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Die Zukunft der Homöopathie

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  • Kazimieras Simonavicius University
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Upper respiratory tract infections (URTI) are very common and associated with considerable healthcare costs. We evaluated the clinical benefit of a homeopathic add-on therapy. In this randomized controlled multinational clinical trial, patients (age range 1-65 years) with feverish URTI received either on-demand symptomatic standard treatment (ST group: paracetamol, ambroxol, and/or oxymetazoline), or homeopathic medication (IFC group: Influcid®) for 7 days plus the same on-demand standard treatment. URTI symptoms were assessed using the Wisconsin Upper Respiratory Symptom Survey-21. Response at day 4, defined as absence of fever and absence or very mild degree of URTI symptoms, was the primary outcome measure. 523 patients (265 IFC group, 258 ST group) were randomized in 12 Ukrainian and 10 German centers. The responder rate on day 4 was 15.4% in the IFC group and 6.7% in the ST group (x0394;IFC-ST = 8.7%, 95% confidence interval 2.9-14.5%). The IFC group used less symptomatic medication, and symptoms were alleviated 1-2 days earlier. 3 and 8 adverse events (AEs) in the IFC and ST group, respectively, were assessed as possibly treatment-related; 2 out of the 3 AEs in the IFC group were possibly related to symptomatic therapy, 1 (vomiting) to IFC treatment. The homeopathic treatment shortened URTI duration, reduced the use of symptomatic medication, and was well tolerated. © 2015 S. Karger GmbH, Freiburg.
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Benveniste's experiments (also known as " memory of water " or " digital biology " experiments) remain unresolved. In some research areas, which have in common the description of cognition mechanisms and information processing, quantum-like statistical models have been proposed to address problems that were " paradoxical " in a classical frame. Therefore, the outcomes of the cognitive state of the experimenter were calculated for a series of Benveniste's experiments using a quantum-like statistical model (i.e. a model inspired by quantum physics and taking into consideration superpo-sition of quantum states, non-commutable observables, and contextuality). Not only were the probabilities of " success " and " failure " of the experiments modeled according to their context, but the emergence of a signal from background was also taken into account. For the fi rst time, a formal framework devoid of any reference to " memory of water " or " digital biology " describes all the characteristics of these disputed results. In particular, the diffi culties encountered by Benveniste (reproducibility of the experiments, disturbances after blinding) are simply explained in this model without additional ad hoc hypotheses. It is thus proposed that we see Benveniste's experiments as the result of quantum-like probability interferences of cognitive states.
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DNA hypermethylation induces cancer progression involving CpG island of DNA and causes inactivation of tumour suppressor genes. In this study, DNA hypermethylation status of lung cancer and ability of ultra-highly diluted Condurango 30C to modulate DNA methylation were ascertained by analysis of lung cancer-specific tumour suppressor genes in respect to placebo. DNA methylation status, if any, was determined by PCR-SSCP analyses in lung cancer-specific tumour suppressor genes (p15, p16 and p53) using H460-NSCLC cell and BaP-induced lung cancer of rats. The ability of Condurango 30C to modulate DNA methylation, if any, was verified against placebo control in blinded manner. Condurango 30C-treated DNA showed significant decrease in band intensity of p15 and p53 genes especially in methylated condition in vitro, at IC50 dose (2.43µl/100µl). SSCP analysis of p15 and p53 genes in Condurango 30C-treated DNA also suggests that Condurango 30C can decrease methylation, in vitro. Inhibition of p15 hypermethylation was observed in post-cancer treatment of rats with Condurango 30C. SSCP results gave a better indication of differences in band position of p15 and p53 in Condurango 30C-treated lung samples. Condurango 30C could trigger epigenetic modification in lung cancer via modulation of DNA hypermethylation. © 2015 S. Karger GmbH, Freiburg.
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Even though homeopathy is regarded as a harmless intervention, homeopathic practice may not be entirely risk-free. Risk in homeopathy can be divided into direct and indirect risk. Direct risk refers to traditional adverse effects of an intervention; indirect risk is related to adverse effects in a treatment context, e.g. the practitioner. Available data suggest that the risk profile of homeopathic remedies in ultra-molecular potencies is minor, but there is a potential for indirect risk related to homeopathic practice. The concept of 'homeopathic aggravation' which is unique for homeopathy may impose a particular risk as it allows the health status of the patients to deteriorate before there is a possible improvement. In that respect it is imperative to distinguish homeopathic aggravations from adverse effects. In a general risk evaluation of the homeopathic treatment it may be useful to assess the patient's symptoms in accordance with the natural course of disease and to evaluate any negative deviation from the normal curve as a possible adverse effect of the treatment. It is imperative that more emphasis is placed on patient safety during the education in homeopathy, and that students are trained to identify serious and red flag situations. © 2015 S. Karger GmbH, Freiburg.
