WorldWideScience

Sample records for medicinal product systematic

  1. Community pharmacist's responsibilities with regards to traditional medicine/complementary medicine products: A systematic literature review.

    Science.gov (United States)

    Ung, Carolina Oi Lam; Harnett, Joanna; Hu, Hao

    The use of Traditional Medicine/Complementary Medicine (TM/CM) products has gained popularity in many countries. There is a growing body of evidence to support that concomitant use of TM/CM products with certain pharmaceutical medicines may adversely affect treatment outcomes. There is a general consensus that pharmacists have a role to play in the safe and appropriate use of these products. However, the extent of their involvement and responsibilities are not yet defined. Clear guidelines that inform their duty of care are essential for pharmacists to establish their role in the management of TM/CM product use. The purpose of this study was to determine pharmacist's responsibilities with regards to TM/CM products that have been discussed in the literature since 2000. A literature search in 3 electronic databases (Web of Science, Science Direct and PubMed) was used to extract publications from 2000 to 2015 that related pharmacist to TM/CM products. Out of the 2859 publications extracted for abstract review, 171 documents were selected for full text assessment. 41 publications which reported findings from exploratory studies or discussed pharmacists' responsibilities towards TM/CM products were selected for inclusion in this study. Seven major responsibilities were frequently discussed in the literature: (1) to acknowledge the use; (2) to be knowledgeable about the TM/CM products; (3) to ensure safe use of TM/CM products; (4) to document the use of TM/CM products; (5) to report ADRs related to TM/CM products; (6) to educate about TM/CM products; and (7) to collaborate with other health care professionals. Various forms and levels of pharmacists' responsibilities with TM/CM products have been mentioned in the literature. Subsequent work towards a common consensus must take into account three influential factors strategically: the scope of TM/CM products, objectives of pharmacists' involvement and the perspectives of key stakeholders. Copyright © 2016 Elsevier Inc

  2. Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2016-07-01

    We have systematically identified medicinal products withdrawn worldwide because of adverse drug reactions, assessed the level of evidence used for making the withdrawal decisions, and explored the patterns of withdrawals over time. We searched PubMed, the WHO database of withdrawn products, and selected texts. We included products that were withdrawn after launch from 1950 onwards, excluding non-human and over-the-counter medicines. We assessed the levels of evidence on which withdrawals were based using the Oxford Center for Evidence Based Medicine Levels of Evidence. Of 353 medicinal products withdrawn from any country, only 40 were withdrawn worldwide. Anecdotal reports were cited as evidence for withdrawal in 30 (75%) and deaths occurred in 27 (68%). Hepatic, cardiac, and nervous system toxicity accounted for over 60% of withdrawals. In 28 cases, the first withdrawal was initiated by the manufacturer. The median interval between the first report of an adverse drug reaction that led to withdrawal and the first withdrawal was 1 year (range 0-43 years). Worldwide withdrawals occurred within 1 year after the first withdrawal in any country. In conclusion, the time it takes for drugs to be withdrawn worldwide after reports of adverse drug reactions has shortened over time. However, there are inconsistencies in current withdrawal procedures when adverse drug reactions are suspected. A uniform method for establishing worldwide withdrawal of approved medicinal products when adverse drug reactions are suspected should be developed, to facilitate global withdrawals. Rapid synthesis of the evidence on harms should be a priority when serious adverse reactions are suspected.

  3. Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Simone de Souza Nascimento

    2013-01-01

    Full Text Available To assess the effects of medicinal plants (MPs or related natural products (RNPs on fibromyalgia (FM patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs involving 475 patients. The methodological quality of all studies included was determined according to JADAD and “Risk of Bias” with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects.

  4. Sustainable Utilization of Traditional Chinese Medicine Resources: Systematic Evaluation on Different Production Modes

    Directory of Open Access Journals (Sweden)

    Xiwen Li

    2015-01-01

    Full Text Available The usage amount of medicinal plant rapidly increased along with the development of traditional Chinese medicine industry. The higher market demand and the shortage of wild herbal resources enforce us to carry out large-scale introduction and cultivation. Herbal cultivation can ease current contradiction between medicinal resources supply and demand while they bring new problems such as pesticide residues and plant disease and pests. Researchers have recently placed high hopes on the application of natural fostering, a new method incorporated herbal production and diversity protecting practically, which can solve the problems brought by artificial cultivation. However no modes can solve all problems existing in current herbal production. This study evaluated different production modes including cultivation, natural fostering, and wild collection to guide the traditional Chinese medicine production for sustainable utilization of herbal resources.

  5. The safety of herbal medicinal products derived from Echinacea species: a systematic review.

    Science.gov (United States)

    Huntley, Alyson L; Thompson Coon, Joanna; Ernst, Edzard

    2005-01-01

    Echinacea spp. are native to North America and were traditionally used by the Indian tribes for a variety of ailments, including mouth sores, colds and snake-bites. The three most commonly used Echinacea spp. are E. angustifolia, E. pallida and E. purpurea. Systematic literature searches were conducted in six electronic databases and the reference lists of all of the papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting programmes of the WHO and national drug safety bodies. Twenty-three manufacturers of echinacea were contacted and asked for data held on file. Finally our own departmental files were searched. No language restrictions were imposed. Combination products and homeopathic preparations were excluded. Data from clinical studies and spontaneous reporting programmes suggest that adverse events with echinacea are not commonly reported. Gastrointestinal upsets and rashes occur most frequently. However, in rare cases, echinacea can be associated with allergic reactions that may be severe. Although there is a large amount of data that investigates the efficacy of echinacea, safety issues and the monitoring of adverse events have not been focused on. Short-term use of echinacea is associated with a relatively good safety profile, with a slight risk of transient, reversible, adverse events. The association of echinacea with allergic reactions is supported by the present evaluation. While these reactions are likely to be rare, patients with allergy or asthma should carefully consider their use of echinacea. The use of echinacea products during pregnancy and lactation would appear to be ill-advised in light of the paucity of data in this area.

  6. Systematic Reviews in Sports Medicine.

    Science.gov (United States)

    DiSilvestro, Kevin J; Tjoumakaris, Fotios P; Maltenfort, Mitchell G; Spindler, Kurt P; Freedman, Kevin B

    2016-02-01

    The number of systematic reviews published in the orthopaedic literature has increased, and these reviews can help guide clinical decision making. However, the quality of these reviews can affect the reader's ability to use the data to arrive at accurate conclusions and make clinical decisions. To evaluate the methodological and reporting quality of systematic reviews and meta-analyses in the sports medicine literature to determine whether such reviews should be used to guide treatment decisions. The hypothesis was that many systematic reviews in the orthopaedic sports medicine literature may not follow the appropriate reporting guidelines or methodological criteria recommended for systematic reviews. Systematic review. All clinical sports medicine systematic reviews and meta-analyses from 2009 to 2013 published in The American Journal of Sports Medicine (AJSM), The Journal of Bone and Joint Surgery (JBJS), Arthroscopy, Sports Health, and Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA) were reviewed and evaluated for level of evidence according to the guidelines from the Oxford Centre for Evidence-Based Medicine, for reporting quality according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, and for methodological quality according to the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Analysis was performed by year and journal of publication, and the levels of evidence included in the systematic reviews were also analyzed. A total of 200 systematic reviews and meta-analyses were identified over the study period. Of these, 53% included evidence levels 4 and 5 in their analyses, with just 32% including evidence levels 1 and 2 only. There were significant differences in the proportion of articles with high levels of evidence (P Sports Health and KSSTA on the PRISMA and AMSTAR. The average PRISMA score by year varied from 85% to 89%, and the average AMSTAR score varied from 70% to 76%. Systematic reviews

  7. A systematic overview of the first pasteurised VWF/FVIII medicinal product, Haemate P/ Humate -P: history and clinical performance

    DEFF Research Database (Denmark)

    Berntorp, E.; Archey, W.; Auerswald, G.

    2008-01-01

    , plasma-derived VWF/FVIII medicinal product, which was first licensed in Germany in 1981 for the treatment of HA-associated bleeding. It has since then come to be accepted as the gold standard for both the treatment and prophylaxis of bleeding in VWD, especially in cases where desmopressin [1-deamino-8-D......-arginine vasopressin (DDAVP)] has been ineffective. Haemate P was the first effectively virus-inactivated (pasteurisation: 60 degrees C for 10 h in aqueous solution) FVIII product, whereby the risk of potentially threatening infective complications of plasma-derived products was reduced. Haemate P was also shown...... including surgical interventions. By virtue of its plasma-derived combination of VWF and FVIII, in addition to its high VWF:FVIII content ratio (2.4:1), Haemate P is also associated with successful immune tolerance induction in those patients developing inhibitor antibodies. Although the theoretical risk...

  8. Publication productivity in nuclear medicine.

    Science.gov (United States)

    McKellar, Cheryl; Currie, Geoff

    2015-06-01

    Publications form the knowledge base of any profession. Patterns in professional publications provide insight into the profession's maturity and global status. To our knowledge, publication productivity in nuclear medicine technology has not been reported. A recent study on publication productivity in radiography and radiation therapy provided interesting insight; however, a sampling bias resulted in study flaws. The most productive medical radiation technologists were determined by collecting data from 7 key, international peer-reviewed journals for the medical radiation sciences over a 5-y period. A full list of the technologists' publications, for the 5-y period, was obtained using a PubMed and ResearchGate search, and the authors were analyzed. In total, 165 medical radiation technologists were identified who had published 3 or more articles between 2009 and 2013. Of these authors, 55.2% (91/165) were radiographers, 35.2% (58/165) were radiation therapists, and 9.6% (16/165) were nuclear medicine technologists. Overall, the majority of the most prolific authors were academics (104/165; 63.0%). After we applied a correction factor (the productivity per member of the registered workforce), radiography had the fewest authors publishing, compared with the relative workflow sizes. Nuclear medicine technologists demonstrated a high degree of productivity both absolutely and relatively. Consequently, nuclear medicine technologists have a productive research culture and command a large footprint within and outside the key medical radiation science journals. © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

  9. Systematic reviews of herbal medicines--an annotated bibliography

    NARCIS (Netherlands)

    Linde, K.; ter Riet, G.; Hondras, M.; Vickers, A.; Saller, R.; Melchart, D.

    2003-01-01

    OBJECTIVE: To provide a comprehensive collection and a summary of systematic reviews of clinical trials on herbal medicines. METHODS: Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of

  10. The Traditional Medicine and Modern Medicine from Natural Products

    Directory of Open Access Journals (Sweden)

    Haidan Yuan

    2016-04-01

    Full Text Available Natural products and traditional medicines are of great importance. Such forms of medicine as traditional Chinese medicine, Ayurveda, Kampo, traditional Korean medicine, and Unani have been practiced in some areas of the world and have blossomed into orderly-regulated systems of medicine. This study aims to review the literature on the relationship among natural products, traditional medicines, and modern medicine, and to explore the possible concepts and methodologies from natural products and traditional medicines to further develop drug discovery. The unique characteristics of theory, application, current role or status, and modern research of eight kinds of traditional medicine systems are summarized in this study. Although only a tiny fraction of the existing plant species have been scientifically researched for bioactivities since 1805, when the first pharmacologically-active compound morphine was isolated from opium, natural products and traditional medicines have already made fruitful contributions for modern medicine. When used to develop new drugs, natural products and traditional medicines have their incomparable advantages, such as abundant clinical experiences, and their unique diversity of chemical structures and biological activities.

