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Propositions d’évaluation de l’homéopathie issues des données de la littérature scientifique
Abstract
Résumé
À partir de l’analyse de la littérature scientifique en homéopathie, des propositions sont faites en recherche fondamentale et clinique. La poursuite de ces études scientifiques est essentielle pour maintenir l’intégration de l’homéopathie dans notre système de santé.
... Si la recherche clinique est l'objet de débats et doit être poursuivie en intégrant la sémiologie précise et individualisée de la prescription homéopathique, la recherche fondamentale, clinique et biologique a déjà fait l'objet d'études positives fréquemment reproduites, que ce soit en biologie [19] ou en physique [20], démontrant que le médicament homéopathique a une véritable réalité pharmacologique, même après la 12 CH, correspondant à une dilution à 10 -24 , c'est-à-dire au-delà du nombre d'Avogadro. Il est nécessaire de poursuivre ces travaux, que ce soit en recherche clinique ou en recherche fondamentale [21] à l'instar des travaux de recherche en physique, reconnus comme étant ceux de meilleure qualité, conduits par Jean-Louis Demangeat, médecin strasbourgeois, spécialiste en médecine nucléaire. ...
EDITORIAL:
La « semblable souffrance » telle est l’étymologie grecque de l’homéopathie et la définition parfaite de cette thérapeutique médicale dont l’originalité est de soigner par les semblables. Nous qui avons été formés à soigner par les contraires, antibiotiques, anti-inflammatoires, antidépresseurs, antimitotiques et autres antiseptiques, sommes d’emblée confrontés à un changement complet de paradigme thérapeutique.
Objectives:
In Part 1 of the review of physicochemical research performed on homeopathic preparations the authors identified relevant publications of sufficient reporting quality for further in-depth analysis. In this article, the authors analyze these publications to identify any empirical evidence for specific physicochemical properties of homeopathic preparations and to identify most promising experimental techniques for future studies.
Methods:
After an update of the literature search up to 2018, the authors analyzed all publications in terms of individual experiments. They extracted information regarding methodological criteria such as blinding, randomization, statistics, controls, sample preparation, and replications, as well as regarding experimental design and measurement methods applied. Scores were developed to identify experimental techniques with most reliable outcomes.
Results:
The publications analyzed described 203 experiments. Less than 25% used blinding and/or randomization, and about one third used adequate controls to identify specific effects of homeopathic preparations. The most promising techniques used so far are nuclear magnetic resonance (NMR) relaxation, optical spectroscopy, and electrical impedance measurements. In these three areas, several sets of replicated high-quality experiments provide evidence for specific physicochemical properties of homeopathic preparations.
Conclusions:
The authors uncovered a number of promising experimental techniques that warrant replication to assess the reported physicochemical properties of homeopathic preparations compared with controls. They further discuss a range of experimental aspects that highlight the many factors that need to be taken into consideration when performing basic research into homeopathic potentization. For future experiments, the authors generally recommend using succussed (vigorously shaken) controls, or comparing different homeopathic preparations with each other to reliably identify any specific physicochemical properties.
Objectives:
The last systematic review of physicochemical research performed on homeopathic preparations was published in 2003. The aim of the study is to update and expand the current state of knowledge in the area of physicochemical properties of homeopathic preparations. In part 1 of the study, we aim to present an overview of the literature with respect to publication quality and methods used. In part 2, we aim to identify the most interesting experimental techniques. With this, we aim to be in a position to generate meaningful hypotheses regarding a possible mode of action of homeopathic preparations.
Methods:
A two-step procedure was adopted: (1) an extensive literature search, followed by a bibliometric and quality analysis on the level of publications and (2) a thorough qualitative analysis of the individual physicochemical investigations found. In this publication, we report on step (1). We searched major scientific databases to find publications reporting physicochemical investigations of homeopathy from its origin to the end of 2015. Publications were assessed using a scoring scheme, the Manuscript Information Score (MIS). Information regarding country of origin of the research and experimental techniques used was extracted.
Results:
We identified 183 publications (compared to 44 in the last review), 122 of which had an MIS ≥5. The rate of publication in the field was ∼2 per year from the 1970s until 2000. Afterward, it increased to over 5.5 publications per year. The quality of publications was seen to increase sharply from 2000 onward, whereas before 2000, only 12 (13%) publications were rated as "high quality" (MIS ≥7.5); 44 (48%) publications were rated as "high quality" from 2000 onward. Countries with most publications were Germany (n = 42, 23%), France (n = 29, 16%), India (n = 27, 15%), and Italy (n = 26, 14%). Techniques most frequently used were electrical impedance (26%), analytical methods (20%), spectroscopy (20%), and nuclear magnetic resonance (19%).
Conclusions:
Physicochemical research into homeopathic preparations is increasing both in terms of quantity and quality of the publications.
