A Review of Homeopathy

Each year, Americans shell out almost $3 billion on homeopathic products — and that number is rising.

In the 2007 National Health Interview Survey conducted by the Centers for Disease Control and Prevention (CDC), researchers found that more than 38 percent of all adults and 11 percent of children use alternative medicine as a form of medical treatment. This includes chiropractic treatment, massage therapy, acupuncture, herbal remedies and homeopathy (4 percent of the surveyed population).

What is homeopathy?

The term "homeopathy" is derived from the Greek words "homeo-," meaning similar, and "-pathos," meaning suffering or disease.

Homeopathy was introduced in the late 1700s by a German physician named Samuel Hahnemann and is intended to treat physical and emotional symptoms, to produce lifestyle changes and to improve nutritional status.

How is homeopathy said to work?

Hahnemann formulated the "Law of Similars" which theorizes that "like cures like." This law claims that a substance that produces a set of symptoms in a healthy person has the ability to cure an ill person who has those same symptoms if it is administered at low doses. The administration of a homeopathic remedy allegedly causes the body to react to the worsening of symptoms induced by the remedy, thus promoting a cure. For example, if a given agent appears to cause a runny nose, that same agent might be effective in treating a runny nose if administered at low doses.

This theory is based on the premise of extreme dilutions — the "Law of Infinitesimals." Dilutions are created by taking one part of the original substance and nine parts of liquid, usually water, and mixing vigorously ("succussion"). This product is then considered to be a 1X solution. Subsequently, one part of the 1X solution is added to another nine parts of water and shaken. This product is then a 2X solution. This process can occur upwards of 400 times in some homeopathic remedies. After 24 dilutions there is only a 60 percent chance that one molecule of the original substance is still present if a standard amount of the substance called one mole was used. By contrast a single 200 mg ibuprofen pill contains almost 600 billion-billion molecules (6 followed by 20 zeros). Advocates of homeopathy believe that, despite the many dilutions, the substance initially present can modify the properties of pure water ("water memory"), thereby creating remedies that may treat illness.

Is homeopathy effective?

The idea that no molecule of the original substance may be present in a homeopathic remedy that is said to work has raised questions about the effectiveness of these remedies. How can something so diluted actually rid people of symptoms or illness?

There have been a number of studies that have reported favorable effects for homeopathy in treating various conditions. However, most of these studies were too small, poorly conducted or conducted by homeopathy advocates. Findings favorable toward homeopathy are more likely to be published in part because homeopathy advocates may not be interested in disseminating information that undermines their claims. We are aware of no condition for which a beneficial effect of homeopathy has been documented and replicated in well-conducted trials.

What attracts people to homeopathy?

At some level, it is known that since there is not a very high concentration of active ingredients in these products, they are much safer than traditional prescription or over-the counter drugs. Their perceived effectiveness, in the absence of any supporting scientific evidence, is based on two factors: Most conditions that homeopathy claims to treat are self-limiting (meaning that they will go away without treatment) and relatively minor. Because these symptoms resolve spontaneously, it is easy to attribute the spontaneous resolution of the illness to the drug’s effectiveness. Second, problems such as pain are known to respond to a placebo, which explains why, as mentioned above, homeopathy products do not consistently work better than placebos in randomized trials.

This combination of accurately-perceived safety (assuming the preparations are actually the profoundly diluted solutions that define homeopathy — see FDA actions against Zicam, below) and misperceived effectiveness clearly drives the market for these products.

How are homeopathic medicines regulated by the Food and Drug Administration?

According to the 1938 Food, Drug, and Cosmetic Act, homeopathic remedies are regulated as drugs. The 5 percent of homeopathic remedies, that are intended to treat serious conditions such as cancer can be sold only with a prescription, while the other 95 percent, which treat self-limiting conditions, can be sold over-the-counter.

Homeopathic remedies are thus, in theory, subject to regulation of good manufacturing practices, labeling and advertising, that are identical to those required of conventional medications. Whether the FDA enforces these requirements is less certain. Homeopathic remedies are exempt from requirements for expiration dating and determinations of active ingredient identity and strength (presumably because no active ingredient can be detected much of the time). The Federal Trade Commission has jurisdiction over advertising claims by over-the-counter homeopathic remedies but rarely, if ever, takes action.

