Objective: To evaluate clinical and cost-effectiveness of individualised homeopathic treatment of children diagnosed with attention deficit hyperactivity disorder (ADHD) between age 6 and 16 during 10 years. Methods: Public lectures made families with inattentive or hyperactive children children getting interested in a randomized, double blind, placebo controlled trial (RCT), embedded in a prospective observational study. After diagnostic screening and a primary run-in phase of homeopathic treatment, crossover RCT was followed by open-label long-term follow-up and cost-effectiveness evaluation. At diagnosis, beginning of, and after each crossover period, and at yearly intervals during long-term follow-up, parents reported Conners’ Global Index (CGI, 10 items, rated 0-3 points each; primary variable) by questionnaire or telephone interview. Results: A total of 140 children was recruited, 43 were excluded by a screening questionnaire, another 14 did not meet strict diagnostic criteria (according to DSM-IV), resulting in 83 children treated with individually prescribed homeopathic remedies. As 13 patients did not improve at least 50% in CGI values (RCT inclusion criterion), the remaining 62 children (84%) participated in, and 58 finished the double-blind cross-over RCT phase. After ten years of open-label therapy, 56/62 children were eligible for follow-up (90%). According to ITT-analysis, 38/62 (62%) children were without any homeopathic (HOM) or medical treatment. In the remaining children, successful results were achieved in 6 with HOM, 9 with methylphenidate (MPH) and 3 with both, HOM and MPH. During cross-over RCT, CGI values detected clinically and statistically significant differences in verum and placebo phase, respectively. Cost-effectiveness evaluation demonstrated non-inferiority of homeopathic treatment compared to stimulant treatment, even in the first year including case-taking and repertory analysis. Discussion: The innovative design of this study enabled both, to show clinical and cost-effectiveness of integrated homeopathic treatment in children dignosed with ADHD, and to detect a specific effect of the individual homeopathic remedy. The clinical result is comparable to conventional stimulant treatment. This again raises the question about the mode of action of homeopathically potentized substances. Conclusion: In children with ADHD, individualized homeopathic therapy and conventional stimulant treatment have comparable both, clinically significant, and specific effects persistent over ten years.
David M Shaw recently published a critique of our Health Technology Assessment (HTA) on homoeopathy in this journal [1], which calls for a response. We expected a scientific debate to ensue on our chosen research methods and were surprised to be confronted with a biased mixture of false or incomplete citations, wrong matches and, as a consequence, incorrect conclusions that reveal a lack of familiarity and experience with both homoeopathy and the Swiss setting. We will refute the allegations and rectify misunderstandings, in the order of appearance in Shaw’s text. Because of numerous repetitions in Shaw’s text we have subsumed some of the allegations thematically:
Homeopathic preparations are used in homeopathy and anthroposophic medicine. Although there is evidence of effectiveness in several clinical studies, including double-blinded randomized controlled trials, their nature and mode of action could not be explained with current scientific approaches yet. Several physical methods have already been applied to investigate homeopathic preparations but it is yet unclear which methods are best suited to identify characteristic physicochemical properties of homeopathic preparations. The aim of this study was to investigate homeopathic preparations with UV-spectroscopy. In a blinded, randomized, controlled experiment homeopathic preparations of copper sulfate (CuSO(4); 11c-30c), quartz (SiO(2); 10c-30c, i.e., centesimal dilution steps) and sulfur (S; 11×-30×, i.e., decimal dilution steps) and controls (one-time succussed diluent) were investigated using UV-spectroscopy and tested for contamination by inductively coupled plasma mass spectrometry (ICP-MS). The UV transmission for homeopathic preparations of CuSO(4) preparations was significantly lower than in controls. The transmission seemed to be also lower for both SiO(2) and S, but not significant. The mean effect size (95% confidence interval) was similar for the homeopathic preparations: CuSO(4) (pooled data) 0.0544% (0.0260-0.0827%), SiO(2) 0.0323% (-0.0064% to 0.0710%) and S 0.0281% (-0.0520% to 0.1082%). UV transmission values of homeopathic preparations had a significantly higher variability compared to controls. In none of the samples the concentration of any element analyzed by ICP-MS exceeded 100 ppb. Lower transmission of UV light may indicate that homeopathic preparations are less structured or more dynamic than their succussed pure solvent.
