REHBaR: a Publication Guideline for Homeopathic Basic Research

2021 ◽  
Vol 11 (40) ◽  
pp. 157-158
Author(s):  
Stephan Baumgartner ◽  
Beate Stock-Schröer

Background: Specific efficacy of homeopathically prepared substances in high dilution levels is controversial due to the comparably low number of randomized controlled clinical trials and due to the low concentrations of the substances potentised. No generally accepted theoretical model is currently available to explain specific effects of such preparations. In order to unequivocally demonstrate any such effects, experimental research has to meet very high standards. Aims: Objective was to compile guidelines for homeopathic basic research regarding experimental design, implementation, execution, evaluation and publication. Methods: A Delphi Process was conducted, involving European researchers who published experimental work within the last five years. The Delphi process included a total of five rounds, three rounds of adjusting and phrasing plus two consensus conferences [1]. Eligible criteria were collected from existing publications concerned with the quality of homeopathic basic research. In advance a short questionnaire was sent to a selection of research institutes in Germany active in non-homeopathic basic research. Results: Regarding experimental design, the most important points to consider are: randomized and coded (blinded) allocation of the treatments, several independent experiments (including independent production lots), potentised or succussed controls, positive controls (to control reactivity of the system) and systematic negative control experiments to document test system stability and adequacy of the statistical evaluation [1–4]. A detailed publication guideline for authors was developed. REHBaR (Reporting experiments in Homeopathic Basic Research) provides a checklist of 23 items, supplemented with detailed examples [4]. Background, objectives and possible hypotheses should be given in the part ‘introduction’. Special emphasis is put on the ‘materials and methods’ section, where a detailed description of chosen controls, object of investigation, experimental setup, replication, parameters, intervention, allocation, blinding, and statistical methods is required. The section ‘results’ should present sufficient details on analyzed data, descriptive as well as inferential. Authors should discuss their results and give an interpretation in the context of current evidence. Conclusions: Guidelines how to prepare detailed and informative publications are very common in clinical research [5]. To the best to our knowledge REHBaR is the first guideline to be applied by authors when preparing their manuscripts and to be used by scientific journals in the reviewing process in the field of homeopathic basic research. Furthermore the REHBaR guideline can be helpful for planning and conducting experiments as it includes fundamental qualitative standards. To which extent REHBAR can be used also as an instrument to evaluate the quality of a publication will be discussed.

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
B. Stock-Schröer ◽  
H. Albrecht ◽  
L. Betti ◽  
G. Dobos ◽  
C. Endler ◽  
...  

The objective of this study was to develop a criteria catalogue serving as a guideline for authors to improve quality of reporting experiments in basic research in homeopathy. A Delphi Process was initiated including three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last 5 years were involved. A checklist for authors provide a catalogue with 23 criteria. The “Introduction” should focus on underlying hypotheses, the homeopathic principle investigated and state if experiments are exploratory or confirmatory. “Materials and methods” should comprise information on object of investigation, experimental setup, parameters, intervention and statistical methods. A more detailed description on the homeopathic substances, for example, manufacture, dilution method, starting point of dilution is required. A further result of the Delphi process is to raise scientists' awareness of reporting blinding, allocation, replication, quality control and system performance controls. The part “Results” should provide the exact number of treated units per setting which were included in each analysis and state missing samples and drop outs. Results presented in tables and figures are as important as appropriate measures of effect size, uncertainty and probability. “Discussion” in a report should depict more than a general interpretation of results in the context of current evidence but also limitations and an appraisal of aptitude for the chosen experimental model. Authors of homeopathic basic research publications are encouraged to apply our checklist when preparing their manuscripts. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.


2021 ◽  
Vol 11 (40) ◽  
pp. 129-130
Author(s):  
Tim Jäger ◽  
Claudia Scherr ◽  
Meinhard Simon ◽  
Peter Heusser ◽  
Ursula Wolf ◽  
...  