BackgroundA rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment. Methods
Literature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised ‘reliable evidence’ if its risk of bias was low or it was unclear in one specified domain of assessment. ‘Effect size’ was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy. ResultsForty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as ‘high risk of bias’ and 23 as ‘uncertain risk of bias’; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was –0.33 (95% confidence interval (CI) –0.44, –0.21), which was attenuated to –0.16 (95% CI –0.31, –0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: –0.18 (95% CI –0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence. Conclusions
The quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.
Background: the aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting. Methods: the study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (? 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy. Results: data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838). Conclusion: in primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment
Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.ClinicalTrials.gov NCT01635218.https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].
Background
The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who strictly prescribe conventional medicines (GP-CM), regularly prescribe homeopathy in a mixed practice (GP-Mx), or are certified homeopathic GPs (GP-Ho).
Methods
This was one of three epidemiological cohort studies (EPI3) on general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.
Results
Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, with Odds ratio (OR) = 0.29; 95 % confidence interval (CI): 0.19 to 0.44, and OR = 0.62; 95 % CI: 0.41 to 0.94 respectively, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group (OR = 1.70; 95 % CI: 1.00 to 2.87), but not for the GP-Mx group (OR = 1.49; 95 % CI: 0.89 to 2.50).
Conclusions
Patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians’ management and patients’ preferences as well as statistical regression to the mean.
Introduction: This paper focuses exclusively on experimental models with ultra high dilutions (i.e. beyond 10e-23) that have been submitted to replication scrutiny. It updates previous surveys, considers suggestions made by the research community and compares the state of replication in 1994 with that in 2015.
Methods: Following literature research, biochemical, immunological, botanical, cell biological and zoological studies on ultra high dilutions (potencies) were included. Reports were grouped into initial studies, laboratory-internal, multicentre and external replications. Repetition could yield either comparable, or zero, or opposite results. The null-hypothesis was that test and control groups would not be distinguishable (zero effect).
Results: A total of 126 studies were found. From these, 28 were initial studies. When all 98 replicative studies were considered, 70.4% (i.e. 69) reported a result comparable to that of the initial study, 20.4% (20) zero effect and 9.2% (9) an opposite result. Both for the studies until 1994 and the studies 1995-2015 the null-hypothesis (dominance of zero results), should be rejected. Furthermore, the odds of finding a comparable result are generally higher than of finding an opposite result. Although this is true for all three types of replication studies, the fraction of comparable studies diminishes from laboratory-internal (total 82.9%) to multicentre (total 75%) to external (total 48.3%), while the fraction of opposite results was 4.9%, 10.7% and 13.8%. Furthermore, it became obvious that the probability of an external replication producing comparable results is bigger for models that had already been further scrutinized by the initial researchers.
Conclusions: We found 28 experimental models which underwent replication. In total, 24 models were replicated with comparable results, 12 models with zero effect, and 6 models with opposite results. Five models were externally reproduced with comparable results. We encourage further replications of studies in order to learn more about the model systems used.
In 1994, Madeleine Bastide described experimental models in immunology that were used during the 1980s to investigate high dilution effects on several biological systems. She classified the available papers in four categories: High dilutions of antigens; High dilutions of thymus, bursa and other hormones; High dilutions of cytokines; Immunopharmacological activity of silica. The studies about high dilutions of antigens were not continued after this period, but gave rise to a long process of a series of invitro models on antigens and histamine dilutions, that led to the demonstration of the biological modulation effects of these preparations on basophil degranulation. During this process, a multi-centre study was performed, with a high degree of reproducibility among different independent laboratories.The studies about high diluted cytokines, thymulin and other hormones opened a new line of scientific investigation, about the regulatory properties of endogenous substances prepared according to homeopathic methods. The most frequently studied substance, thymulin, when administered to mice at 5cH potency, is able to improve the activity of phagocytes in different experimental situations, such as viral, bacterial and parasitic infections. The immunopharmacological activity of silica was demonstrated, at that time, as an invivo illustration of the homeopathic 'similia principle'. More recently, studies on silica have assumed another focus: the putative role of silica as active contaminant present in high dilutions. This paper presents a follow-up summary on these items, considering the evolution of discoveries from 1994 to 2014.
A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos.
The review's methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial's risk of bias to be designated as low, unclear or high. A trial was judged to comprise 'reliable evidence' if its risk of bias was low or was unclear in one specified domain. 'Effect size' was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.
Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed 'uncertain risk of bias', three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed 'high risk of bias'. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).
Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous 'global' systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.
Prescribing of antibiotics for upper respiratory tract infections (URTI) varies substantially in primary care.
To describe and compare antibiotic and antipyretic/anti-inflammatory drugs use, URTI symptoms' resolution and occurrence of potentially-associated infections in patients seeking care from general practitioners (GPs) who exclusively prescribe conventional medications (GP-CM), regularly prescribe homeopathy within a mixed practice (GP-Mx), or are certified homeopathic GPs (GP-Ho).
