scholarly journals Differentiated Evaluation of Extract-Specific Evidence onCimicifuga racemosa's Efficacy and Safety for Climacteric Complaints

2013 ◽  
Vol 2013 ◽  
pp. 1-21 ◽  
Author(s):  
A.-M. Beer ◽  
A. Neff
Keyword(s):  
Marketing Authorisation ◽  
Ethanolic Extract ◽  
Risk Profile ◽  
Evidence Based ◽  
Efficacy And Safety ◽  
Medicinal Products ◽  
Cimicifuga Racemosa ◽  
Regulatory Status ◽  
Climacteric Complaints ◽  
First Time

Past reviews onCimicifuga racemosa(CR) without differentiation between extracts, quality, and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system's logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product), and indication. A literature search for clinical studies examining CR's efficacy and safety for menopausal complaints was conducted. The results were sorted by type of extract, regulatory status, and indication. Accordingly, Oxford Levels of Evidence (LOE) and Grades of Recommendation (GR) were determined. CR extracts demonstrated a good to very good safety in general, on estrogen-sensitive organs and the liver. However, only registered CR medicinal products were able to prove their efficacy. Best evidence was provided by the isopropanolic CR extract (iCR): the multitude of studies including more than 11,000 patients demonstrated consistent confirmatory evidence of LOE 1b (LOE 1a for safety) leading to GR A. The studies on the ethanolic extract BNO 1055 including more than 500 patients showed exploratory evidence of LOE 2b resulting in GR B. A positive benefit-risk profile is stated and limited toCimicifuga racemosaproducts holding a marketing authorisation for treating climacteric complaints.

scholarly journals New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

2010 ◽  
Vol 61 (3) ◽  
pp. 311-322
Author(s):  
Adrijana Martinac ◽  
Siniša Tomić ◽  
Mirna Šimičić
Keyword(s):  
European Commission ◽  
Medicinal Product ◽  
Marketing Authorisation ◽  
Regulatory System ◽  
Efficacy And Safety ◽  
Medicinal Products ◽  
Commission Regulation ◽  
Approval Procedure ◽  
Definition Of ◽  
The Eu

New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian LegislationVariations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

scholarly journals Constituents of Chamaecrista diphylla (L.) Greene Leaves with Potent Antioxidant Capacity: A Feature-Based Molecular Network Dereplication Approach

Pharmaceutics ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 681
Author(s):  
Paulo Gomes ◽  
Luis Quirós-Guerrero ◽  
Abraão Muribeca ◽  
José Reis ◽  
Sônia Pamplona ◽  
...  
Keyword(s):  
Antioxidant Capacity ◽  
Ethanolic Extract ◽  
Oxygen Radical ◽  
Molecular Network ◽  
Antioxidant Compounds ◽  
Herbaceous Plant ◽  
Network Approach ◽  
Feature Based ◽  
Promising Source ◽  
First Time

Chamaecrista diphylla (L.) Greene (Fabaceae/Caesalpiniaceae) is a herbaceous plant that is widely distributed throughout the Americas. Plants from this genus have been used in traditional medicine as a laxative, to heal wounds, and to treat ulcers, snake and scorpion bites. In the present study, we investigated the chemical composition of Chamaecrista diphylla leaves through a mass spectrometry molecular network approach. The oxygen radical absorbance capacity (ORAC) for the ethanolic extract, enriched fractions and isolated compounds was assessed. Overall, thirty-five compounds were annotated for the first time in C. diphylla. Thirty-two of them were reported for the first time in the genus. The isolated compounds 9, 12, 24 and 33 showed an excellent antioxidant capacity, superior to the extract and enriched fractions. Bond dissociation energy calculations were performed to explain and sustain the antioxidant capacity found. According to our results, the leaves of C. diphylla represent a promising source of potent antioxidant compounds.