In homeopathic basic research, the question as to the most adequate test systems and apt methodology is still open. This investigation examined the hypothesis that more complex organisms show stronger reactions to homeopathic remedies than less complex ones. We compared two Arsenic (As5+) stressed bioassays with duckweed (Lemna gibba, a multi-cellular autotrophic organism) and yeast (Saccharomyces cerevisiae, a single-cellular heterotrophic organism) regarding their response to homeopathic preparations [1]. For duckweed, growth rates of leaf area and leaf number were evaluated. For yeast, growth kinetics were determined by measuring slope, yield and Et50 (point in time when yield was half maximum) of the sigmoid growth curve. The experiments with duckweed and yeast were performed in parallel (same day, same location and identical homeopathic preparations). After screening 17 substances, three homeopathic preparations (Arsenicum album, nosode, gibberellic acid) were chosen for repeated experimental series [2]. Five independent experiments were conducted for each remedy with both organisms in parallel. Potency levels used were in the range of 17x–33x for duckweed and 17x–30x for yeast. To control for test system stability, systematic negative control experiments were conducted over the complete experimentation period. All experiments were blinded and randomized. The systematic negative control experiments did not yield any significant effects. Application of potentized Arsenicum album in the duckweed bioassay yielded the largest effects compared to water controls without remedies for the parameters leaf area and leaf number (p


Homeopathy ◽  
2018 ◽  
Vol 107 (02) ◽  
pp. 115-129 ◽  
Author(s):  
Stephan Baumgartner ◽  
Anezka Sokol ◽  
Roman Huber ◽  
Paul Doesburg ◽  
Tim Jäger ◽  
...  

Background Plant-based test systems have been described as a useful tool for investigating possible effects of homeopathic preparations. The last reviews of this research field were published in 2009/2011. Due to recent developments in the field, an update is warranted. Publications on plant-based test systems were analysed with regard to publication quality, reproducibility and potential for further research. Methods A literature search was conducted in online databases and specific journals, including publications from 2008 to 2017 dealing with plant-based test systems in homeopathic basic research. To be included, they had to contain statistical analysis and fulfil quality criteria according to a pre-defined manuscript information score (MIS). Publications scoring at least 5 points (maximum 10 points) were assumed to be adequate. They were analysed for the use of adequate controls, outcome and reproducibility. Results Seventy-four publications on plant-based test systems were found. Thirty-nine publications were either abstracts or proceedings of conferences and were excluded. From the remaining 35 publications, 26 reached a score of 5 or higher in the MIS. Adequate controls were used in 13 of these publications. All of them described specific effects of homeopathic preparations. The publication quality still varied: a substantial number of publications (23%) did not adequately document the methods used. Four reported on replication trials. One replication trial found effects of homeopathic preparations comparable to the original study. Three replication trials failed to confirm the original study but identified possible external influencing factors. Five publications described novel plant-based test systems. Eight trials used systematic negative control experiments to document test system stability. Conclusions Regarding research design, future trials should implement adequate controls to identify specific effects of homeopathic preparations and include systematic negative control experiments. Further external and internal replication trials, and control of influencing factors, are needed to verify results. Standardised test systems should be developed.


Author(s):  
Л.В. Кузнецова ◽  
Л.Ю. Бахтина ◽  
И.Ю. Малышев

В кратком обзоре обсуждаются задачи фармацевтических компаний, и вопросы о наиболее рациональном соотношении скорости, стоимости и качества процесса разработки лекарств и технологий (DDD). Делается заключение, что экспериментальный дизайн и методы медико-фармакологических исследований должны разрабатываться на основании современных принципов и представлений о содержании этапов DDD, с особым акцентом на высокое качество научных исследований на этапе открытия. This brief review discusses challenges of pharmaceutical companies and issues of the most rational relationship between the speed, cost, and quality of the process for drug and technology development (DTD). It was concluded that the experimental design and methods of medical and pharmacological research should be developed on the basis of modern principles and ideas about the essence of DTD stages with a particular emphasis on the high quality of scientific research at the stage of discovery.


2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
G Brown ◽  
A Young ◽  
R Rymell

Abstract Aim MDT discussion is the gold standard for cancer care in the UK. With the cancer incidence and complexity of treatments both increasing, demand for MDT discussion is growing. The need for efficiency, whilst maintaining high standards, is therefore clear. Paper-based MDT quality assessment tools and discussion checklists may represent a practical method of monitoring and improving MDT practice. This review aims to describe and appraise these tools, as well as consider their value to quality improvement. Method MEDLINE, Embase and PsycInfo were searched using pre-defined terms. PRISMA methodology was followed throughout. Studies were included if they described the development of a relevant tool/checklist, or if an element of the methodology further informed tool quality assessment. To investigate efficacy, studies using a tool as a method of quality improvement in MDT practice were also included. Study quality was appraised using the COSMIN risk of bias checklist or the Newcastle-Ottawa scale, depending on study type. Results The search returned 6888 results. 17 studies were included, and 6 different tools were identified. Overall, methodological quality in tool development was adequate to very good for assessed aspects of validity and reliability. Clinician feedback was positive. In one study, the introduction of a discussion checklist improved MDT ability to reach a decision from 82.2% to 92.7%. Improvement was also noted in the quality of information presented and the quality of teamwork. Conclusions Several tools for assessing and guiding MDT discussions are available. Although limited, current evidence indicates sufficient rigour in their development and their potential for quality improvement.


