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Serious mistakes in meta-analysis of homeopathic research

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George Vithoulkas at University of the Aegean
George Vithoulkas
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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.
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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
well as randomized controlled trials face the conflict
between fulfilling statistical demands and meeting the
homeopathic reality. Due to substantial flaws, the
outcome of former meta-analyses of placebo‐controlled
RCTs on the use of homeopathy [1-5] are inconclusive.
Explanations for this have been a different and sometimes
arbitrary selection of trials [6], a suspected publication
bias [2], heterogeneity [1] and a low quality of the existing
trials [2,3,5,7]. However, we wanted to focus on an aspect
that was not sufficiently stressed in the past, but was
neither of less importance: The fact that most trials
included in the analyses did not respect either the
homeopathic principles or the indications of the
prescribed homeopathic remedies. Recently, a tool for the
quality-assessment of homeopathic trials was introduced
into the research debates [8] and meta-analytic
parameters. It resulted again in a minimized set of trials to
be analyzed. Further, the tool has not been evaluated
independently so far. To our concern, it still does not allow
a differentiated and accurate appraisal of the conducted
trials. The following comments should help clarifying
many of the inherent issues of homeopathic methodology
that are causing, and may continue to cause, confusing
results.
For example, homeopathy demands individual
assessment of each case in order to reveal the remedy
that will have the best possible therapeutic effect on the
individual patient (Law of similarity). However, in almost
all the trials reviewed in the meta-analyses, this critical
parameter was clearly ignored. Further, in homeopathy, a
sound knowledge of the properties of the remedies is of
great importance. This is a fact that again seems to be
neglected by most of the researchers. As an example, we
wanted to comment on the study of Rhus-tox D6, which
was tested in osteoarthritis and found to have no effect
[9]. Not only, that the law of similarity was not respected,
but also deciding the remedy based on the pathology was
wrong. As it is commonly known to homeopaths, Rhus–
tox is almost never indicated in osteoarthritis cases,
although it has been useful in some cases of fibrositis and
some rheumatic diseases. Other remedies like
Causticum, the Kali salts, the Calcarea salts or the
Natrium salts could have been tried for this pathology
under a specific protocol, but Rhus-tox should have been
excluded. The negative conclusion reached by this study
would be similar to testing, for example, the use of
antibiotics in treating anxiety neurosis, finding that they do
not work in this pathology, and then concluding that all
conventional medicine is useless!
Journal of Medicine and Life Vol. 10, Issue 1, January-March 2017
48
Keeping this in mind, this and all similar trials are
seriously flawed from the homeopathic point of view. Not
even one quarter of the existing studies tested
individualized homeopathy [6] and all the trials in the
Lancet meta-analysis [1] exhibit the problem of using a
remedy for a specific pathology. Hence, the overall
conclusions are compromised. This means that all the
research work and expenditure put in such trials added
little to the understanding of the effectiveness of
homeopathy as a complementary therapeutic method.
The most recent meta-analysis respected the
fact that the individualized method and a homeopathic
quality-assessment are essential for the purpose of a fair
evaluation of the effectiveness of homeopathic
interventions. Still, only 19 out of the 32 placebo-
controlled randomized controlled trials were found to have
acceptable “model validity” [10]. Most of those trials that
investigated acute conditions or very advanced stages of
pathology were that the effect of homeopathy was more
comparable to the conventional understanding of the
improvement [11]. In most other chronic diseases, the
individual undergoes an “initial aggravation of the existing
symptoms” or a “symptom shift” [11]. Generally, it
appeared that the proposed “model validity” could be
working only for the cases in which the first intervention
with a remedy would have shown some beneficial effect
for the patient. The contemporary state of health of the
western population, especially the European and North
American patients, concerning their chronic conditions,
require a treatment of few years and will need a series of
remedies [12], before they showed tangible therapeutic
results. The reason is that the immune system in the
majority of such cases is very compromised [11]. This
aspect was not considered in the rating process. Also,
patients in the beginning stages of chronic diseases might
even undergo such severe initial aggravation, after a
correct prescription, that they drop out from the studies or
interfere with allopathic drugs in order to minimize the
intensity of the aggravated symptoms. In both cases, the
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
immune system of the patient. This issue has not been
dealt with at all in homeopathic research so far nor have
the initial aggravations been taken into consideration in
the planning of homeopathic trials. Thus, it further
contributes to the reduced amount of suitable trials for
meta-analysis.