  11. The Traditional Medicine and Modern Medicine from Natural Products.

    Science.gov (United States)

    Yuan, Haidan; Ma, Qianqian; Ye, Li; Piao, Guangchun

    2016-04-29

    Natural products and traditional medicines are of great importance. Such forms of medicine as traditional Chinese medicine, Ayurveda, Kampo, traditional Korean medicine, and Unani have been practiced in some areas of the world and have blossomed into orderly-regulated systems of medicine. This study aims to review the literature on the relationship among natural products, traditional medicines, and modern medicine, and to explore the possible concepts and methodologies from natural products and traditional medicines to further develop drug discovery. The unique characteristics of theory, application, current role or status, and modern research of eight kinds of traditional medicine systems are summarized in this study. Although only a tiny fraction of the existing plant species have been scientifically researched for bioactivities since 1805, when the first pharmacologically-active compound morphine was isolated from opium, natural products and traditional medicines have already made fruitful contributions for modern medicine. When used to develop new drugs, natural products and traditional medicines have their incomparable advantages, such as abundant clinical experiences, and their unique diversity of chemical structures and biological activities.

  12. Research Productivity of Sports Medicine Fellowship Faculty

    OpenAIRE

    Cvetanovich, Gregory L.; Saltzman, Bryan M.; Chalmers, Peter N.; Frank, Rachel M.; Cole, Brian J.; Bach, Bernard R.

    2016-01-01

    Background: Research productivity is considered an important factor in academic advancement in sports medicine. No study to date has evaluated academic productivity and correlates of academic rank for sports medicine fellowship faculty. Purpose: To describe the academic productivity of American Orthopaedic Society for Sports Medicine (AOSSM) fellowship program faculty and to determine the association between academic productivity, fellowship characteristics, and academic rank. Study Design: D...

  13. Research Productivity of Sports Medicine Fellowship Faculty.

    Science.gov (United States)

    Cvetanovich, Gregory L; Saltzman, Bryan M; Chalmers, Peter N; Frank, Rachel M; Cole, Brian J; Bach, Bernard R

    2016-12-01

    Research productivity is considered an important factor in academic advancement in sports medicine. No study to date has evaluated academic productivity and correlates of academic rank for sports medicine fellowship faculty. To describe the academic productivity of American Orthopaedic Society for Sports Medicine (AOSSM) fellowship program faculty and to determine the association between academic productivity, fellowship characteristics, and academic rank. Descriptive epidemiology study. Characteristics of orthopaedic sports medicine fellowship programs were obtained from the AOSSM and program websites. Metrics of academic productivity (Hirsch index [ h index], I-10 index, publications, citations, and number of publications in several journals) were obtained from Scopus. Statistical analyses were conducted to determine whether academic productivity differs with fellowship attributes and academic rank. A total of 90 AOSSM sports medicine fellowship programs with 610 associated faculty members were identified. Faculty were predominantly male (94%), at academic medical centers (74%), members of AOSSM (71%), and sports medicine-fellowship trained (84%). Faculty had a median of 18 (range, 0-684) publications overall, including a median of 3 (range, 0-161) publications since 2012. All measures of academic productivity were significantly higher among faculty employed at academic medical centers compared with those not employed at academic centers ( P Sports Medicine and Arthroscopy per faculty member ( P sports medicine fellowship faculty. Research productivity was higher among faculty employed at academic centers in the Northeast and Midwest regions and at programs with a larger number of fellows.

  14. Nigerian Journal of Natural Products and Medicine

    African Journals Online (AJOL)

    Nigerian Journal of Natural Products and Medicine is published by the Nigerian Society of Pharmacognosy, a non profit organisation established in 1982 dedicated to the promotion of Pharmacognosy, Natural Products and Traditional Medicine. It has a current circulation of about 500 to scientists in Nigeria and abroad.

  15. Research Productivity of Sports Medicine Fellowship Faculty

    Science.gov (United States)

    Cvetanovich, Gregory L.; Saltzman, Bryan M.; Chalmers, Peter N.; Frank, Rachel M.; Cole, Brian J.; Bach, Bernard R.

    2016-01-01

    Background: Research productivity is considered an important factor in academic advancement in sports medicine. No study to date has evaluated academic productivity and correlates of academic rank for sports medicine fellowship faculty. Purpose: To describe the academic productivity of American Orthopaedic Society for Sports Medicine (AOSSM) fellowship program faculty and to determine the association between academic productivity, fellowship characteristics, and academic rank. Study Design: Descriptive epidemiology study. Methods: Characteristics of orthopaedic sports medicine fellowship programs were obtained from the AOSSM and program websites. Metrics of academic productivity (Hirsch index [h index], I-10 index, publications, citations, and number of publications in several journals) were obtained from Scopus. Statistical analyses were conducted to determine whether academic productivity differs with fellowship attributes and academic rank. Results: A total of 90 AOSSM sports medicine fellowship programs with 610 associated faculty members were identified. Faculty were predominantly male (94%), at academic medical centers (74%), members of AOSSM (71%), and sports medicine–fellowship trained (84%). Faculty had a median of 18 (range, 0-684) publications overall, including a median of 3 (range, 0-161) publications since 2012. All measures of academic productivity were significantly higher among faculty employed at academic medical centers compared with those not employed at academic centers (P Sports Medicine and Arthroscopy per faculty member (P sports medicine fellowship faculty. Research productivity was higher among faculty employed at academic centers in the Northeast and Midwest regions and at programs with a larger number of fellows. PMID:28210650

  16. Readability of medicinal package leaflets: a systematic review

    Science.gov (United States)

    Pires, Carla; Vigário, Marina; Cavaco, Afonso

    2015-01-01

    OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use. METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online, comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded. RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions. CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the

  17. Readability of medicinal package leaflets: a systematic review.

    Science.gov (United States)

    Pires, Carla; Vigário, Marina; Cavaco, Afonso

    2015-01-01

    OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use. METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords "Readability and Package Leaflet" and "Readability and Package Insert" in the academic search engine Biblioteca do Conhecimento Online, comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded. RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions. CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

  18. [Systematic economic assessment and quality evaluation for traditional Chinese medicines].

    Science.gov (United States)

    Sun, Xiao; Guo, Li-ping; Shang, Hong-cai; Ren, Ming; Lei, Xiang

    2015-05-01

    To learn about the economic studies on traditional Chinese medicines in domestic literatures, in order to analyze the current economic assessment of traditional Chinese medicines and explore the existing problems. Efforts were made to search CNKI, VIP, Wanfang database and CBM by computer and include all literatures about economic assessment of traditional Chinese medicines published on professional domestic journals in the systematic assessment and quality evaluation. Finally, 50 articles were included in the study, and the systematic assessment and quality evaluation were made for them in terms of titles, year, authors' identity, expense source, disease type, study perspective, study design type, study target, study target source, time limit, cost calculation, effect indicator, analytical technique and sensitivity analysis. The finally quality score was 0.74, which is very low. The results of the study showed insufficient studies on economics of traditional Chinese medicines, short study duration and simple evaluation methods, which will be solved through unremitting efforts in the future.

  19. Ancient Egyptian Medicine: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Samuel Adu-Gyamfi

    2015-12-01

    Full Text Available Our present day knowledge in the area of medicine in Ancient Egypt has been severally sourced from medical papyri several of which have been deduced and analyzed by different scholars. For educational purposes it is always imperative to consult different literature or sources in the teaching of ancient Egypt and medicine in particular. To avoid subjectivity the author has found the need to re-engage the efforts made by several scholars in adducing evidences from medical papyri. In the quest to re-engage the efforts of earlier writers and commentaries on the medical papyri, we are afforded the opportunity to be informed about the need to ask further questions to enable us to construct or reconstruct both past and modern views on ancient Egyptian medical knowledge. It is this vocation the author sought to pursue in the interim, through a preliminary review, to highlight, comment and reinvigorate in the reader or researcher the need for a continuous engagement of some pertinent documentary sources on Ancient Egyptian medical knowledge for educational and research purposes. The study is based on qualitative review of published literature. The selection of those articles as sources was based on the focus of the review, in order to purposively select and comment on articles that were published based either on information from a medical papyrus or focused on medical specialization among the ancient Egyptians as well as ancient Egyptian knowledge on diseases and medicine. It was found that the Egyptians developed relatively sophisticated medical practices covering significant medical fields such as herbal medicine, gynecology and obstetrics, anatomy and physiology, mummification and even the preliminary form of surgery. These practices, perhaps, were developed as remedies for the prevailing diseases and the accidents that might have occurred during the construction of their giant pyramids. It must be stated that they were not without flaws. Also, the

  20. Medicinal plants: production and biochemical characterization

    International Nuclear Information System (INIS)

    Chunzhao Liu; Zobayed, S.M.A; Murch, S.J.; Saxena, P.K.

    2002-01-01

    Recent advances in the area of biotechnology offer some possibility for the development of new technologies for the conservation, characterization and mass production of medicinal plant species, (i.e. in vitro cell culture techniques for the mass production of sterile, consistent, standardized medicinal plant materials). This paper discussed the following subjects - plant tissue culture, de novo shoot organogenesis, de novo root organogenesis, somatic embryogenesis, large scale propagation in bioreactors and discovery of unique biomolecules

  1. ANTI-VIRAL EFFECTS OF MEDICINAL PLANTS IN THE MANAGEMENT OF DENGUE: A SYSTEMATIC REVIEW.

    Science.gov (United States)

    Frederico, Éric Heleno Freira Ferreira; Cardoso, André Luiz Bandeira Dionísio; Moreira-Marconi, Eloá; de Sá-Caputo, Danúbia da Cunha; Guimarães, Carlos Alberto Sampaio; Dionello, Carla da Fontoura; Morel, Danielle Soares; Paineiras-Domingos, Laisa Liane; de Souza, Patricia Lopes; Brandão-Sobrinho-Neto, Samuel; Carvalho-Lima, Rafaelle Pacheco; Guedes-Aguiar, Eliane de Oliveira; Costa-Cavalcanti, Rebeca Graça; Kutter, Cristiane Ribeiro; Bernardo-Filho, Mario

    2017-01-01

    Dengue is considered as an important arboviral disease. Safe, low-cost, and effective drugs that possess inhibitory activity against dengue virus (DENV) are mostly needed to try to combat the dengue infection worldwide. Medicinal plants have been considered as an important alternative to manage several diseases, such as dengue. As authors have demonstrated the antiviral effect of medicinal plants against DENV, the aim of this study was to review systematically the published research concerning the use of medicinal plants in the management of dengue using the PubMed database. Search and selection of publications were made using the PubMed database following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA statement). Six publications met the inclusion criteria and were included in the final selection after thorough analysis. It is suggested that medicinal plants' products could be used as potential anti-DENV agents.

