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Journal of Medicine and Life Vol. 10, Issue 1, January-March 2017, pp.

47-49

Serious mistakes in meta-analysis of


homeopathic research
Vithoulkas G
International Academy of Classical Homeopathy, Alonissos, Greece

Correspondence to: Prof. George Vithoulkas,


International Academy of Classical Homeopathy,
Alonissos 37005, Greece,
Phone: +30 24240 65142, Fax: +30 24240 65147, E-mail: george@vithoulkas.com

Received: September 24th, 2016 – Accepted: December 14th, 2016

Abstract
The article discussed the immanent problems of meta-analyses selecting a number of independent trials in homeopathy, within
which, the purpose was to examine the effectiveness of homeopathic treatment. Our focus lied in clarifying that the complex effects
of homeopathic treatment known from history and day-to-day practice have not been respected so far.
The examination of most of the homeopathic trials showed that studies rarely account for homeopathic principles, in order to assess
the effectiveness of the treatment. The main flaw was that trials reflect the point of view that the treatment with a specific remedy
could be administered in a particular disease. However, homeopathy aims to treat the whole person, rather than the diseases and
each case has to be treated individually with an individualized remedy. Furthermore, the commonly known events during the course
of homeopathic treatment, such as “initial aggravation” and “symptom-shift” were not considered in almost all the studies. Thus, only
few trials were eligible for meta-analyses, if at all. These and other factors were discussed and certain homeopathic principles were
suggested to be respected in further trials. It is expected, that a better understanding of homeopathic principles would provide
guidelines for homeopathic research, which are more acceptable to both homeopathy and conventional medicine.

Keywords: serious mistakes, meta-analysis, homeopathic research

In the field of homeopathy, meta-analyses as For example, homeopathy demands individual


well as randomized controlled trials face the conflict assessment of each case in order to reveal the remedy
between fulfilling statistical demands and meeting the that will have the best possible therapeutic effect on the
homeopathic reality. Due to substantial flaws, the individual patient (Law of similarity). However, in almost
outcome of former meta-analyses of placebo‐controlled all the trials reviewed in the meta-analyses, this critical
RCTs on the use of homeopathy [1-5] are inconclusive. parameter was clearly ignored. Further, in homeopathy, a
Explanations for this have been a different and sometimes sound knowledge of the properties of the remedies is of
arbitrary selection of trials [6], a suspected publication great importance. This is a fact that again seems to be
bias [2], heterogeneity [1] and a low quality of the existing neglected by most of the researchers. As an example, we
trials [2,3,5,7]. However, we wanted to focus on an aspect wanted to comment on the study of Rhus-tox D6, which
that was not sufficiently stressed in the past, but was was tested in osteoarthritis and found to have no effect
neither of less importance: The fact that most trials [9]. Not only, that the law of similarity was not respected,
included in the analyses did not respect either the but also deciding the remedy based on the pathology was
homeopathic principles or the indications of the wrong. As it is commonly known to homeopaths, Rhus–
prescribed homeopathic remedies. Recently, a tool for the tox is almost never indicated in osteoarthritis cases,
quality-assessment of homeopathic trials was introduced although it has been useful in some cases of fibrositis and
into the research debates [8] and meta-analytic some rheumatic diseases. Other remedies like
parameters. It resulted again in a minimized set of trials to Causticum, the Kali salts, the Calcarea salts or the
be analyzed. Further, the tool has not been evaluated Natrium salts could have been tried for this pathology
independently so far. To our concern, it still does not allow under a specific protocol, but Rhus-tox should have been
a differentiated and accurate appraisal of the conducted excluded. The negative conclusion reached by this study
trials. The following comments should help clarifying would be similar to testing, for example, the use of
many of the inherent issues of homeopathic methodology antibiotics in treating anxiety neurosis, finding that they do
that are causing, and may continue to cause, confusing not work in this pathology, and then concluding that all
results. conventional medicine is useless!
Journal of Medicine and Life Vol. 10, Issue 1, January-March 2017

