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1. What is homeopathy?
2. What is the history of the discovery and use of homeopathy?
3. What kind of training do homeopathic practitioners receive?
4. What do homeopathic practitioners do in treating patients?
5. What are homeopathic remedies?
6. How does the U.S. Food and Drug Administration (FDA) regulate homeopathic
remedies?
7. Have any side effects or complications been reported from the use of
homeopathy?
8. References
9. Appendix I
10. Appendix II
Top
Homeopathy ("home-ee-AH-pah-thy"), also known as homeopathic medicineA
whole medical system that originated in Europe. Homeopathy seeks to stimulate
the body's ability to heal itself by giving very small doses of highly diluted
substances that in larger doses would produce illness or symptoms (an approach
called "like cures like")., is a form of health care that developed
in Germany and has been practiced in the United States since the early 19th
century. Homeopathic practitioners are commonly called homeopaths. This
fact sheet answers some frequently asked questions on homeopathyA whole
medical system that originated in Europe. Homeopathy seeks to stimulate
the body's ability to heal itself by giving very small doses of highly diluted
substances that in larger doses would produce illness or symptoms (an approach
called "like cures like"). and reviews scientific research on
its use and effectiveness.
Key Points
* In homeopathy, a key premise is that every person has energy called a
vital force or self-healing response. When this energy is disrupted or imbalanced,
health problems develop. Homeopathy aims to stimulate the body's own healing
responses.
* Homeopathic treatment involves giving extremely small doses of substances
that produce characteristic symptoms of illness in healthy people when given
in larger doses. This approach is called "like cures like."
* Various explanations have been proposed as to how homeopathy might work.
However, none of these explanations has been scientifically verified.
* Research studies on homeopathy have been contradictory in their findings.
Some analyses have concluded that there is no strong evidence supporting
homeopathy as effective for any clinical condition. However, others have
found positive effects from homeopathy. The positive effects are not readily
explained in scientific terms.
* It is important to inform all of your health care providers about any
therapy that you are currently using or considering, including homeopathic
treatment. This is to help ensure a safe and coordinated course of care.
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1. What is homeopathy?
The term homeopathy comes from the Greek words homeo, meaning similar,
and pathos, meaning suffering or disease. Homeopathy is an alternative
medical system. Alternative medical systems are built upon complete systems
of theory and practice, and often have evolved apart from and earlier than
the conventional medical approach used in the United States.a Homeopathy
takes a different approach from conventional medicineMedicine as practiced
by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees
and by their allied health professionals such as physical therapists, psychologists,
and registered nurses. in diagnosing, classifying, and treating medical
problems.
Key concepts of homeopathy include:
* Homeopathy seeks to stimulate the body's defense mechanisms and processes
so as to prevent or treat illness.
* Treatment involves giving very small doses of substances called remedies
that, according to homeopathy, would produce the same or similar symptoms
of illness in healthy people if they were given in larger doses.
* Treatment in homeopathy is individualized (tailored to each person). Homeopathic
practitioners select remedies according to a total picture of the patient,
including not only symptoms but lifestyle, emotional and mental states,
and other factors.
a. Conventional medicine, as defined by NCCAM, is medicine as practiced
by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees
and by their allied health professionals, such as physical therapists, psychologists,
and registered nurses. Some conventional medical practitioners are also
practitioners of complementary and alternative medicine. To find out more
about these terms, see the NCCAM fact sheet "What Is Complementary
and Alternative Medicine?"
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2. What is the history of the discovery and use of homeopathy?b
In the late 1700s, Samuel Hahnemann, a physician, chemist, and linguist
in Germany, proposed a new approach to treating illness. This was at a time
when the most common medical treatments were harsh, such as bloodletting,c
purging, blistering, and the use of sulfur and mercury. At the time, there
were few effective medications for treating patients, and knowledge about
their effects was limited.
Hahnemann was interested in developing a less-threatening approach to medicine.
The first major step reportedly was when he was translating an herbal text
and read about a treatment (cinchona bark) used to cure malaria. He took
some cinchona bark and observed that, as a healthy person, he developed
symptoms that were very similar to malaria symptoms. This led Hahnemann
to consider that a substance may create symptoms that it can also relieve.
This concept is called the "similia principle" or "like cures
like." The similia principle had a prior history in medicine, from
Hippocrates in Ancient Greece--who noted, for example, that recurrent vomiting
could be treated with an emetic (such as ipecacuanha) that would be expected
to make it worse--to folk medicine.14,15 Another way to view "like
cures like" is that symptoms are part of the body's attempt to heal
itself--for example, a fever can develop as a result of an immune response
to an infection, and a cough may help to eliminate mucus--and medication
may be given to support this self-healing response.
Hahnemann tested single, pure substances on himself and, in more dilute
forms, on healthy volunteers. He kept meticulous records of his experiments
and participants' responses, and he combined these observations with information
from clinical practice, the known uses of herbs and other medicinal substances,
and toxicology,d eventually treating the sick and developing homeopathic
clinical practice.