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Seasonal allergic rhinitis (SAR), also known as hay fever, is a widespread chronic respiratory disease. In treatment of SAR the use of complementary therapies is increasing, but little has been published about homeopathic complex remedies so far. Therefore, we think it is time to conduct and publish an appropriate observational study. Course of single symptoms, impairment of quality of life, general efficacy, and tolerability of a homeopathic complex remedy containing active substances on a low dilution level have been assessed and analyzed. Altogether, 123 patients with a history of allergic rhinitis of up to 45 years have been observed for about 4 weeks. The majority of symptoms were shown to improve substantially and the patients' quality of life increased clearly. The overall symptom score decreased significantly from 10.3 ± 4.7 to 3.9 ± 3.1 points (p < 0.0001), and reduction of impairment of quality of life from 5.7 ± 2.3 to 1.9 ± 1.8 score points was also significant (p < 0.0001). Rating of efficacy of study medication was markedly better than efficacy rating of previous therapies (p = 0.0193). Apart from one temporary allergic reaction, the treatment was well tolerated. The homeopathic complex remedy (Pascallerg®) tested in this observational study offers a useful option in treatment of SAR in children and adults. © 2015 S. Karger GmbH, Freiburg.
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Even though homeopathy is regarded as a harmless intervention, homeopathic practice, may not be entirely risk free. Risk in homeopathy can be divided into direct and indirect risk. Direct risk includes traditional adverse effects of an intervention and indirect risk is related to adverse effect related to the treatment context, for example the practitioner. Available data suggest that the risk profile of homeopathic remedies is minor, but there is a potential for indirect risk related to homeopathic practice. The concept of “homeopathic aggravation” which is unique for homeopathy, may impose a particular risk as it allows the health status of the patients to deteriorate before there is a possible improvement. In that respect it is imperative to distinguish homeopathic aggravations from adverse effects. In a general risk evaluation of the homeopathic treatment it may be useful to assess the patients symptoms in accordance with the natural course of disease and to evaluate any deviation from the normal curve as a possible adverse effect of the treatment. It is imperative that more emphasis is placed on patient safety during the education in homeopathy, and that the students are trained to identify serious and red flag situations.
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In homeopathy, ultra-low doses of drugs at ultra-high dilutions are often used with great benefits to patients although at such dilutions physical existence of even a single molecule of the original drug substance is highly improbable. Despite serious challenges thrown by scientists and rationalists from time to time, homeopathy has managed to survive over 200 years now, and is no more considered a myth. Research activities on homeopathy in recent years, at clinical, physical, chemical, biological and medical levels with acceptable scientific norms and approach have paved the way for more rigorous research, particularly at the molecular level to understand the physico-chemical nature and mechanism of action of ultra-high dilutions. Although major breakthrough has been made in understanding many physical aspects and interactions between the “drug” and “aquatic ethanol” used as vehicle/solvent/diluents, certain aspects in regard to structure of water/aquatic ethanol and the latter’s changing structural organization still remain unclear. In recent years, the quest for understanding the mechanism of biological action of the ultra-high dilutions has made homeopathy a hot bed of research. Much progress has been made in understanding the molecular mechanism in the light of the “gene regulatory hypothesis” that can explain the action of the homeopathic high dilutions in all living organisms, both in higher and lower animals as well as in plants. The present review focuses mainly on research in support of the gene regulatory hypothesis, and mention has been made of some relevant physical and biological aspects at cellular and molecular levels.
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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.
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An open-label pilot study of individualized homeopathy for attention deficit hyperactivity disorder (ADHD) was conducted to assess the potential for future studies with a focus on the feasibility of the recruitment plan and outcome measure schedules; identification of any group characteristics of participants who respond significantly to the therapy; and establishing the length of time required for an improvement in ADHD symptoms. Participants (aged 6-16) were recruited through community advertisement and outreach. Participants completed 1 screening and 9 individualized homeopathic follow-up consultations. ADHD symptoms were assessed using the Conners 3 - Parent Questionnaire administered at each consultation. The pre- and post-study difference in Conners Global Index - Parent (CGI-P) T-score was evaluated for each participant. Baseline data of those who showed a statistically significant improvement (responders) were compared to those who did not (non-responders). 35 participants were enrolled over 11 months. 80% completed all 10 consultations in a median of 12.1 months. 63% had a statistically significant improvement in the primary outcome, first occurring after a mean of 4.5 visits. Overall scores for participants completing at least 2 data points decreased from a baseline median of 85.5 to 74.0 (p < 0.001, CI 95%). There were no significant baseline differences between responders and non-responders. No serious adverse events related to the therapy were reported. The change in the median CGI-P T-score from baseline to the end of this open-label pilot study was statistically significant. The research methods are feasible. Future studies are warranted. NCT01141634. © 2014 S. Karger GmbH, Freiburg.