Therefore, we wanted to emphasize that the
homeopathic community needs a standardized protocol
[13] and should not accept research that does not comply
with, or does not respect the homeopathic principles.
Which are these homeopathic principles to be
respected?
1. Homeopathy does not treat diseases, but only diseased
individuals. Therefore, every case may need a different
remedy although the individuals may be suffering from the
same pathology. This rule was violated by almost all the
trials in most meta-analyses.
2. In the homeopathic treatment of serious chronic
pathology, if the remedy is correct usually a strong initial
aggravation takes place [14-16]. Such an aggravation
may last from a few hours to a few weeks and even then
we may have a syndrome-shift and not the therapeutic
results expected. If the measurements take place in the
aggravation period, the outcome will be classified
negative.
This factor was also ignored in most trials [10].
At least sufficient time should be given in the design of the
trial, in order to account for the aggravation period. The
contrary happened in a recent study [17], where the
aggravation period was evaluated as a negative sign and
the homeopathic group was pronounced worse than the
placebo [18].
3. In severe chronic conditions, the homeopath may need
to correctly prescribe a series of remedies before the
improvement is apparent. Such a second or third
prescription should take place only after evaluating the
effects of the previous remedies [11]. Again, this rule has
also been ignored in most studies.
4. As the prognosis of a chronic condition and the length
of time after which any amelioration set in may differ from
one to another case [11], the treatment and the study-
design respectively should take into consideration the
length of time the disease was active and also the
severity of the case.
5. In our experience, Homeopathy has its best results in
the beginning stages of chronic diseases, where it might
be possible to prevent the further development of the
chronic state and this is its most important
contribution. Examples of pathologies to be included in
such RCTs trials are ulcerative colitis, sinusitis, asthma,
allergic conditions, eczema, gangrene rheumatoid arthritis
as long as they are within the first six months of their
appearance.
Conclusion
In conclusion, three points should be taken into
consideration relating to trials that attempt to evaluate the
effectiveness of homeopathy.
First, it is imperative that from the point of view of
homeopathy, the above-mentioned principles should be
discussed with expert homeopaths before researchers
undertake the design of any homeopathic protocol.
Second, it would be helpful if medical journals
invited more knowledgeable peer-reviewers who
understand the principles of homeopathy.
Third, there is a need for at least one
standardized protocol for clinical trials that will respect not
only the state-of-the art parameters from conventional
medicine but also the homeopathic principles [13].
Journal of Medicine and Life Vol. 10, Issue 1, January-March 2017
49
Fourth, experience so far has shown that the
therapeutic results in homeopathy vary according to the
expertise of the practitioner. Therefore, if the objective is
to validate the homeopathic therapeutic modality, the
organizers of the trial have to pick the best possible
prescribers existing in the field.
Only when these points are transposed and put
into practice, the trials will be respected and accepted by
both homeopathic practitioners and conventional
medicine and can be eligible for meta-analysis.
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  • Dec 2020
Em vista da homeopatia estar fundamentada em pressupostos científicos distintos dos empregados pela prática médica convencional, frequentemente, é alvo de críticas infundadas disseminadas por indivíduos que, de forma sistemática, negam os princípios homeopáticos e qualquer evidência científica que os comprovem, por estarem envoltos em um negacionismo dogmático que impede uma análise correta e isenta de preconceitos. São pseudocéticos disfarçados em pseudocientistas. Para esclarecer médicos, pesquisadores, profissionais de saúde e a população em geral, desmistificando posturas dogmáticas culturalmente arraigadas e a falácia pseudocética de que "não existem evidências científicas para homeopatia", em 2017, a Câmara Técnica de Homeopatia do Conselho Regional de Medicina do Estado de São Paulo (CT-Homeopatia, Cremesp) elaborou e publicou o "Dossiê Especial Evidências Científicas em Homeopatia", disponibilizado livremente na Revista de Homeopatia (São Paulo), periódico científico da Associação Paulista de Homeopatia (APH). Englobando nove revisões narrativas em diversas linhas de pesquisa homeopática (histórico-social, educação médica, farmacológica, básicas, clínica, segurança do paciente e patogenética) e dois ensaios clínicos randomizados e placebos-controlados desenvolvidos por membros da CT-Homeopatia, contendo centenas de artigos científicos publicados em inúmeras revistas científicas indexadas e revisadas por pares, este dossiê destaca para a classe médica e científica, bem como para o público em geral, o 'estado da arte' da pesquisa em homeopatia.