Hahnemann added two additional elements to homeopathy:
* A concept that became "potentization," which holds that systematically
diluting a substance, with vigorous shaking at each step of dilution, makes
the remedy more, not less, effective by extracting the vital essence of
the substance. If dilution continues to a point where the substance's molecules
are gone, homeopathy holds that the "memory" of them--that is,
the effects they exerted on the surrounding water molecules--may still be
therapeutic.
* A concept that treatment should be selected based upon a total picture
of an individual and his symptoms, not solely upon symptoms of a disease.
Homeopaths evaluate not only a person's physical symptoms but her emotions,
mental states, lifestyle, nutrition, and other aspects. In homeopathy, different
people with the same symptoms may receive different homeopathic remedies.
Hans Burch Gram, a Boston-born doctor, studied homeopathy in Europe and
introduced it into the United States in 1825. European immigrants trained
in homeopathy also made the treatment increasingly available in America.
In 1835, the first homeopathic medical college was established in Allentown,
Pennsylvania. By the turn of the 20th century, 8 percent of all American
medical practitioners were homeopaths, and there were 20 homeopathic medical
colleges and more than 100 homeopathic hospitals in the United States.
In the late 19th and early 20th centuries, numerous medical advances were
made, such as the recognition of the mechanisms of disease; Pasteur's germ
theory; the development of antiseptic techniques; and the discovery of ether
anesthesia. In addition, a report (the so-called "Flexner Report")
was released that triggered major changes in American medical education.
Homeopathy was among the disciplines negatively affected by these developments.
Most homeopathic medical schools closed down, and by the 1930s others had
converted to conventional medical schools.
In the 1960s, homeopathy's popularity began to revive in the United States.
According to a 1999 survey of Americans and their health, over 6 million
Americans had used homeopathy in the preceding 12 months.16 The World Health
Organization noted in 1994 that homeopathy had been integrated into the
national health care systems of numerous countries, including Germany, the
United Kingdom, India, Pakistan, Sri Lanka, and Mexico.7 Several schools
of practice exist within homeopathy.17
Persons using homeopathy do so to address a range of health concerns, from
wellness and prevention to treatment of injuries, diseases, and conditions.
Studies have found that many people who seek homeopathic care seek it for
help with a chronic medical condition.18,19,20 Many users of homeopathy
treat themselves with homeopathic products and do not consult a professional.13
b. Items 1-13 in the references served as general sources for this historical
discussion.
c. Bloodletting was a healing practice used for many centuries. In bloodletting,
incisions were made in the body to drain a quantity of blood, in the belief
that this would help drain out the "bad blood" or sickness.
d. Toxicology is the science of the effects of chemicals on human health.
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3. What kind of training do homeopathic practitioners receive?
In European countries, training in homeopathy is usually pursued either
as a primary professional degree completed over 3 to 6 years or as postgraduate
training for doctors.14
In the United States, training in homeopathy is offered through diploma
programs, certificate programs, short courses, and correspondence courses.
Also, homeopathic training is part of medical education in naturopathyA
whole medical system that originated in Europe. Naturopathy aims to support
the body's ability to heal itself through the use of dietary and lifestyle
changes together with CAM therapies such as herbs, massage, and joint manipulation..e
Most homeopathy in the United States is practiced along with another health
care practice for which the practitioner is licensed, such as conventional
medicine, naturopathy, chiropractic, dentistry, acupunctureA family of procedures
that originated in traditional Chinese medicine. Acupuncture is the stimulation
of specific points on the body by a variety of techniques, including the
insertion of thin metal needles though the skin. It is intended to remove
blockages in the flow of qi and restore and maintain health., or veterinary
medicine (homeopathy is used to treat animals).
Laws about what is required to practice homeopathy vary among states. Three
states (Connecticut, Arizona, and Nevada) license medical doctors specifically
for homeopathy.
e. Naturopathy, also known as naturopathic medicine, is an alternative medical
system that emphasizes natural healing approaches (such as herbs, nutrition,
and movement or manipulation of the body). Some elements of naturopathy
are similar to homeopathy, such as an intent to support the body's own self-healing
response.
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4. What do homeopathic practitioners do in treating patients?
Typically, in homeopathy, patients have a lengthy first visit, during which
the provider takes an in-depth assessment of the patient. This is used to
guide the selection of one or more homeopathic remedies. During followup
visits, patients report how they are responding to the remedy or remedies,
which helps the practitioner make decisions about further treatment.
5. What are homeopathic remedies?
Most homeopathic remedies are derived from natural substances that come
from plants, minerals, or animals. A remedy is prepared by diluting the
substance in a series of steps (as discussed in Question 2). Homeopathy
asserts that this process can maintain a substance's healing properties
regardless of how many times it has been diluted. Many homeopathic remedies
are so highly diluted that not one molecule of the original natural substance
remains.12,21 Remedies are sold in liquid, pellet, and tablet forms.
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6. How does the U.S. Food and Drug Administration (FDA) regulate homeopathic
remedies?
Because of their long use in the United States, the U.S. Congress passed
a law in 1938 declaring that homeopathic remedies are to be regulated by
the FDA in the same manner as nonprescription, over-the-counter (OTC) drugs,
which means that they can be purchased without a physician's prescription.
