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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

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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.



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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 2002
j
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-Analyses
k 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.