| The already published research on homeopathy
in the last ten years, in its majority, has followed wrong lines
and therefore is causing and will continue to cause confusion and
uncertainties within the medical profession. The problem was created
from peer-reviewers who obviously were not eligible to peer review
such a new subject.
Yet, homeopathy is growing in the preferences of the patients.
Therefore, research should be the first step in a series of decisions,
for putting an order to the anarchistic way that this therapeutic
modality is developing at the moment. If the medical community wants
to see the real effect and also the limits of homeopathy should
aim in having good research. If this crucial problem is not understood
and solved, mainly by the prestigious medical journals, then homeopathy
will continue to expand unbelievably but haphazardly while the medical
profession will pretend that such a thing does not exist.
Most of the papers published on homeopathic trials till today
are confused and confusing. In homeopathy, there is no such thing
as giving a remedy for a specific ailment or disease. The idea of
double blind research is valid for conventional medicine but not
for homeopathy which is based on the principle of giving a remedy
for a totality of symptoms of an individual and not only for his
single ailment, disease or pathology. If such papers continue to
be published then the real homeopathic community, the practitioners
who apply homeopathy in everyday practice will never accept this
type of research.
Therefore I believe, the following comments will help to clarify
a lot of issues that are causing and will continue to cause confusing
remarks concerning the efficacy of homeopathy.
Out of six homeopathic meta-analysis1-6 published in
medical journals four1-4 were somewhat positive and two5-6
negative, compared with placebo, but all of them wrongly conceived
and inaccurately evaluated from the aspect of homeopathy.
The latest fashion of meta-analysis applied to homeopathic trials
is coming to a climax, but from a homeopathic point of view without
guiding lines, and without the possibility of reaching ever a final
and definite conclusion concerning the effectiveness of homeopathy.
I would like to show why such meta-analyses will prove to be useless,
unreliable and misleading, whether the outcome be positive or negative,
if it continues to take in to account the kind of trials existing
till this day.
The main pillar of meta-analysis is that it should be based on
reliable trials. Are the bulk of the trials reviewed in these meta-analyses
reliable?
The answer is a clear "no"1-10. My objection
is that all these trials were not structured according to the well
established principles of homeopathy.
Homeopathy demands individualization of the cases in order to
show its best therapeutic effect. But in almost all the trials reviewed
in the 6 meta-analysis studies these critical parameters were obviously
ignored.
I will take as an example the Lancet paper Klaus Linde et al1.
I will only comment on two trials within this meta-analysis, though
all of the papers included will not withstand any serious scrutiny
from the homeopathic point of view:
1. The Shipley, Jenkins et al trial11 that was the
most negative for homeopathy:
Rhus-tox D6 was tested in osteoarthritis and found to
have no effect.
Rhus-tox. as every homeopath knows is almost never indicated in
osteoarthritis cases (is useful perhaps in some cases of fibrositis
or in rheumatic complains). Other remedies like the Causticum, the
Kali salts the Calcarea salts or the Natrum salts could have been
tried for this pathology under a specific protocol, but never the
Rhus-tox.
This research was similar to testing antibiotics in. . . anxiety
neurosis and finding that they do not work, we arrived at the conclusion
that all conventional medicine is useless. I consider this paper
the worst type of homeopathic trials, though many others in the
same meta-analysis have similar problems.
2. On the Hariveau, et al trial12 that was the most positive
for homeopathy:
The remedy Cuprum were tested and found very effective
in reducing cramps.
Though Cuprum is effective in some cases for cramps, yet is not
as effective as this trial tried to show. Mossinger's similar trials13
that did not show such a dramatic effect confirm this point of mine.
The bulk of the rest of the trials in this meta-analysis have
very little to do with testing the effectiveness of homeopathy.
They were conceived according to conventional way of thinking (a
remedy for a specific disease) This is not homeopathy as I explained
above. The only conclusion one could draw from these trials is that
highly diluted substances can still have an effect upon the human
organism.
Therefore, the homeopathic community should not accept research
that does not comply and does not respect the homeopathic principles.
Which are these principles:
- That homeopathy does not treat diseases, but only diseased
individuals. Therefore every case may need a different
remedy though suffering with the same pathology. This rule was
violated by almost all trials in all the meta-analysis, even in
those trials that were coined as classical. An exception was the
trials that attempted to be closer to the idea of the homeopathic
principles as well. P. Fisher et al14 Jacobs et al15
and Schwab16. These trials showed excellent results
in spite of the fact they did not follow a process of complete
individualization of the cases.
