Essentials of Homeopathy™ CD-ROM

About Homeopathy

  • Homeopathy is an alternative medical system.

  • Alternative medical systems are built upon complete systems of theory and practice.

  • Diagnose, classify, and treat medical problems.

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Questions on Homeopathy

7.Have any side effects or complications been reported from the use of homeopathy?
8.What has scientific research found out about whether homeopathy works?
9. Are there scientific controversies associated with homeopathy?
10.Is NCCAM funding research on homeopathy?
11. Appendix I
12. Appendix II

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.

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.

     
  • 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.

     
  • 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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8. What has scientific research found out about whether homeopathy works?

This section summarizes results from (1) individual clinical trials (research studies in people) and (2) broad analyses of groups of clinical trials.

The results of individual, controlled clinical trials of homeopathy have been contradictory. In some trials, homeopathy appeared to be no more helpful than a placebo; in other studies, some benefits were seen that the researchers believed were greater than one would expect from a placebo. Appendix I details findings from clinical trials.

Systematic reviews and meta-analyses take a broader look at collections of a set of results from clinical trials. Recent examples of these types of analyses are detailed in Appendix II. In sum, systematic reviews have not found homeopathy to be a definitively proven treatment for any medical condition. Two groups of authors listed in Appendix II found some positive evidence in the groups of studies they examined, and they did not find this evidence to be explainable completely as placebo effects (a third group found 1 out of 16 trials to have some added effect relative to placebo). Each author or group of authors criticized the quality of evidence in the studies. Examples of problems they noted include weaknesses in design and/or reporting, choice of measuring techniques, small numbers of participants, and difficulties in replicating results. A common theme in the reviews of homeopathy trials is that because of these problems and others, it is difficult or impossible to draw firm conclusions about whether homeopathy is effective for any single clinical condition.

f. A placebo is designed to resemble as much as possible the treatment being studied in a clinical trial, except that the placebo is inactive. An example of a placebo is a pill containing sugar instead of the drug or other substance being studied. By giving one group of participants a placebo and the other group the active treatment, the researchers can compare how the two groups respond and get a truer picture of the active treatment's effects. In recent years, the definition of placebo has been expanded to include other things that could have an effect on the results of health care, such as how a patient and a health care provider interact, how a patient feels about receiving the care, and what he or she expects to happen from the care.

g. In a systematic review, data from a set of studies on a particular question or topic are collected, analyzed, and critically reviewed. A meta-analysis uses statistical techniques to analyze results from individual studies.

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9. Are there scientific controversies associated with homeopathy?

Yes. Homeopathy is an area of complementary and alternative medicine (CAM) that has seen high levels of controversy and debate, largely because a number of its key concepts do not follow the laws of science (particularly chemistry and physics).

  • It is debated how something that causes illness might also cure it.

     
  • It has been questioned whether a remedy with a very tiny amount (perhaps not even one molecule) of active ingredient could have a biological effect, beneficial or otherwise.

    There have been some research studies published on the use of ultra-high dilutions (UHDs) of substances, diluted to levels compatible with those in homeopathy and shaken hard at each step of dilution. The results are claimed to involve phenomena at the molecular level and beyond, such as the structure of water, and waves and fields. Both laboratory research and clinical trials have been published. There have been mixed results in attempts to replicate them. Reviews have not found UHD results to be definitive or compelling.

    There have been some studies that found effects of UHDs on isolated organs, plants, and animals. There have been controversy and debate about these findings as well.

     
  • Effects in homeopathy might be due to the placebo or other non-specific effect.

     
  • There are key questions about homeopathy that are yet to be subjected to studies that are well-designed--such as whether it actually works for some of the diseases or medical conditions for which it is used, and if so, how it might work.

     
  • There is a point of view that homeopathy does work, but that modern scientific methods have not yet explained why. The failure of science to provide full explanations for all treatments is not unique to homeopathy.

     
  • Some people feel that if homeopathy appears to be helpful and safe, then scientifically valid explanations or proofs of this alternative system of medicine are not necessary.

     

h. For some examples, see references 26-29.

i. For examples of debates on UHDs and reviewers' papers, see especially references 13, 15, and 30-33.

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10. Is NCCAM funding research on homeopathy?

Yes, NCCAM supports a number of studies in this area. For example:

  • Homeopathy for physical, mental, and emotional symptoms of fibromyalgia (a chronic disorder involving widespread musculoskeletal pain, multiple tender points on the body, and fatigue).

     
  • Homeopathy for brain deterioration and damage in animal models for stroke and dementia.

     
  • The homeopathic remedy cadmium, to find out whether it can prevent damage to the cells of the prostate when those cells are exposed to toxins.

     

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For More Information

  • NCCAM Clearinghouse

    Toll-free in the U.S.: 1-888-644-6226
    International: 301-519-3153
    TTY (for deaf and hard-of-hearing callers): 1-866-464-3615

    E-mail: info@nccam.nih.gov
    NCCAM Web site: nccam.nih.gov
    Address: NCCAM Clearinghouse, P.O. Box 7923, Gaithersburg, MD 20898-7923

    Fax: 1-866-464-3616
    Fax-on-Demand service: 1-888-644-6226

    The NCCAM Clearinghouse provides information on CAM and on NCCAM. Services include fact sheets, other publications, and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

  • CAM on PubMed

    CAM on PubMed, a database on the Internet developed jointly by NCCAM and the National Library of Medicine, offers citations to (and in most cases, brief summaries of) articles on CAM in scientifically based, peer-reviewed journals . CAM on PubMed also links to many publisher Web sites, which may offer the full text of articles.

  • U.S. Food and Drug Administration (FDA)

     

     

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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.

     
  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:

     
  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.

     
  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.

     
  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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