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ABSTRACT: Homeopathic remedies are produced by potentising, that is, the serial logarithmic dilution and succussion of a mother tincture. Techniques like ultraviolet spectroscopy, nuclear magnetic resonance, calorimetry, or thermoluminescence have been used to investigate their physical properties. In this study, homeopathic centesimal (c) potencies (6c to 30c) of copper sulfate, Hypericum perforatum, and sulfur as well as succussed water controls were prepared. Samples of these preparations were exposed to external physical factors like heat, pressure, ultraviolet radiation, or electromagnetic fields to mimic possible everyday storage conditions. The median transmissions from 190 nm to 340 nm and 220 nm to 340 nm were determined by ultraviolet light spectroscopy on five measurement days distributed over several months. Transmissions of controls and potencies of sulfur differed significantly on two of five measurement days and after exposure to physical factors. Transmissions of potencies exposed to ultraviolet light and unexposed potencies of copper sulfate and Hypericum perforatum differed significantly. Potency levels 6c to 30c were also compared, and wavelike patterns of higher and lower transmissions were found. The Kruskal-Wallis test yielded significant differences for the potency levels of all three substances. Aiming at understanding the physical properties of homeopathic preparations, this study confirmed and expanded the findings of previous studies.
Evidence-based Complementary and Alternative Medicine 01/2013; 2013:370609. · 4.77 Impact Factor
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ABSTRACT: 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 (600/500MHz) 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 10ppb. In the first measurement series (600MHz), 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 (500MHz) 1year 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.
Naturwissenschaften 04/2012; 96(9):1079-1089. · 2.28 Impact Factor
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Tim Jäger,
Claudia Scherr,
Devika Shah,
Vera Majewsky,
Lucietta Betti,
Grazia Trebbi,
Leoni Bonamin,
Ana Paula Simões-Wüst, Ursula Wolf,
Meinhard Simon,
Peter Heusser,
Stephan Baumgartner
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ABSTRACT: 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.
Homeopathy: the journal of the Faculty of Homeopathy 10/2011; 100(4):275-87. · 1.13 Impact Factor
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ABSTRACT: The aim is to study cerebral vascular functional connectivity during motor tasks and resting state using multichannel frequency-domain near-infrared spectrophotometry. Maps of 5.7 × 10.8 cm size displaying changes in cerebral oxyhemoglobin (O(2)Hb), deoxyhemoglobin (HHb), and total hemoglobin (tHb) concentrations were measured in the motor cortex in 12 subjects (mean age of 28.8±12.7 yrs) during resting state and during two palm squeezing tasks with different timing. For each condition, phase plane plots, cross correlation functions, and connectivity indices were generated for O(2)Hb, HHb, and tHb. The amplitude of the concentration changes in O(2)Hb and HHb depends on the age of the subject. We found large regions of connectivity, which were similar for resting state and task conditions. This means the spatial relationships during resting state, when changes in O(2)Hb, HHb, and tHb corresponded to spontaneous oscillations, were correlated to the spatial patterns during the activation tasks, when changes in O(2)Hb, HHb, and tHb concentration were related to the alternation of stimulation and rest. Thus, the vascular functional connectivity was also present during resting state. The findings suggest that the vascular response to functional activation may be a nonlinear synchronization phenomenon and that resting state processes are more important than previously expected.
Journal of Biomedical Optics 08/2011; 16(8):087013. · 3.16 Impact Factor
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ABSTRACT: Recently it has been shown that artistic speech therapy (AST) has effects on heart rate variability. The aim of this pilot study was to investigate whether AST also affects hemodynamics and tissue oxygenation in the brain and skeletal muscle measured by near infrared spectrophotometry(NIRS). The results show that ATS has effects on important physiological parameters, i.e., it leads to a decrease in cerebral blood flow during recitation and to brain activation thereafter.