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Background: Oxidative stress is a major mediator in the pathophysiology of several kidney diseases. The cellular damage is mediated by an alteration in the antioxidant status, which increases the concentration of reactive oxygen species (ROS) in the stationary state (oxidative stress). Therefore, interventions favoring the scavenging and/or depuration of ROS should attenuate or prevent the oxidative stress, thereby safeguarding the kidneys against damage. In this sense, this study attempts to evaluate the extent of oxidative stress in experimental urolithiasis by measuring some parameters of oxidant stress and antioxidant defenses in rat kidneys, before and after Berberis vulgaris homeopathic preparation supplementation, and to assess the role, if any, of homeopathic treatment in mitigating free radical toxicity in kidney stone disease. Methods: Rat model of urolithiasis was established by administering 0.75% ethylene glycol (EG) in drinking water, and the effects of a homeopathic preparation of B. vulgaris root bark (HPBV) on the renal antioxidative defense system as well as on potent markers of free radical activities were investigated. Results: HPBV brought about an augmentation in the activities of enzymatic antioxidants such as superoxide dismutase, catalase, glutathione peroxidase, glutathione reductase, and glucose-6-phosphate dehydrogenase and improved the nonenzymatic antioxidants, e.g., tocopherol, ascorbic acid, and glutathione. HPBV ameliorated the malondialdehyde and protein carbonyl levels and restored renal thiols almost completely. Conclusion: Thus, it is shown that HPBV acts as a renoprotective remedy in alleviating the renal calculi-associated oxidative damage by upregulating the antioxidant status.
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The “memory of water” was a major international controversy that remains unresolved. Taken seriously or not, this hypothesis leads to logical contradictions in both cases. Indeed, if this hypothesis is held as wrong, then we have to explain how a physiological signal emerged from the background and we have to elucidate a bulk of coherent results. If this hypothesis is held as true, we must explain why these experiments were difficult to reproduce by other teams and why some blind experiments were so disturbing for the expected outcomes. In this article, a third way is proposed by modeling these experiments in a quantum-like probabilistic model. It is interesting to note that this model does not need the hypothesis of the “memory of water” and, nevertheless, all the features of Benveniste’s experiments are taken into account (emergence of a signal from the background, difficulties faced by other teams in terms of reproducibility, disturbances during blind experiments, and apparent “jumps of activity” between samples). In conclusion, it is proposed that the cognitive states of the experimenter exhibited quantum-like properties during Benveniste’s experiments.
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Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients. We conducted a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). For a direct comparison, matched pairs with patients of the same tumour entity and comparable prognosis were to be formed. Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months. Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by fatigue (MFI) and by anxiety and depression (HADS). HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from 75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did not change. CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12 months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 - SD 8.9) to t1 (32.1 - SD 8.9) and declined again after a year (31.6 - SD 9.4). For fatigue, anxiety, and depression, no relevant changes were found. 120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a comparative study. In our prospective study, we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take considerably larger samples to find matched pairs suitable for comparison in order to establish a definite causal relation between these effects and homeopathic treatment.
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Homeopathic aggravation is a temporary worsening of existing symptoms following the administration of a correct homeopathic prescription. The aim of this study was to explore and compose criteria that may differentiate homeopathic aggravations from adverse effects. A qualitative approach was employed using focus group interviews. 2 interviews, with 11 experienced homeopaths, were performed in Oslo, Norway. The practitioners have practiced classical homeopathy over a period of 10-32 years. Qualitative content analysis was used to analyze the text data. The codes were defined before and during the data analysis. We found that aggravations were subtle and multifaceted events. Moreover, highly skilled homeopaths are required to identify and report aggravations. Adverse effect may be defined as an 'undesirable effect of a remedy'. This definition is pragmatic, flexible, and more in line with the holistic paradigm that the homeopaths represent. 8 criteria that distinguish aggravation from adverse effect were found. Highly sensitive persons hold a unique position regarding safety, as it is important to identify these patients in order to treat them correctly and avoid undesirable effects of the treatment. This study rigorously explored homeopaths' views and experience on aggravation and adverse effects. The 8 criteria developed in this study may ensure patient safety and support therapists in identifying an 'undesirable effect of a remedy'.
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In homeopathy, ability of ultra-high diluted drugs at or above potency 12C (diluted beyond Avogadro's limit) in ameliorating/curing various diseases is often questioned, particularly because the mechanism of action is not precisely known. We tested the hypothesis if suitable modulations of signal proteins could be one of the possible pathways of action of a highly diluted homeopathic drug, Secale cornutum 30C (diluted 10(60) times; Sec cor 30). It could successfully combat DMBA + croton oil-induced skin papilloma in mice as evidenced by histological, cytogenetical, immunofluorescence, ELISA and immunoblot findings. Critical analysis of several signal proteins like AhR, PCNA, Akt, Bcl-2, Bcl-xL, NF-κB and IL-6 and of pro-apoptotic proteins like cytochrome c, Bax, Bad, Apaf, caspase-3 and -9 revealed that Sec cor 30 suitably modulated their expression levels along with amelioration of skin papilloma. FACS data also suggested an increase of cell population at S and G2 phases and decrease in sub-G1 and G1 phages in carcinogen-treated drug-unfed mice, but these were found to be near normal in the Sec cor 30-fed mice. There was reduction in genotoxic and DNA damages in bone marrow cells of Sec Cor 30-fed mice, as revealed from cytogenetic and Comet assays. Changes in histological features of skin papilloma were noted. Immunofluorescence studies of AhR and PCNA also suggested reduced expression of these proteins in Sec cor 30-fed mice, thereby showing its anti-cancer potentials against skin papilloma. Furthermore, this study also supports the hypothesis that potentized homeopathic drugs act at gene regulatory level.