  2. Introduction to systematic reviews in animal agriculture and veterinary medicine.

    Science.gov (United States)

    Sargeant, J M; O'Connor, A M

    2014-06-01

    This article is the first in a series of six articles related to systematic reviews in animal agriculture and veterinary medicine. In this article, we overview the methodology of systematic reviews and provide a discussion of their use. Systematic reviews differ qualitatively from traditional reviews by explicitly defining a specific review question, employing methods to reduce bias in the selection and inclusion of studies that address the review question (including a systematic and specified search strategy, and selection of studies based on explicit eligibility criteria), an assessment of the risk of bias for included studies and objectively summarizing the results qualitatively or quantitatively (i.e. via meta-analysis). Systematic reviews have been widely used to address human healthcare questions and are increasingly being used in veterinary medicine. Systematic reviews can provide veterinarians and other decision-makers with a scientifically defensible summary of the current state of knowledge on a topic without the need for the end-user to read the vast amount of primary research related to that topic. © 2014 Blackwell Verlag GmbH.

  3. Apitherapy Products for Medicinal Use.

    Science.gov (United States)

    Fratellone, Patrick M; Tsimis, Flora; Fratellone, Gregory

    2016-12-01

    For the past 10 years, beekeeping has increased due to a growing awareness of the disappearance of bees since Colony Collapse Disorder. Most of the disappearance of honey bees can be attributed to the use of pesticides. Apitherapy is the science and art of maintaining health with the use of products from the honeybee hive: honey, bee pollen, propolis, royal jelly, and bee venom. We have been beekeeping for the last 10 years. We use every product from the beehive for both personal and patient use.

  4. Understanding the productive author who published papers in medicine using National Health Insurance Database: A systematic review and meta-analysis.

    Science.gov (United States)

    Chien, Tsair-Wei; Chang, Yu; Wang, Hsien-Yi

    2018-02-01

    Many researchers used National Health Insurance database to publish medical papers which are often retrospective, population-based, and cohort studies. However, the author's research domain and academic characteristics are still unclear.By searching the PubMed database (Pubmed.com), we used the keyword of [Taiwan] and [National Health Insurance Research Database], then downloaded 2913 articles published from 1995 to 2017. Social network analysis (SNA), Gini coefficient, and Google Maps were applied to gather these data for visualizing: the most productive author; the pattern of coauthor collaboration teams; and the author's research domain denoted by abstract keywords and Pubmed MESH (medical subject heading) terms.Utilizing the 2913 papers from Taiwan's National Health Insurance database, we chose the top 10 research teams shown on Google Maps and analyzed one author (Dr. Kao) who published 149 papers in the database in 2015. In the past 15 years, we found Dr. Kao had 2987 connections with other coauthors from 13 research teams. The cooccurrence abstract keywords with the highest frequency are cohort study and National Health Insurance Research Database. The most coexistent MESH terms are tomography, X-ray computed, and positron-emission tomography. The strength of the author research distinct domain is very low (Gini < 0.40).SNA incorporated with Google Maps and Gini coefficient provides insight into the relationships between entities. The results obtained in this study can be applied for a comprehensive understanding of other productive authors in the field of academics.

  5. Systematic review of traditional Chinese medicine for geriatrics.

    Science.gov (United States)

    Takayama, Shin; Iwasaki, Koh

    2017-05-01

    The Japan Geriatrics Society revised its criteria for the medical treatment and safety of the elderly in 2015. The Japan Geriatrics Society guidelines contain a chapter for traditional Chinese medicine (TCM; traditional medicines in East Asian countries, such as China, Japan, Korea, Taiwan, Vietnam and Singapore), because it is widely used for elderly patients and is sometimes covered by national medical insurance in Japan. The updated guidelines should be improved based on a comprehensive, systematic review and evidence grading. TCM is rapidly expanding in the literature, and is under intensive investigation in clinical trials. The objective of the present trial was to review TCM systematically and reflect the results to update the TCM chapter of the Japan Geriatrics Society guidelines. Here, we introduce the results of the systemic review of TCM for geriatrics. Geriatr Gerontol Int 2017; 17: 679-688. © 2016 The Authors. Geriatrics & Gerontology International published by John Wiley & Sons Australia, Ltd on behalf of Japan Geriatrics Society.

  6. Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

    Science.gov (United States)

    Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

    2011-06-01

    To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

  7. Medicinal plants for primary dysmenorrhoea: A systematic review.

    Science.gov (United States)

    Pellow, Janice; Nienhuis, Chantelle

    2018-04-01

    Primary dysmenorrhoea is a common complaint experienced by many females in their reproductive years. The use of medicinal plants in the treatment of various gynaecological conditions is on the increase, despite the limited evidence available regarding efficacy and safety of their use. The aim of this systematic review was to synthesise the most recent evidence relating to the treatment of primary dysmenorrhoea with medicinal plants. A thorough database search was conducted using defined search terms, and randomised controlled trials (RCTs) published in English between 2008 and 2016, pertaining to the use of medicinal plants (single use) for the treatment of primary dysmenorrhoea, were assessed. Studies evaluating dysmenorrhoeal pain and associated symptoms as a primary or secondary outcome were considered and assessed by two reviewers independently of each other, using the JADAD scale and the Cochrane risk of bias tool,. 22 RCTs were included in the review; 9 were placebo-controlled trials and 13 were comparative studies to pharmacological treatment or nutritional supplements. Most of the evaluated medicinal plants showed evidence of efficacy in relieving menstrual pain in at least one RCT. The low or unclear quality of the majority of these studies however warrants caution in interpreting these results. This review adds to the knowledge-base on the use of these medicinal plants in the treatment of primary dysmenorrhoea. Further research is needed before definitive conclusions can be made regarding the efficacy and safety of the use of these medicinal plants. Copyright © 2018 Elsevier Ltd. All rights reserved.

  8. Medicinal Product Regulation: Portugal׳s Framework.

    Science.gov (United States)

    Herdeiro, Maria Teresa; Bastos, Paulo D; Teixeira-Rodrigues, António; Roque, Fátima

    2016-09-01

    The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  9. Substandard and counterfeit medicines: a systematic review of the literature

    Science.gov (United States)

    Almuzaini, Tariq; Choonara, Imti; Sammons, Helen

    2013-01-01

    Objective To explore the evidence available of poor-quality (counterfeit and substandard) medicines in the literature. Design Systematic review. Data sources Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013. Eligibility criteria Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines. Study appraisal and synthesis Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income. Data extraction Data extracted: place of study; type of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations included; origin of the drugs; chemical analysis and stated issues of counterfeit/substandard medicines. Results 44 prevalence studies were identified, 15 had good methodological quality. They were conducted in 25 different countries; the majority were in low-income countries (11) and/or lower middle-income countries (10). The median prevalence of substandard/counterfeit medicines was 28.5% (range 11–48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (pcounterfeit medicines. Most studies assessed only a single therapeutic class of antimicrobials. Conclusions The prevalence of poor-quality antimicrobial medicines is widespread throughout Africa and Asia in lower income countries and lower middle-income countries . The main problem identified was inadequate amounts of the active

  10. Herbal Medicine for Oligomenorrhea and Amenorrhea: A Systematic Review of Ancient and Conventional Medicine

    Directory of Open Access Journals (Sweden)

    Arezoo Moini Jazani

    2018-01-01

    Full Text Available Introduction. Menstrual bleeding cessation is one of the most frequent gynecologic disorders among women in reproductive age. The treatment is based on hormone therapy. Due to the increasing request for alternative medicine remedies in the field of women’s diseases, in present study, it was tried to overview medicinal plants used to treat oligomenorrhea and amenorrhea according to the pharmaceutical textbooks of traditional Persian medicine (TPM and review the evidence in the conventional medicine. Methods. This systematic review was designed and performed in 2017 in order to gather information regarding herbal medications of oligomenorrhea and amenorrhea in TPM and conventional medicine. This study had several steps as searching Iranian traditional medicine literature and extracting the emmenagogue plants, classifying the plants, searching the electronic databases, and finding evidences. To search traditional Persian medicine references, Noor digital library was used, which includes several ancient traditional medical references. The classification of plants was done based on the repetition and potency of the plants in the ancient literatures. The required data was gathered using databases such as PubMed, Scopus, Google Scholar, Cochrane Library, Science Direct, and web of knowledge. Results. In present study of all 198 emmenagogue medicinal plants found in TPM, 87 cases were specified to be more effective in treating oligomenorrhea and amenorrhea. In second part of present study, where a search of conventional medicine was performed, 12 studies were found, which had 8 plants investigated: Vitex agnus-castus, Trigonella foenum-graecum, Foeniculum vulgare, Cinnamomum verum, Paeonia lactiflora, Sesamum indicum, Mentha longifolia, and Urtica dioica. Conclusion. Traditional Persian medicine has proposed many different medicinal plants for treatment of oligomenorrhea and amenorrhea. Although just few plants have been proven to be effective for

  11. traditional medicinal uses of small mammal products

    African Journals Online (AJOL)

    Dr. Nelson Boniface

    particularly in Asian countries. The cultural use of animal products for medicinal purposes in many societies has led to the development of pharmaceuticals worldwide, although it has been largely responsible for extinction or near extinction of some animals, especially large ones (Cavaliere 2010). Tanzania is among African ...

  12. Research studies on patients' illness experience using the Narrative Medicine approach: a systematic review.

    Science.gov (United States)

    Fioretti, Chiara; Mazzocco, Ketti; Riva, Silvia; Oliveri, Serena; Masiero, Marianna; Pravettoni, Gabriella

    2016-07-14

    Since its birth about 30 years ago, Narrative Medicine approach has increased in popularity in the medical context as well as in other disciplines. This paper aims to review Narrative Medicine research studies on patients' and their caregivers' illness experience. MEDLINE, Psycinfo, EBSCO Psychological and Behavioural Science, The Cochrane Library and CINAHL databases were searched to identify all the research studies which focused on the Narrative Medicine approach reported in the title, in the abstract and in the keywords the words 'Narrative Medicine' or 'Narrative-based Medicine'. number of participants, type of disease, race and age of participants, type of study, dependent variables, intervention methods, assessment. Of the 325 titles screened, we identified 10 research articles fitting the inclusion criteria. Our systematic review showed that research on Narrative Medicine has no common specific methodology: narrative in Medicine is used as an intervention protocol as well as an assessment tool. Patients' characteristics, types of disease and data analysis procedures differ among the screened studies. Narrative Medicine research in medical practice needs to find clear and specific protocols to deepen the impact of narrative on medical practice and on patients' lives. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  13. Herbal medicine for adults with asthma: A systematic review.

