By Stephen Barrett, M.D., and Varro E. Tyler, Ph.D., posted November 26, 2001
Homeopathic remedies enjoy a unique status in the health marketplace: They are the only category of spurious products legally marketable as drugs. This situation is the result of two circumstances. First, the 1938 Federal Food, Drug, and Cosmetic Act, which was shepherded through Congress by a senator who was a homeopathic physician, recognizes as drugs all substances included in the Homeopathic Pharmacopoeia of the United States. Second, FDA has not held homeopathic products to the same standards as other drugs.
Homeopathy dates back to the late 1700s, when Samuel Hahnemann (1755-1843), a German physician, began formulating its basic principles. Hahnemann was justifiably distressed about bloodletting, leeching, purging, and other medical procedures of his day that did far more harm than good. Thinking that these treatments were intended to balance the body's "humors" by opposite effects, he developed his "law of similars" -- a notion that symptoms of disease can be cured by extremely small amounts of substances that produce similar symptoms in healthy people when administered in large amounts . The word "homeopathy" is derived from the Greek words homoios (similar) and pathos (suffering or disease) .
Hahnemann and his early followers conducted "provings," in which they administered herbs, minerals, and other substances to healthy people, including themselves, and kept detailed records of what they observed. These records were compiled into lengthy reference books that are used to match a patient's symptoms with a corresponding drug.
Hahnemann declared that diseases represent a disturbance in the body's ability to heal itself and that only a small stimulus is needed to begin the healing process. He also claimed that chronic diseases are manifestations of a suppressed itch, a kind of miasma or evil spirit.
At first he used small doses of accepted medications, but later he used enormous dilutions and theorized that the smaller the dose, the more powerful the effect -- a principle he called the "law of infinitesimals." That, of course, is just the opposite of the dose-response relationship that pharmacologists have demonstrated.
The basis for inclusion in the Homeopathic Pharmacopoeia is not modern scientific testing, but homeopathic provings conducted during the 1800s and early 1900s. The current edition describes how more than a thousand substances are prepared for homeopathic use . It does not identify the symptoms or diseases for which homeopathic products should be used; that is decided by the practitioner (or manufacturer). The fact that substances listed in the Homeopathic Pharmacopoeia are legally recognized as drugs does not mean that either the law or FDA recognizes them as effective [4, 5].
Because homeopathic remedies were actually less dangerous than those of nineteenth-century medical orthodoxy, many medical practitioners began using them. At the turn of the twentieth century, homeopathy had about 14,000 practitioners and 22 schools in the United States. But as medical science and medical education advanced, homeopathy's popularity declined sharply in the United States, and its schools either closed or converted to modern methods. The last purely homeopathic school in this country closed during the 1920s .
Homeopathic products are made from minerals, botanical substances, and several other sources. If the original substance is soluble, one part is diluted with either 9 or 99 parts of distilled water or alcohol and shaken vigorously; if insoluble, it is finely ground and pulverized in similar proportions with powdered lactose. One part of the diluted medicine is then further diluted, and the process is repeated until the desired concentration is reached. Dilutions of 1:10 are designated by the Roman numeral X (1X = 1/10, 3X = 1/ 103, 6X = 1/106). Dilutions of 1:100 are designated by the Roman numeral C (1C = 1/100, 3C = 1/1003, and so on). Most remedies today range from 6X to 30X, but products of 30C or more are marketed.
A 30X dilution means that the original substance has been diluted 1030 times. Assuming that a milliliter of water contains 15 drops, 1010 drops of water would fill a container more than 50 times the size of the Earth. Imagine placing a drop of red dye into such a container full of water so that it disperses evenly. Homeopathy's law of infinitesimals is the equivalent of saying that any drop of water subsequently removed from that container will possess an "essence" of redness. Robert L. Park, Ph.D., a prominent physicist who is a professor of physics at the University of Maryland, has noted that, since the smallest amount of a substance that could exist in a solution is one molecule, a 30C solution would have to have at least one molecule of the original substance dissolved in a minimum of 1060 molecules of water. This would require a container more than 30 billion times the size of the Earth .
Hahnemann himself realized that there is virtually no chance that even one molecule of original substance would remain after extreme dilutions. However, he believed that the vigorous shaking or pulverizing with each step of dilution leaves behind a spirit-like essence -- no longer perceptible to the senses -- which cures by reviving the body's "vital force."' This notion is unsubstantiated. Moreover, if it were true, every substance encountered by a molecule of water might imprint an essence that could exert powerful (and unpredictable) medicinal effects when the water is ingested by a person.
Since many homeopathic remedies contain no detectable amount of active ingredient, it is impossible to test whether they contain what their label says. Unlike most prescription and nonprescription drugs, homeopathic remedies have not been proven effective against disease by double-blind clinical testing.
Hill and Doyon analyzed 40 randomized trials that had compared homeopathic treatment with standard treatment, a placebo, or no treatment. All but three of the trials had major flaws in their design; only one of those three reported homeopathic treatment as more effective than standard treatment or placebo. The authors concluded that there is no evidence that homeopathic treatment has any more value than a placebo .
Proponents trumpet the few studies that support homeopathic treatments as proof that homeopathy works. Even if the results can be consistently reproduced (which seems unlikely), the most that the study of a single remedy for a single disease could prove is that the remedy is effective against that disease. It would not validate homeopathy's basic theories or prove that homeopathic treatment is useful for other diseases.