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Homeopathy is scientifically banned, both for lack of consistent empirical findings, but more so for lack of a sound theoretical model to explain its purported effects. This paper makes an attempt to introduce an explanatory idea based on a generalized version of quantum mechanics (QM), the weak quantum theory (WQT). WQT uses the algebraic formalism of QM proper, but drops some restrictions and definitions typical for QM. This results in a general axiomatic framework similar to QM, but more generalized and applicable to all possible systems. Most notably, WQT predicts entanglement, which in QM is known as Einstein-Podolsky-Rosen (EPR) correlatedness within quantum systems. According to WQT, this entanglement is not only tied to quantum systems, but is to be expected whenever a global and a local variable describing a system are complementary. This idea is used here to reconstruct homeopathy as an exemplification of generalized entanglement as predicted by WQT. It transpires that homeopathy uses two instances of generalized entanglement: one between the remedy and the original substance (potentiation principle) and one between the individual symptoms of a patient and the general symptoms of a remedy picture (similarity principle). By bringing these two elements together, double entanglement ensues, which is reminiscent of cryptographic and teleportation applications of entanglement in QM proper. Homeopathy could be a macroscopic analogue to quantum teleportation. This model is exemplified and some predictions are derived, which make it possible to test the model.
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Despite the increasing demand for acupuncture and homoeopathy in Germany, little is known about the effects of these treatments in routine care. We set up a pragmatic documentation study in general practice funded within the scope of project launched by a German health insurer. Patients were followed-up for up to four years. The aim of the project was to study the effects and benefits of acupuncture and/or homoeopathy, and to assess patient satisfaction within a prospective documentation of over 5000 acupuncture and over 900 homoeopathy patients. As data sources, we used the documentation made available by therapists on every individual visit and a standardised quality-of-life questionnaire (MOS SF-36); these were complemented by questions concerning the patient's medical history and by questions on patient satisfaction. The health insurer provided us with data on work absenteeism. Descriptive analyses of the main outcomes showed benefit of treatment with middle to large-sized effects for the quality of life questionnaire SF-36 and about 1 point improvement on a rating scale of effects, given by doctors. Data on the treatment and the patients' and physicians' background suggests chronically ill patients treated by fairly regular schemes. Since the results showed evidence of a subjective benefit for patients from acupuncture and homoeopathy, this may account for the increase in demand for these treatments especially when patients are chronically ill and unsatisfied with the conventional treatment given previously.
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Unlabelled: An increasing number of parents turn to homeopathy for treatment of their hyperactive child. Two publications, a randomised, partially blinded trial and a clinical observation study, conclude that homeopathy has positive effects in patients with attention deficit hyperactivity disorder (ADHD). The aim of this study was to obtain scientific evidence of the effectiveness of homeopathy in ADHD. A total of 83 children aged 6-16 years, with ADHD diagnosed using the Diagnostic and Statistical Manual of Mental Disorders-IV criteria, were recruited. Prior to the randomised, double blind, placebo controlled crossover study, they were treated with individually prescribed homeopathic medications. 62 patients, who achieved an improvement of 50% in the Conners' Global Index (CGI), participated in the trial. Thirteen patients did not fulfill this eligibility criterion (CGI). The responders were split into two groups and received either verum for 6 weeks followed by placebo for 6 weeks (arm A), or vice-versa (arm B). At the beginning of the trial and after each crossover period, parents reported the CGI and patients underwent neuropsychological testing. The CGI rating was evaluated again at the end of each crossover period and twice in long-term follow-up. At entry to the crossover trial, cognitive performance such as visual global perception, impulsivity and divided attention, had improved significantly under open label treatment (P<0.0001). During the crossover trial, CGI parent-ratings were significantly lower under verum (average 1.67 points) than under placebo (P =0.0479). Long-term CGI improvement reached 12 points (63%, P <0.0001). Conclusion: The trial suggests scientific evidence of the effectiveness of homeopathy in the treatment of attention deficit hyperactivity disorder, particularly in the areas of behavioural and cognitive functions.
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On the range of diagnoses, course of treatment, and long-term outcome in patients who chose to receive homeopathic medical treatment very little is known. We investigated homeopathic practice in an industrialized country under everyday conditions. In a prospective, multicentre cohort study with 103 primary care practices with additional specialisation in homeopathy in Germany and Switzerland, data from all patients (age > 1 year) consulting the physician for the first time were observed. The main outcome measures were: Patient and physician assessments (numeric rating scales from 0 to 10) and quality of life at baseline, and after 3, 12, and 24 months. A total of 3,981 patients were studied including 2,851 adults (29% men, mean age 42.5 +/- 13.1 years; 71% women, 39.9 +/- 12.4 years) and 1,130 children (52% boys, 6.5 +/- 3.9 years; 48% girls, 7.0 +/- 4.3 years). Ninety-seven percent of all diagnoses were chronic with an average duration of 8.8 +/- 8 years. The most frequent diagnoses were allergic rhinitis in men, headache in women, and atopic dermatitis in children. Disease severity decreased significantly (p < 0.001) between baseline and 24 months (adults from 6.2 +/- 1.7 to 3.0 +/- 2.2; children from 6.1 +/- 1.8 to 2.2 +/- 1.9). Physicians' assessments yielded similar results. For adults and young children, major improvements were observed for quality of life, whereas no changes were seen in adolescents. Younger age and more severe disease at baseline were factors predictive of better therapeutic success. Disease severity and quality of life demonstrated marked and sustained improvements following homeopathic treatment period. Our findings indicate that homeopathic medical therapy may play a beneficial role in the long-term care of patients with chronic diseases.