The EPI3 survey was a nationwide population-based study of a representative sample of 825 GPs and their patients in France (2007-2008). GP recruitment was stratified by self-declared homeopathic prescribing preferences. Adults and children with confirmed URTI were asked to participate in a standardized telephone interview at inclusion, one-, three- and twelve-month follow up. Study outcomes included medication consumption, URTI symptoms' resolution and potentially-associated infections (sinusitis or otitis media/externa) as reported by patients. Analyses included calibration to account for non-respondents and groups were compared using multivate analyses adjusting for baseline differences with a propensity score.
518 adults and children with URTI (79.3% rhinopharyngitis) were included (36.9% response rate comparable between groups). As opposed to GP-CM patients, patients in the GP-Ho group showed significantly lower consumption of antibiotics (Odds ratio (OR) = 0.43, 95% confidence interval (CI): 0.27-0.68) and antipyretic/anti-inflammatory drugs (OR = 0.54, 95% CI: 0.38-0.76) with similar evolution in related symptoms (OR = 1.16, 95% CI: 0.64-2.10). An excess of potentially-associated infections (OR = 1.70, 95% CI: 0.90-3.20) was observed in the GP-Ho group (not statistically significant). No difference was found between GP-CM and GP-Mx patients.
Patients who chose to consult GPs certified in homeopathy used less antibiotics and antipyretic/anti-inflammatory drugs for URTI than those seen by GPs prescribing conventional medications. No difference was observed in patients consulting GPs within mixed-practice. A non-statistically significant excess was estimated through modelling for associated infections in the GP-Ho group and needs to be further studied.
Extreme dilutions especially, homeopathic remedies of 30c, 200c and higher potencies are prepared by a process of serial dilution of 1:100 per step. As a result, dilution factors of 10^60, 10^400 or even greater, are achieved. Therefore, both, the presence of any active ingredient as well as the therapeutic efficacy of these medicines, have been contentious because existence of even traces of the starting raw materials in them is inconceivable. However, physicochemical studies of these solutions have unequivocally established the presence of the starting raw materials in nanoparticulate form even in these extreme (super-Avogadro, >10^23) dilutions. In this paper, we propose and validate a hypothesis to explain how nanoparticles are retained even at such enormous dilution levels. We show that once the bulk concentration is below a threshold level of a few nanograms/millilitre (ng/ml), at the end of each dilution step, all the nanoparticles levitate to the surface and are accommodated as a monolayer at the top. This dominant population at the air-liquid interface is preserved and carried to the subsequent step thereby forming an asymptotic concentration. Thus, all dilutions are only apparent, and not real in terms of the concentrations of the starting raw materials.
Background:
Homeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause.
Objective:
The objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women.
Study design:
This was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011.
Setting:
The study was conducted in 35 active centers in France (gynecologists in private practice).
Patients:
One hundred and eight menopausal women, ≥ 50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥ 5 hot flashes per day with a significant negative effect on the women's professional and/or personal life.
Intervention:
Treatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks.
Main outcome measure:
The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded.
Results:
One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01.
Conclusion:
BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication. Trial registration number (EudraCT): 2009-016959-21.
Low-field (0.02–4 MHz) proton nuclear magnetic resonance (NMR) longitudinal relaxometry was applied to ultrahighly diluted
aqueous solutions in order to detect physical modifications induced in the solvent by the dilution process. A mixture of silica-lactose
(1.67·10−5 M silica, 2.92·10−2 M lactose) was initially solubilized in water or in saline, then submitted to eighteen iterative centesimal dilutions in
water or in saline under vigorous vortex agitation and rigorously controlled atmospheric conditions, and compared to similarly
treated pure water and saline as controls. Several independent series of samples were measured according to a blind protocol
(total of 140 code-labelled samples). A slight frequency dispersion (about 4%) was found within the 0.02–4 MHz range, centered
around 0.55 MHz, and ascribed to combined effects of silica and trace paramagnetic contaminants, both concentrated and in
a reduced motion at the borosilicate wall tube interface. The iterative dilution-agitation process in pure water and saline
induced no significant effect on relaxivity. Slightly increased relaxivity compared to solvent was found in the initial silica-lactose
dilution (especially in saline, about 4%), which vanished unexpectedly slowly upon dilution, as adjusted to an arbitrary log-linear
model. Statistical analysis was applied to succeed in discriminating solutions from their solvents beyond the 10−12 level of dilution. No clear explanation emerged, but post-experiment chemical analysis revealed high amounts (6 ppm) of released
silica from the glass material used, with excess in silicalactose samples, and lower amounts of trace paramagnetic contaminants
in highly diluted silica-lactose samples, which could provide a clue.
To investigate the intrinsic effects of individually prescribed homoeopathic medicines.
Randomised double blind placebo controlled study.
Paediatric outpatient department of university hospital.