    Science.gov (United States)

    Shergis, Johannah L; Wu, Lei; Zhang, Anthony L; Guo, Xinfeng; Lu, Chuanjian; Xue, Charlie C

    2016-08-01

    Many people with asthma use herbal medicines to help reduce symptoms and improve asthma control. To update the systematic review and meta-analysis of randomised controlled trials of herbal medicine for adult asthma. Nine English and Chinese databases were searched (PubMed, Embase, CINAHL, CENTRAL, AMED, CBM, CNKI, CQVIP, Wanfang). Herbal medicines combined with routine pharmacotherapies compared with the same pharmacotherapies alone or placebo. Cochrane Risk of Bias Tool and GRADE Summary of Findings tables were used to evaluate methodological quality. Twenty-nine (29) studies involving 3,001 participants were included. Herbal interventions used multi-ingredients such as licorice root, crow-dipper, astragali, and angelica. Compared with routine pharmacotherapies alone, herbal medicines as add-on therapy improved lung function (FEV1: MD 7.81%, 95% CI 5.79, 9.83, I(2) = 63%; PEFR: MD 65.14 L/min, 95% CI 58.87, 71.41, I(2) = 21%); asthma control (MD 2.47 points, 95% CI 1.64, 3.29, I(2) = 55%); reduced salbutamol usage (MD -1.14 puffs/day, 95% CI -2.20, -0.09, I(2) = 92%); and reduced acute asthma exacerbations over one year (MD -1.20, 95% CI -1.82, -0.58, one study). Compared with placebo plus pharmacotherapies herbal medicines as add-on therapy improved lung function (FEV1: MD 15.83%, 95% CI 13.54, 18.12 and PEFR: MD 55.20 L/min, 95% CI 33.41, 76.99). Other outcomes were not reported in these placebo studies. Included studies were low to moderate quality. Adverse events were rare. Herbal medicines combined with routine pharmacotherapies improved asthma outcomes greater than pharmacotherapies alone. Included studies did not blind participants therefore more studies that address such weaknesses are warranted.

  14. Budget impact analysis of medicines: updated systematic review and implications.

    Science.gov (United States)

    Faleiros, Daniel Resende; Álvares, Juliana; Almeida, Alessandra Maciel; de Araújo, Vânia Eloisa; Andrade, Eli Iola Gurgel; Godman, Brian B; Acurcio, Francisco A; Guerra Júnior, Augusto A

    2016-01-01

    This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.

  15. DNA Barcoding of Philippine Herbal Medicinal Products.

    Science.gov (United States)

    Pedales, Ronniel D; Damatac, Amor M; Limbo, Carlo A; Marquez, Cielo Mae D; Navarro, Anna Isabel B; Molina, Jeanmaire

    2016-11-01

    The Philippine government established the Traditional and Alternative Medicine Act in 1997 to promote traditionally used herbal products and to provide an effective yet affordable alternative to conventional medicines. However, government regulation of herbal medicinal products (HMPs) is not stringent, relying only on submitted quality data from the manufacturer. In this study we validated the taxonomic identity of 26 plant samples contained within 22 HMPs, each produced by different local manufacturers, through DNA barcoding of the nuclear internal transcribed spacer-2 (ITS2) region. We recovered 19 ITS2 barcodes from 26 samples. These were compared to sequences in GenBank using MEGABLAST, but ambiguous results (similar max scores for different species) were phylogenetically analyzed. Twelve of the 19 samples matched the indicated species on the product label, three were equivocal in specific identity but were placed in the expected genus, and four other samples from three manufacturers contained contamination and/or substitution. GenBank's reference database was at times problematic because some sequences were lacking or were misidentified, but the database was still useful. Overall, ITS2 barcoding was successful in authenticating the HMPs, and it is recommended during the premarket evaluation process so as to obtain a certificate of registration from the government. The government should also develop a comprehensive database of barcodes for Philippine plants, and should prioritize the development of the traditional pharmacopeia because many locally produced HMPs are not indigenous.

  16. Editorial for Special Issue on Herbal Medicines and Natural Products.

    Science.gov (United States)

    Zhou, Zhi-Wei; Zhou, Shu-Feng

    2015-11-16

    Herbal medicines and natural products have been the most productive source of drug development and there is a large line of evidence on the applications of herbal medicines and natural products for the management of body function and the treatment of aliments. The multiple bioactive components in herbal medicines and natural products can explain the multiple targets effect in their medical applications. The increasing usage of state-of-art computational, molecular biological, and analytical chemistry techniques will promote the exploration of the pharmacological effect of previously inaccessible sources of herbal medicines and natural products. Notably, with the increasing reports on the safety issues regarding the medical use of herbal medicines and natural products, the awareness of pharmacovigilance in herbal medicines and natural products needs to be strengthened. To prevent the adverse drug reactions related to herbal medicines and natural products, physicians need to be aware of potential risks and alert patients in the use of herbal medicines and natural products.

  17. Complementary and Alternative Medicine for Posttraumatic Stress Disorder Symptoms: A Systematic Review.

    Science.gov (United States)

    Wahbeh, Helané; Senders, Angela; Neuendorf, Rachel; Cayton, Julien

    2014-07-01

    To (1) characterize complementary and alternative medicine studies for posttraumatic stress disorder symptoms, (2) evaluate the quality of these studies, and (3) systematically grade the scientific evidence for individual CAM modalities for posttraumatic stress disorder. Systematic review. Eight data sources were searched. Selection criteria included any study design assessing posttraumatic stress disorder outcomes and any complementary and alternative medicine intervention. The body of evidence for each modality was assessed with the Natural Standard evidence-based, validated grading rationale. Thirty-three studies (n = 1329) were reviewed. Scientific evidence of benefit for posttraumatic stress disorder was strong for repetitive transcranial magnetic stimulation and good for acupuncture, hypnotherapy, meditation, and visualization. Evidence was unclear or conflicting for biofeedback, relaxation, Emotional Freedom and Thought Field therapies, yoga, and natural products. Considerations for clinical applications and future research recommendations are discussed. © The Author(s) 2014.

  18. Antiviral Natural Products and Herbal Medicines

    Directory of Open Access Journals (Sweden)

    Liang-Tzung Lin

    2014-01-01

    Full Text Available Viral infections play an important role in human diseases, and recent outbreaks in the advent of globalization and ease of travel have underscored their prevention as a critical issue in safeguarding public health. Despite the progress made in immunization and drug development, many viruses lack preventive vaccines and efficient antiviral therapies, which are often beset by the generation of viral escape mutants. Thus, identifying novel antiviral drugs is of critical importance and natural products are an excellent source for such discoveries. In this mini-review, we summarize the antiviral effects reported for several natural products and herbal medicines.

  19. Medicinal properties of 'true' cinnamon (Cinnamomum zeylanicum): a systematic review.

    Science.gov (United States)

    Ranasinghe, Priyanga; Pigera, Shehani; Premakumara, G A Sirimal; Galappaththy, Priyadarshani; Constantine, Godwin R; Katulanda, Prasad

    2013-10-22

    In traditional medicine Cinnamon is considered a remedy for respiratory, digestive and gynaecological ailments. In-vitro and in-vivo studies from different parts of the world have demonstrated numerous beneficial medicinal effects of Cinnamomum zeylanicum (CZ). This paper aims to systematically review the scientific literature and provide a comprehensive summary on the potential medicinal benefits of CZ. A comprehensive systematic review was conducted in the following databases; PubMed, Web of Science, SciVerse Scopus for studies published before 31st December 2012. The following keywords were used: "Cinnamomum zeylanicum", "Ceylon cinnamon", "True cinnamon" and "Sri Lankan cinnamon". To obtain additional data a manual search was performed using the reference lists of included articles. The literature search identified the following number of articles in the respective databases; PubMed=54, Web of Science=76 and SciVerse Scopus=591. Thirteen additional articles were identified by searching reference lists. After removing duplicates the total number of articles included in the present review is 70. The beneficial health effects of CZ identified were; a) anti-microbial and anti-parasitic activity, b) lowering of blood glucose, blood pressure and serum cholesterol, c) anti-oxidant and free-radical scavenging properties, d) inhibition of tau aggregation and filament formation (hallmarks of Alzheimer's disease), e) inhibitory effects on osteoclastogenesis, f) anti-secretagogue and anti-gastric ulcer effects, g) anti-nociceptive and anti-inflammatory activity, h) wound healing properties and i) hepato-protective effects. The studies reported minimal toxic and adverse effects. The available in-vitro and in-vivo evidence suggests that CZ has many beneficial health effects. However, since data on humans are sparse, randomized controlled trials in humans will be necessary to determine whether these effects have public health implications.

  20. Economic evaluation studies in reproductive medicine: a systematic review of methodologic quality

    NARCIS (Netherlands)

    Moolenaar, Lobke M.; Vijgen, Sylvia M. C.; Hompes, Peter; van der Veen, Fulco; Mol, Ben Willem J.; Opmeer, Brent C.

    2013-01-01

    To evaluate the methodologic quality of economic analyses published in the field of reproductive medicine. Systematic review. Centers for reproductive care. Infertility patients. We performed a Medline search to identify economic evaluation studies in reproductive medicine. We included studies that

  1. Systematic reviews of complementary therapies - an annotated bibliography. Part 2: herbal medicine

    NARCIS (Netherlands)

    Linde, K.; ter Riet, G.; Hondras, M.; Vickers, A.; Saller, R.; Melchart, D.

    2001-01-01

    BACKGROUND: Complementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with herbal medicine.

  2. Characteristics and quality of systematic reviews of acupuncture, herbal medicines, and homeopathy

    NARCIS (Netherlands)

    Linde, K.; ter Riet, G.; Hondras, M.; Melchart, D.; Willich, S. N.

    2003-01-01

    Background: We aimed to describe the approaches and characteristics of systematic reviews on three major complementary therapies and to assess their methodological quality. Methods: Systematic reviews of clinical trials of acupuncture, herbal medicines, and homeopathy were identified from a database

  3. Prevalence of medicine use among Brazilian adults: a systematic review.

    Science.gov (United States)

    Gomes, Vanessa Pereira; Silva, Marcus Tolentino; Galvão, Taís Freire

    2017-08-01

    The use of medicine in adults has been assessed by some population-based studies in Brazil, but to date there has been no overall estimate of the prevalence of drug consumption. We therefore aimed to estimate the prevalence of medicine use as measured in previously reported cross-sectional studies among Brazilian adults. We conducted a systematic review of the literature, searching in MEDLINE, Embase among others to a date ending January 2017. Two researchers selected the studies, extracted data and assessed methodological quality of those chosen for inclusion. The consumption prevalence were combined in meta-analyses, the heterogeneity measured by I2 and investigated by subgroup analyses and meta-regression. The search identified 4,005 publications, of which 14 were ultimately included in the study. Most studies (12/14) measured the consumption over the previous 15 days, finding a consumption prevalence of 49.1% (95% CI: 48.5-49.6%, I2 = 100%). The recall period explains part of the heterogeneity found (R2 = 23%, p = 0.048), however the subgroup analysis did not allow for more homogeneous results. The use of medications occurs among almost half of all Brazilian adults. Appropriate pharmaceutical assistance and care are necessary to ensure the rational use of these technologies.

  4. A Systematic Review of Iran's Medicinal Plants With Anticancer Effects.

    Science.gov (United States)

    Asadi-Samani, Majid; Kooti, Wesam; Aslani, Elahe; Shirzad, Hedayatollah

    2016-04-01

    Increase in cases of various cancers has encouraged the researchers to discover novel, more effective drugs from plant sources. This study is a review of medicinal plants in Iran with already investigated anticancer effects on various cell lines. Thirty-six medicinal plants alongside their products with anticancer effects as well as the most important plant compounds responsible for the plants' anticancer effect were introduced. Phenolic and alkaloid compounds were demonstrated to have anticancer effects on various cancers in most studies. The plants and their active compounds exerted anticancer effects by removing free radicals and antioxidant effects, cell cycle arrest, induction of apoptosis, and inhibition of angiogenesis. The investigated plants in Iran contain the compounds that are able to contribute effectively to fighting cancer cells. Therefore, the extract and active compounds of the medicinal plants introduced in this review article could open a way to conduct clinical trials on cancer and greatly help researchers and pharmacists develop new anticancer drugs. © The Author(s) 2015.