The main difference between homeopathic and conventional medications is that drugs must be proved safe and effective based on often-rigorously conducted clinical trials, but homeopathic remedies are typically exempt from such important requirements. They are considered safe and effective as long as they are listed in the Homeopathic Pharmacopeia of the United States (HPUS), a publication produced since 1841 by advocates of homeopathy. Currently, there are about 1,300 substances listed in the HPUS, but an overwhelming majority of these were simply "grandfathered" in 1975 and were not subject to any modern clinical testing.

For new products to be entered into the HPUS, substances must go through clinical studies to demonstrate safety and effectiveness. These might resemble the randomized, controlled trials conducted to secure FDA approval for drugs, but it is unclear how many have entered the HPUS on that basis.

Rather, new homeopathic remedies are typically evaluated under a process unique to homeopathy called "proving." Supporters of homeopathy consider such studies more useful than conventional clinical trials.

In a modern-day proving, a small number of healthy people are given a placebo for a pretrial period followed by a period in which they receive the homeopathic remedy. Participants in the study are asked to self-report symptoms into a diary. At the conclusion of the study, all of the symptoms are compiled and analyzed. If a symptom is more common in the treated than in the placebo period in this healthy population, it is considered a potential treatment for people suffering from that same symptom. Subsequent studies administer the remedy to those suffering from the symptom, but typically are not randomized or controlled.

The lack of adequate testing for safety and efficacy need not be indicated on the labels of these products the way it is for dietary supplements. As a result, many consumers are unaware that, despite being legally considered drugs, homeopathic remedies have not been subject to the same level of FDA scrutiny as conventional medications.

What are the dangers associated with taking homeopathic remedies?

Homeopathic remedies are potentially associated with both direct and indirect harms. In a recent commentary in the highly respected medical journal The Lancet, Garattini and Bertelé posit the danger of "distracting physicians and patients from effective medicine, and industry from the difficult and costly search for innovative products to a less risky, more profitable market." In addition, homeopathic remedies may include contaminants or even non-homeopathic quantities of pharmacologically active compounds.

Moreover, these products cost between $5 and $9 for each retail unit, a cost patients must pay for out of pocket. All of these risks and costs are unacceptable when there is no commensurate evidence of the products’ effectiveness.

What are some examples of homeopathic products?

Some popular homeopathic remedies on sale in major drug stores include Loma Lux AcnePill to treat acne pimples and blemishes; Hyland’s Nerve Tonic to relieve nervous tension and stress; oscillococcinum to reduce the severity and shorten the duration of flu symptoms; and Coldcalm to relieve cold symptoms such as sneezing, runny rose, nasal congestion and minor sore throat. Homeopathic remedies are amongst the top 10 best-selling nonprescription drugs for the cough, cold and flu in the United States.

What actions has the FDA taken against homeopathic products?

Because the FDA is limited in its options for regulating homeopathic remedies, having to defer on the crucial safety and efficacy questions to the HPUS, and because the potential lack of any active ingredient in homeopathic products reduces their potential dangers, the agency has taken few actions against them.

The usual form of sanction occurs when the product is actually homeopathic, but the company violates the requirements for drugs. For example, on Nov. 22, 2005, the FDA issued a warning letter to NativeRemedies.com regarding its homeopathic product OralFlu Protect. The company claimed that its product could, among other things, protect people against flu. However, the product failed to include the risks, warnings, and contraindications that are required of all drugs. Moreover, the product was sold over the Internet, whereas drugs for the flu require prescriptions.

More recently, there have been hints that the FDA may take a more aggressive stance toward some homeopathic remedies. In June 2009, the agency issued Matrixx Initiatives, the makers of intranasal ZICAM, a warning letter regarding several of their homeopathic nasal cold remedies. While the agency has typically allowed such products to come to market based on their listing in the HPUS, in this case, the agency is requiring a formal application of the kind required for new drugs.

The FDA appears to be particularly interested in this product because actual harm has been demonstrated: More than 130 reports of loss of the sense of smell, some irreversible, have been filed with the FDA. (The documented toxicity of the preparation tends to suggest that the product was not actually homeopathic in that it contained enough active compound — zinc, a known cause of loss of the sense of smell — to produce toxicity.) Since the warning letter, the company has voluntarily removed the questionable products from the market.

What You Can Do

While homeopathic remedies may appear to provide relief to ill patients, their actual efficacy has not been demonstrated in a convincing fashion and their apparent efficacy is more likely due to symptoms resolving naturally. Given the uncertainties over the actual content of homeopathic remedies and their cost, we recommend that you not use homeopathic remedies to treat symptoms or illness.