Reporting experiments in homeopathic basic research-description of the checklist development.

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.

Quantitative MRI of the liver: Evaluation of extracellular volume fraction and other quantitative parameters in comparison to MR elastography for the assessment of hepatopathy.

BACKGROUND: Chronic liver diseases pose a major health problem worldwide, while common tests for diagnosis and monitoring of diffuse hepatopathy have considerable limitations. Preliminary data on the quantification of hepatic extracellular volume fraction (ECV) with magnetic resonance imaging (MRI) for non-invasive assessment of liver fibrosis are encouraging, with ECV having the potential to overcome several of these constraints. PURPOSE: To clinically evaluate ECV provided by quantitative MRI for assessing the severity of liver disease. MATERIALS AND METHODS: In this prospective study, multiparametric liver MRI, including T1 mapping and magnetic resonance elastography (MRE), was performed in subjects with and without hepatopathy between November 2018 and October 2019. T1, T2, T2*, proton density fat fraction and stiffness were extracted from parametric maps by regions of interest and ECV was calculated from T1 relaxometries. Serum markers of liver disease were obtained by clinical database research. For correlation analysis, Spearman rank correlation was used. ROC analysis of serum markers and quantitative MRI data for discrimination of liver cirrhosis was performed with MRE as reference standard. RESULTS: 109 participants were enrolled (50.7 ± 16.1 years, 61 men). ECV, T1 and MRE correlated significantly with almost all serum markers of liver disease, with ECV showing the strongest associations (up to r = 0.67 with MELD, p < 0.01). ECV and T1 correlated with MRE (0.75 and 0.73, p < 0.01 each). ECV (AUC 0.89, cutoff 32.2%, sensitivity 85%, specificity 87%) and T1 mapping (AUC 0.85, cutoff 592.5 ms, sensitivity 83%, specificity 75%) featured good performances in detection of liver cirrhosis with only ECV performing significantly superior to model of end stage liver disease (MELD), AST/ALT ratio and international normalized ratio (p < 0.01, respectively). CONCLUSION: Quantification of hepatic extracellular volume fraction with MRI is suitable for estimating the severity of liver disease when using MRE as the standard of reference. It represents a promising tool for non-invasive assessment of liver fibrosis and cirrhosis.

Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit.

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.