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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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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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