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Introduction: Beauvais presented the application of a so-called 'quantum-like model of homeopathy' by introducing the idea of a type of randomization/unblinding which he called 'in situ'. He predicted that randomized studies based on this type of randomization/unblinding lead to more pronounced effects in placebo controlled randomized homeopathic trials. We designed an experiment regarding wheat germination and stalk length to investigate Beauvais' idea of 'in situ randomization/unblinding' using a homeopathic dilution of sulphur (LM VI) as compared to placebo as well as to water. Aim and method: The primary aim of this double-blind randomized controlled experiment was to investigate whether there are differences of 'in situ randomization/unblinding' vs 'central randomization/unblinding' with respect to the effect of a homeopathic substance compared to placebo. The secondary aim of our study was to examine possible differences between the sulphur and the placebo group in the 'in situ' arm regarding germination and/or stalk growth of wheat seedlings measured after a seven days exposure. Wheat was treated either with sulphur LM VI, placebo, or water. The wheat grains were placed on glass lids and treatment was performed following the 'in situ randomization/unblinding' as well as 'central randomization/unblinding' method. Germination was measured and classified into three categories. Results: Under 'in situ' randomization/unblinding the odds of a seed not to germinate is 40% lower if treated with sulphur compared to placebo (p=0.004). In contrast, these odds are practically equal in the 'central' meta-group (OR=1.01, p=0.954). Under 'in situ' randomization/unblinding the odds of a seed to germinate with a length ≥1mm is practically equal if treated with sulphur or with placebo (OR=0.96, p=0.717). In contrast, these odds are 21% higher under sulphur compared to placebo in the 'central' meta-group (OR=1.21, p=0.062). In summary, we found a sulphur effect that is significantly different between 'in situ' and 'central' randomization/unblinding relating to all three stages of germination.
Article
Background: To date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT). Objectives: The purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results. Design: Systematic review with meta-analysis. Methods: As previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study. Main outcome measures: For each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation ('high', 'moderate, "low", 'very low'), based on the GRADE principle of 'downgrading'. Results: Merging the assessment of MVHT and RoB identified three trials of 'high quality', eight of 'moderate quality', 18 of 'low quality' and three of 'very low quality'. There was no association between a trial's MVHT and its RoB or its direction of treatment effect (P>0.05). The three 'high quality' trials were those already labelled 'reliable evidence' based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy. Conclusion: Accommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.
Article
Background: Homeopathic drug provings or pathogenetic trials (HPTs) are the pillar of homeopathy. This review summarizes the authors' findings and interpretations derived from a series of homeopathic drug proving between 1994 and 2015. It gives an overview over a series of attempts to use modern scientific experimental methodology to answer the question, whether such HPTs produce symptoms in healthy volunteers that can be distinguished from placebo symptoms. Methods: Various experimental models were used: repeated crossover trials with categorical data collection, and a single-case, randomised study. Final models use diligent qualitative data-collection in experienced volunteers. In those, raters decide whether symptoms are typical for a remedy delivered or not. The design is triple-blind and placebo-controlled. Result: While previous attempts were inconclusive, this new model allowed to separate placebo symptoms from verum symptoms repeatedly in a series of two definitive studies following promising pilot studies. Results were statistically significant. Also, some signs of the purported non-local signature of homeopathic effects were visible, and the consequences for future methodology is discussed. Conclusion: Provided some cautionary notes are taken into account, HPTs can be used to separate out true specific symptoms from placebo symptoms. By the same token this is a road to experimental proof that homeopathic remedies are not just placebos. However, this needs to be taken forward by independent groups.
Article
Deriving clinical indications for the HIV nosode by conducting a double-blind, placebo-controlled homeopathic pathogenetic trial (HPT) with the aim to introduce a new nosode to the profession. The HPT was conducted in 22 volunteers, 15 of which received HIV nosode in 30c potency pills, while 7 received identical placebo pills orally, once a week, for 4 weeks. The volunteers' symptoms during initial 7 days of run-in period were noted. All symptoms for both groups produced during run-in period were excluded from final analysis. Informed consent form, approval by Ethics Committee, laboratory investigations as well as safety and ethical measures were provided. The volunteers were trained to write data in prescribed diaries, and the data were analyzed. The HPT of the HIV nosode exhibited qualitatively distinct symptoms, which can be applied in clinical practice. Number of symptoms reported in verum group was 130, in placebo group 60. Quantitative pathogenetic index was 0.285 in verum group, 0.238 in placebo group; qualitative pathogenetic index was 0.1402 in the verum group as compared to placebo (0.0907). Safe use was documented. This study brought in guiding symptoms, which will help the profession to employ this nosode in practice. © 2015 S. Karger GmbH, Freiburg.