  5. Adverse effects of herbal medicines: an overview of systematic reviews.

    Science.gov (United States)

    Posadzki, Paul; Watson, Leala K; Ernst, Edzard

    2013-02-01

    This overview of systematic reviews (SRs) aims to evaluate critically the evidence regarding the adverse effects of herbal medicines (HMs). Five electronic databases were searched to identify all relevant SRs, with 50 SRs of 50 different HMs meeting our inclusion criteria. Most had only minor weaknesses in methods. Serious adverse effects were noted only for four HMs: Herbae pulvis standardisatus, Larrea tridentate, Piper methysticum and Cassia senna. The most severe adverse effects were liver or kidney damage, colon perforation, carcinoma, coma and death. Moderately severe adverse effects were noted for 15 HMs: Pelargonium sidoides, Perna canaliculus, Aloe vera, Mentha piperita, Medicago sativa, Cimicifuga racemosa, Caulophyllum thalictroides, Serenoa repens, Taraxacum officinale, Camellia sinensis, Commifora mukul, Hoodia gordonii, Viscum album, Trifolium pratense and Stevia rebaudiana. Minor adverse effects were noted for 31 HMs: Thymus vulgaris, Lavandula angustifolia Miller, Boswellia serrata, Calendula officinalis, Harpagophytum procumbens, Panax ginseng, Vitex agnus-castus, Crataegus spp., Cinnamomum spp., Petasites hybridus, Agave americana, Hypericum perforatum, Echinacea spp., Silybum marianum, Capsicum spp., Genus phyllanthus, Ginkgo biloba, Valeriana officinalis, Hippocastanaceae, Melissa officinalis, Trigonella foenum-graecum, Lagerstroemia speciosa, Cnicus benedictus, Salvia hispanica, Vaccinium myrtillus, Mentha spicata, Rosmarinus officinalis, Crocus sativus, Gymnema sylvestre, Morinda citrifolia and Curcuma longa. Most of the HMs evaluated in SRs were associated with only moderately severe or minor adverse effects.

  6. Interactions between herbal medicines and prescribed drugs: a systematic review.

    Science.gov (United States)

    Izzo, A A; Ernst, E

    2001-01-01

    (Echinacea angustifolia, E. purpurea, E. pallida) and saw palmetto (Serenoa repens). In conclusion, interactions between herbal medicines and synthetic drugs exist and can have serious clinical consequences. Healthcare professionals should ask their patients about the use of herbal products and consider the possibility of herb-drug interactions.

  7. Systematic review of the most important medicinal plants and place them in the international treatment of diseases

    Directory of Open Access Journals (Sweden)

    azadeh Khonsari

    2010-03-01

    Full Text Available Herbal medicine, a complementary and alternative medical system has been used to treat various diseases over thousands of years in many countries and the use of herbal medicine is growing in all of the world. Exploring the most frequently used herbs and herbal products in alternative and complementary medicine worldwide is a challenging issue because herbal medicine has been increased popularity among physicians and patients. The aim of this study was to systematically review literature reporting on the use of the herbal medicine to determine the genus of the most frequently used herbs in alternative medicine and the diseases under treatment. Material and Methods: Systematic searches were carried out in the databases Medline, Pubmed, Sciencedirect and Springer. Each databases was searched from Jan 2000 until Jan 2008 with the keywords of herbal medicine, herb medicine, phytotherapy and extract medicine. Systematic reviews and meta – analysis were included and no language restrictions were imposed, to find the genus of commonly used herbs and studied diseases. The findings were evaluated according to frequency of usage. Results: In this paper we have reported 8 plants which are the most common ones and have been in vogue from ancient time in the world. These most frequently used plants are Ginseng, Salvia, Ginkgo biloba, Hypericum, Garlic, Ginger, Aloe vera and Marijuana. According to findings neurologic, inflammatory – immunogenic, digestive and urinary – kidney diseases are the most interested fields in herbal medicine. Although most of the reviewed articles (89.2% showed a positive effect but side effects of herbal medicine are reported in the others and also need to furthermore works was mentioned as a necessity in 49.7% of them. Discussion: According to the present findings, herbal medicine has historically been efficacious in the treatment and management of many health problems. The ultimate purpose of the herbal medicine is to

  8. New veterinary medicinal products authorised by centralised procedure

    Directory of Open Access Journals (Sweden)

    Simona Sturzu

    2012-06-01

    Full Text Available Veterinary medicinal products that are subject to authorization via the centralized procedure according to Regulation (EC no. 726/2004 are included in the Community register of veterinary medicines, that is published on the European Commission website and product information of them are published on the website of the European Medicines Agency. Each competent authority involved in the linguistic review process of product information annexed to the Marketing Authorization for medicinal products authorized centrally (SPC, leaflet, information about the marketing authorization holder, product labeling conditions, approve the version in the language mother of each Member State. In the second half of 2011 have received marketing authorization via the centralized procedure a total of four veterinary medicinal products, presented above.

  9. [Technology transfer to the facility for production of medicines].

    Science.gov (United States)

    Beregovykh, V V; Spitskiĭ, O P

    2013-01-01

    Innovation development of pharmaceutical industry is close connected to knowledge transfer going to each subsequent life cycle phase of medicinal product. Formal regulation of technology and knowledge transfer is essential for achievement high quality during production of medicines designed during development phase. Conceptual tools, approaches and requirements are considered that are necessary for knowledge and technology transfer across all the life cycle phases of medicines. They are based on scientific knowledge of medicinal products and take into account both international and Russian regulations in the area of development, production and distribution of medicines. Importance of taking into consideration all aspects related to quality of medicines in all steps of technology transfer is shown. An approach is described for technology transfer organization for Russian pharmaceutical manufacturers based on international guides in this area.

  10. Traditional medicinal uses of small mammal products: a case study ...

    African Journals Online (AJOL)

    Traditional medicines, both plant and animal products, have been used to cure various diseases since time immemorial especially in rural areas worldwide. Many studies have focused on traditional plant products, but little research has been conducted on animal traditional medicines. This study investigated the use of ...

  11. Nigerian Journal of Natural Products and Medicine: Editorial Policies

    African Journals Online (AJOL)

    Focus and Scope. Nigerian Journal of Natural Products and Medicine is published by the Nigerian Society of Pharmacognosy, a non profit organisation established in 1982 dedicated to the promotion of Pharmacognosy, Natural Products and Traditional Medicine. It has a current circulation of about 500 to scientists in ...

  12. In situ biomolecule production by bacteria; a synthetic biology approach to medicine.

    Science.gov (United States)

    Flores Bueso, Yensi; Lehouritis, Panos; Tangney, Mark

    2018-04-10

    The ability to modify existing microbiota at different sites presents enormous potential for local or indirect management of various diseases. Because bacteria can be maintained for lengthy periods in various regions of the body, they represent a platform with enormous potential for targeted production of biomolecules, which offer tremendous promise for therapeutic and diagnostic approaches for various diseases. While biological medicines are currently limited in the clinic to patient administration of exogenously produced biomolecules from engineered cells, in situ production of biomolecules presents enormous scope in medicine and beyond. The slow pace and high expense of traditional research approaches has particularly hampered the development of biological medicines. It may be argued that bacterial-based medicine has been "waiting" for the advent of enabling technology. We propose that this technology is Synthetic Biology, and that the wait is over. Synthetic Biology facilitates a systematic approach to programming living entities and/or their products, using an approach to Research and Development (R&D) that facilitates rapid, cheap, accessible, yet sophisticated product development. Full engagement with the Synthetic Biology approach to R&D can unlock the potential for bacteria as medicines for cancer and other indications. In this review, we describe how by employing Synthetic Biology, designer bugs can be used as drugs, drug-production factories or diagnostic devices, using oncology as an exemplar for the concept of in situ biomolecule production in medicine. Copyright © 2018 Elsevier B.V. All rights reserved.

  13. The relevance of pharmacognosy in pharmacological research on herbal medicinal products.

    Science.gov (United States)

    Pferschy-Wenzig, Eva-Maria; Bauer, Rudolf

    2015-11-01

    pharmacological and toxicological studies, many features inherent in herbal medicinal products need to be considered in order to guarantee valid results: concerning in vitro studies, difficulties are often related to lacking knowledge of ADME characteristics of the bioactive constituents, nuisance compounds producing false positive and false negative results, and solubility problems. In in vivo animal studies, the route of administration is a very important issue. Clinical trials on herbal medicinal products in humans very often suffer from a poor reporting quality. This often hampers or precludes the pooling of clinical data for systematic reviews. In order to overcome this problem, appropriate documentation standards for clinical trials on herbal medicinal products have been defined in an extension of the CONSORT checklist. This article is part of a Special Issue entitled "Botanicals for Epilepsy". Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Systematic organization of medicinal plant information: a monograph template proposal

    Directory of Open Access Journals (Sweden)

    Ana C.B. Carvalho

    Full Text Available The use of medicinal plants in Brazil is widespread and is supported by public policies; it has the objective of providing the population with safe and effective herbal medicines of adequate quality. An action in these policies is to develop medicinal plant monographs to gather published information and decide which medicinal plants should be financed by the Brazilian government and distributed by the public health system. Currently, the monographs published worldwide do not present unified information regarding medicinal plants, and generally, they do not cover enough requirements for herbal medicine registration. The aim of this study is to develop a monograph model with standardized information not only about botany, agronomy, quality control, safety, and efficacy but also about relating regulatory aspects that support herbal medicine regulation. The development of standardized monographs favors the fast authorization and distribution of herbal medicines in the public system. The model also points out the lacking studies that should be carried out to supplement the necessary regulatory information of medicinal plants.

  15. Topical herbal medicines for atopic eczema: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Thandar, Y; Gray, A; Botha, J; Mosam, A

    2017-02-01

    Despite the availability of medicines with proven efficacy, many patients use complementary or alternative medicines (CAMs) to manage atopic eczema (AE). Due to the lack of objective information on topical CAMs, this systematic review evaluates the current evidence for the efficacy and safety of topical herbal preparations in AE. Using Cochrane systematic review methodology, PubMed, the Cochrane Library, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (via EBSCO), MEDLINE (via EBSCO), Proquest Health and Medical Complete, GREAT and CAM-QUEST were searched from inception until June 2014. Bibliographies of retrieved studies were hand searched for further relevant trials. All controlled clinical trials of topical herbal medicines for AE in humans of any age were included regardless of the control intervention or randomization. Only English-language publications were considered. Eight studies met the inclusion criteria. Seven investigated extracts of single plants and one an extract from multiple plants. Only two studies that showed a positive effect were considered to have a low risk of bias across all domains (those of liquorice gel and Hypericum perforatum). In these two, the test product was reported to be superior to placebo. Despite variations in diagnostic criteria and lack of validated tools for outcome assessments in one of these, the promising results may warrant continued research in better-designed studies. No meta-analysis was performed due to heterogeneity in all studies. There is currently insufficient evidence of efficacy for any topical herbal extract in AE. Many studies had methodological flaws and even those showing efficacy were single trials with small patient cohorts. © 2016 British Association of Dermatologists.