Today, although conventional prescription drugs and new OTC drugs must undergo
thorough testing and review by the FDA for safety and effectiveness before
they can be sold, this requirement does not apply to homeopathic remedies.
Remedies are required to meet certain legal standards for strength, quality,
purity, and packaging. In 1988, the FDA required that all homeopathic remedies
list the indications for their use (i.e., the medical problems to be treated)
on the label.22,23 The FDA also requires the label to list ingredients,
dilutions, and instructions for safe use.
The guidelines for homeopathic remedies are found in an official guide,
the Homeopathic Pharmacopoeia of the United States, which is authored
by a nongovernmental, nonprofit organization of industry representatives
and homeopathic experts.24 The Pharmacopoeia also includes provisions
for testing new remedies and verifying their clinical effectiveness. Remedies
on the market before 1962 have been accepted into the Homeopathic Pharmacopoeia
of the United States based on historical use, rather than scientific
evidence from clinical trials.
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7. Have any side effects or complications been reported from the use
of homeopathy?
The FDA has learned of a few reports of illness associated with the use
of homeopathic remedies. However, the FDA reviewed these reports and decided
that the remedies were not likely to be the cause, because of the high dilutions.3
Here is some general information that has been reported about risks and
side effects in homeopathy:
* Homeopathic medicines in high dilutions, taken under the supervision of
trained professionals, are considered safe and unlikely to cause severe
adverse reactions.25
* Some patients report feeling worse for a brief period of time after starting
homeopathic remedies. Homeopaths interpret this as the body temporarily
stimulating symptoms while it makes an effort to restore health.
* Liquid homeopathic remedies can contain alcohol and are permitted to have
higher levels of alcohol than conventional drugs for adults. This may be
of concern to some consumers. However, no adverse effects from the alcohol
levels have been reported either to the FDA or in the scientific literature.3
* Homeopathic remedies are not known to interfere with conventional drugs;
however, if you are considering using homeopathic remedies, you should discuss
this with your health care provider. If you have more than one provider,
discuss it with each one.
As with all medicinal products, a person taking a homeopathic remedy is
best advised to:
* Contact his health care provider if his symptoms continue unimproved for
more than 5 days.
* Keep the remedy out of the reach of children.
* Consult a health care provider before using the product if the user is
a woman who is pregnant or nursing a baby.
Top
References
1. Tedesco, P. and Cicchetti, J. "Like Cures Like: Homeopathy."
American Journal of Nursing. 2001. 101(9):43-9.
2. Merrell, W.C. and Shalts, E. "Homeopathy." Medical Clinics
of North America. 2002. 86(1):47-62.
3. Stehlin, I. "Homeopathy: Real Medicine or Empty Promises?"
FDA Consumer. 1996. 30(10):15-19. Also available at: www.fda.gov/fdac/features/096_home.html.
4. Der Marderosian, A.H. "Understanding Homeopathy." Journal
of the American Pharmaceutical Association. 1996. NS36(5):317-21.
5. Flexner, A. Medical Education in the United States and Canada: A Report
to the Carnegie Foundation for the Advancement of Teaching. Menlo Park,
California: Carnegie Foundation for Advancement of Teaching, 1910. Available
at: www.carnegiefoundation.org/elibrary/DOCS/flexner_report.pdf.
6. Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F., Hedges,
L.V., and Jonas, W.B. "Are the Clinical Effects of Homeopathy Placebo
Effects? A Meta-Analysis of Placebo-Controlled Trials." Lancet.
1997. 350(9081):834-43.
7. Zhang, X. Communication to the Congress of the International Homeopathic
Medical Organization, Paris, France. Cited in reference 9.
8. Whorton, J.C. "Traditions of Folk Medicine in America." Journal
of the American Medical Association. 1987. 257(12):1632-5.
9. Poitevin, B. "Integrating Homoeopathy in Health Systems." Bulletin
of the World Health Organization. 1999. 77(2):160-6.
10. Ballard, R. "Homeopathy: An Overview." Australian Family
Physician. 2000. 29(12):1145-8.
11. Dean, M.E. "Homeopathy and 'The Progress of Science.' " History
of Science. 2001. 39(125 Pt. 3):255-83.
12. Ernst, E. and Kaptchuk, T.J. "Homeopathy Revisited." Archives
of Internal Medicine. 1996. 156(19):2162-4.
13. Jonas, W.B., Kaptchuk, T.J., and Linde, K. "A Critical Overview
of Homeopathy." Annals of Internal Medicine. 2003. 138(5):393-9.
14. European Council for Classical Homeopathy. "European Guidelines
for Homeopathic Education," 2nd ed. 2000. Available at: www.homeopathy-ecch.org/education.html.
15. Vallance, A.K. "Can Biological Activity Be Maintained at Ultra-High
Dilution? An Overview of Homeopathy, Evidence, and Bayesian Philosophy."
Journal of Alternative and Complementary Medicine. 1998. 4(1):49-76.