Article
Background: Several homeopathic remedies are applied in the treatment of periodontal inflammation. However, little is known about their basic active principles. Therefore, we aimed at investigating the effects of homeopathic drugs in periodontal inflammation by observing lymphocyte migration activity in vitro. Material and M hods: Lymphocytes from blood samples of 3 periodontitis patients and 3 matched healthy volunteers were extracted and embedded in collagen matrix migration assays together with highly diluted (D12 and C200) aqueous extracts from Mercurius solubilis, Silicea, Sulphur, Tuberculinum, or placebo. Lymphocyte migration and lymphocyte speed were observed in a 60-min time frame. Statistical analysis was performed using univariate statistics and SiZer time series analysis. Results: While C-dilutions did not reveal clear differences between placebo and substances, strong effects were observed in D-dilutions compared to placebo. The strongest effects were achieved in lymphocytes exposed to Sulfur D12. While most specific effects were observed in Sulphur D12 showing an activating effect on periodontitis patient lymphocytes (mean activity: 11,1% (placebo) vs. 23,8% (verum)), there was no effect in healthy volunteers (25,8% (placebo) vs. 25,6% (verum)). SiZer analysis confirmed this effect to be significant. Conclusion: The basic active principles of highly diluted substances are still a matter of controversial debate. Although conclusions are limited due to low sample size, results from our pilot study might encourage further investigations on the role of highly diluted Sulphur in the treatment of periodontitis. Apart from a reproduction study with Sulphur, other immunological experiments, i.e. the investigation of cell limes via flow cytometry, should be performed to underpin these results.
Article
Background: In order to further improve the methodology and quality of data collection in homeopathic drug provings (HDP), there is a need for a minimum standardised HDP protocol. The objective of the present study was to test the feasibility of this type of protocol. Materials and methods: The study protocol embraced a multi-centre, randomised, double-blind, placebo-controlled trial with 2 parallel groups. It was approved by an ethics review committee. During the pre-approval phase, discordances between the regulatory and homeopathic requirements for the protocol were checked and solutions found. The study medication was Potentilla anserina. 6 participants received verum and 4 placebo. The resulting symptom list will be published elsewhere. The procedure was accepted by all participants. Results: Three important issues were addressed: the requirement to keep all participants blinded; the adverse events reporting to regulatory authorities; and the necessity of a placebo control group. Other issues that need further investigations were identified, e.g. sample size, observation period and dosage regimen. Conclusions: A minimum protocol of a HDP is feasible. All important design elements of HDP could be solved in discussions with the respective regulatory authorities, and participating homeopaths accepted the procedure.
Article
Evidence-based medicine (EbM) has proved to be very useful in healthcare; thanks to its methodology the reliability of our knowledge of the benefits and harms of interventions can be assessed. This at least applies to interventions which are based on a plausible concept for their mechanism of action and which have already achieved positive effects in experiments and simple studies. However, for interventions whose concepts contradict scientific findings EbM has proved to be unsuitable; it has not been able to prevent that they are still regarded as effective amongst wide parts of the population and medical experts. Particularly Homeopathy has managed to even present itself as scientifically justified by using EbM. With the aim of highlighting the speculative character of homeopathy and other procedures and of preventing EbM from getting damaged, the concept of scientability is introduced in this article. This concept only approves of clinical studies if the intervention that is to be tested does not contradict definite scientific findings.
Article
In the first decade of the evidence-based era, which began in the mid-1990s, meta-analyses were used to scrutinize homeopathy for evidence of beneficial effects in medical conditions. In this review, meta-analyses including pooled data from placebo-controlled clinical trials of homeopathy and the aftermath in the form of debate articles were analyzed. In 1997 Klaus Linde and co-workers identified 89 clinical trials that showed an overall odds ratio of 2.45 in favor of homeopathy over placebo. There was a trend toward smaller benefit from studies of the highest quality, but the 10 trials with the highest Jadad score still showed homeopathy had a statistically significant effect. These results challenged academics to perform alternative analyses that, to demonstrate the lack of effect, relied on extensive exclusion of studies, often to the degree that conclusions were based on only 5-10% of the material, or on virtual data. The ultimate argument against homeopathy is the 'funnel plot' published by Aijing Shang's research group in 2005. However, the funnel plot is flawed when applied to a mixture of diseases, because studies with expected strong treatments effects are, for ethical reasons, powered lower than studies with expected weak or unclear treatment effects. To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be disregarded. Alternatively, flawed statistical methods had to be applied. Future meta-analyses should focus on the use of homeopathy in specific diseases or groups of diseases instead of pooling data from all clinical trials. © 2013 S. Karger GmbH, Freiburg.