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"Evidencias Científicas de la Homeopatía" - La Homeopatía de México - Edición Especial de Aniversario (90 años)
Article
Full-text available
  • Mar 2023
La Homeopatía de México | Evidencias Científicas de la Homeopatía | Edición Especial de Aniversario (90 años) | 2023 || EDITORIAL: Para aquellos que demandan evidencias científicas de la Homeopatía. Marcus Zulian Teixeira. | ARTÍCULOS: Homeopatía: una breve descripción de esta especialidad médica. Marcelo Pustiglione, Eduardo Goldenstein, Y. Moisés Checinski. | Formación médica en la terapéutica no convencional en el mundo (Homeopatía y acupuntura). Marcus Zulian Teixeira. | Bases científicas del principio de curación homeopática en la farmacología moderna. Marcus Zulian Teixeira. | La solidez de la investigación homeopática fundamental. Leoni Villano Bonamin. | Efectos de las diluciones homeopáticas altas sobre los modelos in vitro: revisión de la literatura. Silvia Waisse. | Efectos de las diluciones homeopáticas altas sobre las plantas: revisión de la literatura. Marcus Zulian Teixeira, Solange M.T.P.G. Carneiro. | Investigación clínica en Homeopatía: revisiones sistemáticas y estudios clínicos aleatorizados. Silvia Waisse. | Estrógeno potenciado en el tratamiento homeopático del dolor pélvico asociado a endometriosis: Un estudio aleatorizado, doble ciego, controlado con placebo, de 24 semanas. Marcus Zulian Teixeira, Sérgio Podgaec, Edmund Chada Baracat. | Estudio aleatorizado, doble ciego, sobre la eficacia del tratamiento homeopático en niños con amigdalitis recurrente. Sérgio E. Furuta, Luc L. M. Weckx, Cláudia R. Figueiredo. | ¿Los medicamentos homeopáticos provocan agravación o efectos adversos dependientes de los fármacos? Flávio Dantas. | ¿Los medicamentos homeopáticos inducen síntomas en voluntarios aparentemente sanos? Contribución brasileña al debate sobre los estudios patogénicos homeopáticos. Flávio Dantas. |
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“Evidências Científicas de la Homeopatía” – La Homeopatía de México – Edición Especial de Aniversário (90 Años) - 2023
Article
  • Mar 2023
La Homeopatía de México | Evidencias Científicas de la Homeopatía | Edición Especial de Aniversario (90 años) | 2023 || EDITORIAL: Para aquellos que demandan evidencias científicas de la Homeopatía. Marcus Zulian Teixeira. | ARTÍCULOS: Homeopatía: una breve descripción de esta especialidad médica. Marcelo Pustiglione, Eduardo Goldenstein, Y. Moisés Checinski. | Formación médica en la terapéutica no convencional en el mundo (Homeopatía y acupuntura). Marcus Zulian Teixeira. | Bases científicas del principio de curación homeopática en la farmacología moderna. Marcus Zulian Teixeira. | La solidez de la investigación homeopática fundamental. Leoni Villano Bonamin. | Efectos de las diluciones homeopáticas altas sobre los modelos in vitro: revisión de la literatura. Silvia Waisse. | Efectos de las diluciones homeopáticas altas sobre las plantas: revisión de la literatura. Marcus Zulian Teixeira, Solange M.T.P.G. Carneiro. | Investigación clínica en Homeopatía: revisiones sistemáticas y estudios clínicos aleatorizados. Silvia Waisse. | Estrógeno potenciado en el tratamiento homeopático del dolor pélvico asociado a endometriosis: Un estudio aleatorizado, doble ciego, controlado con placebo, de 24 semanas. Marcus Zulian Teixeira, Sérgio Podgaec, Edmund Chada Baracat. | Estudio aleatorizado, doble ciego, sobre la eficacia del tratamiento homeopático en niños con amigdalitis recurrente. Sérgio E. Furuta, Luc L. M. Weckx, Cláudia R. Figueiredo. | ¿Los medicamentos homeopáticos provocan agravación o efectos adversos dependientes de los fármacos? Flávio Dantas. | ¿Los medicamentos homeopáticos inducen síntomas en voluntarios aparentemente sanos? Contribución brasileña al debate sobre los estudios patogénicos homeopáticos. Flávio Dantas. |
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Why homoeopathy is pseudoscience
Article
Full-text available
  • Sep 2022
  • SYNTHESE