175 children with frequently recurring upper respiratory tract infections. Of the 170 children evaluable, 86 were randomised to homoeopathic medicines (47 boys, 39 girls; median age at start 4.2 years; median number of episodes in past year 4) and 84 to placebo (43 boys, 41 girls; median age at start 3.6 years; median number of episodes in past year 4).
Mean score for daily symptoms, number of antibiotic courses, and number of adenoidectomies and tonsillectomies over one year of follow up.
The mean daily symptom score was 2.61 in the placebo group and 2.21 in the treatment group (difference 0.41; 95% confidence interval -0.02 to 0.83). In both groups the use of antibiotics was greatly reduced compared with that in the year before entering the trial (from 73 to 33 in the treatment group and from 69 to 43 in the placebo group). The proportion of children in the treatment group having adenoidectomies was lower in the treatment group (16%, 8/50) than in the placebo group (21%, 9/42). The proportion having tonsillectomies was the same in both groups (5%).
Individually prescribed homoeopathic medicines seem to add little to careful counselling of children with recurrent upper respiratory tract infection in reducing the daily burden of symptoms, use of antibiotics, and need for adenoidectomy and tonsillectomy.
To test the hypothesis that homoeopathy is a placebo by examining its effect in patients with allergic rhinitis and so contest the evidence from three previous trials in this series. Design: Randomised, double blind, placebo controlled, parallel group, multicentre study.
Four general practices and a hospital ear, nose, and throat outpatient department.
51 patients with perennial allergic rhinitis. Intervention: Random assignment to an oral 30c homoeopathic preparation of principal inhalant allergen or to placebo.
Changes from baseline in nasal inspiratory peak flow and symptom visual analogue scale score over third and fourth weeks after randomisation.
Fifty patients completed the study. The homoeopathy group had a significant objective improvement in nasal airflow compared with the placebo group (mean difference 19.8 l/min, 95% confidence interval 10.4 to 29.1, P=0.0001). Both groups reported improvement in symptoms, with patients taking homoeopathy reporting more improvement in all but one of the centres, which had more patients with aggravations. On average no significant difference between the groups was seen on visual analogue scale scores. Initial aggravations of rhinitis symptoms were more common with homoeopathy than placebo (7 (30%) v 2 (7%), P=0.04). Addition of these results to those of three previous trials (n=253) showed a mean symptom reduction on visual analogue scores of 28% (10.9 mm) for homoeopathy compared with 3% (1.1 mm) for placebo (95% confidence interval 4.2 to 15.4, P=0.0007).
The objective results reinforce earlier evidence that homoeopathic dilutions differ from placebo.
To assess the efficacy of individualized classical homeopathy in the treatment of fibromyalgia.
This study was a double-blind, randomized, parallel-group, placebo-controlled trial of homeopathy. Community-recruited persons (N = 62) with physician-confirmed fibromyalgia (mean age 49 yr, s.d. 10 yr, 94% women) were treated in a homeopathic private practice setting. Participants were randomized to receive oral daily liquid LM (1/50,000) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo. Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths, at baseline, 2 months and 4 months (prior to a subsequent optional crossover phase of the study which is reported elsewhere). Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care, self-rating scales on fibromyalgia-related quality of life, pain, mood and global health at baseline and 3 months, were the primary clinical outcome measures for this report.
Fifty-three people completed the treatment protocol. Participants on active treatment showed significantly greater improvements in tender point count and tender point pain, quality of life, global health and a trend toward less depression compared with those on placebo.
This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy. Using a broad selection of remedies and the flexible LM dose (1/50,000 dilution factor) series, the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia.
The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting.
The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (< or = 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy.
Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89-2.22) in children and 0.92 (0.63-1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838).
In primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment.
Résumé
La critique de l’homéopathie repose sur l’absence théorique de l’ingrédient de départ dans les dilutions ultramoléculaires au-delà de 12 CH (limite d’Avogadro), et corrélativement sur l’absence de mécanisme d’action biologique. Or, la préparation spécifique par dilution/dynamisation implique des processus d’interaction itératifs avec l’atmosphère (nanobulles), les parois des contenants (silice et autres éléments chimiques), et avec la micropipette de prélèvement (adsorption). La RMN a montré depuis 2003 des nanostructures (NS) dans les dilutions ultramoléculaires, confirmées plus récemment par diverses techniques (filtration, diffusion laser, diffraction RX, microscopie électronique). Ces nanostructures/nanoparticules (NS/NPs) persistent et même s’accroissent avec la hauteur de dilution, et sont différenciables selon la substance de départ, à condition d’avoir été dynamisées. Plusieurs études montrent la présence inattendue de matériel dans les hautes dilutions, et souvent même la rémanence du matériel initial au-delà de 12 CH. Ces NS/NPs ne sont pas observées à basse dilution. La gamme 2-4 CH correspond à la transition entre l’état « moléculaire » et « nanoparticulaire » du principe actif qui pourrait expliquer les inversions d’effets observés en biologie. Compte tenu des propriétés particulières de biodisponibilité et réactivité des NPs, l’hypothèse des hautes dilutions agissant comme nanomédecine peut raisonnablement être avancée.