Quantitative meta-analyses of randomized clinical trials investigating the specific therapeutic efficacy of homeopathic remedies yielded statistically significant differences compared to placebo. Since the remedies used contained mostly only very low concentrations of pharmacologically active compounds, these effects cannot be accounted for within the framework of current pharmacology. Theories to explain clinical effects of homeopathic remedies are partially based upon changes in diluent structure. To investigate the latter, we measured for the first time high-field (600/500 MHz) 1H T1 and T2 nuclear magnetic resonance relaxation times of H2O in homeopathic preparations with concurrent contamination control by inductively coupled plasma mass spectrometry (ICP-MS). Homeopathic preparations of quartz (10c–30c, n = 21, corresponding to iterative dilutions of 100−10–100−30), sulfur (13x–30x, n = 18, 10−13–10−30), and copper sulfate (11c–30c, n = 20, 100−11–100−30) were compared to n = 10 independent controls each (analogously agitated dilution medium) in randomized and blinded experiments. In none of the samples, the concentration of any element analyzed by ICP-MS exceeded 10 ppb. In the first measurement series (600 MHz), there was a significant increase in T1 for all samples as a function of time, and there were no significant differences between homeopathic potencies and controls. In the second measurement series (500 MHz) 1 year after preparation, we observed statistically significant increased T1 relaxation times for homeopathic sulfur preparations compared to controls. Fifteen out of 18 correlations between sample triplicates were higher for controls than for homeopathic preparations. No conclusive explanation for these phenomena can be given at present. Possible hypotheses involve differential leaching from the measurement vessel walls or a change in water molecule dynamics, i.e., in rotational correlation time and/or diffusion. Homeopathic preparations thus may exhibit specific physicochemical properties that need to be determined in detail in future investigations.
Introduction: An increasing number of parents turn to homeopathy for treatment of their children with attention defict hyperactivity disorder (ADHD). The Swiss ADHD-study aimed at obtaining scientific evidence for the effectiveness of homeopathy in hyperactive children by a randomized placebo controlled double blind trial, followed by five years of open label observation.Methods: A total of 83 children, aged 6-16 years, with ADHD diagnosed using the Diagnostic and Statistical Mannual of Mental Disorders-IV (DSM-IV), were recruited. Their mean Conners Global Index (CGI)-rating was 19 points. Prior to the randomised double blind placebo controlled crossover study, they were treated with individually prescribed homeopathic medications (screening phase). 70 patients achieved an improvement of 50% or more in the CGI, which was confirmed by neuropsychological testing. 62 patients participated in the crossover trial. They were split into two groups and received either verum for 6 weeks followed by placebo for 6 weeks (group A), or vice versa (group B). CGI-evaluations were performed at the beginning of the trial and after each crossover period. The Conners Parent and Teacher Raing Scales were evaluated at diagnosis and again after the crossover trial, and CGI ratings were obtained at 18 and 60 months after treatment start.Results: At the end of the open label screening phase cognitive performance such as visual global perception, impulsivity and divided attention, had improved significantly (p<0.0001). The comparison of suboptimal and optimal homeopathic prescriptions revealed a highly significant difference in the mean CGI-improvement per month (p<0.0001), showing that (optimal) remedies, which perfectly cover the patients symptoms, cause a much stronger improvement than (suboptimal) remedies with an insufficient coverage of the symptoms. During the crossover trial CGI parent-ratings were significantly lower under verum than under placebo (p=0.0479). Five years after treatment start mean CGI- ratings by parents reached 7 points (64% improvement, p<0.0001) in 28 patients who had continued homeopathy, and 9 points (53% improvement, p=0.0001) in 25 patients who had stopped any treatment. Seven participants had changed to Methylphenidate (MPD) after the crossover trial. Their final mean CGI-parent rating under MPD was 11 points.Conclusion: The trial reveals specific effects of homeopathic treatment in ADHD, particularly in the areas of behavioural and cognitive functions. In longtime follow up 74% of all patients benefited from homeopathy without needing any other treatment.
Letters| October 08 2009 On: Piltan D, Rist L, Simões-Wüst A, Saller R: Test of a homeopathic dilution of Aconitum napellus. A clinical, randomized, double-blind, controlled crossover study in healthy volunteers. Forsch Komplementmed 2009;16:168–173 Subject Area: Further Areas , General Medicine André Thurneysen André Thurneysen Institute of Complementary Medicine (KIKOM) University of Berne Search for other works by this author on: This Site PubMed Google Scholar Forschende Komplementärmedizin / Research in Complementary Medicine (2009) 16 (5): 349. https://doi.org/10.1159/000243809 Article history Published Online: October 08 2009 Content Tools Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn Email Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation André Thurneysen; On: Piltan D, Rist L, Simões-Wüst A, Saller R: Test of a homeopathic dilution of Aconitum napellus. A clinical, randomized, double-blind, controlled crossover study in healthy volunteers. Forsch Komplementmed 2009;16:168–173. Forschende Komplementärmedizin / Research in Complementary Medicine 1 November 2009; 16 (5): 349. https://doi.org/10.1159/000243809 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentAll JournalsComplementary Medicine Research Search Advanced Search This content is only available via PDF. 2009Copyright / Drug Dosage / DisclaimerCopyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements. Article PDF first page preview Close Modal You do not currently have access to this content.