Homoeopathy is commonly recognised as pseudoscience. However, there is, to date, no systematic discussion that seeks to establish this view. In this paper, we try to fill this gap. We explain the nature of homoeopathy, discuss the notion of pseudoscience, and provide illustrative examples from the literature indicating why homoeopathy fits the bill. Our argument contains a conceptual and an empirical part. In the conceptual part, we introduce the premise that a doctrine qualifies as a pseudoscience if, firstly, its proponents claim scientific standing for it and, secondly, if they produce bullshit to defend it, such that, unlike science, it cannot be viewed as the most reliable knowledge on its topic. In the empirical part, we provide evidence that homoeopathy fulfils both criteria. The first is quickly established since homoeopaths often explicitly claim scientificity. To establish the second, we dive into the pseudo-academic literature on homoeopathy to provide evidence of bullshit in the arguments of homoeopaths. Specifically, we show that they make bizarre ontological claims incompatible with natural science, illegitimately shift the burden of proof to sceptics, and mischaracterise, cherry-pick, and misreport the evidence. Furthermore, we demonstrate that they reject essential parts of established scientific methodology and use epistemically unfair strategies to immunise their doctrine against recalcitrant evidence.
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Method for appraising model validity of randomised controlled trials of homeopathic treatment: Multi-rater concordance study
Article
Full-text available
A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.
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The “continuum” of a unified theory of diseases
Article
Full-text available
  • Feb 2010
  • MED SCI MONITOR
This essay's theme was inspired by a question asked by a child: 'Why do I get ill?' The question is very interesting, but has no easy answer. This paper discusses a few possible answers to this difficult question. Through the life of a person, from birth to death, there is a "continuum" in the pathological conditions a person may experience. The body, as a whole, suffers deeply any time there is an acute or a chronic condition that is either maltreated or neglected. Chronic and acute diseases in the medical history of a person constitute a rigidly related chain of immune responses in the form of a real "continuum" that at every point in time indicates the end result of this continuum. The idea promoted here is that suppression of diseases, through excess of chemical drugs or other means, many times overwhelms the body's natural defenses and forces the immune system to compromise and start a deeper line of defense, which then constitute the beginning of a new chronic condition. Thus, the original inflammation of an acute condition may continue as a sub-acute inflammatory process on a deeper level. Acute inflammatory conditions must therefore be treated very carefully from their beginnings in childhood in order not to force the immune system to compromise. It is also suggested here that all chronic degenerative conditions have a sub-acute inflammatory character, and that "inflammation" constitutes the main common parameter of all diseases.
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Clinical trials of homoeopathy
Article
Full-text available
  • Mar 1991
To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. Controlled trials published world wide. Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials.
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Classical Homeopathic Treatment of Chronic Headaches
Article
Full-text available
  • May 1997
We conducted a randomized, placebo-controlled, double-blind clinical trial in order to determine the efficacy of classical homeopathic therapy in patients with chronic headaches. After 6 weeks of baseline observation, patients received either the prescribed individualized homeopathic medication or an indistinguishable placebo for 12 weeks. Outcome parameters were headache frequency, duration, and intensity, measured daily by diary. Use of medication for acute headache was also monitored. Of the 98 patients in the sample, 37 were randomized to receive placebo, 61 received individualized homeopathic remedies. Groups were comparable at the beginning of the treatment. The median age was 48.5 years; 76% suffered from migraine, 51% from tension-type headaches, and 94% were previously treated for headache. The median headache frequency was 3 days a week. Headaches were present for 23 years (median). In both groups, patients showed an improvement of one headache day less per month. The use of medication for acute headache was reduced. The headache frequency of 21 patients was reduced by more than 40%. Thirty-nine patients either did not improve or experienced aggravations. There was no significant difference in any parameter between homeopathy and placebo.