Résumé
La récente évaluation de l’efficacité des médicaments homéopathiques par la Haute Autorité de Santé (HAS) a été essentiellement centrée sur le médicament alors que l’homéopathie constitue une thérapeutique qu’il est nécessaire d’évaluer dans son ensemble. Après avoir décrit les caractéristiques essentielles de cette thérapeutique, l’examen des résultats obtenus dans différentes situations cliniques examinées par la HAS permet de faire des propositions d’évaluation clinique, avec des études d’observation et des essais cliniques adaptés à la singularité essentielle de la thérapeutique : l’individualisation du traitement. La poursuite de l’intégration du médicament homéopathique dans le système de santé français et de son remboursement est une condition indispensable pour assurer le développement de la recherche et la sécurité des patients.
Résumé
Le médicament homéopathique Silicea a fait l’objet d’études biologiques, physiques et cliniques. En biologie, Silicea active la production de Paf acether par les macrophages péritonéaux de souris. Les hautes dilutions de Silicea ont été étudiées en résonnance magnétique nucléaire avec une modification reproductible des temps de relaxation des protons de l’eau. En clinique, Siliceaa été utilisé en Inde dans le traitement de lymphadénites tuberculeuses et pourrait être inclus dans le traitement homéopathique complémentaire du traitement standard des tuberculoses pulmonaires multirésistantes.
Background
NMR proton relaxation is sensitive to the dynamics of the water molecule H2O, through the interaction of the spin of the proton (¹H) with external magnetic and electromagnetic fields.
Methods
We measured dilution and potentization processes through measurements of ¹H spin-lattice T1 and spin–spin T2 relaxation times. In order to interpret the recorded fluctuations in T1- or T2-values, experimental data were linearized by investigating how the area under a fluctuating time = f(dilution) curve (dilution integral or DI) changes with dilution. Two kinds of fitting procedures were considered: chi-square fitting with a goodness-of-fit probability, and least absolute deviations criterion with Pearson's linear correlation coefficient.
Results
We showed that fluctuations are not attributable to random noise and/or experimental errors, evidencing a memory effect quantifiable by the slope of the DI = f(dilution) straight line. For all experiments, correlation coefficients were found to lie above 0.9999, against 0.999 for random noise. The discrimination between experimental slopes and slopes associated with random noise data was very good at a five-sigma level of confidence (i.e. probability 3 × 10⁻⁷). Discrimination between experimental slopes at a five-sigma level was possible in most cases, with three exceptions: gelsemium aqua pura v gelsemium dilution (four-sigma); copper aqua pura v gelsemium aqua pura (four-sigma) and copper simple dilution v gelsemium simple dilution (three-sigma). All potentized samples show very good discrimination (at least nine-sigma level) against aqua pura, lactose or simple dilution. It was possible to transform the associated relaxation times into a molecular rotational correlation time τc and an average spin–spin distance d. Our experiments thus point to a considerable slowing down of molecular movements (τc > 1300 ps or T = 224–225 K) around water molecules up to a distance of 3.7 Å, values. It was also possible to rule out other possible mechanisms of relaxation (diffusive motion, ¹⁷O-¹H relaxation or coupling with the electronic spin, S = 1, of dissolved dioxygen molecules).
Conclusion
There is clear evidence that homeopathic solutions cannot be considered as pure water as commonly assumed. Instead, we have evidenced a clear memory effect upon dilution/potentization of a substance (water, lactose, copper, gelsemium) reflected by different rotational correlation times and average H⋯H distances. A possible explanation for such a memory effect may lie in the formation of mesoscopic water structures around nanoparticles and/or nanobubbles mediated by zero-point fluctuations of the vacuum electromagnetic field as suggested by quantum field theories. The existence of an Avogadro's ‘wall’ for homeopathically-prepared medicines is not supported by our data. Rather it appears that all dilutions have a specific material configuration determined by the potentized substance, also by the chemical nature of the containers, and dissolved gases and the electromagnetic environment. This sensitivity of homeopathically-prepared medicines to electromagnetic fields may be amplified by the highly non-linear processing routinely applied in the preparation of homeopathic medicines. Future work is needed in such directions. The time is now ripe for a demystification of the preparation of homeopathic remedies.
Le gouvernement australien a récemment publié un rapport étudiant l’efficacité de l’homéopathie dans de nombreuses pathologies, ceci en utilisant, comme source, des revues systématiques relatives aux essais cliniques réalisés en homéopathie. L’étude de 57 revues systématiques a permis l’analyse de 68 états pathologiques. Cependant, cette méthode conduit à l’exclusion d’essais bien conduits et à des analyses parfois excessivement tranchées. De plus, aucun médecin homéopathe expert sur le sujet n’a participé à ce travail. Analysant chaque situation étudiée par le groupe de travail, nous apportons des informations complémentaires et effectuons des propositions afin de déterminer dans quels domaines des essais cliniques contrôlés ou des études plus pragmatiques peuvent être effectués.