Keeping this in mind, this and all similar trials are remedy although the individuals may be suffering from the
seriously flawed from the homeopathic point of view. Not same pathology. This rule was violated by almost all the
even one quarter of the existing studies tested trials in most meta-analyses.
individualized homeopathy [6] and all the trials in the 2. In the homeopathic treatment of serious chronic
Lancet meta-analysis [1] exhibit the problem of using a pathology, if the remedy is correct usually a strong initial
remedy for a specific pathology. Hence, the overall aggravation takes place [14-16]. Such an aggravation
conclusions are compromised. This means that all the may last from a few hours to a few weeks and even then
research work and expenditure put in such trials added we may have a syndrome-shift and not the therapeutic
little to the understanding of the effectiveness of results expected. If the measurements take place in the
homeopathy as a complementary therapeutic method. aggravation period, the outcome will be classified
The most recent meta-analysis respected the negative.
fact that the individualized method and a homeopathic This factor was also ignored in most trials [10].
quality-assessment are essential for the purpose of a fair At least sufficient time should be given in the design of the
evaluation of the effectiveness of homeopathic trial, in order to account for the aggravation period. The
interventions. Still, only 19 out of the 32 placebo- contrary happened in a recent study [17], where the
controlled randomized controlled trials were found to have aggravation period was evaluated as a negative sign and
acceptable “model validity” [10]. Most of those trials that the homeopathic group was pronounced worse than the
investigated acute conditions or very advanced stages of placebo [18].
pathology were that the effect of homeopathy was more 3. In severe chronic conditions, the homeopath may need
comparable to the conventional understanding of the to correctly prescribe a series of remedies before the
improvement [11]. In most other chronic diseases, the improvement is apparent. Such a second or third
individual undergoes an “initial aggravation of the existing prescription should take place only after evaluating the
symptoms” or a “symptom shift” [11]. Generally, it effects of the previous remedies [11]. Again, this rule has
appeared that the proposed “model validity” could be also been ignored in most studies.
working only for the cases in which the first intervention 4. As the prognosis of a chronic condition and the length
with a remedy would have shown some beneficial effect of time after which any amelioration set in may differ from
for the patient. The contemporary state of health of the one to another case [11], the treatment and the study-
western population, especially the European and North design respectively should take into consideration the
American patients, concerning their chronic conditions, length of time the disease was active and also the
require a treatment of few years and will need a series of severity of the case.
remedies [12], before they showed tangible therapeutic 5. In our experience, Homeopathy has its best results in
results. The reason is that the immune system in the the beginning stages of chronic diseases, where it might
majority of such cases is very compromised [11]. This be possible to prevent the further development of the
aspect was not considered in the rating process. Also, chronic state and this is its most important
patients in the beginning stages of chronic diseases might contribution. Examples of pathologies to be included in
even undergo such severe initial aggravation, after a such RCTs trials are ulcerative colitis, sinusitis, asthma,
correct prescription, that they drop out from the studies or allergic conditions, eczema, gangrene rheumatoid arthritis
interfere with allopathic drugs in order to minimize the as long as they are within the first six months of their
intensity of the aggravated symptoms. In both cases, the appearance.
evaluation would be misleading. The apparent initial
aggravation is, from the homeopathic point of view,
considered as a positive sign and a re-awakening of the Conclusion
immune system of the patient. This issue has not been
In conclusion, three points should be taken into
dealt with at all in homeopathic research so far nor have
consideration relating to trials that attempt to evaluate the
the initial aggravations been taken into consideration in
effectiveness of homeopathy.
the planning of homeopathic trials. Thus, it further
First, it is imperative that from the point of view of
contributes to the reduced amount of suitable trials for
homeopathy, the above-mentioned principles should be
meta-analysis.
discussed with expert homeopaths before researchers
Therefore, we wanted to emphasize that the
undertake the design of any homeopathic protocol.
homeopathic community needs a standardized protocol
Second, it would be helpful if medical journals
[13] and should not accept research that does not comply
invited more knowledgeable peer-reviewers who
with, or does not respect the homeopathic principles.
understand the principles of homeopathy.
Third, there is a need for at least one
Which are these homeopathic principles to be
standardized protocol for clinical trials that will respect not
respected?
only the state-of-the art parameters from conventional
1. Homeopathy does not treat diseases, but only diseased
medicine but also the homeopathic principles [13].
individuals. Therefore, every case may need a different

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Journal of Medicine and Life Vol. 10, Issue 1, January-March 2017

Fourth, experience so far has shown that the Only when these points are transposed and put
therapeutic results in homeopathy vary according to the into practice, the trials will be respected and accepted by
expertise of the practitioner. Therefore, if the objective is both homeopathic practitioners and conventional
to validate the homeopathic therapeutic modality, the medicine and can be eligible for meta-analysis.
organizers of the trial have to pick the best possible
prescribers existing in the field.

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