Article
The randomized controlled trial (RCT) is the 'gold standard' of modern clinical pharmacology. However, for many practitioners of homeopathy, blind RCTs are an inadequate research tool for testing complex therapies such as homeopathy. Classical probabilities used in biological sciences and in medicine are only a special case of the generalized theory of probability used in quantum physics. I describe homeopathy trials using a quantum-like statistical model, a model inspired by quantum physics and taking into consideration superposition of states, non-commuting observables, probability interferences, contextuality, etc. The negative effect of blinding on success of homeopathy trials and the 'smearing effect' ('specific' effects of homeopathy medicine occurring in the placebo group) are described by quantum-like probabilities without supplementary ad hoc hypotheses. The difference of positive outcome rates between placebo and homeopathy groups frequently vanish in centralized blind trials. The model proposed here suggests a way to circumvent such problems in masked homeopathy trials by incorporating in situ randomization/unblinding. In this quantum-like model of homeopathy clinical trials, success in open-label setting and failure with centralized blind RCTs emerge logically from the formalism. This model suggests that significant differences between placebo and homeopathy in blind RCTs would be found more frequently if in situ randomization/unblinding was used.
Article
Aim: The aim of this systematic review was to critically evaluate the evidence regarding the adverse effects (AEs) of homeopathy. Method: Five electronic databases were searched to identify all relevant case reports and case series. Results: In total, 38 primary reports met our inclusion criteria. Of those, 30 pertained to direct AEs of homeopathic remedies; and eight were related to AEs caused by the substitution of conventional medicine with homeopathy. The total number of patients who experienced AEs of homeopathy amounted to 1159. Overall, AEs ranged from mild-to-severe and included four fatalities. The most common AEs were allergic reactions and intoxications. Rhus toxidendron was the most frequently implicated homeopathic remedy. Conclusion: Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly.
Article
Experimental research on the effects of homeopathic treatments on impaired plants was last reviewed in 1990. To compile a systematic review of the existing literature on basic research in homeopathy with abiotically stressed plants using predefined criteria. The literature search was carried out on publications that reported experiments on homeopathy using abiotically stressed whole plants, seeds, plant parts and cells from 1920 to 2010. Outcomes had to be measured by established procedures and statistically evaluated. Using of a Manuscript Information Score (MIS) we identified those publications that provided sufficient information for proper interpretation (MIS≥5). A further evaluation was based on the use of adequate controls to investigate specific effects of homeopathic preparations and on the use of systematic negative control experiments. A total of 34 publications with abiotically stressed plants was identified, published between 1965 and 2010. The 34 publications described a total of 37 experimental studies. Twenty-two studies included statistics, 13 had a MIS≥5, 8 were identified with adequate controls and 4 with negative control experiments. Significant and reproducible effects with decimal and centesimal potencies were found, including dilution levels beyond Avogadro's number. One experimental model was independently assessed by another research team and yielded inverted results compared to the original trial. Abiotically stressed plant models seem to be a useful approach to investigate homeopathic basic research questions, but more experimentation and especially more independent replication trials are needed. Systematic negative control experiments should be implemented on a routine basis to exclude false-positive results.
Article
Background: Mortality in patients with severe sepsis remains high despite the development of several therapeutic strategies. The aim of this randomized, double-blind, placebo-controlled trial was to evaluate whether homeopathy is able to influence long-term outcome in critically ill patients suffering from severe sepsis. Methods: Seventy patients with severe sepsis received homeopathic treatment (n = 35) or placebo (n = 35). Five globules in a potency of 200c were given at 12h interval during the stay at the intensive care unit. Survival after a 30 and 180 days was recorded. Results: Three patients (2 homeopathy, 1 placebo) were excluded from the analyses because of incomplete data. All these patients survived. Baseline characteristics including age, sex, BMI, prior conditions, APACHE II score, signs of sepsis, number of organ failures, need for mechanical ventilation, need for vasopressors or veno-venous hemofiltration, and laboratory parameters were not significantly different between groups. On day 30, there was non-statistically significantly trend of survival in favour of homeopathy (verum 81.8%, placebo 67.7%, P= 0.19). On day 180, survival was statistically significantly higher with verum homeopathy (75.8% vs 50.0%, P = 0.043). No adverse effects were observed. Conclusions: Our data suggest that homeopathic treatment may be a useful additional therapeutic measure with a long-term benefit for severely septic patients admitted to the intensive care unit. A constraint to wider application of this method is the limited number of trained homeopaths.
Article
The literature on the applications of homeopathy for controlling plant diseases in both plant pathological models and field trials was first reviewed by Scofield in 1984. No other review on homeopathy in plant pathology has been published since, though much new research has subsequently been carried out using more advanced methods. To conduct an up-to-date review of the existing literature on basic research in homeopathy using phytopathological models and experiments in the field. A literature search was carried out on publications from 1969 to 2009, for papers that reported experiments on homeopathy using phytopathological models (in vitro and in planta) and field trials. The selected papers were summarized and analysed on the basis of a Manuscript Information Score (MIS) to identify those that provided sufficient information for proper interpretation (MIS>or=5). These were then evaluated using a Study Methods Evaluation Procedure (SMEP). A total of 44 publications on phytopathological models were identified: 19 papers with statistics, 6 studies with MIS>or=5. Publications on field were 9, 6 with MIS>or=5. In general, significant and reproducible effects with decimal and centesimal potencies were found, including dilution levels beyond the Avogadro's number. The prospects for homeopathic treatments in agriculture are promising, but much more experimentation is needed, especially at a field level, and on potentisation techniques, effective potency levels and conditions for reproducibility. Phytopathological models may also develop into useful tools to answer pharmaceutical questions.