  16. An efficient system for the production of the medicinally important ...

    African Journals Online (AJOL)

    An efficient system for the production of the medicinally important plant: Asparagus cochinchinensis (Lour.) Merr. J Xiang-Hui, Z Gui-Ping, OL Jun, S Chao-Wen. Abstract. An in vitro cultivation protocol was developed for Asparagus cochinchinensis a species threatened by over collection due to its importance as a medicinal ...

  17. Quality Measures in Orthopaedic Sports Medicine: A Systematic Review.

    Science.gov (United States)

    Abrams, Geoffrey D; Greenberg, Daniel R; Dragoo, Jason L; Safran, Marc R; Kamal, Robin N

    2017-10-01

    To report the current quality measures that are applicable to orthopaedic sports medicine physicians. Six databases were searched with a customized search term to identify quality measures relevant to orthopaedic sports medicine surgeons: MEDLINE/PubMed, EMBASE, the National Quality Forum (NQF) Quality Positioning System (QPS), the Agency for Healthcare Research and Quality (AHRQ) National Quality Measures Clearinghouse (NQMC), the Physician Quality Reporting System (PQRS) database, and the American Academy of Orthopaedic Surgeons (AAOS) website. Results were screened by 2 Board-certified orthopaedic surgeons with fellowship training in sports medicine and dichotomized based on sports medicine-specific or general orthopaedic (nonarthroplasty) categories. Hip and knee arthroplasty measures were excluded. Included quality measures were further categorized based on Donabedian's domains and the Center for Medicare and Medicaid (CMS) National Quality Strategy priorities. A total of 1,292 quality measures were screened and 66 unique quality measures were included. A total of 47 were sports medicine-specific and 19 related to the general practice of orthopaedics for a fellowship-trained sports medicine specialist. Nineteen (29%) quality measures were collected within PQRS, with 5 of them relating to sports medicine and 14 relating to general orthopaedics. AAOS Clinical Practice Guidelines (CPGs) comprised 40 (60%) of the included measures and were all within sports medicine. Five (8%) additional measures were collected within AHRQ and 2 (3%) within NQF. Most quality measures consist of process rather than outcome or structural measures. No measures addressing concussions were identified. There are many existing quality measures relating to the practice of orthopaedic sports medicine. Most quality measures are process measures described within PQRS or AAOS CPGs. Knowledge of quality measures are important as they may be used to improve care, are increasingly being used to

  18. Laboratory research at the clinical trials of Veterinary medicinal Products

    OpenAIRE

    ZHYLA M.I.

    2011-01-01

    The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

  19. Evaluating the quality of systematic reviews in the emergency medicine literature.

    Science.gov (United States)

    Kelly, K D; Travers, A; Dorgan, M; Slater, L; Rowe, B H

    2001-11-01

    The objective of this study was to examine the scientific quality of systematic reviews published in 5 leading emergency medicine journals. MEDLINE and EMBASE databases were electronically searched to identify published systematic reviews. Searches were only conducted in emergency medicine journals during the past 10 years; 4 of the journals were also hand searched. Potential reviews were assessed independently by 2 reviewers for inclusion. Data regarding methods were extracted from each review independently by 2 reviewers. All systematic reviews were retrieved and rated for quality by using the 10 questions from the overview quality assessment questionnaire. Twenty-nine reviews were identified from more than 100 citations. The overall scientific quality of the systematic reviews was low (mean score, 2.7; 95% confidence interval 2.1 to 3.2; maximum possible score, 7.0). Selection and publication biases were rarely addressed in this collection of reviews. For example, the search strategies were only identified in 9 (31%) reviews, whereas independent study selection (6 [21%]) and quality assessment of included studies (9 [31%]) were infrequently performed. Overall, the majority of reviews had extensive flaws, and only 3 (10%) had minimal flaws. The results of the study indicate that many of the systematic reviews published in the emergency medicine literature contain major flaws; reviews with poor methodology may limit the validity of reported results. Further efforts should be made to improve the design, reporting, and publication of systematic reviews in emergency medicine.

  20. A systematic review of counterfeit and substandard medicines in field quality surveys

    Directory of Open Access Journals (Sweden)

    Alghannam AFA

    2014-09-01

    Full Text Available Abdulaziz Fahad Abdulaziz Alghannam, Zoe Aslanpour, Sara Evans, Fabrizio Schifano Department of Pharmacy, University of Hertfordshire, Hatfield, Hertfordshire, United Kingdom Objectives: Counterfeit and substandard medicines pose a great threat to public health and the economy worldwide. Reports suggest their prevalence is increasing and can no longer be ignored. A detailed account on the current nature of the problem and identification of knowledge limitations in terms of geographical location, medicine classes, and type of medicine analysis performed is not available. Our objective was to systematically review articles that have reported investigations of counterfeit and substandard medicines. Design: Systematic review. Data sources: PubMed, Scopus, and ISI Web of Knowledge. Data Selection: Prospective field quality surveys on counterfeit and substandard medicines were selected from all available records within the selected databases up to December 31, 2013. All prospective studies performing chemical analysis on medicine samples were identified using the key search terms “counterfeit” or “substandard” and “medicine” or “drug” or “pharmaceutical.” The title, abstract, and/or full articles were reviewed for relevance according to a predetermined set of inclusion and exclusion criteria. Medicines procured from the Internet are beyond the scope of this review. Results: Sixty-six research articles were found that fulfilled our inclusion criteria. The majority of medicine quality surveys were conducted in specific areas of Africa and Asia. Within these two continents, medicine quality reports covering the Northern part of Africa and the Western part of Asia in the Middle East are extremely scarce. Other continents such as North or South America and Europe were covered in limited articles, whereas the Australian continent had no reports. Moreover, most studies examined medicines that treat infectious diseases; very few articles

  1. Chinese herbal medicine for the treatment of primary hypertension: a methodology overview of systematic reviews.

    Science.gov (United States)

    Xinke, Zhao; Yingdong, Li; Mingxia, Feng; Kai, Liu; Kaibing, Chen; Yuqing, Lu; Shaobo, Sun; Peng, Song; Bin, Liu

    2016-10-20

    Chinese herbal medicine has been used to treat hypertension in China and East Asia since centuries. In this study, we conduct an overview of systematic reviews of Chinese herbal medicine in the treatment of primary hypertension to 1) summarize the conclusions of these reviews, 2) evaluate the methodological quality of these reviews, and 3) rate the confidence in the effect on each outcome. We comprehensively searched six databases to retrieve systematic reviews of Chinese herbal medicine for primary hypertension from inception to December 31, 2015. We used AMSTAR to evaluate the methodological quality of included reviews, and we classified the quality of evidence for each outcome in included reviews using the GRADE approach. A total of 12 systematic reviews with 31 outcomes were included, among which 11 systematic reviews focus on the therapeutic effect of Chinese herbal medicine combined with conventional medicine or simple Chinese herbal medicine versus simple conventional medicine. Among the 11 items of AMSTAR, the lowest quality was "providing a priori design" item, none review conformed to this item, the next was "stating the conflict of interest" item, only three reviews conformed to this item. Five reviews scored less than seven in AMSTAR, which means that the overall methodological quality was fairly poor. For GRADE, of the 31 outcomes, the quality of evidence was high in none (0 %), moderate in three (10 %), low in 19 (61 %), and very low in nine (29 %). Of the five downgrading factors, risk of bias (100 %) was the most common downgrading factor in the included reviews, followed by imprecision (42 %), inconsistency (39 %), publication bias (39 %), and indirectness (0 %). The methodological quality of systematic reviews about Chinese herbal medicine for primary hypertension is fairly poor, and the quality of evidence level is low. Physicians should be cautious when applying the interventions in these reviews for primary hypertension patients in

  2. Herbal medicine for idiopathic central precocious puberty: A protocol for a systematic review of controlled trials.

    Science.gov (United States)

    Lee, Hye Lim; Lee, Yoo Been; Choi, Jun-Yong; Lee, Ju Ah

    2018-03-01

    Herbal medicine is widely used in East Asia to treat idiopathic central precocious puberty (ICPP). Most of the available clinical trials that investigated herbal medicine for ICPP have been included in this review. This systematic review will assess the efficacy and safety of herbal medicine for ICPP. Eleven databases, including Asian databases, will be searched for studies conducted through 2018. We will include randomized controlled trials assessing herbal medicine for ICPP. The risk of bias will be evaluated using the Cochrane risk of bias assessment tool, and confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation instrument. This systematic review will be published in a peer-reviewed journal and disseminated both electronically and in print. The review will be updated to inform and guide health care practices. PROSPER 2018 CRD42018087988.

  3. Library support for systematic reviews at the London School of\\ud Hygiene & Tropical Medicine

    OpenAIRE

    Falconer, Jane

    2015-01-01

    Systematic reviews are well established in evidence-based medicine, where experimental\\ud results are used to support decision making. The methodology is gradually spreading to\\ud other subject areas, including the social sciences, with the support of organisations such\\ud as the Campbell Collaboration1 and the EPPI Centre2. This paper describes the support\\ud provided to systematic reviewers at the London School of Hygiene & Tropical Medicine\\ud by Library & Archives Service staff.\\ud A syst...

  4. A systematic review of natural health product treatment for vitiligo

    Directory of Open Access Journals (Sweden)

    Boon Heather S

    2008-05-01

    Full Text Available Abstract Background Vitiligo is a hypopigmentation disorder affecting 1 to 4% of the world population. Fifty percent of cases appear before the age of 20 years old, and the disfigurement results in psychiatric morbidity in 16 to 35% of those affected. Methods Our objective was to complete a comprehensive, systematic review of the published scientific literature to identify natural health products (NHP such as vitamins, herbs and other supplements that may have efficacy in the treatment of vitiligo. We searched eight databases including MEDLINE and EMBASE for vitiligo, leucoderma, and various NHP terms. Prospective controlled clinical human trials were identified and assessed for quality. Results Fifteen clinical trials were identified, and organized into four categories based on the NHP used for treatment. 1 L-phenylalanine monotherapy was assessed in one trial, and as an adjuvant to phototherapy in three trials. All reported beneficial effects. 2 Three clinical trials utilized different traditional Chinese medicine products. Although each traditional Chinese medicine trial reported benefit in the active groups, the quality of the trials was poor. 3 Six trials investigated the use of plants in the treatment of vitiligo, four using plants as photosensitizing agents. The studies provide weak evidence that photosensitizing plants can be effective in conjunction with phototherapy, and moderate evidence that Ginkgo biloba monotherapy can be useful for vitiligo. 4 Two clinical trials investigated the use of vitamins in the therapy of vitiligo. One tested oral cobalamin with folic acid, and found no significant improvement over control. Another trial combined vitamin E with phototherapy and reported significantly better repigmentation over phototherapy only. It was not possible to pool the data from any studies for meta-analytic purposes due to the wide difference in outcome measures and poor quality ofreporting. Conclusion Reports investigating the

  5. Nigerian Journal of Natural Products and Medicine - Vol 13 (2009)

    African Journals Online (AJOL)

    Nigerian Journal of Natural Products and Medicine. ... Quality control of Harpagophytum procumbens products using High Pressure Liquid Chromatography-Diode Array Detection (HPLC-DAD) · EMAIL FULL TEXT EMAIL FULL ... Patenting for economic development: how aware are Nigerian pharmaceutical researchers?