16. Ni, H., Simile, C., and Hardy, A.M. "Utilization of Complementary
and Alternative Medicine by United States Adults: Results from the 1999
National Health Interview Survey." Medical Care. 2002. 40(4):353-8.
17. Cucherat, M., Haugh, M.C., Gooch, M., and Boissel, J.-P. "Evidence
of Clinical Efficacy of Homeopathy: A Meta-Analysis of Clinical Trials."
European Journal of Clinical Pharmacology. 2000. 56(1):27-33.
18. Goldstein, M.S. and Glik, D. "Use of and Satisfaction with Homeopathy
in a Patient Population." Alternative Therapies in Health and Medicine.
1998. 4(2):60-5.
19. Vincent, C. and Furnham, A. "Why Do Patients Turn to Complementary
Medicine? An Empirical Study." British Journal of Clinical Psychology.
1996. 35:37-48.
20. Jacobs, J., Chapman, E.H., and Crothers, D. "Patient Characteristics
and Practice Patterns of Physicians Using Homeopathy." Archives
of Family Medicine. 1998. 7(6):537-40.
21. Kleijnen, J., Knipschild, P., and ter Riet, G. "Clinical Trials
of Homeopathy." British Medical Journal. 1991. 302(6782):316-23.
22. Junod, S.W. "Alternative Drugs: Homeopathy, Royal Copeland, and
Federal Drug Regulation." Pharmacy in History. 2000. 42(1-2):13-35.
23. Food and Drug Administration. "Conditions Under Which Homeopathic
Drugs May Be Marketed." Compliance Policy Guides Manual, Sec.
400.400. Available at: www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html.
24. Homeopathic Pharmacopoeia Convention of the United States. Homeopathic
Pharmacopoeia of the United States. Southeastern, PA: HPCUS.
25. Dantas, F. and Rampes, H. "Do Homeopathic Medicines Provoke Adverse
Effects? A Systematic Review." British Homeopathic Journal.
2000. 89 Suppl 1:S35-S38.
26. Belon, P., Cumps, J., Ennis, M., Mannaioni, P.F., Sainte-Laudy, J.,
Roberfroid, M., and Wiegant, F.A. "Inhibition of Human Basophil Degranulation
by Successive Histamine Dilutions: Results of a European Multi-Centre Trial."
Inflammation Research. 1999. 48 (Suppl. 1):S17-S18.
27. Davenas, E., Beauvais, F., Amara, J., Oberbaum, M., Robinzon, B., Miadonna,
A., Tedeschi, A., Pomeranz, B., Fortner, P., Belon, P., Sainte-Laudy, J.,
Poitevin, B., and Benveniste, J. "Human Basophil Degranulation Triggered
by Very Dilute Antiserum Against IgE." Nature. 1988. 333(6176):816-8.
28. Lewith, G.T., Watkins, A.D., Hyland, M.E., Shaw, S., Broomfield, J.A.,
Dolan, G., and Holgate, S.T. "Use of Ultramolecular Potencies of Allergen
To Treat Asthmatic People Allergic to House Dust Mite: Double Blind Randomised
Controlled Clinical Trial." British Medical Journal. 2002. 324(7336):520-4.
29. Bell, I.R., Lewis, D.A., Brooks, A.J., Lewis, S.E., and Schwartz, G.E.
"Gas Discharge Visualization Evaluation of Ultramolecular Doses of
Homeopathic Medicines Under Blinded, Controlled Conditions." Journal
of Alternative and Complementary Medicine. 2003. 9(1): 25-38.
30. Abbott, A. and Stiegler, G. "Support for Scientific Evaluation
of Homeopathy Stirs Controversy." Nature. 1996. 383(6598):285.
31. Maddox, J., Randi, J., and Stewart, W.W. " 'High-Dilution' Experiments
a Delusion." Nature. 1988. 334(6180):287-90.
32. Benveniste, J. "Benveniste on the Benveniste Affair." Nature.
1988. 335(6193):759.
33. Ernst, E. "A Systematic Review of Systematic Reviews of Homeopathy."
British Journal of Clinical Pharmacology. 2002. 54(6):577-82.
34. Vickers, A.J. and Smith, C. "Homoeopathic Oscillococcinum for Preventing
and Treating Influenza and Influenza-Like Syndromes." Cochrane Database
of Systematic Reviews. 2002. (2):CD001957.
35. Oberbaum, M., Yaniv, I., Ben-Gal, Y., Stein, J., Ben-Zvi, N., Freedman,
L. S., and Branski, D. "A Randomized, Controlled Clinical Trial of
the Homeopathic Medication Traumeel S in the Treatment of Chemotherapy-Induced
Stomatitis in Children Undergoing Stem Cell Transplantation." Cancer.
2001. 92(3):684-90.
36. Taylor, M.A., Reilly, D., Llewellyn-Jones, R.H., McSharry, C., and Aitchison,
T.C. "Randomised Controlled Trial of Homoeopathy versus Placebo in
Perennial Allergic Rhinitis with Overview of Four Trial Series." British
Medical Journal. 2000. 321(7259):471-6.
