingredient in baby teething tablets.) Homeopathic treatments can be made in the form of liquids, pills to be placed under the tongue, ointments, gels, drops, creams, and tablets.
"It's a very individualized form of medicine," says Ronald Whitmont, a physician and homeopath. It focuses on the whole person.
4. How did harmful products get onto drugstore shelves?
Homeopathic remedies are not regulated by the FDA the same way that conventional over-the-counter and prescription drugs are. ANew England Journal of Medicinecommentary last year referred to "more than a century of missed opportunities to regulate homeopathic medicines." But homeopathic products are not entirely without government oversight: Since 1988, the remedies have been required to conform to the FDA's Compliance Policy Guide, which states that products must meet certain conditions regarding ingredients, labeling, prescription status, and good manufacturing practices. They are also covered by the Homeopathic Pharmacopoeia of the United States (HPUS), an official compendium that lists all homeopathic drugs and the potencies at which they can be administered. "Homeopathic manufacturers are encouraged to utilize HPUS guidelines, but some choose not to," says homeopathic physician Ronald D. Whitmont. "There have been companies that market so-called homeopathic products that contain steroids or antibiotics or herbs that are not homeopathic. These hybrid compounds can slip under the umbrella of homeopathic marketing protection even though they're not technically homeopathic."
5. How is homeopathy practiced?
"Homeopathy is very different from conventional medicine, and one of the big differences is the individualized nature of the treatment approach," says medical doctor Michelle L. Dossett, an instructor in medicine at the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital. "If I were going to homeopathically treat someone with pneumonia, there would be maybe 100 to 200 medicines that I could choose from." Homeopathy's focus on the whole person, rather than a single organ system or body part, is what attracts many people to the practice. Homeopaths say that prescribing a treatment can be as exacting as matching a fingerprint. To learn how, homeopaths receive 3 to 4 years of training. (Here are 6 alternative doctors you should consider seeing.)
6. Why is homeopathy better than traditional medicine, according to its practitioners?
Dossett believes that homeopathy has a number of public health benefits, including a reduction in unnecessary use of antibiotics, improvement in perimenopausal depression equivalent to that seen with SSRI drugs, and positive health outcomes in chronically ill individuals.
There are plenty of people who claim homeopathic medicine has worked for them. Betty Allen, 62,of Millerton, NY, has been seeing Whitmont for the past 4 years. "I was impressed with his reassuring manner and explanations of how the body fights disease. It was more than 'OK, you're sick. Here, take this,'." she says. Since then, Betty has consulted him about her migraines, acid reflux, and high cholesterol and stress levels. She says homeopathic treatments have helped her reduce or eliminate all of these ailments. "If I listened to everyone who wanted to give me drugs, I would be taking acid reflux medicine, an inhaler three times a day for my asthma, an allergy pill, cholesterol medication, and migraine medicine," she says. "I don't want to go that route."
7. Does homeopathy really work?
Many scientists say the practice doesn't meet the standards of modern medicine. The National Center for Complementary and Integrative Health's website states: "There is little evidence to support homeopathy as an effective treatment for any specific condition." D. Craig Hopp, deputy director for extramural research at the NCCIH, says, "There isn't any evidence for benefit. Homeopathy doesn't make sense."
Many traditional doctors attribute positive results of a homeopathic treatment to the placebo effect. "Someone's expectation of benefit can have a very powerful impact," says Hopp. "This could explain some of the perceived benefits of homeopathy."
MORE:12 Foods That Lower Cholesterol Naturally
8. How could remedies considered safe cause such harm?
Proponents claim that compared with OTC drugs like acetaminophen or stomach-acid blockers, homeopathic medicines are orders of magnitude safer. "The examples of harm that have come up are from a very slim minority of the products that are out there," says Hopp.
Practitioners also blame homeopathic remedy manufacturers for the recent problems. "Unfortunately, some companies out there are mislabeling products and misleading consumers," says Dossett. In the case of the teething tablets, the FDA's Meyer says, if they'd been manufactured according to homeopathic standards, "you should not be able to detect any amount of belladonna."
Not everyone believes the products are completely safe, however, even when manufactured to exacting standards. For instance, toxic substances, even when very diluted, may cause harm if they're given too frequently or over a long period of time, according to Trine Stub, a senior researcher at the National Research Center in Complementary and Alternative Medicine, the Arctic University of Norway, who looked at adverse events in a large review of homeopathy studies published last year. "Homeopathy is medicine, and any medicine can have side effects or adverse effects if someone is sensitive to it or if the medicine is abused or used incorrectly," says Whitmont.
Even if the substances themselves are nontoxic, other experts are concerned that patients favoring homeopathy may delay essential treatment with more effective, conventional medicine.
The ease with which these products can be purchased is another factor contributing to recent problems. The tablets and creams sometimes sit on the shelves next to conventional OTC drugs like aspirin and antihistamines. Many people may not even realize they're homeopathic without closely reading the labels. Homeopathic drugs intended for serious conditions not covered by OTC treatments must be prescribed by homeopathic practitioners. In the recent cases, the people who were harmed had purchased products over the counter, without necessarily having consulted a homeopath.
"There is little evidence to support homeopathy as an effective treatment for any specific condition," says a US government website.
9. What is the government doing now to protect people?
It's one thing for regulators to overlook the question of effectiveness when products are thought, at the very least, to be harmless. But the tragedy of babies becoming sick and even dying after receiving homeopathic teething tablets has thrown an entire healing philosophy into question. Given the medical establishment's unequivocal claims of homeopathy's ineffectiveness, combined with the rapid growth in sales of homeopathic remedies in mainstream pharmacies, the government decided it was time to step in.
Last November, the FTC issued an ultimatum: Efficacy and safety claims for homeopathic drugs will be held to the same standards that apply to claims for nonhomeopathic OTC drugs, and if scientific evidence doesn't exist, advertising and product labeling should say that:
- There is no scientific evidence that the product works.
- The product's claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
Currently, the FTC is focusing on educational programs and speaking with and answering questions from homeopathic marketers, according to Michael Ostheimer, a senior staff attorney in the FTC's Division of Advertising Practices. "There is no set time frame for moving forward to enforcement, meaning those new labels may not be on products any time soon," he says. The FDA, which also held a public workshop on homeopathy and its regulation, is still considering the workshop's public comments and may issue its own new regulatory guidelines this year.
Video: Homeopathy Explained – Gentle Healing or Reckless Fraud?
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