  6. European regulatory tools for advanced therapy medicinal products.

    Science.gov (United States)

    Flory, Egbert; Reinhardt, Jens

    2013-12-01

    Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

  7. Publication productivity of faculty of medicine, Mansoura University ...

    African Journals Online (AJOL)

    Conclusion: The publication productivity of Mansoura Faculty of Medicine showed fluctuating pattern from the end of the calendar year 2012 and earlier. Future prospects for increasing research productivity should be considered to increase the number and quality of publications and academic staff participating in ...

  8. Determination of impurities and degradation products from veterinary medicinal products by HPLC method

    Directory of Open Access Journals (Sweden)

    Elena Gabriela Oltean

    2014-06-01

    Full Text Available The organic or inorganic impurities in the veterinary medicinal product can derive from starting materials, manufacturing process, incomplete purification, inappropriate storage. The acceptable levels of impurities in pharmaceuticals are estimated by comparison with standard solutions, according to the appropriate monographs. Forced degradation studies determine the stability of the method of dosage for the active compounds and for the entire finished product under excessive accelerated degradation conditions. They also provide information on degradation pathways and selectivity of analytical methods applied. The information provided by the degradation studies on the active compound and finished pharmaceutical product should demonstrate the specificity of the analytical method regarding impurities. Forced degradation studies should demonstrate that the impurities and degradation products generated do not interfere with the active compound. The current forced degradation methods consist of acid hydrolysis, basic hydrolysis, oxidation, exposure of the medicinal product to temperature and light. HPLC methods are an integral analytical instrument for the analysis of the medicinal product. The HPLC method should be able to separate, detect and quantify various specific degradation products that can appear after manufacture or storage of the medicinal product, as well as new elements appearing after synthesis. FDA and ICH guidelines recommend the enclosure of the results, including the chromatograms specific to the forced degradation-subjected medicinal product, in the documentation for marketing authorization. Using HPLC methods in forced degradation studies on medicinal products provides relevant information on the method of determination for the formulation of the medicinal product, synthesis product, packaging methods and storage.

  9. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications.

    Science.gov (United States)

    Riboh, Jonathan C; Saltzman, Bryan M; Yanke, Adam B; Cole, Brian J

    2016-09-01

    Amniotic membrane (AM)-derived products have been successfully used in ophthalmology, plastic surgery, and wound care, but little is known about their potential applications in orthopaedic sports medicine. To provide an updated review of the basic science and preclinical and clinical data supporting the use of AM-derived products and to review their current applications in sports medicine. Systematic review. A systematic search of the literature was conducted using the Medline, EMBASE, and Cochrane databases. The search term amniotic membrane was used alone and in conjunction with stem cell, orthopaedic, tissue engineering, scaffold, and sports medicine. The search identified 6870 articles, 80 of which, after screening of the titles and abstracts, were considered relevant to this study. Fifty-five articles described the anatomy, basic science, and nonorthopaedic applications of AM-derived products. Twenty-five articles described preclinical and clinical trials of AM-derived products for orthopaedic sports medicine. Because the level of evidence obtained from this search was not adequate for systematic review or meta-analysis, a current concepts review on the anatomy, physiology, and clinical uses of AM-derived products is presented. Amniotic membranes have many promising applications in sports medicine. They are a source of pluripotent cells, highly organized collagen, antifibrotic and anti-inflammatory cytokines, immunomodulators, and matrix proteins. These properties may make it beneficial when applied as tissue engineering scaffolds, improving tissue organization in healing, and treatment of the arthritic joint. The current body of evidence in sports medicine is heavily biased toward in vitro and animal studies, with little to no human clinical data. Nonetheless, 14 companies or distributors offer commercial AM products. The preparation and formulation of these products alter their biological and mechanical properties, and a thorough understanding of these

  10. A systematic review of retracted publications in emergency medicine.

    Science.gov (United States)

    Chauvin, Anthony; De Villelongue, Cedric; Pateron, Dominique; Yordanov, Youri

    2017-08-18

    The objective of this study was to characterize retracted publications in emergency medicine. We searched MEDLINE, Web of Science and Cochrane Central Register of Controlled Trials to identify all retracted publications in the field of emergency medicine. We also searched an independent website that reports and archives retracted scientific publications. Two researchers independently screened titles, abstracts and full text of search results. Data from all included studies were then independently extracted. We identified 28 retraction notes. Eleven (39%) articles were published by authors from Europe. The oldest retracted article was published in 2001. The 28 retracted papers were published by 22 different journals. Two authors were named on multiples retractions. The median impact factor of journals was 1.03 (0.6-1.9). Almost all studies were available online [26/28 (93%)], but only 40% had watermarking on the article. The retraction notification was available for all articles. Three (11%) retraction notices did not clearly report the retraction reasons, and most retraction notices were issued by the editors [14 (56%)]. The most frequent retraction reasons were plagiarism [eight (29%)], duplicate publication [three (11%)] and overlap [two (2%)]. Retracted articles were cited on average 14 times. In most cases, the retraction cause did not invalidate the study's results [17 (60%)]. The most common reason for retraction was related to a misconduct by the authors. These results can question the necessity to normalize retraction procedures among the large number of biomedical editors and to educate future researchers on research integrity.

  11. Educational games in geriatric medicine education: a systematic review.

    Science.gov (United States)

    Alfarah, Ziad; Schünemann, Holger J; Akl, Elie A

    2010-04-23

    To systematically review the medical literature to assess the effect of geriatric educational games on the satisfaction, knowledge, beliefs, attitudes and behaviors of health care professionals. We conducted a systematic review following the Cochrane Collaboration methodology including an electronic search of 10 electronic databases. We included randomized controlled trials (RCT) and controlled clinical trials (CCT) and excluded single arm studies. Population of interests included members (practitioners or students) of the health care professions. Outcomes of interests were participants' satisfaction, knowledge, beliefs, attitude, and behaviors. We included 8 studies evaluating 5 geriatric role playing games, all conducted in United States. All studies suffered from one or more methodological limitations but the overall quality of evidence was acceptable. None of the studies assessed the effects of the games on beliefs or behaviors. None of the 8 studies reported a statistically significant difference between the 2 groups in terms of change in attitude. One study assessed the impact on knowledge and found non-statistically significant difference between the 2 groups. Two studies found levels of satisfaction among participants to be high. We did not conduct a planned meta-analysis because the included studies either reported no statistical data or reported different summary statistics. The available evidence does not support the use of role playing interventions in geriatric medical education with the aim of improving the attitudes towards the elderly.

  12. Indicators of quality use of medicines in South-East Asian countries : a systematic review

    NARCIS (Netherlands)

    Nguyen, H. T.; Wirtz, V. J.; Haaijer-Ruskamp, F. M.; Taxis, K.

    2012-01-01

    Objectives To identify indicators of quality use of medicines used in South-East Asian region. Methods A systematic review was conducted searching MEDLINE, Embase and The International Network for Rational Use of Drugs (INRUD) and The World Health Organization (WHO) website. Original studies or

  13. Prevalence of Complementary and Alternative Medicine Use among U.S. College Students: A Systematic Review

    Science.gov (United States)

    Nowak, Amy L. Versnik; Hale, Heidi M.

    2012-01-01

    Research shows that Americans are using increasing amounts of complementary and alternative medicine (CAM) and that education is a significant predictor of CAM use. The purpose of this systematic review is to summarize key research findings on CAM use rates among U.S. college students and recommend future actions for researchers and health…

  14. Brazilian scientific production on herbal medicines used in dentistry

    Directory of Open Access Journals (Sweden)

    R.D. Castro

    2014-09-01

    Full Text Available The objective of this study was to critically analyze the scientific production published in specialized Brazilian journals concerning the use of medicinal plants in dentistry. A literature review was carried out using an indirect documentation technique by means of a bibliographical study. Four examiners performed independent searches in Brazilian journals of medicinal plants indexed in the database SciELO (Brazilian Journal of Pharmacognosy; Brazilian Journal of Medicinal Plants; Brazilian Journal of Pharmaceutical Sciences; and Acta Botanica Brasilica using the descriptors "herbal medicine/phytotherapy" or "medicinal plants" and "dentistry ". The articles published from 2002 to 2012 addressing the use of medicinal plants in dentistry were included and analyzed. The searches based on the descriptors and reading of abstracts, resulted in 155 articles. Of these, 44 were read in full and a total of 16 publications met the eligibility criteria and were selected. Laboratory studies predominated (10 and were limited to the evaluation of antimicrobial properties by means of tests for determining inhibitory, fungicidal and bactericidal concentrations. Three literature reviews and only one clinical trial with no blinding and randomization were found. It is highlighted the need for better methodological designs in the researches and greater production of clinical or in vivo studies.

  15. Mind-Body Medicine for Multiple Sclerosis: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Angela Senders

    2012-01-01

    Full Text Available Background. Mind-body therapies are used to manage physical and psychological symptoms in many chronic health conditions. Objective. To assess the published evidence for using mind-body techniques for symptom management of multiple sclerosis. Methods. MEDLINE, PsycINFO, and Cochrane Clinical Trials Register were searched from inception to March 24, 2012. Eleven mind-body studies were reviewed (meditation, yoga, biofeedback, hypnosis, relaxation, and imagery. Results. Four high quality trials (yoga, mindfulness, relaxation, and biofeedback were found helpful for a variety of MS symptoms. Conclusions. The evidence for mind-body medicine in MS is limited, yet mind-body therapies are relatively safe and may provide a nonpharmacological benefit for MS symptoms.

  16. Turning Regenerative Medicine Breakthrough Ideas and Innovations into Commercial Products.

    Science.gov (United States)

    Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Culme-Seymour, Emily; Mason, Chris; Stroemer, Paul; Najimi, Mustapha; Sokal, Etienne; Wilson, Clayton; Barone, Joe; Aras, Rahul; Chiesi, Andrea

    2015-12-01

    The TERMIS-Europe (EU) Industry committee intended to address the two main critical issues in the clinical/commercial translation of Advanced Therapeutic Medicine Products (ATMP): (1) entrepreneurial exploitation of breakthrough ideas and innovations, and (2) regulatory market approval. Since January 2012, more than 12,000 publications related to regenerative medicine and tissue engineering have been accepted for publications, reflecting the intense academic research activity in this field. The TERMIS-EU 2014 Industry Symposium provided a reflection on the management of innovation and technological breakthroughs in biotechnology first proposed to contextualize the key development milestones and constraints of allocation of financial resources, in the development life-cycle of radical innovation projects. This was illustrated with the biofuels story, sharing similarities with regenerative medicine. The transition was then ensured by an overview of the key identified challenges facing the commercialization of cell therapy products as ATMP examples. Real cases and testimonies were then provided by a palette of medical technologies and regenerative medicine companies from their commercial development of cell and gene therapy products. Although the commercial development of ATMP is still at the proof-of-concept stage due to technology risks, changing policies, changing markets, and management changes, the sector is highly dynamic with a number of explored therapeutic approaches, developed by using a large diversity of business models, both proposed by the experience, pitfalls, and successes of regenerative medicine pioneers, and adapted to the constraint resource allocation and environment in radical innovation projects.