Background:
Experiments about basic research in Immuno-allergology reported by M. Bastide and B. Poitevin in Ultra High Dilution (1994) have been appraised from a 20 year perspective. The numerous experiments published mainly focus on immunological regulation, inflammatory process and basophil activation. They are analyzed according to one essential criterion: repeatability.
Methods:
The commentary reflects the research details made available in a recently published literature review, also published in French.
Results:
The regulatory effect of high dilution of bursin on immune response has been observed in multiple experiments but not reproduced by independent teams. The immunomodulating effect of Thymulin has been confirmed in mice. Rhus toxicodendron has an anti-inflammatory activity on different models, from mother tincture (TM) to very high dilutions. The homeopathic complex Canova activates macrophages in vitro and in vivo, induces lymphocyte proliferation, and reduces the size of tumors and mortality of sarcoma-bearing mice. Some homeopathic medicines used in clinical inflammation modulate in vitro the neutrophil activation, with variability in the protocols used and in the medicines tested. In allergology, high dilution histamine has an inhibitory effect on basophil activation in multicenter trials and with independent teams, either with methods implying a change in basophil staining or with flow cytometry. However, high dilution histamine had no effect in some well-conducted experiments. The inhibitory effect of Apis mellifica has not been studied with the flow cytometry method, as well as the activation of basophil by anti-IgE high dilution, published in Nature.
Conclusions:
Despite considerable research activity in immuno-allergology and a great increase in the number of publications, there is still not in this domain a "gold standard" trial in basic research in homeopathy. The most studied system, the inhibitory effect of histamine high dilutions on basophil activation, requires clarifications of various factors, including individual sensitivity. For scientific and epistemological reasons, the same work should be carried out for independent reproduction of the experiments conducted with anti-IgE and Apis mel high dilution, in complement of the new axes of research in immunoallergology developed since 20 years.
Background:
The "Ultra High Dilution 1994" project was an endeavour to take stock of the findings and theories on homeopathic extreme dilutions that were under research at the time in areas of biology, biophysics, physics and medicine. The project finally materialized into an anthology assembling contributions of leading scientists in the field. Over the following two decades, it became widely quoted within the homeopathic community and also known in other research communities. The aim of the present project was to re-visit and review the 1994 studies from the perspective of 2015.
Method:
The original authors from 1994 or close laboratory colleagues were asked to contribute papers covering their research efforts and learnings in the period from 1994 up to 2015. These contributions were edited and cross-referenced, and a selection of further contributions was added.
Results:
About a dozen contributions reported on follow-up experiments and studies, including further developments in theory. Only few of the models that had seemed promising in 1994 had not been followed up later. Most models presented in the original publication had meanwhile been submitted to intra-laboratory, multicentre or independent scrutiny. The results of the follow-up research seemed to have rewarded the efforts. Furthermore, contributions were provided on new models that had been inspired by the original ones or that may be candidates for further in-depth ultra high dilution (UHD) research.
Conclusion:
The project "Ultra High Dilution 1994 revisited 2015" is the latest output of what might be considered the "buena vista social club" of homeopathy research. However, it presents new developments and results of the older, established experimental models as well as a general survey of the state of UHD research.
We tested, under independent conditions, the reproducibility of evidence from two previous trials that homoeopathy differs from placebo. The test model was again homoeopathic immunotherapy. 28 patients with allergic asthma, most of them sensitive to house-dust mite, were randomly allocated to receive either oral homoeopathic imm;notherapy to their principal allergen or identical placebo. The test treatments were given as a complement to their unaltered conventional care. A daily visual analogue scale of overall symptom intensity was the outcome measure. A difference in visual analogue score in favour of homoeopathic immunotherapy appeared within one week of starting treatment and persisted for up to 8 weeks (p=0.003). There were similar trends in respiratory function and bronchial reactivity tests. A meta-analysis of all three trials strengthened the evidence that homoeopathy does more than placebo (p=0.0004). Is the reproducibility of evidence in favour of homoeopathy proof of its activity or proof of the clinical trial's capacity to produce false-positive results?
Nanobubbles (NBs) have been a subject of intensive research over the past decade. Their peculiar characteristics, including extremely low buoyancy, longevity, enhanced solubility of oxygen in water, zeta potentials and burst during collapse, have led to many applications in the industrial, biological and medical fields. NBs may form spontaneously from dissolved gas but the process is greatly enhanced by gas supersaturation and mechanical actions such as dynamization. Therefore, the formation of NBs during the preparation of homeopathic dilutions under atmospheric pressure cannot be ignored. I suggested in 2009 the involvement of NBs in nanometric superstructures revealed in high dilutions using NMR relaxation. These superstructures seemed to increase in size with dilution, well into the ultramolecular range (>12c). I report here new experiments that confirm the involvement of NBs and prove the crucial role of dynamization to create superstructures specific to the solute. A second dynamization was shown to enhance or regenerate these superstructures. I postulate that superstructures result from a nucleation process of NBs around the solute, with shells of highly organized water (with ions and silicates if any) which protect the solute against out-diffusion and behave as nucleation centres for further dilution steps. The sampling tip may play an active role by catching the superstructures and thus carry the encaged solute across the dilution range, possibly up to the ultramolecular range. The superstructures were not observed at low dilution, probably because of a destructuring of the solvent by the solute and/or of an inadequate gas/solute ratio.
Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.
There is a great overlap between the way of seeing the world in clinical homeopathy and in the technical philosophical system known as phenomenology. A knowledge of phenomenologic principles reveals Hahnemann to have been an unwitting phenomenologist. The ideas of phenomenology as applied to medicine show that homeopathy is the ideal medical system to fulfill the goals of coming ever closer to true patient concerns and experience of illness.
The NMR properties of water in the vicinity of molecules in solution differ from those of water in the pure state. Water molecules interact with the solute via hydrogen bonds and/or electrostatic forces related to their high dipolar momentum. At room temperature, the correlation times t of rotational and translational movements, of the order of 10-11 to 10-12 s in pure water may increase to 10-8 or even 10-6 in the hydration layer of macromolecules (Packer, 1977; Fung, 1977; Mathur-DeVré, 1979), giving rise to a drastic reduction in Tl and T2 water proton NMR relaxation times from 2–3 s to a few hundred milliseconds. Similarly, lowering the temperature of pure water promotes hydrogen bonding and affects relaxation in the same way as the introduction of a solute, leading to water correlation times as high as 10–5 s in ice (Glasel, 1972). Due to the wide 10-5-10-11 s range in correlation times observed in biological or non biological systems, NMR relaxation in the 1–100 MHz domain is one of the potent techniques capable of demonstrating modifications in the mobility and degree of organization of water molecules in solutions or tissues, although it is not very precise in determining the absolute structure. NMR medical imaging is a clear strong successful application of this principle.
We investigated 20MHz water proton NMR longitudinal (T1) and transverse (T2) relaxation in ultrahigh dilutions (range 10−7M–10−47M) of a mixture of silica–lactose (Sil/Lac) in various media (water, 0.15M NaCl, 0.15M LiCl) and in various containers (glass, polyethylene). The samples were prepared by iterative centesimal dilutions under vigorous agitation and rigorously controlled laboratory conditions. Water and salt media were similarly and simultaneously treated, as controls. No significant effect on relaxation times was induced by the iterative dilution/agitation process in pure water and salt controls. By contrast, a slight increase in T1 and decrease in T2 was observed with increasing dilution in silica–lactose solutions, resulting in a marked progressive increase in T1/T2, especially in LiCl medium, distinguishable up to the ultrahigh dilution level. Cross-correlation analyses between T1, T2 and T1/T2 managed to demonstrate opposite behaviours of controls and Sil/Lac dilutions, even in the ultramolecular range of dilution. The effect seemed dependent on the medium (LiCl>NaCl>Water), and was observed in the glassware and polyethylene series as well. After a heating/cooling cycle directly in the sealed NMR tubes, the relaxation variations observed as a function of dilution totally vanished, and the T1/T2 ratio dropped, indicating a less ordered structure. These findings were interpreted in terms of nanosized superstructures with motional correlation time greater than 5.10−9s, nucleated around the solute, and composed of water, ions and nanobubbles generated during the vigorous mechanical process. Incidentally, a striking catalytic enhancement of silica leaching was observed during the preparation of silica–lactose dilutions in glassware; but this did not influence the NMR relaxation results.
To evaluate homeopathy as an adjunctive treatment for bronchial asthma in children.
In a prospective observational longitudinal study the effects of individualised homeopathic medicines were assessed in 30 children with asthma as an adjunct to conventional treatment. The main outcome measures were frequency of attacks, use of medication, night awakening and spirometry at baseline and at follow-up till 6 months.
There were clinically relevant and statistically significant changes in those measuring severity, indicating relative improvements after 3 months and absolute improvements after 6 months of treatment by homeopathic medicines.
This study provides evidence that homeopathic medicines, as prescribed by experienced homeopathic practitioners, improve severity of asthma in children. Controlled studies should be conducted.