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Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials
Article
Full-text available
  • Sep 1997
Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo. We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, "remedy", population, and outcomes. The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05). The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.
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Model validity of randomised placebo-controlled trials of individualised homeopathic treatment
Article
  • Jan 2014
Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated. As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment. From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary. Nineteen trials were judged overall as 'acceptable' MVHT, nine as 'uncertain' MVHT, and four as 'inadequate' MVHT. These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with 'uncertain' or 'inadequate' MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.
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Evidence of clinical efficacy of homeopathy - A meta-analysis of clinical trials
Article
  • Jan 2000
Objective: To establish, using a systematic review and meta-analysis, whether there is any evidence from randomised controlled clinical trials of the efficacy of homeopathic treatment in patients with any disease. Data sources: Published and unpublished reports of controlled clinical trials available up to June 1998, identified by searching bibliographic databases (Medline, Embase, Biosis, PsychInfo, Cinahl, British Library Stock Alert Service, SIGLE, Amed), references lists of selected papers, hand searching homeopathic journals and conference abstracts, and contacting pharmaceutical companies. Trials selection: Trials were selected using an unblinded process by two reviewers. The selection criteria were randomised, controlled trials in which the efficacy of homeopathic treatment was assessed relative to placebo in patients using clinical or surrogate endpoints. Prevention trials or those evaluating only biological effects were excluded. One hundred and eighteen randomised trials were identified and evaluated for inclusion. Sixteen trials, representing 17 comparisons and including a total of 2617 evaluated patients, fulfilled the inclusion criteria. Data extraction: Data were extracted by two reviewers independently, using a summary form. Disagreements were resolved by a third person. Data synthesis: The evidence was synthesised by combining the significance levels (P values) for the primary outcomes from the individual trials. The combined P value for the 17 comparisons was highly significant P=0.000036. However, sensitivity analysis showed that the P value tended towards a non-significant value (P=0.08) as trials were excluded in a stepwise manner based on their level of quality. Conclusions: There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.
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Controlled trial of homeopathic treatment of osteoarthritis
Article
  • Feb 1983
In a double-blind, placebo-controlled crossover study to compare the homoeopathic remedy Rhus tox. 6X with fenoprofen in osteoarthritis of the hip and knee, fenoprofen was shown to have beneficial analgesic and anti-inflammatory effects which differed significantly from those of placebo. The effects of Rhus tox. 6X and placebo did not differ significantly. Patient preference was for fenoprofen. Side-effects were not severe but were seen more frequently with fenoprofen. Similar results were seen in all patients regardless of whether they had been referred to and assessed by a homoeopathic physician or a rheumatologist.
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Homeopathy for Postoperative Ileus
Article
  • Dec 1997
Homeopathic remedies are advocated for the treatment of postoperative ileus, yet data from clinical trials are inconclusive. We therefore performed meta-analyses of existing clinical trials to determine whether homeopathic treatment has any greater effect than placebo administration on the restoration of intestinal peristalsis in patients after abdominal or gynecologic surgery. We conducted systematic literature searches to identify relevant clinical trials. Meta-analyses were conducted using RevMan software. Separate meta-analyses were conducted for any homeopathic treatment versus placebo; homeopathic remedies of < 12C potency versus placebo; homeopathic remedies of > or = 12C potency versus placebo. A "sensitivity analysis" was performed to test the effect of excluding studies of low methodologic quality. Our endpoint was time to first flatus. Meta-analyses indicated a statistically significant (p < 0.05) weighted mean difference (WMD) in favor of homeopathy (compared with placebo) on the time to first flatus. Meta-analyses of the three studies that compared homeopathic remedies > or = 12C versus placebo showed no significant difference (p > 0.05). Meta-analyses of studies comparing homeopathic remedies < 12C with placebo indicated a statistically significant (p < 0.05) WMD in favor of homeopathy on the time to first flatus. Excluding methodologically weak trials did not substantially change any of the results. There is evidence that homeopathic treatment can reduce the duration of ileus after abdominal or gynecologic surgery. However, several caveats preclude a definitive judgment. These results should form the basis of a randomized controlled trial to resolve the issue.
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