37. Jacobs, J., Jimenez, L.M., Malthouse, S., Chapman, E., Crothers, D.,
Masuk, M., and Jonas, W.B. "Homeopathic Treatment of Acute Childhood
Diarrhea: Results from a Clinical Trial in Nepal." Journal of Alternative
and Complementary Medicine. 2000. 6(2):131-9.
38. Weiser, M., Gegenheimer, L.H., and Klein, P. "A Randomized Equivalence
Trial Comparing the Efficacy and Safety of Luffa comp.-Heel Nasal Spray
with Cromolyn Sodium Spray in the Treatment of Seasonal Allergic Rhinitis."
Forschende Komplementärmedizin. 1999. 6(3):142-8.
39. Rastogi, D.P., Singh, V.P., Singh, V., Dey, S.K., and Rao, K. "Homeopathy
in HIV Infection: A Trial Report of Double-Blind Placebo Controlled Study."
British Homeopathic Journal. 1999. 88(2):49-57.
40. Vickers, A.J., Fisher, P., Smith, C., Wyllie, S.E., and Rees, R. "Homeopathic
Arnica 30x Is Ineffective for Muscle Soreness After Long-Distance Running:
A Randomized, Double-Blind, Placebo-Controlled Trial." The Clinical
Journal of Pain. 1998. 14(3):227-31.
41. Weiser, M., Strosser, W., and Klein, P. "Homeopathic vs Conventional
Treatment of Vertigo: A Randomized Double-Blind Controlled Clinical Study."
Archives of Otolaryngology-Head & Neck Surgery. 1998. 124(8):879-85.
42. Linde, K., Jonas, W.B., Melchart, D., and Willich, S. "The Methodological
Quality of Randomized Controlled Trials of Homeopathy, Herbal Medicines
and Acupuncture." International Journal of Epidemiology. 2001.
30(3):526-31.
43. Ernst, E. and Pittler, M.H. "Efficacy of Homeopathic Arnica: A
Systematic Review of Placebo-Controlled Clinical Trials." Archives
of Surgery. 1998. 133(11):1187-90.
44. Long, L. and Ernst, E. "Homeopathic Remedies for the Treatment
of Osteoarthritis: A Systematic Review." British Homeopathic Journal.
2001. 90(1):37-43.
45. Jonas, W.B., Linde, K., and Ramirez, G. "Homeopathy and Rheumatic
Disease." Rheumatic Disease Clinics of North America. 2000.
26(1):117-23.
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Appendix I.
Clinical Trials on Homeopathy Published from 1998 to 2002j
Citation Description Findings
Vickers and Smith, 200234 Seven trials were included in the review (three
prevention and four treatment trials); only two studies had sufficient information
for complete data extraction. The homeopathic remedy oscillococcinum appears
safe and effective in reducing the duration of influenza, but has
no effect on prevention.
Lewith et al., 200228 Randomized, double-blinded, placebo-controlled trial
of 242 participants aged 18 to 55 years. Trial compared an oral homeopathic
treatment to placebo in asthmatic people allergic to house dust.
Authors found the homeopathic treatment "no better than placebo."
They noted "some differences between the homeopathic immunotherapy
and placebo for which we have no explanation."
Oberbaum et al., 200135 Randomized, double-blinded, placebo-controlled trial
in 32 children; 30 completed the study. Traumeel S, a homeopathic skin cream,
may significantly reduce the severity and length of pain and inflammation
of the tissues lining the inside of the mouth from chemotherapy in children
being treated with bone marrow transplantation.
Taylor et al., 200036 Randomized, double-blinded, placebo-controlled trial
of 51 participants aged 17 years or older (50 completed the study). Team
tested the hypothesis that homeopathy is a placebo by examining effects
of an oral homeopathic preparation in patients with perennial allergic
rhinitis. They found a "significant objective improvement in nasal
airflow" compared with the placebo group. However, both groups reported
subjective improvement in "nasal symptoms" (with no statistically
significant difference between groups). Authors concluded that the objective
evidence supports that "homeopathic dilutions differ from placebo."
Jacobs et al., 200037 Randomized, double-blinded, placebo-controlled trial
of 126 children; 116 completed the study. Individualized homeopathic treatments
improved digestive problems in children with acute childhood diarrhea.
Results are consistent with findings of a previous study.
Weiser et al., 199938 Randomized, double-blinded trial of 146 people. For
the treatment of hay fever, a homeopathic nasal spray is as efficient
and well tolerated as a conventional therapy, cromolyn sodium.
Rastogi et al., 199939 Randomized, double-blinded, placebo-controlled trial
of 100 people between 18 and 50 (71 percent male/29 percent female). A subgroup
of patients with HIV in the symptomatic phase, receiving treatment,
had increased levels of CD4 cells at the end of the trial; the placebo subgroup
did not.
Vickers et al., 199840 Randomized, double-blinded, placebo-controlled trial
of 519 people; 400 completed the study. Homeopathic remedies, including
arnica, are not effective for muscle soreness following long-distance
running.