We measured 20-MHz R1 and R2 water proton NMR relaxation rates in ultrahigh dilutions (range 5.43 · 10− 8 M–5.43 · 10− 48 M) of histamine in water (Hist-W) and in saline (Hist-Sal), prepared by iterative centesimal dilutions under vigorous agitation in controlled atmospheric conditions. Water and saline were similarly and simultaneously treated, as controls. The samples were immediately sealed in the NMR tubes after preparation, and then code-labelled. Six independent series of preparations were performed, representing about 7000 blind measurements. R2 exhibited a very broad scatter of values in both native histamine dilutions and solvents. No variation in R1 and R2 was observed in the solvents submitted to the iterative dilution/agitation process. By contrast, histamine dilutions exhibited slightly higher R1 values than solvents at low dilution, followed by a slow progressive return to the values of the solvents at high dilution. Unexpectedly, histamine dilutions remained distinguishable from solvents up to ultrahigh levels of dilution (beyond 10− 20 in Hist-Sal). A significant increase in R2 with increased R2/R1 was observed in Hist-W. R1 and R2 were linearly correlated in solvents, but uncorrelated in histamine dilutions. After a 10-min heating/cooling cycle of the samples in their sealed NMR tubes (preventing any modification of the chemical composition and gas content), all of the relaxation variations observed as a function of dilution vanished, the R2/R1 ratio and the scatter of the R2 values dropped in all solutions and solvents, and the correlation between R1 and R2 reappeared in the Hist-W samples. All these results pointed to a more organized state of water in the unheated samples, more pronounced in histamine solutions than in solvents, dependent on the level of dilution. It was suggested that stable supramolecular structures, involving nanobubbles of atmospheric gases and highly ordered water around them, were generated during the vigorous mechanical agitation step of the preparation, and destroyed after heating. Histamine molecules might act as nucleation centres, amplifying the phenomenon which was thus detected at high dilution levels.
The hypothesis that homoeopathic potencies are placebos was tested in a randomised, double-blind, placebo-controlled trial. The study model chosen compared the effects of a homoeopathic preparation of mixed grass pollens with placebo in 144 patients with active hayfever. The homoeopathically treated patients showed a significant reduction in patient and doctor assessed symptom scores. The significance of this response was increased when results were corrected for pollen count and the response was associated with a halving of the need for antihistamines. An initial aggravation of symptoms was noted more often in patients receiving the potency and was followed by an improvement in that group. No evidence emerged to support the idea that placebo action fully explains the clinical responses to homoeopathic drugs.
Twenty-three patients with rheumatoid arthritis on orthodox first-line anti-inflammatory treatment plus homeopathy were compared wtih a similar group of twenty-three patients on orthodox first-line treatment plus an inert preparation. There was a significant improvement in subjective pain, articular index, stiffness and grip strength in those patients receiving homoeopathic remedies whereas there was no significant change in the patients who received placebo. Two physicians were involved in prescribing for the patients and there were no significant differences in the results which they obtained. No side effects were observed with the homoeopathic remedies.
Acute diarrhea is the leading cause of pediatric morbidity and mortality worldwide. Oral rehydration treatment can prevent death from dehydration, but does not reduce the duration of individual episodes. Homeopathic treatment for acute diarrhea is used in many parts of the world. This study was performed to determine whether homeopathy is useful in the treatment of acute childhood diarrhea.
A randomized double-blind clinical trial comparing homeopathic medicine with placebo in the treatment of acute childhood diarrhea was conducted in León, Nicaragua, in July 1991. Eighty-one children aged 6 months to 5 years of age were included in the study. An individualized homeopathic medicine was prescribed for each child and daily follow-up was performed for 5 days. Standard treatment with oral rehydration treatment was also given.
The treatment group had a statistically significant (P < .05) decrease in duration of diarrhea, defined as the number of days until there were less than three unformed stools daily for 2 consecutive days. There was also a significant difference (P < .05) in the number of stools per day between the two groups after 72 hours of treatment.
The statistically significant decrease in the duration of diarrhea in the treatment group suggests that homeopathic treatment might be useful in acute childhood diarrhea. Further study of this treatment deserves consideration.
The use of antibiotics in the initial treatment of acute otitis media is currently being questioned. Homeopathy has been used historically to treat this illness, but there have been no methodologically rigorous trials to determine whether there is a positive treatment effect.
A randomized double blind placebo control pilot study was conducted in a private pediatric practice in Seattle, WA. Seventy-five children ages 18 months to 6 years with middle ear effusion and ear pain and/or fever for no more than 36 h were entered into the study. Children received either an individualized homeopathic medicine or a placebo administered orally three times daily for 5 days, or until symptoms subsided, whichever occurred first. Outcome measures included the number of treatment failures after 5 days, 2 weeks and 6 weeks. Diary symptom scores during the first 3 days and middle ear effusion at 2 and 6 weeks after treatment were also evaluated.
There were fewer treatment failures in the group receiving homeopathy after 5 days, 2 weeks and 6 weeks, with differences of 11.4, 18.4 and 19.9%, respectively, but these differences were not statistically significant. Diary scores showed a significant decrease in symptoms at 24 and 64 h after treatment in favor of homeopathy (P < 0.05). Sample size calculations indicate that 243 children in each of 2 groups would be needed for significant results, based on 5-day failure rates.
These results suggest that a positive treatment effect of homeopathy when compared with placebo in acute otitis media cannot be excluded and that a larger study is justified.
Released of an annotated version of the 2012 draft report: The effectiveness of Homéopathy: an overview review of secondary evidence
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