Evidence-Based Practice in Audiology: Rehabilitation Options for Adults With Hearing Impairment

2013 ◽  
Vol 22 (2) ◽  
pp. 329-331 ◽  
Author(s):  
Louise Hickson ◽  
Ariane Laplante-Lévesque ◽  
Lena Wong
Keyword(s):  
Hearing Impairment ◽  
Hearing Aids ◽  
Evidence Based Practice ◽  
Hearing Screening ◽  
Activity Limitations ◽  
Evidence Based ◽  
Reduce Activity ◽  
Participation Restrictions ◽  
Communication Programs ◽  
First Time

Purpose The authors address 3 questions: (a) What is evidence-based practice (EBP), and why is it important for adults with hearing impairment? (b) What is the evidence about intervention options for adults who fail a hearing screening and are identified with hearing impairment? (c) What intervention options do adults choose when identified with hearing impairment for the first time? Method The 5 steps of the EBP process are discussed in relation to a clinical question about whether hearing aids and communication programs reduce activity limitations and participation restrictions compared with no treatment for adults who fail a hearing screening and are identified with hearing impairment. Results Systematic reviews of the evidence indicate that both hearing aids and communication programs reduce activity limitations and participation restrictions for this population and are therefore appropriate options. A study is then described in which these options were presented to 153 clients identified with hearing impairment for the first time: 43% chose hearing aids, 18% chose communication programs, and the remaining 39% chose not to take any action. Conclusion EBP supports the offer of intervention options to adults who fail a hearing screening and are identified with hearing impairment.

scholarly journals Therapeutic Strategies for the Treatment of Chronic Hyperuricemia: An Evidence-Based Update

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 58
Author(s):  
Arrigo F. G. Cicero ◽  
Federica Fogacci ◽  
Masanari Kuwabara ◽  
Claudio Borghi
Keyword(s):  
Clinical Trials ◽  
Uric Acid ◽  
Clinical Research ◽  
Safety Profile ◽  
Therapeutic Strategies ◽  
Evidence Based ◽  
Acute Management ◽  
Efficacy And Safety ◽  
Uricosuric Agents ◽  
Xanthine Oxidase Inhibitors

This article aims to critically review the evidence on the available therapeutic strategies for the treatment of hyperuricemia. For this reason, several papers were reviewed. Xanthine oxidase inhibitors are the safest and most effective uric acid lowering drugs for the management of chronic hyperuricemia, while the efficacy of uricosuric agents is strongly modulated by pharmacogenetics. Emergent drugs (lesinurad, peglotidase) were found to be more effective for the acute management of refractory hyperuricemia, but their use is supported by a relatively small number of clinical trials so that further well-designed clinical research is needed to deepen their efficacy and safety profile.

Resurrection of the genus Similisinocarum (Apiaceae) based on evidence from morphology and ITS sequences

Phytotaxa ◽  
2021 ◽  
Vol 497 (2) ◽  
pp. 127-137
Author(s):  
XIAN-LIN GUO ◽  
MEGAN PRICE ◽  
WEI GOU ◽  
SONG-DONG ZHOU ◽  
XIN-FEN GAO ◽  
...  
Keyword(s):  
Type Species ◽  
Genetic Distances ◽  
Its Sequences ◽  
Evidence Based ◽  
Molecular Phylogenetic ◽  
First Time ◽  
Entire Margin

The genus Similisinocarum Cauwet & Farille (Apiaceae, Apioideae), was first described by Cauwet & Farille in 1984, but it has been considered as a synonym of Sinocarum H.Wolff ex R.H. Shan & F.T. Pu. In this study, Simlisinocarum normanianum, the type species of Similisinocarum was found in China for the first time, and the molecular phylogenetic evidence based on ITS sequences reveals that Similisinocarum normanianum occupies an individual clade, which is sister to the clade comprising seven species of Acronema, Sinocarum, and Oreocomopsis in Acronema clade, the values of genetic distances (ITS) between Similisinocarum and Acronema, Similisinocarum and Oreocomopsis, Similisinocarum and Pternopetalum, Similisinocarum and Sinocarum are close (≥0.0916), while deviated from the values within Acronema, Sinocarum and Pternopetalum (≤0.0580). Morphologically, we found Similisinocarum normanianum develops reflex bracteoles with white membranous margin, petals with an entire margin and incurved apex, and mericarps with many vittae in the furrow (≥ 3) and commissure (6), which are distinguishable from other species of the Acronema clade. Consequently, results manifested in molecular and morphological analyses indicate that Similisinocarum should be treated as an independent genus distinct from Sinocarum.