Advances in experimental medicine and biology 01/2011; 701:21-5. · 1.09 Impact Factor
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ABSTRACT: Arts speech therapy (AST) is a therapeutic method within complementary medicine and has been practiced for decades for various medical conditions. It comprises listening and the recitation of different forms of speech exercises under the guidance of a licensed speech therapist. The aim of our study was to noninvasively investigate whether different types of recitation influence hemodynamics and oxygenation in the brain and skeletal leg muscle using near-infrared spectroscopy (NIRS). Seventeen healthy volunteers (eight men and nine women, mean age ± standard deviation 35.6 ± 12.7 years) were enrolled in the study. Each subject was measured three times on different days with the different types of recitation: hexameter, alliteration, and prose verse. Before, during, and after recitation, relative concentration changes of oxyhemoglobin (Δ[O2Hb]), deoxyhemoglobin (Δ[HHb]), total hemoglobin (Δ[tHb]), and tissue oxygenation saturation (StO2) were measured in the brain and skeletal leg muscle using a NIRS device. The study was performed with a randomized crossover design. Significant concentration changes were found during recitation of all verses, with mainly a decrease in Δ[O2Hb] and ΔStO2 in the brain, and an increase in Δ[O2Hb] and Δ[tHb] in the leg muscle during recitation. After the recitations, significant changes were mainly increases of Δ[HHb] and Δ[tHb] in the calf muscle. The Mayer wave spectral power (MWP) was also significantly affected, i.e., mainly the MWP of the Δ[O2Hb] and Δ[tHb] increased in the brain during recitation of hexameter and prose verse. The changes in MWP were also significantly different between hexameter and alliteration, and hexameter and prose. Possible physiological explanations for these changes are discussed. A probable reason is a different effect of recitations on the sympathetic nervous system. In conclusion, these changes show that AST has relevant effects on the hemodynamics and oxygenation of the brain and muscle.
TheScientificWorldJOURNAL 01/2011; 11:1206-15. · 1.66 Impact Factor
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ABSTRACT: 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%, Et50 0.3%, 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.
TheScientificWorldJOURNAL 01/2011; 11:568-83. · 1.66 Impact Factor
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ABSTRACT: Clinical trials have reported statistically significant and clinically relevant effects of homeopathic preparations. We applied ultraviolet (UV) spectroscopy to investigate the physical properties of homeopathic preparations and to contribute to an understanding of the not-yet-identified mode of action. In previous investigations, homeopathic preparations had significantly lower UV light transmissions than controls. The aim of this study was to explore the possible effects of external factors (UV light and temperature) on the homeopathic preparations. Homeopathic centesimal (c) dilutions, 1c to 30c, of copper sulfate (CuSO(4)), decimal dilutions of sulfur (S(8)), 1x to 30x, and controls (succussed potentization medium) were prepared, randomized, and blinded. UV transmission was measured at six different time points after preparation (from 4 to 256 days). In addition, one series of samples was exposed to UV light of a sterilization lamp for 12 h, one was incubated at 37 degrees Celsius for 24 h, and one was heated to 90 degrees Celsius for 15 min. UV light transmission values from 190 or 220 nm to 340 nm were measured several times and averaged. After each exposure, UV transmission of the homeopathic preparations of CuSO(4) was significantly reduced compared to the controls, particularly after heating to 37 degrees Celsius. Overall, the nonexposed CuSO(4) preparations did not show significantly lower UV transmission compared to controls; however, the pooled subgroup of measurements at days 26, 33, and 110 yielded significant differences. UV light transmission for S(8) preparations did not show any differences compared to controls. Our conclusion is that exposure to external factors, incubation at 37 degrees Celsius in particular, increases the difference in light transmission of homeopathic CuSO(4) preparations compared to controls.
TheScientificWorldJOURNAL 01/2010; 10:49-61. · 1.66 Impact Factor
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ABSTRACT: 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) 1HT(1) and T(2) 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 T(1) 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 T(1) 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.
Naturwissenschaften 07/2009; 96(9):1079-89. · 2.28 Impact Factor
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ABSTRACT: 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.
Evidence-based Complementary and Alternative Medicine 06/2009; 2011:692798. · 4.77 Impact Factor
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ABSTRACT: Homeopathically potentized antimony 6x is traditionally used in anthroposophic medicine for an alleged pro-coagulatory effect in bleeding disorders. However, the scientific evidence base is yet insufficient. Results of a previous in vitro study suggested a slight increase of maximal clot firmness (MCF) and a tendency towards a shorter clotting time (CT). The objective of this study was to investigate the pro-coagulatory effects of antimony in vivo, and possible unexpected or adverse events.
A randomized placebo controlled double blind crossover study was carried out in 30 healthy volunteers (15 males, 15 females). Each participant received intravenously 10 ml of antimony 6x and placebo in a randomized order at an interval of 1 month. Thrombelastography (TEG) was carried out immediately before and 30 and 60 min after the injection.
Statistically significant pro-coagulatory effects were observed 30 min after injection for CT in men (p = 0.0306), and for MCF in men and women combined (p = 0.0476). The effect of antimony was significantly larger on test day 1 than on test day 2, whereas the effect of placebo was similar on both test days. No unexpected adverse or adverse events causally related to antimony were observed.
This study adds evidence to the hypothesis that homeopathically potentized antimony may be efficacious in vivo. The consistency of the results with previous in vitro results indicates an effect on MCF and CT. The in vivo application of antimony 6x is safe.