Weiser et al., 199841 Randomized, double-blinded, controlled trial of 119
people; 105 completed the study. The homeopathic treatment vertigoheel,
and the standard treatment of betahistine, are equally effective in reducing
the frequency, duration, and intensity of vertigo attacks.
j. Due to the large number of trials, these studies have been selected to
give a representative overview of the findings published in peer-reviewed
scientific and medical journals in English and indexed in the National Library
of Medicine's MEDLINE database.
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Appendix II.
Systematic Reviews and Meta-Analysesk of Clinical Trials of Homeopathy
Citation Description Findings
Ernst, 200233 Analyzed 17 systematic reviews (including meta-analyses) of
controlled clinical trials for homeopathy. Author found that the reviews
failed to provide strong evidence in favor of homeopathy. No homeopathic
remedy was proven by convincing evidence to yield clinical effects that
are different from placebo or from other control intervention for any medical
condition. Positive recommendations for use of homeopathy in clinical practice
are not supported, and "homeopathy cannot be viewed as an evidence-based
form of therapy" until more convincing results are available.
Linde et al., 200142 Analyzed the methodological quality of 207 randomized
trials collected for 5 previously published reviews on homeopathy, two herbal
medicines (St. John's wort and echinacea), and acupuncture. Authors found
that the majority of trials had major weaknesses in methodology and/or reporting.
Homeopathy trials were "less frequently randomized...and reported less
details on dropouts and withdrawals" than the other types.
Cucherat et al., 200017 Analyzed 16 randomized, controlled trials (17 comparisons
were made) comparing homeopathic treatment to placebo. Work was part of
a report prepared for the European Union on the effectiveness of homeopathy.
Authors found that the "strength of evidence remains low" because
of trial flaws and other limitations. They added that "at least one
[of the tested homeopathic treatments] shows an added effect relative to
placebo." Group recommended that homeopathy be studied further using
the same methods used to study conventional medicine.
Ernst and Pittler, 199843 Systematic review of eight trials. Rigorous clinical
trials indicate arnica is not more effective than a placebo; most trials
studied use of arnica for tissue trauma.
Linde et al., 19976 Analyzed 89 trials. Each trial was controlled; compared
homeopathy to a placebo; was either randomized or double-blinded; and yielded
a written report. Authors concluded that their results were not compatible
with a hypothesis that the clinical effects of homeopathy are completely
due to placebo. However, they found insufficient evidence that homeopathy
is clearly efficacious for any single clinical condition. They stated that
further research is warranted if it is rigorous and systematic.
Kleijnen et al., 199121 Assessed 105 controlled trials of homeopathy, 68
randomized. Authors found a positive trend in the evidence, regardless of
the quality of the trial or the method of homeopathy used. They cautioned,
however, that definitive conclusions about homeopathy could not be drawn,
because many of the trials were not of good quality and the role of publication
bias was unknown.
Systematic Reviews of Clinical Trials on Single Medical Conditions
Long and Ernst, 200144 Systematic review of four osteoarthritis clinical
trials. Research on homeopathic treatment for osteoarthritis is insufficient
to reliably assess the clinical effectiveness of homeopathic treatment of
osteoarthritis.
Jonas et al., 200045 Meta-analysis of six controlled clinical trials. Controlled
clinical trials indicate that homeopathic remedies appear to work better
than a placebo in studies of rheumatic syndromes, but there are too
few studies to draw definitive conclusions, and efficacy results are mixed.
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An Introduction to Dietary Supplements
* Introduction
* Questions and Answers
* For More Information
* References
Introduction
Dietary supplements are a topic of great public interest. Whether you are
in a store, using the Internet, or talking to people you know, you may hear
about supplements and claims of benefits for health. How do you find out
whether "what's in the bottle" is safe to take, and whether science
has proven that the product does what it claims? This fact sheet provides
some answers.
Questions and Answers
1. What are dietary supplements?
3. Is using supplements considered conventional medicine or complementary
and alternative medicine (CAM)?
4. How can I get science-based information on a supplement?
5. If I am interested in using a supplement as CAM, how can I do so most
safely?
6. I see the word "natural" on a lot of supplement labels. Does
"natural" always mean "safe"?
7. Does the Federal Government regulate supplements?
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1. What are dietary supplements?
Dietary supplements (also called nutritional supplements, or supplements
for short) were defined in a law passed by Congress in 1994 (see the below).1,
2
About Dietary Supplements
A dietary supplementA product that contains vitamins, minerals, herbs or
other botanicals, amino acids, enzymes, and/or other ingredients intended
to supplement the diet. The U.S. Food and Drug Administration has special
labeling requirements for dietary supplements. must meet all of the following
conditions:
* It is a product (other than tobacco) that is intended to supplement the
diet and that contains one or more of the following: vitamins, minerals,
*herbs or otherbotanicals, amino acids, or any combination of the above
ingredients.
* It is intended to be taken in tablet, capsule, powder, softgel, gelcap,
or liquid form.
* It is not represented for use as a conventional food or as a sole item
of a meal or the diet.
* It is labeled as being a dietary supplement.
* Linked terms are defined at the end of this fact sheet.