Article
The last comprehensive review of experimental research on effects of homeopathic treatments on plants was published in 1984, and lacked formal predefined criteria to assess study quality. Since then several new studies with more advanced methods have been published. To compile a review of the literature on basic research in homeopathy with healthy plants with particular reference to studies investigating specific effects of homeopathic remedies. The literature search included English, French, German, Italian, Portuguese and Spanish publications from 1920 to April 2009, using predefined selection criteria. We included experiments with healthy whole plants, seeds, plant parts and cells. The outcomes had to be measured by established procedures and statistically evaluated. We developed a Manuscript Information Score (MIS) and included only publications which provided enough information for proper interpretation (MIS>or=5). A formalised Study Methods Evaluation Procedure (SMEP) was used to evaluate these studies, and the subgroup of studies with adequate controls to identify specific effects. A total of 86 studies in 79 publications was identified, 43 studies included statistics, 29 had MIS>or=5, and 15 studies investigated the specificity of homeopathic preparations. Specific effects of decimal, centesimal and fifty millesimal potencies were found including dilution levels far beyond the Avogadro number. In consecutive series of potencies only some of the tested potencies showed effects. There were many individual studies with diverse methods and very few reproduction trials. Healthy plant models seem an useful approach to investigate basic research questions about the specificity of homeopathic preparations. More investigations with more advanced methods are recommended, especially in the sectors of potentisation techniques, effective potency levels and conditions for reproducibility. Systematic negative control experiments should become a routine procedure to control the stability of the experimental systems.
Article
Among homeopaths the common idea about a working hypothesis for homeopathic effects seems to be that, during the potentization process, 'information' or 'energy' is being preserved or even enhanced in homeopathic remedies. The organism is said to be able to pick up this information, which in turn will stimulate the organism into a self-healing response. According to this view the decisive element of homeopathic therapy is the remedy which locally contains and conveys this information. I question this view for empirical and theoretical reasons. Empirical research has shown a repetitive pattern, in fundamental and clinical research alike: there are many anomalies in high-dilution research and clinical homeopathic trials which will set any observing researcher thinking. But no single paradigm has proved stable enough in order to produce repeatable results independent of the researcher. I conclude that the database is too weak and contradictory to substantiate a local interpretation of homeopathy, in which the remedy is endowed with causal-informational content irrespective of the circumstances. I propose a non-local interpretation to understand the anomalies along the lines of Jung's notion of synchronicity and make some predictions following this analysis.
Article
The sharp increase of the prescription of methylphenidate (MPD) in hyperactive children in recent years is a matter of increasing uneasiness among professionals, parents and politicians. There is little awareness of treatment alternatives. The purpose of this prospective trial was to assess the efficacy of homeopathy in hyperactive patients and to compare it MPD. The study was performed in a paediatric practice with conventional and homeopathic backgrounds. Children aged 3-17 y, conforming to the DSM-IV criteria for attention deficit hyperactivity disorder (ADHD) with a Conners Global Index (CGI) of 14 or higher were eligible for the study. All of them received an individual homeopathic treatment. When clinical improvement reached 50%, the parents were asked to reevaluate the symptoms. Those who did not improve sufficiently on homeopathy were changed to MPD, and again evaluated after 3 months. One hundred and fifteen children (92 boys, 23 girls) with a mean age of 8.3 y at diagnosis were included in the study. Prior to treatment the mean CGI was 20.63 (14-30), the mean index of the homeopathy group 20.52 and of the MPD-group 20.94. After an average treatment time of 3.5 months 86 children (75%) had responded to homeopathy, reaching a clinical improvement rating of 73% and an amelioration of the CGI of 55%. Twenty-five children (22%) needed MPD; the average duration of homeopathic (pre-) treatment in this group was 22 months. Clinical improvement under MPD reached 65%, the lowering of the CGI 48%. Three children did not respond to homeopathy nor to MPD, and one left the study. In cases where treatment of a hyperactive child is not urgent, homeopathy is a valuable alternative to MPD. The reported results of homeopathic treatment appear to be similar to the effects of MPD. Only children who did not reach the high level of sensory integration for school had to be changed to MPD. In preschoolers, homeopathy appears a particularly useful treatment for ADHD.
35 Beauvais F: A quantum-like model of homeopathy clinical trials: importance of in situ randomization and unblinding
35 Beauvais F: A quantum-like model of homeopathy clinical trials: importance of in situ randomization and unblinding. Homeopathy 2013; 102: 106-113.