Placebo effects can be powerful, but the potential benefit of relieving symptoms with placebos should be weighed against the harm that can result from relying on -- and wasting money on -- ineffective products. Spontaneous remission is also a factor in homeopathy's popularity. We suspect that most people who credit a homeopathic product for their recovery would have fared equally well without it.
Homeopaths are working hard to have their services covered under national health insurance. They claim to provide care that is safer, gentler, more natural, and less expensive than conventional care, and they claim to be more concerned with prevention than conventional physicians. However, homeopathic treatments prevent nothing, and many homeopathic leaders preach against immunization .
Need for More Regulation
If FDA required homeopathic remedies to be proven effective in order to remain marketable -- the standard it applies to other categories of drugs -- homeopathy would face extinction in the United States. However, there is no indication that the agency is considering this. FDA officials regard homeopathy as relatively benign (compared, for example, with unsubstantiated products marketed for cancer and AIDS) and believe that other problems should get enforcement priority . If FDA attacks homeopathy too vigorously, its proponents might even persuade a lobby-susceptible Congress to rescue them.
Regardless of this risk, FDA should not permit worthless drug products to be marketed with claims that they are effective. In August 1994, we and 40 other prominent critics of quackery and pseudoscience asked the agency to curb the sale of homeopathic products . Our petition urged FDA to initiate a rulemaking procedure to require that all nonprescription homeopathic drugs meet the same standards of safety and effectiveness as nonprescription non-homeopathic drugs. It also asked for a public warning that, although FDA has permitted homeopathic remedies to be sold, it does not recognize them as effective.
Meanwhile, we urge pharmacists not to stock homeopathic remedies and to inform customers that such products simply don't work. We also hope that pharmacy educators, journal editors, and pharmacy organizations will regard this as an important ethical issue.
1. Hahnemann S. Organon of Medicine, Edition 6, 1842. English translation: Los Angeles: J.P. Tarcher, Inc., 1982.
2. Cummings S, Ullman D. Everybody's guide to homeopathic medicines. Los Angeles: Jeremy P. Tarcher, 1984.
3. Homeopathic Pharmacopoeial Convention of the United States. Homeopathic Pharmacopoeia of the United States Revision Service. Washington, DC: Homeopathic Pharmacopoeia Convention of the United States, 1994.
4. Food and Drug Administration. Conditions under which homeopathic drugs may be marketed. FDA Compliance Policy Guide 7132.15. Rockville, MD: U.S. Department of Health and Human Services, 1988, revised 1995.
5. Skolnick AA. FDA petitioned to 'stop homeopathy scam.' JAMA 272:1154-1154, 1994.
6. Kaufman M. Homeopathy in America: the rise and fall of a medical heresy. Baltimore, MD: Johns Hopkins Press; 1971.
7. Barrett S, Herbert V. The vitamin pushers: how the "health food" industry is selling America a bill of goods. Amherst, NY: Prometheus Books, 1994.
8. Hill C, Doyon F. Review of randomized trials of homeopathy. Review of Epidemiology 38:139-142, 1990.
9. Rados B. Riding the coattails of homeopathy's revival. FDA Consumer 19(2):30-44, 1985.
10. Barrett S et al. Petition regarding homeopathic drugs. FDA docket no. 94P-0316/CP 1. Aug 25, 1994.
Dr. Tyler, who died in 2001, was the Lilly distinguished professor of pharmacognosy (the science of medicines from natural sources) at Purdue University. A world-renowned authority, he wrote The Honest Herbal, an evaluation of popular herbs, and was senior author of the textbook Pharmacognosy. This article originally appeared in slightly different form in the May 1, 1995, issue of American Journal of Health System Pharmacists.
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By Stephen Adams, March 16, 2011
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Children's herbal cough and cold withdrawn as potentially dangerous
By Rebecca Smith, Medical Editor, August 4, 2012
A children's herbal medicine has been withdrawn after regulators found it was unlicensed and potentially dangerous.
Parents have been warned not to give their children Echinacea & Golden Root for Juniors sold by Holland and Barrett.
The pictures on the bottle, used for coughs and colds, do not match the description and the botanical name given was also incorrect.
A spokesman for the Medicines and Healthcare products Regulatory Agency said the bottle appeared to show Goldenseal root (Hydrastis canadensis) and not Golden root (Rhodiola rosea). The botanical name on the product Berberis aquifolium is also incorrect.
He added that high doses of berberine are reported to cause stomach upset, nausea, vomiting, nervousness, depression, heart damage, low blood pressure, seizures, paralysis, spasms, and death.
Overdoses of hydrastine are reported to cause exaggerated reflexes, convulsions, paralysis, and respiratory failure. Berberine is reported to cause or worsen jaundice in newborns and could lead to a life-threatening form of brain damage called kernicterus.
Rhodiola rosea it is not recommended in children and adolescents under 18 years of age due to the lack of adequate safety data, the MHRA said.
Richard Woodfield MHRA Head of Herbal Policy said: “Parents need to remember that just because a product is labelled as natural does not mean it is safe.
“When buying herbal products you should look for those that have a traditional herbal registration which can be identified by a THR number on their label. This ensures that the product is safe and avoids consumers putting their health in jeopardy.
“Anyone that has this herbal product at home should stop using it immediately and return any unused product to Holland and Barrett.
"If you have taken this product and have any concerns then please speak to your GP or healthcare professional."
THIS COMPILATION OF INFORMATION WILL BE UPDATED FROM TIME TO TIME