Homeopathy ◽  
2017 ◽  
Vol 106 (03) ◽  
pp. 145-154 ◽  
Author(s):  
Claudia Scherr ◽  
Claudia Schneider ◽  
Sebastian Patrick Arlt ◽  
Stephan Baumgartner ◽  
Vera Majewsky

Background: A previous study reported a significant statistical interaction between experiment date and treatment effect of Argentum nitricum 14x–30x on the growth rate of duckweed (Lemna gibba L.). The aim of the present study was to investigate the stability of the test system and intra-laboratory reproducibility of the effects found. Methods: Duckweed was treated with A. nitricum potencies (14x–30x) as well as succussed and unsuccussed water controls. The outcome parameter area-related growth rate for day 0–7 was determined by a computerised image analysis system in two series of independent randomised and blinded experiments. Systematic negative control (SNC) experiments were carried out to investigate test system stability. Statistical analysis was performed with full two-way analysis of variance (ANOVA) and protected Fisher's Least Significant Difference (LSD) test. Results: In the first repetition series we found a significant treatment effect (p = 0.016), while in the second series no effect was observed. The negative control experiments showed that the experimental system was stable. An a posteriori subgroup analysis concerning gibbosity revealed the importance of this growth state of L. gibba for successful reproduction of the statistically significant interaction in the original study; flat: no interaction (p = 0.762); slight gibbosity: no interaction (p = 0.356); medium gibbosity: significant interaction (p = 0.031), high gibbosity: highly significant interaction (p = 0.005). Conclusions: With the original study design (disregarding gibbosity status of L. gibba) results of the original study could not be reproduced sensu stricto. We conclude that the growth state gibbosity is crucial for successful reproduction of the original study. Different physiological states of the test organisms used for bioassays for homeopathic basic research must carefully be considered.


2021 ◽  
Vol 11 (40) ◽  
pp. 196-197
Author(s):  
Vera Majewsky ◽  
Claudia Scherr ◽  
Sebastian Arlt ◽  
Peter Klocke ◽  
Stephan Baumgartner

Background: Reproducibility of investigations in homeopathy is still challenging. Duckweed (Lemna gibba L.), a monocotyledonous waterplant which mostly reproduces vegetatively and therefore builds genetically identical clones, may be a suitable test system for standardised trials. Aims: This study investigated if formerly observed effects of gibberellic acid 14x – 30x on growth of Lemna gibba were reproducible. Methododology: Duckweed was grown in dilutions of gibberellic acid (14x–30x) as well as once succussed (c1) and unsuccussed (c0) water control. Area-related growth rate for day 0–7 was determined by a computerised image analysis system. Three series including five independent blinded and randomised experiments each were carried out in the same way as in the original study. Only time and conductor of experiments were modified. System stability was controled by three series of systematic negative control (SNC) experiments with the same set-up, but distilled and autoclaved water was used as the only test substance. According to the series with gibberellic acid, each serie of SNC experiments included five experiments. Full two-way ANOVA (α = 5%) was used for statistical analysis. Independent variables were treatment and experiment number, dependent variable was r(area) for day 0–7. Data of each experiment was normalised to its mean value to allow a better comparison between experiments. Only if the global ANOVA F-test was significant (p < 0.05) we compared the investigated groups with Fisher`s LSD test (protected Fisher`s LSD). Results: No specific effects of agitated dilutions of gibberellic acid were found in the first two replication series (p=0.263 and p=0.062). In the third serie with gibbous Lemna gibba L. we observed a significant effect (p=0.009) of the homeopathic treatment, however growth was increased in contrast to decreasing in the former study. Variability in experiments with gibberellic acid 14x – 30x was lower than in SNC experiments. The stability of the experimental system was verified by the SNC experiments. Conclusions: When designing new studies to investigate reproducibility, different physiological states of the test organism must be considered. Variability might be an interesting parameter to investigate effects of homeopathic remedies in basic research.