BACKGROUND:Two experimental studies on wheat preintoxicated with Arsenic trioxide yielded a significant shoot growth increase after an isopathic application of Ars-alb 45x. One independent reproduction trial however, yielded an effect inversion: wheat shoot growth was significantly decreased after application of Ars-alb 45x. AIMS:In this study we investigated the role of three potential confounding factors on the experimental outcome: geographical location of the experiments, influence of the main experimenter, and seed sensitivity to Arsenic poisoning. Laboratory-internal reproducibility was assessed by meta-analysis. MATERIAL AND METHODS:Wheat poisoned with Arsenic trioxide was cultivated in vitro in either Ars-alb 45x, water 45x, or unpotentised water. Treatments were blinded and randomised. Shoot length was measured after 7 days. The stability of the experimental set-up was assessed by systematic negative control (SNC) experiments. RESULTS:The SNC experiments did not yield significant differences between the three groups treated with unpotentised water. Thus the experimental set-up seemed to be stable. We did not observe any shoot growth increase after a treatment with Ars-alb 45x in any of the newly performed experiments. In contrast, the meta-analysis of all 17 experiments performed (including earlier experiments already published) yielded a statistically significant shoot growth decrease (-3.2%, p=0.017) with isopathic Ars-alb 45x treatment. This effect was quantitatively similar across all five series of experiments. CONCLUSIONS:Ultramolecular Ars-alb 45x led to statistically significant specific effects in arsenic poisoned wheat when investigated by two independent working groups. Effect size and effect direction differ, however. The investigated factors (geographical location, experimenter, seed sensitivity to Arsenic poisoning) did not seem to be responsible for the effect inversion. Laboratory external reproducibility of basic research into homeopathic potentisation remains a difficult issue.
Background This study is part of a nationwide evaluation of complementary medicine in Switzerland (Programme Evaluation of Complementary Medicine PEK) and was funded by the Swiss Federal Office of Public Health. The main objective of this study is to investigate patient satisfaction and perception of side effects in homeopathy compared with conventional care in a primary care setting. Methods We examined data from two cross-sectional studies conducted in 2002–2003. The first study was a physician questionnaire assessing structural characteristics of practices. The second study was conducted on four given days during a 12-month period in 2002/2003 using a physician and patient questionnaire at consultation and a patient questionnaire mailed to the patient one month later (including Europep questionnaire). The participating physicians were all trained and licensed in conventional medicine. An additional qualification was required for medical doctors providing homeopathy (membership in the Swiss association of homeopathic physicians SVHA). Results A total of 6778 adult patients received the questionnaire and 3126 responded (46.1%). Statistically significant differences were found with respect to health status (higher percentage of chronic and severe conditions in the homeopathic group), perception of side effects (higher percentage of reported side effects in the conventional group) and patient satisfaction (higher percentage of satisfied patients in the homeopathic group). Conclusion Overall patient satisfaction was significantly higher in homeopathic than in conventional care. Homeopathic treatments were perceived as a low-risk therapy with two to three times fewer side effects than conventional care
Objectives: Investigation of the conditions for reproducibility of dwarf pea shoot growth stimutation through homeopathic potencies of gibberellic acid.Methods: 4 batches of pea seed (Pisum sativum L. cv. Fruher Zwerg; harvests from 1997, 1998, 1999, and 2000) were tested regarding their reaction to gibberellic acid 17x and 18x (compared to unsuccussed and succussed water (1x) as controls) in 8 independent randomized and blinded experiments. Pea seed was immersed for 24h in watery solutions of homeopathic potencies or controls, and cultivated under controlled laboratory conditions. Pea shoot length was measured after 14 days. Two systematic negative control experiments assessed the stability of the experimental set-up.Results: The systematic negative control experiments yielded no significant effects and confirmed the stability of the experimental set-up. 2 out of 4 seed batches reacted to the homeopathic treatment (p < 0.05). Seed batch 1997 showed a reproducible reaction to gibbereltic acid 17x (shoot length stimulation of + 11.2%, p=0.007), and seed batch 1998 showed a significant varying response (increase/decrease). Seed batch 1997 differed from the other 3 batches by an increased glucose and fructose content, and reduced 1000kernel weight. Meta-anatysis with data of earlier experiments is in accordance with the results of the present experimental series.Conclusions: We identified 'seed quality' as a possible trigger factor for successful reproducibility in homeopathic basic research. Premature harvesting as a possible key factor for responsiveness of dwarf peas to homeopathic potencies of gibberellic acid is our current working hypothesis to be tested in future experiments. (C) 2008 Elsevier Ltd. All rights reserved.
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.
In den Jahren 2001 bis 2005 wurde an der Universität Bern von einem interdisziplinären Studienteam eine wissenschaftlich rigorose Studie mit homöopathischer Behandlung von 62 ADS-Kindern durchgeführt. Das Studiendesign umfasste eine offene Screening-Phase, in der das bestpassende homöopathische Arzneimittel bestimmt werden musste, danach eine doppelblinde Crossover-Studie und schließlich eine offene Langzeitbehandlung von durchschnittlich 19 Monaten Dauer. Die vorliegende Doppelblindstudie ergibt eine wissenschaftliche Evidenz für die Wirkung homöopathischer Medikamente beim ADS.