Forschende Komplementärmedizin / Research in Complementary Medicine 03/2009; 16(1):14-8. · 1.65 Impact Factor
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ABSTRACT: In her book 'Living on Light', Jasmuheen tries to animate people worldwide to follow her drastic nutrition rules in order to boost their quality of life. Several deaths have been reported as a fatal consequence. A doctor of chemistry who believably claimed to have been 'living on light' for 2 years, except for the daily intake of up to 1.5 l of fluid containing no or almost no calories was interested in a scientific study on this phenomenon. PARTICIPANT AND METHODS: The 54-year-old man was subjected to a rigorous 10-day isolation study with complete absence of nutrition. During the study he obtained an unlimited amount of tea and mineral water but had no caloric intake. Parameters to monitor his metabolic and psychological state and vital parameters were measured regularly and the safety of the individual was ensured throughout the study. The subject agreed on these terms and the study was approved by the local ethics committee.
The most important observations were a permanent urinary excretion of ketones, up to a 3-fold increase in free fatty acid plasma levels, a mean weight loss of 0.26 kg/d, and an initially secondary hyperaldosteronism. Additionally, his ability to exercise was reduced. The subject remained psychologically stable and testing did not reveal any relevant changes.
The results refute the claim and indicate a phase-II fasting state.
Forschende Komplementärmedizin / Research in Complementary Medicine 02/2008; 15(4):203-9. · 1.65 Impact Factor
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ABSTRACT: Measurements in muscle tissue are often performed at a selected single location over the muscle of interest. The hypothesis is that the values obtained reflect the status within the entire muscle or muscle group. This, however, may not be the case. The study was performed to investigate whether this hypothesis is true for hemodynamics and oxygenation in the healthy human calf muscle at rest.
Hemoglobin flow, blood flow, oxygen consumption, and venous hemoglobin oxygen saturation were mapped at 22 locations in 30 legs of 15 healthy subjects (nine women, six men aged 26-37 years) simultaneously by using frequency-domain near-infrared spectrophotometry with a specially designed probe during venous occlusion.
For all parameters, spatial heterogeneity was found between subjects and within individual legs. All parameters were highly significantly different when comparing proximal and distal regions. Differences were also found between medial and lateral regions. The global mean values (+/-standard deviation) over all measurements were as follows: hemoglobin flow, 1.27 micromol per 100 mL/min +/- 0.88; blood flow, 0.56 mL per 100 g/min +/- 0.38; oxygen consumption, 0.016 mL per 100 g/min +/- 0.011; and venous oxygen saturation, 77.6% +/- 5.9. The thickness of the overlying adipose tissue had an influence on the measurements and must be considered.
Highly significant spatial heterogeneity of hemodynamics and oxygenation was found in the healthy human calf muscle.
Journal of Vascular and Interventional Radiology 10/2007; 18(9):1094-101. · 2.08 Impact Factor
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ABSTRACT: Within the framework of the Swiss governmental Program of Evaluation of Complementary Medicine (PEK) we assessed the prevalence, use, perceived effectiveness and appreciation of complementary medicine (CAM) in Switzerland, according to published surveys.
Search was performed through electronic databases, by hand-searching and by contacting experts at universities, hospitals, health insurances, patient organizations and pharmaceutical companies.
Surveys were carried out among the general population (40%), physicians (20%), hospitalized patients (30%) and obstetric institutions (5%). The number of publications increased strongly between 1981 and 2004. The mean +/- SD prevalence (use) of CAM is 49 +/- 22% and varies depending on the survey's topic and the population group interviewed. The acceptance, appreciation or demand for CAM among individuals specifically interviewed on CAM is 91 +/- 6%. When asked about favored general improvements in healthcare, 6.5% of the individuals spontaneously mentioned CAM. CAM therapies are considered to be effective by the majority of CAM users and by about 40% of cancer patients using CAM. Approximately 50% of the population stated a preference for hospitals that also provide CAM. 85% of the population wishes the costs for CAM to be covered by the basic health insurance.
Approximately half of the Swiss population has used CAM. CAM treatment is considered to be effective by the majority of CAM users. About 50% of the population would prefer hospitals that also provide CAM therapies and the majority of the population wishes the cost for CAM therapies to be covered by basic health insurance.
Forschende Komplementärmedizin / Research in Complementary Medicine 02/2006; 13 Suppl 2:4-6.
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ABSTRACT: A summary of main aspects from a Health Technology Assessment report on Traditional Chinese Medicine (TCM) in Switzerland concerning effectiveness and safety is given.
Literature search was performed through 13 databases, by scanning reference lists of articles and by contacting experts. Assessed were quality of documentation, internal and external validity.