2021 ◽  
Author(s):  
George T F Brown ◽  
Hilary L Bekker ◽  
Alastair L Young

Abstract Background MDT discussion is the gold standard for cancer care in the UK. With the incidence of cancer on the rise, demand for MDT discussion is increasing. The need for efficiency, whilst maintaining high standards, is therefore clear. Paper-based MDT quality assessment tools and discussion checklists may represent a practical method of monitoring and improving MDT practice. This reviews aims to describe and appraise these tools, as well as consider their value to quality improvement. Methods Medline, EMBASE and PsycInfo were searched using pre-defined terms. The PRISMA model was followed throughout. Studies were included if they described the development of a relevant tool, or if an element of the methodology further informed tool quality assessment. To investigate efficacy, studies using a tool as a method of quality improvement in MDT practice were also included. Study quality was appraised using the COSMIN risk of bias checklist or the Newcastle-Ottawa scale, depending on study type. Results The search returned 6888 results. 17 studies were included. In total 6 tools were identified. Overall, methodological quality in tool development was adequate to very good for assessed aspects of validity and reliability. Clinician feedback was positive. In one study, the introduction of a discussion checklist improved MDT ability to reach a decision from 82.2–92.7%. Improvement was also noted in the quality of information presented and the quality of teamwork. Conclusions Several tools for assessment and guidance of MDTs are available. Although limited, current evidence indicates sufficient rigour in their development and their potential for quality improvement.


2011 ◽  
Vol 11 ◽  
pp. 568-583 ◽  
Author(s):  
Tim Jäger ◽  
Claudia Scherr ◽  
Ursula Wolf ◽  
Meinhard Simon ◽  
Peter Heusser ◽  
...  

This study investigated the response of arsenic-stressed yeast (Saccharomyces cerevisiae) towards homeopathically potentized Arsenicum album, a duckweed nosode, and gibberellic acid. The three test substances were applied in five potency levels (17x, 18x, 24x, 28x, 30x) and compared to controls (unsuccussed and succussed water) with respect to influencing specific growth parameters. Five independent experiments were evaluated for each test substance. Additionally, five water control experiments were analyzed to investigate the stability of the experimental setup (systematic negative control experiments). All experiments were randomized and blinded. Yeast grew in microplates over a period of 38 h in either potentized substances or water controls with 250 mg/l arsenic(V) added over the entire cultivation period. Yeast's growth kinetics (slope, Et50, and yield) were measured photometrically. The test system exhibited a low coefficient of variation (slope 1.2%, Et500.3%, yield 2.7%). Succussed water did not induce any significant differences compared to unsuccussed water. Data from the control and treatment groups were both pooled to increase statistical power. In this study with yeast, no significant effects were found for any outcome parameter or any homeopathic treatment. Since in parallel experiments arsenic-stressed duckweed showed highly significant effects after application of potentized Arsenicum album and duckweed nosode preparations from the same batch as used in the present study, some specific properties of this experimental setup with yeast must be responsible for the lacking response.


2017 ◽  
Vol 24 (1) ◽  
pp. 87-106
Author(s):  
Wiharyanto Wiharyanto

The study aims to analyze about the low graduation and certification exam training participants of the procurement of goods / services of the government and its contributing factors, and formulate a strategy of education and training and skills certification exams procurement of goods / services of the government. Collecting data using the method of study documentation, interviews, and questionnaires. Is the official source of information on the structural and functional Regional Employment Board, as well as the participants of the training and skills certification exams procurement of goods / services of the government in Magelang regency government environment. Analysis using 4 quadrant SWOT analysis, to determine the issue or strategic factors in improving the quality of education and training and skills certification exams procurement of government goods / services within the Government of Magelang regency. The results show organizer position is in quadrant I, which is supporting the growth strategy, with 3 alternative formulation strategies that improve the quality of education and training and skills certification exams procurement of government goods / services, and conducts certification examination of the procurement of government goods / services with computer assisted test system (CAT). Based on the research recommendations formulated advice to the organizing committee, namely: of prospective participants of the training and skills certification exams procurement of goods / services the government should consider the motivation of civil servants, is examinees who have attended training in the same period of the year, the need for simulation procurement of goods / services significantly, an additional allocation of training time, giving sanction to civil servants who have not passed the exam, the provision of adequate classroom space with the number of participants of each class are proportional, as well as explore the evaluation of education and training and skills certification exams procurement of goods / services for Government of participants.


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