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Essentials
of Homeopathy™ CD-ROM
About
Homeopathy
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Homeopathy
is an alternative medical system.
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Alternative
medical systems are built upon complete systems of theory and practice.
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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.
Top
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.
Top
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.
Top
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.
Top
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)
Top
References
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Cicchetti, J. "Like Cures Like: Homeopathy." American
Journal of Nursing. 2001.
101(9):43-9.
- Merrell, W.C. and
Shalts, E. "Homeopathy." Medical
Clinics of North America. 2002.
86(1):47-62.
- Stehlin, I.
"Homeopathy: Real Medicine or Empty Promises?" FDA
Consumer. 1996. 30(10):15-19.
- Der Marderosian, A.H.
"Understanding Homeopathy." Journal
of the American Pharmaceutical Association.
1996. NS36(5):317-21.
- Flexner, A. Medical
Education in the United States and Canada: A Report to the Carnegie
Foundation for the Advancement of Teaching.
Menlo Park, California:
- 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.
- Zhang, X.
Communication to the Congress of the International Homeopathic Medical
Organization, Paris, France. Cited in reference 9.
- Whorton, J.C.
"Traditions of Folk Medicine in America." Journal
of the American Medical Association.
1987. 257(12):1632-5.
- Poitevin, B.
"Integrating Homoeopathy in Health Systems." Bulletin
of the World Health Organization.
1999. 77(2):160-6.
- Ballard, R.
"Homeopathy: An Overview." Australian
Family Physician. 2000.
29(12):1145-8.
- Dean, M.E. "Homeopathy
and 'The Progress of Science.' " History
of Science. 2001. 39(125 Pt.
3):255-83.
- Ernst, E. and
Kaptchuk, T.J. "Homeopathy Revisited." Archives
of Internal Medicine. 1996.
156(19):2162-4.
- Jonas, W.B., Kaptchuk,
T.J., and Linde, K. "A Critical Overview of Homeopathy." Annals
of Internal Medicine. 2003.
138(5):393-9.
- European Council for
Classical Homeopathy. "European Guidelines for Homeopathic Education,"
2nd ed. 2000.
- 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.
- 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.
- 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.
- 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.
- Vincent, C. and
Furnham, A. "Why Do Patients Turn to Complementary Medicine? An
Empirical Study." British
Journal of Clinical Psychology.
1996. 35:37-48.
- 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.
- Kleijnen, J.,
Knipschild, P., and ter Riet, G. "Clinical Trials of Homeopathy." British
Medical Journal. 1991.
302(6782):316-23.
- Junod, S.W.
"Alternative Drugs: Homeopathy, Royal Copeland, and Federal Drug
Regulation." Pharmacy in
History. 2000. 42(1-2):13-35.
- Food and Drug
Administration. "Conditions Under Which Homeopathic Drugs May Be
Marketed." Compliance Policy
Guides Manual, Sec. 400.400.
- Homeopathic
Pharmacopoeia Convention of the United States.
Homeopathic Pharmacopoeia of the United States.
Southeastern, PA: HPCUS.
- Dantas, F. and Rampes,
H. "Do Homeopathic Medicines Provoke Adverse Effects? A Systematic
Review." British Homeopathic
Journal. 2000. 89 Suppl
1:S35-S38.
- 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.
- 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.
- 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.
- 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.
- Abbott, A. and
Stiegler, G. "Support for Scientific Evaluation of Homeopathy Stirs
Controversy." Nature.
1996. 383(6598):285.
- Maddox, J., Randi, J.,
and Stewart, W.W. " 'High-Dilution' Experiments a Delusion." Nature.
1988. 334(6180):287-90.
- Benveniste, J.
"Benveniste on the Benveniste Affair." Nature.
1988. 335(6193):759.
- Ernst, E. "A
Systematic Review of Systematic Reviews of Homeopathy." British
Journal of Clinical Pharmacology.
2002. 54(6):577-82.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Long, L. and Ernst, E.
"Homeopathic Remedies for the Treatment of Osteoarthritis: A Systematic
Review." British Homeopathic
Journal. 2001. 90(1):37-43.
- Jonas, W.B., Linde,
K., and Ramirez, G. "Homeopathy and Rheumatic Disease." Rheumatic
Disease Clinics of North America.
2000. 26(1):117-23.
Top
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.
Top
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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