The Magistral Preparation of Advanced Therapy Medicinal Products (ATMPs)

2020 ◽  
pp. 1-7
Keyword(s):  
Marketing Authorisation ◽  
Health Care Systems ◽  
Human Keratinocytes ◽  
Public Health Care ◽  
Medicinal Products ◽  
Bacteriophage Therapy ◽  
Access To Treatment ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
Advanced Therapies

Advanced Therapy Medicinal Products (ATMPs) embody innovative therapies that have created great hope for patients suffering from previously untreatable diseases. Unfortunately, the pharaonic cost to produce and authorise ATMPs is a challenge for both patients and public health care systems, ultimately reducing patients’ access to treatment. Over the last 11 years, only 15 ATMP marketing authorisation applications received a positive draft opinion from the European Medicines Agency’s (EMA’s) Committee for Advanced Therapies (CAT). Moreover, due to poor return on investment, several ATMPs have already been removed from the market. In addition to the centralised procedure to obtain a marketing authorisation, the legislator foresees an alternative route for authorising ATMPs, the so-called “ATMP Hospital Exemption”. However, such ATMPs must be produced on a limited scale, on a non-routine basis. As a result, valuable ATMP therapies that have been used for years in hospitals may disappear. To avoid this, we propose, in this paper, an additional possibility to regularise ATMPs: the “Magistral Preparation of ATMPs”. It is a feasible pathway, which was already proposed for bacteriophage therapy, and which is particularly suitable for personalised therapies and considerably decreases the cost of the final products. We also discuss the practical impact of the ATMP regulation for (for-profit) industries and for (non-profit) hospitals. Two practical examples, the cultured human chondrocytes and the cultured human keratinocytes, are discussed.

scholarly journals PHYTOCHEMICAL CONSTITUENTS OF THE ROOT OF BERBERIS MICROPHYLLA

2017 ◽  
Vol 10 (6) ◽  
pp. 225 ◽  
Author(s):  
María Cristina Furrianca ◽  
Marysol Alvear ◽  
Tomás Zambrano ◽  
Víctor Fajardo ◽  
Luis Salazar
Keyword(s):  
Secondary Metabolites ◽  
Cardiac Glycosides ◽  
Methanolic Extract ◽  
Ethanolic Extract ◽  
Phytochemical Screening ◽  
Qualitative And Quantitative ◽  
Medicinal Properties ◽  
Phytochemical Constituents ◽  
First Time

Objective: To objective of this work was to perform phytochemical qualitative and quantitative analyzes of the main secondary metabolites in the root of Berberis microphylla.Methods: The extracts of B. microphylla root were tested through phytochemical screening and the quantification of the most important constituents was carried out using spectrophotometric and gravimetric techniques.Results: Phytochemical screening of both extracts showed the presence of alkaloids, flavonoids, glycosides, cardiac glycosides, saponins, terpenes,and tannins, which are pharmacologically important. Quantification of the major phytochemicals groups showed that the ethanolic extract contains 3.9% alkaloids, 0.46% flavonoids, 9.53% tannins, and 3.60% saponins. Similarly, the methanolic extract contains 6.61% alkaloids, 0.41% flavonoids, 7.40% tannins, and 1.43% saponins.Conclusion: This is the first time that the presence of tannins, flavonoids, and saponins in this plant has been reported. The medicinal properties of the root of B. microphylla may exist due to the presence secondary metabolites.

scholarly journals N.V. Gogol’s Works and Censorship

Literary Fact ◽  
2021 ◽  
pp. 238-256
Author(s):  
Igor A. Vinogradov
Keyword(s):  
Literary Criticism ◽  
Good Reason ◽  
Evidence Based ◽  
Previous Period ◽  
Analytical Review ◽  
Negative Role ◽  
The Common ◽  
The Government ◽  
First Time

For the first time, an analytical review of all, without exception, censorship stories of N.V. Gogol’s works is presented. An objective picture of Gogol's relationship with the censorship is being recreated. The findings of the study allow, with good reason, to judge about the interference of censors in the writer's works in a fundamentally different way, in comparison with the ideas offered by literary criticism of the previous period without solid evidence. Based on a thorough analysis, involving numerous archival sources, the common, stereotypical opinions about the extremely negative role of censorship in Gogol’s fate are being revised. The most significant negative result among all censorship interventions in Gogol's works was the activity of the censor of Westernizing views, opposed to the government, a professor at St. Petersburg University, A.V. Nikitenko. It is the numerous reductions of Nikitenko, И.А. Виноградов. Произведения Н .В. Гоголя и цензура 255 a friend of V.G. Belinsky, in Gogol's religious and patriotic book “Selected Passages from Correspondence with Friends” that the writer called “censorship murder”. No less significant was the intervention of the liberal censor in the texts of “Dead Souls”, “Theatrical Travel after the Presentation of a New Comedy” and other works of the writer. It is concluded that, with the exception of this “intrigue” against Gogol by the censor Nikitenko, on the whole Gogol's texts encountered relatively insignificant difficulties in censorship.

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