Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework

Buchholzer, Marie-Luise; Werner, C.; Knoess, Werner

doi:10.1016/j.yrtph.2013.12.008

Cited by 16 publications

(11 citation statements)

References 9 publications

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“…Application of the TTC approach has also been proposed for, or extended to, the risk assessment of other types of substances. These include substances present in consumer products (Antignac et al, 2011;Blackburn et al, 2005;SCCS, SCHER and SCENIHR, 2012;SCCS NfG, 2016): micropollutants, drug residues, pesticide metabolites and other impurities in drinking water (Brüschweiler, 2010;EFSA, 2016;Houeto et al, 2012;Laabs et al, 2015;Melching-Kollmuß et al, 2010;Mons et al, 2013); genotoxic impurities in human pharmaceuticals (EMEA, 2006); herbal preparations (EMEA, 2008); homeopathic medicines (Buchholzer et al, 2014); and human pharmaceutical substances carried over in multiproduct manufacturing facilities (Bercu and Dolan, 2013;Stanard et al, 2015). It has also been used as a first-level screening tool to prioritize for review a large number of substances identified as needing an assessment under the Canadian Environmental Protection Act (Health Canada, 2016).…”

Section: Introductionmentioning

confidence: 99%

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Yang

Barlow²,

Jacobs

et al. 2017

Food and Chemical Toxicology

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a b s t r a c tA new dataset of cosmetics-related chemicals for the Threshold of Toxicological Concern (TTC) approach has been compiled, comprising 552 chemicals with 219, 40, and 293 chemicals in Cramer Classes I, II, and III, respectively. Data were integrated and curated to create a database of No-/Lowest-Observed-AdverseEffect Level (NOAEL/LOAEL) values, from which the final COSMOS TTC dataset was developed. Criteria for study inclusion and NOAEL decisions were defined, and rigorous quality control was performed for study details and assignment of Cramer classes. From the final COSMOS TTC dataset, human exposure thresholds of 42 and 7.9 mg/kg-bw/day were derived for Cramer Classes I and III, respectively. The size of Cramer Class II was insufficient for derivation of a TTC value. The COSMOS TTC dataset was then federated with the dataset of Munro and colleagues, previously published in 1996, after updating the latter using the quality control processes for this project. This federated dataset expands the chemical space and provides more robust thresholds. The 966 substances in the federated database comprise 245, 49 and 672 chemicals in Cramer Classes I, II and III, respectively. The corresponding TTC values of 46, 6.2 and 2.3 mg/kg-bw/day are broadly similar to those of the original Munro dataset.

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Section: Introductionmentioning

confidence: 99%

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Yang

Barlow²,

Jacobs

et al. 2017

Food and Chemical Toxicology

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“…AM medications are prepared from plants, minerals, animals, and from chemically defined substances according to Good Manufacturing Practice and national drug regulations; quality standards of raw materials and manufacturing methods are described in the Anthroposophic Pharmaceutical Codex [ 65 ]. Toxicologically relevant starting materials (e.g., aconite, cinnabar) are highly diluted according to safety requirements of European regulations [ 66 ]. The available evidence suggests that AM medications are generally well tolerated, with infrequent adverse reactions of mostly mild to moderate severity [ 67 , 68 ].…”

Section: Introductionmentioning

confidence: 99%

Antibiotic Use in Children with Acute Respiratory or Ear Infections: Prospective Observational Comparison of Anthroposophic and Conventional Treatment under Routine Primary Care Conditions

Hamre

Glockmann

Schwarz³

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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Children with acute respiratory or ear infections (RTI/OM) are often unnecessarily prescribed antibiotics. Antibiotic resistance is a major public health problem and antibiotic prescription for RTI/OM should be reduced. Anthroposophic treatment of RTI/OM includes anthroposophic medications, nonmedication therapy and if necessary also antibiotics. This secondary analysis from an observational study comprised 529 children <18 years from Europe (AT, DE, NL, and UK) or USA, whose caregivers had chosen to consult physicians offering anthroposophic (A-) or conventional (C-) treatment for RTI/OM. During the 28-day follow-up antibiotics were prescribed to 5.5% of A-patients and 25.6% of C-patients (P < 0.001); unadjusted odds ratio for nonprescription in A- versus C-patients 6.58 (95%-CI 3.45–12.56); after adjustment for demographics and morbidity 6.33 (3.17–12.64). Antibiotic prescription rates in recent observational studies with similar patients in similar settings, ranged from 31.0% to 84.1%. Compared to C-patients, A-patients also had much lower use of analgesics, somewhat quicker symptom resolution, and higher caregiver satisfaction. Adverse drug reactions were infrequent (2.3% in both groups) and not serious. Limitation was that results apply to children of caregivers who consult A-physicians. One cannot infer to what extent antibiotics might be avoided in children who usually receive C-treatment, if they were offered A-treatment.

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“…Toxicologically relevant starting materials (e.g., aconite and cinnabar) are highly diluted according to safety requirements of European regulations [83]. Adverse reactions to these MPs are infrequent and usually of mild to moderate severity; anaphylactic reactions occur but are very rare [40, 84, 85].…”

Section: Resultsmentioning

confidence: 99%

Whole Medical Systems versus the System of Conventional Biomedicine: A Critical, Narrative Review of Similarities, Differences, and Factors That Promote the Integration Process

Baars

Hamre

2017

Evidence-Based Complementary and Alternative Medicine

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Background There is an increasing need for a worldwide professional integration of conventional medicine and traditional/complementary whole medical systems (WMSs). However, the integration is perceived by conventional medicine as problematic or unacceptable, because of a supposed lack of evidence for specific effects of WMSs therapies and supposed prescientific or unscientific paradigms of WMSs. Objectives To review the literature on the features of WMSs, similarities and differences between conventional medicine and WMSs, and scientific and clinical practice issues that should be dealt with in order to promote the integration process. Methods A critical, narrative review of the literature on six WMSs. Results and Conclusions Key factors for the integration of WMSs and conventional medicine are as follows: legal frameworks, quality standards, high-quality research on safety and efficacy of WMS interventions, infrastructure, and financial resources. For scientific assessment of WMSs, there are unresolved ontological, epistemological, and methodological issues and issues of diagnostics, therapy delivery, and outcome assessment in clinical practice. Future research not only should be directed at quality assurance and generating the necessary data on safety and efficacy/effectiveness but also should address more fundamental (ontological, epistemological, and methodological) issues, in order to overcome the differences between WMSs and conventional medicine.

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Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework

Cited by 16 publications

References 9 publications

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Antibiotic Use in Children with Acute Respiratory or Ear Infections: Prospective Observational Comparison of Anthroposophic and Conventional Treatment under Routine Primary Care Conditions

Whole Medical Systems versus the System of Conventional Biomedicine: A Critical, Narrative Review of Similarities, Differences, and Factors That Promote the Integration Process

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