- There is usually an initial aggravation after the first prescription,
especially in chronic cases that should be considered as a positive
sign. That factor has been totally ignored. Also that sufficient
time should be given in the design of the trial, in order to overcome
the aggravation period.
In a recent study published in Cephalalgia17
the aggravation period was evaluated as a negative sign and the
homeopathic group was pronounced worse than the placebo. Cephalalgia
refused to publish my objections to the study.18
- In severe chronic conditions the homeopath may need to prescribe
a second or a third remedy before any sign of improvement is apparent.
Such prescription should take place only after evaluating the
results by the previous remedy. This rule has also been ignored
in all studies.
- Research should take in to consideration the length of time
and the severity of the case. The prognosis of a chronic condition
(the possible time after which an amelioration sets in through
homeopathic treatment) differs according to the length of time
the disease is active and the severity of the case.
In concluding these remarks allow me to suggest:
a. All the above parameters for homeopathy should have been discussed
with expert homeopaths before researchers undertake to design homeopathic
trials, and Medical Journals should provide more knowledgeable peer-reviewers
for clinical trials on homeopathy.
b. There is a need for at least one standardized protocol for
clinical trials that will respect both: the double blind parameters
but also some of the homeopathic principles. Only then such trials
could be acceptable by both the homeopathic and the conventional
medicine. With some of my colleagues we are in the final stage of
completing such a protocol.
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References
- Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges
LV et al. Are the clinical effects of homeopathy placebo effects?
A meta-analysis of placebo-controlled trials. Lancet
1997; 350: 834-43.
- Cucherat M, Haugh MC, Gooch M, Boissel JP, for the HMRAG group.
Evidence of Clinical efficacy of homeopathy. A meta-analysis of
clinical trials. Eur J Clin Pharmacol
2000; 56: 27.
- Barnes J, Resch KL, Ernst E. Homeopathy for post operative
ileus? A meta - analysis. J Clin Gastroenterol 1997
Dec; 25 (4): 628-33.
- Kleijnen J, Knipschild P, ter Riet G. Clinical trials of Homeopathy.
BMJ 1991 Feb 9; 302(6772):316-23.
- Scheen A, Lefebvre P. Is homeopathy superior to placebo? Controversy
apropo of a meta-analysis of controlled studies. Bull
Mem Acad R Med Belg 1999; 154 (7-9); 295-304; discussion
304-7.
- Linde K, Scholz M, Ramirez G, Clausius N, Melchart D, Jonas
WB. Impact of study quality on outcome in placebo- controlled
trials of homeopathy. J Clin Epidemiol
1999 July; 52(7):631-6
- Vandenbroucke JP, Homeopathic trials :going nowhere. Lancet
1997; 350:824.
- Langman MJS. Homeopathy trials: reasons for good ones but are
they warranted ? Lancet 1997 350:825
- Ernst E, Barnes J. Are homeopathic remedies effective for delayed
onset muscle soreness? A systematic review of placebo-controlled
trials. Perfusion 1998; 11: 4-8
- Dean M. Out of step with the Lancet homeopathy meta-analysis:
more objections than objectivity? J Altern Complement
Med 1998 Winter; 4(4): 389-98.
- Shipley M, Berry H, Broster G, Jenkins M, Clover A, Williams
I. Controlled trial of homeopathic treatment of osteoarthritis
Lancet;1983, i: 97-98.
- Hariveauv, et al recherche clinique a L'Institut Boiron Homeopathie
1987;5:55-58.
- Mossinger P. Misslungene Wirksamkeitsnachweise. Allg
homopath Ztg 1976; 221: 26-31
- Fisher P, Greenwood A, Huskisson EC et al. Effect of homoeopathic
treatment on fibrositis (primary fibromyalgia). BMJ
1989; 299: 365-366
- Jacobs J, Jiminez LM, Gloyds SS et al Homoeopathic treatment
of acute childhood diarrhea: a randomized clinical trial in Nicaragua.
Br Hom Journal 1993; 82: 83--86
- Schwab G. Lsst sich eine Wirkung homopathischer Hochpotenzen
nachweisen? Karlsruhe: Deutsche Homopathische Union;
1990.
- Walach H, W. Haeusler T Lowes, D Mussbach, U Schamell, W Springer
et al Classical Hom. Treatm. of Chronic Headaches Cephalalgia
1997;17: 119-26
- Vithoulkas G. Unpublished Critical Review of Class. Hom. Treatm.
of Chronic Headaches in Cephalagia Oct
1997 sent to Cephalalgia and their respond.
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