Effectiveness: 43 articles concerning 'gastrointestinal tract and liver' were assessed. The studies covering 7,436 patients were undertaken in China (35), Japan (3), USA (2) and Australia (3); 33/43 being controlled studies. 34/40 show significantly better results in the TCM-treated group. A comparison of studies on results of treatment based on a diagnosis according to TCM criteria and studies on results of treatment according to Western diagnosis shows that treatment based on TCM diagnosis improves the result. The comparison of treatment by individual medication and standard medication showed a trend in favor of individual medication.
TCM training and practice for physicians in Switzerland are officially regulated. Side effects occur, but no severe effects have been registered up to now in Switzerland. TCM medicinals are imported; admission regulations are being installed. Problems due to production abroad, Internet trade, self-medication or admixtures are possible.
The evaluation of the literature search provides evidence for a basic clinical effectiveness of TCM therapy. Severe side effects were not observed in Switzerland. Regulations for trading and use of medicinals prevent treatment risks. Further clinical studies in a Western context are required.
Forschende Komplementärmedizin / Research in Complementary Medicine 02/2006; 13 Suppl 2:30-41.
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ABSTRACT: The aim of this literature review, performed within the framework of the Swiss governmental Program of Evaluation of Complementary Medicine (PEK), was to investigate costs of complementary and alternative medicine (CAM).
A systematic literature search was conducted in 11 electronic databases. All retrieved titles and reference lists were also hand-searched.
38 publications were found: 23 on CAM of various definitions (medical and non-medical practitioners, over-the-counter products), 13 on homeopathy, 2 on phytotherapy. Studies investigated different kinds of costs (direct or indirect) and used different methods (prospective or retrospective questionnaires, data analyses, cost-effectiveness models). Most studies report 'out of pocket' costs, because CAM is usually not covered by health insurance. Costs per CAM-treatment / patient / month were AUD 7-66, CAD 250 and GBP 13.62 +/- 1.61. Costs per treatment were EUR 205 (range: 15-1,278), USD 414 +/- 269 and USD 1,127. In two analyses phytotherapy proved to be cost-effective. One study revealed a reduction of 1.5 days of absenteeism from work in the CAM group compared to conventionally treated patients. Another study, performed by a health insurance company reported a slight increase in direct costs for CAM. Costs for CAM covered by insurance companies amounted to approximately 0.2-0.5% of the total healthcare budget (Switzerland, 2003). Publications had several limitations, e.g. efficacy of therapies was rarely reported. As compared to conventional patients, CAM patients tend to cause lower costs.
Results suggest lower costs for CAM than for conventional patients, but the limited methodological quality lowers the significance of the available data. Further well-designed studies and models are required.
Forschende Komplementärmedizin / Research in Complementary Medicine 02/2006; 13 Suppl 2:42-5.
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ABSTRACT: It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.
The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation.
A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format.
The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.
BMC Medical Research Methodology 02/2006; 6:56. · 2.67 Impact Factor
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ABSTRACT: The Health Technology Assessment report on effectiveness, cost-effectiveness and appropriateness of homeopathy was compiled on behalf of the Swiss Federal Office for Public Health (BAG) within the framework of the 'Program of Evaluation of Complementary Medicine (PEK)'.
Databases accessible by Internet were systematically searched, complemented by manual search and contacts with experts, and evaluated according to internal and external validity criteria.
Many high-quality investigations of pre-clinical basic research proved homeopathic high-potencies inducing regulative and specific changes in cells or living organisms. 20 of 22 systematic reviews detected at least a trend in favor of homeopathy. In our estimation 5 studies yielded results indicating clear evidence for homeopathic therapy. The evaluation of 29 studies in the domain 'Upper Respiratory Tract Infections/Allergic Reactions' showed a positive overall result in favor of homeopathy. 6 out of 7 controlled studies were at least equivalent to conventional medical interventions. 8 out of 16 placebo-controlled studies were significant in favor of homeopathy. Swiss regulations grant a high degree of safety due to product and training requirements for homeopathic physicians. Applied properly, classical homeopathy has few side-effects and the use of high-potencies is free of toxic effects. A general health-economic statement about homeopathy cannot be made from the available data.
Taking internal and external validity criteria into account, effectiveness of homeopathy can be supported by clinical evidence and professional and adequate application be regarded as safe. Reliable statements of cost-effectiveness are not available at the moment. External and model validity will have to be taken more strongly into consideration in future studies.
Forschende Komplementärmedizin / Research in Complementary Medicine 02/2006; 13 Suppl 2:19-29.
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ABSTRACT: Abstract
Background
It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.
Methods
The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation.
Results
A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemised and transformed into a questionnaire format.
Conclusion
The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.
BMC Medical Research Methodology. 01/2006;