Dietary supplements are sold in grocery, health food, drug, and discount
stores, as well as through mail-order catalogs, TV programs, the Internet,
and direct sales.
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3. Is using supplements considered conventional medicineMedicine
as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy)
degrees and by their allied health professionals such as physical therapists,
psychologists, and registered nurses. or complementary and alternative
medicine (CAM)A group of diverse medical and health care systems, practices,
and products that are not presently considered to be part of conventional
medicine. Complementary medicine is used together with conventional medicine,
and alternative medicine is used in place of conventional medicine.?
Some uses of dietary supplements have become part of conventional medicine
(see below). For example, scientists have found that the vitamin folic acid
prevents certain birth defects, and a regimen of vitamins and zinc can slow
the progression of the eye disease age-related macular degeneration.
On the other hand, some supplements are considered to be CAM--either the
supplement itself or one or more of its uses. An example of a CAM supplement
would be an herbal formula that claims to relieve arthritis pain, but has
not been proven to do so through scientific studies. An example of a
CAM use of a supplement would be taking 1,000 milligrams of vitamin
C per day to prevent or treat a cold, as the use of large amounts of vitamin
C for these purposes has not been proven.
Conventional Medicine
Conventional medicine is medicine as practiced by holders of M.D. (medical
doctor) or D.O. (doctor of osteopathy) degrees and by their allied health
professionals, such as physical therapists, psychologists, and registered
nurses. Other terms for conventional medicine include allopathy; Western,
mainstream, orthodox, and regular medicine; and biomedicineMedicine as practiced
by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees
and by their allied health professionals such as physical therapists, psychologists,
and registered nurses..
Complementary and Alternative Medicine (CAM)
CAM is a group of diverse medical and health care systems, practices,
and products that are not presently considered to be part of conventional
medicine. Complementary medicine is used together with conventional
medicine, and alternative medicine is used in place of conventional
medicine. Some health care providers practice both CAM and conventional
medicine. There is scientific evidence for the effectiveness of some CAM
treatments. But for most, there are key questions yet to be answered through
well-designed scientific studies, such as whether they are safe and work
for the diseases or conditions for which they are used. The National Center
for Complementary and Alternative Medicine (NCCAM), part of the National
Institutes of Health (NIH), is the Federal Government's lead agency for
scientific research on CAM.
4. How can I get science-based information on a supplement?
There are several ways to get information on supplements that is based on
the results of rigorous scientific testing, rather than on testimonials
and other unscientific information.
* Ask your health care provider. Even if your provider does not happen to
know about a particular supplement, he can access the latest medical guidance
about its uses and risks.
* Dietitians and pharmacists also have helpful information.
* You can find out if there are any scientific research findings on the
CAM supplement in which you are interested. NCCAM and other Federal agencies
have free publications, clearinghouses, and databases with this information.
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5. If I am interested in using a supplement as CAM, how can I do so most
safely?
Here are some points to keep in mind:
* Tell your health care providers about any complementary and alternative
practices you use. Give them a full picture of what you do to manage your
health. This will help ensure coordinated and safe care. It is especially
important to talk to your provider if you:
* Are thinking about replacing your regular medical care with one or more
supplements.
* Are taking any medications (whether prescription or over-the-counter).
Some supplements have been found to interact with medications (see box below).
* Have a chronic medical condition.
* Are planning to have surgery. Certain supplements may increase the risk
of bleeding or affect anesthetics and painkillers.
* Are pregnant or nursing a baby.
* Are considering giving a child a dietary supplement. Supplements can act
like drugs, and many have not been tested in pregnant women, nursing mothers,
or children.4
* Do not take a higher dose of a supplement than what is listed on the label,
unless your health care provider advises you to do so.
* If you experience any side effects that concern you, stop taking the supplement,
and contact your provider. You can also report your experience to the U.S.
Food and Drug Administration's (FDA) MedWatch program, which tracks consumer
safety reports on supplements.
* If you are considering or using herbal supplementsA type of dietary supplement
that contains herbs, either alone or in mixtures., there are some special
safety issues to consider. See the NCCAM fact sheet "Herbal Supplements:
Consider Safety, Too."
* For current information from the Federal Government on the safety of particular
supplements, check the "Alerts and Advisories" section of the
NCCAM Web site or the FDA Web site.
Supplements and Drugs Can Interact
* St. John's wort can increase the effects of prescription drugs used to
treat depression. It can also interfere with drugs used to treat HIV infection,
to treat cancer, for birth control, or to prevent the body from rejecting
transplanted organs.5
* Ginseng can increase the stimulant effects of caffeine (as in coffee,
tea, and cola). It can also lower blood sugar levels, creating the possibility
of problems when used with diabetes drugs.5
* Ginkgo, taken with anticoagulant or antiplatelet drugs, can increase the
risk of bleeding. It is also possible that ginkgo might interact with certain
psychiatric drugs and with certain drugs that affect blood sugar levels.5
6. I see the word "natural" on a lot of supplement labels.
Does "natural" always mean "safe"?
There are many supplements, as well as many prescription drugs, that come
from natural sources and are both useful and safe. However, "natural"
does not always mean "safe" or "without harmful effects."
For example, consider mushrooms that grow in the wild--some are safe to
eat, while others are poisonous.
The FDA issues warnings about supplements that pose risks to consumers,
including those used for CAM therapies. A sample list is in the box below6,7.
The FDA found these products of concern because they:
* Could damage health--in some cases severely.
* Were contaminated--with other unlabeled herbs, pesticides, heavy metals,
or prescription drugs.
* Interacted dangerously with prescription drugs.
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Examples of Supplements
That Have Carried FDA Cautions About Safety
* Ephedra
* Kava
* Some "dieter's teas"
* L-tryptophan
* PC SPES and SPES
* Aristolochic acid
* Comfrey
* St. John's wort
* GHB (gamma hydroxybutyric acid), GBL (gamma butyrolactone), and BD (1,4-butanediol)
* Certain products, marketed for sexual enhancement and claimed to be "natural"
versions of the drug Viagra, which were found to contain an unlabeled drug
(sildenafil or tadalafil)
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7. Does the Federal Government regulate supplements?
Yes, the Federal Government regulates supplements through the FDA. Currently,
the FDA regulates supplements as foods rather than drugs. In general, the
laws about putting foods (including supplements) on the market and keeping
them on the market are less strict than the laws for drugs. Specifically:
* Research studies in people to prove a supplement's safety are not
required before the supplement is marketed, unlike for drugs.
* The manufacturer does not have to prove that the supplement is effective,
unlike for drugs. The manufacturer can say that the product addresses
a nutrient deficiency, supports health, or reduces the risk of developing
a health problem, if that is true. If the manufacturer does make a claim,
it must be followed by the statement "This statement has not been evaluated
by the Food and Drug Administration. This product is not intended to diagnose,
treat, cure, or prevent any disease."
* The manufacturer does not have to prove supplement quality. Specifically:
* The FDA does not analyze the content of dietary supplements.
* At this time, supplement manufacturers must meet the requirements of the
FDA's Good Manufacturing Practices (GMPs) for foods. GMPs describe conditions
under which products must be prepared, packed, and stored. Food GMPs do
not always cover all issues of supplement quality. Some manufacturers voluntarily
follow the FDA's GMPs for drugs, which are stricter.
* Some manufacturers use the term "standardized" to describe efforts
to make their products consistent. However, U.S. law does not define standardization.
Therefore, the use of this term (or similar terms such as "verified"
or "certified") does not guarantee product quality or consistency.
* If the FDA finds a supplement to be unsafe once it is on the market, only
then can it take action against the manufacturer and/or distributor, such
as by issuing a warning or requiring the product to be removed from the
marketplace.
In March 2003, the FDA published proposed guidelines for supplements that
would require manufacturers to avoid contaminating their products with other
herbs, pesticides, heavy metals, or prescription drugs. The guidelines would
also require supplement labels to be accurate.
The Federal Government also regulates supplement advertising, through the
Federal Trade Commission. It requires that all information about supplements
be truthful and not mislead consumers.
What's in the Bottle Does Not Always Match What's on the Label
A supplement might:
* Not contain the correct ingredient (plant species). For example, one study
that analyzed 59 preparations of echinacea found that about half did not
contain the species listed on the label.8
* Contain higher or lower amounts of the active ingredient. For example,
an NCCAM-funded study of ginseng products found that most contained less
than half the amount of ginseng listed on their labels.9
* Be contaminated.
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References
1. Dietary Supplement Health and Education Act of 1994. Food and Drug Administration
Web site. Accessed at fda.gov/opacom/laws/dshea.html on April 14, 2003.
2. Dietary supplements: overview. U.S. Food and Drug Administration, Center
for Food Safety and Applied Nutrition Web site. Accessed at cfsan.fda.gov/~dms/supplmnt.html
on August 20, 2003.
3. Kaufman DW, Kelly JP, Rosenberg L, et al. Recent patterns of medication
use in the ambulatory adult population of the United States: the Slone survey.
Journal of the American Medical Association. 2002;287(3):337-344.
4. Federal Trade Commission. Promotions for kids' dietary supplements leave
sour taste. Federal Trade Commission Web site. Accessed at ftc.gov/opa/2004/06/kidsupp.htm
on May 2, 2003.
5. Natural Medicines Comprehensive Database. Natural Medicines Comprehensive
Database Web site. Accessed on August 20, 2003.
6. MedWatch: the FDA safety information and adverse event reporting program.
U.S. Food and Drug Administration Web site. Accessed at fda.gov/medwatch
on August 20, 2003.
7. Dietary supplements: warnings and safety information. U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition Web site. Accessed
at cfsan.fda.gov/~dms/ds-warn.html on April 14, 2003.
8. Gilroy CM, Steiner JF, Byers T, et al. Echinacea and truth in labeling.
Archives of Internal Medicine. 2003;163(6):699-704.
9. Harkey MR, Henderson GL, Gershwin ME, et al. Variability in commercial
ginseng products: an analysis of 25 preparations. American Journal of
Clinical Nutrition. 2001;73(6):1101-1106.