  17. Systematic Quality Improvement in Medicine: Everyone Can Do It

    Directory of Open Access Journals (Sweden)

    Mark L. Zeidel

    2011-07-01

    Full Text Available In this brief review, written from the perspective of a physician-leader who has fostered the development of comprehensive quality improvement efforts at two academic medical centers, I review the need for improvement, some conceptual barriers that must be overcome, the goals of a comprehensive quality improvement (QI effort, some of the results we have obtained, and some observations on how to develop a culture of continuous improvement in an academic medical center. The mandate for quality improvement is clear; current healthcare is wasteful and error-prone, leading to excessive morbidity and mortality and unsustainably high costs. Successful quality improvement requires the abandonment of two paradigms: the craft model of medical practice and the notion that many forms of harm to patients are not preventable. I will describe how dramatic improvement has been achieved in reducing, by up to 10-fold, rates of central line infections, ventilator-associated pneumonias, peritonitis in peritoneal dialysis patients, and mortality due to cardiac arrest in hospital. I will describe as well how these methods can improve access to out-patient clinics dramatically and enhance the reliability and safety of hand-offs between covering physicians. To develop and maintain systematic quality improvement in all phases of medical care we must articulate a culture in which: everyone working at the medical center makes improvements every day; front-line staff, who know best how the work is done, are empowered to improve the processes of care; and multidisciplinary teams create the protocols that reduce variation that is due to physician preference, leaving only the variation required by the individual needs of patients. I will review as well the crucial elements of education of trainees and faculty members needed to guide and sustain a culture of quality. Finally, I will add some observations on how oversight boards and medical center leaders can help create

  18. Systematic quality improvement in medicine: everyone can do it.

    Science.gov (United States)

    Zeidel, Mark L

    2011-07-01

    In this brief review, written from the perspective of a physician-leader who has fostered the development of comprehensive quality improvement efforts at two academic medical centers, I review the need for improvement, some conceptual barriers that must be overcome, the goals of a comprehensive quality improvement (QI) effort, some of the results we have obtained, and some observations on how to develop a culture of continuous improvement in an academic medical center. The mandate for quality improvement is clear; current healthcare is wasteful and error-prone, leading to excessive morbidity and mortality and unsustainably high costs. Successful quality improvement requires the abandonment of two paradigms: the craft model of medical practice and the notion that many forms of harm to patients are not preventable. I will describe how dramatic improvement has been achieved in reducing, by up to 10-fold, rates of central line infections, ventilator-associated pneumonias, peritonitis in peritoneal dialysis patients, and mortality due to cardiac arrest in hospital. I will describe as well how these methods can improve access to out-patient clinics dramatically and enhance the reliability and safety of hand-offs between covering physicians. To develop and maintain systematic quality improvement in all phases of medical care we must articulate a culture in which: everyone working at the medical center makes improvements every day; front-line staff, who know best how the work is done, are empowered to improve the processes of care; and multidisciplinary teams create the protocols that reduce variation that is due to physician preference, leaving only the variation required by the individual needs of patients. I will review as well the crucial elements of education of trainees and faculty members needed to guide and sustain a culture of quality. Finally, I will add some observations on how oversight boards and medical center leaders can help create systematic quality

  19. Systematic Analysis of Theses in the Field of Emergency Medicine in Turkey

    Directory of Open Access Journals (Sweden)

    Erdem CEVIK

    2015-03-01

    Full Text Available SUMMARY: Objectives: The aim of this study is to systematically evaluate the theses in the field of emergency medicine in Turkey and to determine whether they were published as a scientific paper. Methods: This is a retrospective observational study. Theses in the field of emergency medicine between 1998 and 2013 were browsed from the internet database of National Thesis Center (Council of Higher Education. Study type, both if it was in the field of emergency, or if it was published and the journal's scope of published studies were assessed and recorded in the study chart. Results: 579 theses were included in the study. 27.1% of them were published and 14.9% of them were published in SCI/SCI-E journals. Advisors of theses were emergency medicine specialists in 67.6% of theses and 493 (85.1% of them were in the field of emergency medicine. 77.4% of theses were observational and 20.9% were experimental study. Most of the experimental studies (72.7%, n=88 were animal studies. Conclusions: It was concluded that very few theses in the field of emergency medicine were published in journals that were indexed in SCI/SCI-E. Key words: Emergency medicine, systematic analysis, theses

  20. Fighting trafficking of falsified and substandard medicinal products in Russia.

    Science.gov (United States)

    Fayzrakhmanov, N F

    2015-01-01

    The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat to economy and health of populations of most countries, including the Russian Federation. To identify the main achievements and challenges in the fight against trafficking of falsified and substandard medicinal products in the Russian Federation, to formulate possible solutions to these problems. The study of criminal cases and statistical information about the level of crime in the Russian Federation; legal analysis of regulatory legal acts in the sphere of criminal law and turnover of medicinal products; review of scientific and practical publications. The problem of trafficking of falsified and substandard medicinal products in the Russian Federation was publicly discussed in the late 1990s - early 2000-ies, first in the media and special editions, later this phenomenon was the subject of extensive discussions at international conferences, in public authorities and public circles. However, the most significant results in tackling this problem were achieved only in the last 5 years.Thus, in 2010, the Russian Federation first joined the annual international police operation under the code name Pangaea, held since 2008 on the initiative of Interpol and the Medicines and Healthcare products Regulatory Agency of the World Health Organization (MHRA WHO). From year to year, the special operation Pangea unites the efforts of many countries from different continents and aims to eliminate transnational criminal groups operating through a global network the Internet. In 2010, as a result of large-scale international inspections 1 200 Internet sites were revealed, through which the fake medicines were spread and 10,000 boxes of medicines were seized, making more than a million falsified tablets in the amount of 2.6 million USA dollars. In 2011, in a special operation Pangea IV was attended by 165 different organizations from 81 countries

  1. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review.

    Science.gov (United States)

    Jäkel, Anne; von Hauenschild, Phillip

    2011-12-01

    Cranial osteopathic manipulative medicine (OMM) involves the manipulation of the primary respiratory mechanism to improve structure and function in children and adults. To identify and critically evaluate the literature regarding the clinical efficacy of cranial OMM. The clinical keywords "cranial manipulation" OR "osteopathy in the cranial field" OR "cranial osteopathy" OR "craniosacral technique" were searched in the following electronic databases: EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, The Cochrane Central Register of Controlled Trials, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and AMED (Alternative Medicine). Searches were conducted in April 2011 with no date restriction for when the studies were completed. Randomized controlled trials and observational studies that measured the effectiveness of cranial OMM on humans were included in the study. Exclusion criteria included non-English language articles, studies not relevant to cranial OMM, animal studies, and studies in which there was no clear indication of the use of cranial OMM. Studies that described the use of cranial OMM with other treatment modalities and that did not perform subgroup analysis were also excluded. The present study did not have criteria regarding type of disease. Outcome measures on pain, sleep, quality of life, motor function, and autonomic nervous system function were extracted. The methodological quality of the trials was assessed using the Downs and Black checklist. Of the 8 studies that met the inclusion criteria, 7 were randomized controlled trials and 1 was an observational study. A range of cranial OMM techniques used for the management of a variety of conditions were identified in the included studies. Positive clinical outcomes were reported for pain reduction, change in autonomic nervous system function, and improvement of sleeping patterns. Methodological Downs and Black quality scores ranged from 14 to 23 points out of a maximum of

  2. Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

    2014-06-01

    To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Submerged cultivation of medicinal mushrooms: bioprocesses and products (review).

    Science.gov (United States)

    Elisashvili, Vladimir

    2012-01-01

    Medicinal mushrooms belonging to higher Basidiomycetes are an immensely rich yet largely untapped resource of useful, easily accessible, natural compounds with various biological activities that may promote human well-being. The medicinal properties are found in various cellular components and secondary metabolites (polysaccharides, proteins and their complexes, phenolic compounds, polyketides, triterpenoids, steroids, alkaloids, nucleotides, etc.), which have been isolated and identified from the fruiting bodies, culture mycelium, and culture broth of mushrooms. Some of these compounds have cholesterol-lowering, anti-diabetic, antioxidant, antitumor, immunomodulating, antimicrobial, and antiviral activities ready for industrial trials and further commercialization, while others are in various stages of development. Recently, the submerged cultivation of medicinal mushrooms has received a great deal of attention as a promising and reproducible alternative for the efficient production of mushroom mycelium and metabolites. Submerged cultivation of mushrooms has significant industrial potential, but its success on a commercial scale depends on increasing product yields and development of novel production systems that address the problems associated with this technique of mushroom cultivation. In spite of many researchers' efforts for the production of bioactive metabolites by mushrooms, the physiological and engineering aspects of submerged cultures are still far from being thoroughly studied. The vast majority of studies have focused on polysaccharide and ganoderic acid production in submerged cultivation of medicinal mushrooms, and very little has been written so far on the antioxidant and hemagglutinating activity of submerged mushroom cultures. The purpose of this review is to provide an update of the present state of the art and future prospects of submerged cultivation of medicinal mushrooms to produce mycelium and bioactive metabolites, and to make a

  4. Commercial production of radioisotopes for nuclear medicine, 1970-1980

    International Nuclear Information System (INIS)

    Lamb, J.F.

    1981-01-01

    The first small cyclotrons were installed for commercial production of radioisotopes at New England Nuclear Corporation, Billerica, Massachusetts, and at Medi-Physics, Emeryville, California. Both machines were Cyclotron Corporation Cs-22 multiple particle, fixed energy cyclotrons. In the ten years that followed, the total number of commercial radioisotope producing small accelerators has grown to ten, with four more projected for 1981. The beam energy requirement for the first accelerators was modest; 22 MeV protons, 12 MeV deuterons, 24 MeV He-4, and 31 MeV He-3; and commercial radioisotope production for nuclear medicine utilized all four particles. The first product available from cyclotron production was fluorine-18 from the 16 O( 3 He, p) 18 F reaction. Injected intravenously as no-carrier-added Na 18 F, the radionuclide quickly concentrated in bone, providing the nuclear medicine physician with diagnostic information on skeletal abnormalities including metastatic bone disease

  5. Contamination of herbal medicinal products marketed in Kaduna ...

    African Journals Online (AJOL)

    The study aimed to evaluate the bacterial contamination of powdered herbal medicinal preparations sourced from identified herbal retail outlets in different parts of Kaduna metropolis. The assessments of the contamination of the herbal products were carried out using standard procedures: total aerobic bacterial plate count, ...

  6. HEAVY METAL CONTENT OF AYURVEDIC HERBAL MEDICINE PRODUCTS

    Science.gov (United States)

    Case reports of individuals taking Ayurvedic herbal medicine products (HMPs) suggest that they may contain lead, mercury, and/or arsenic. We analyzed the heavy metal content of Ayurvedic HMPs manufactured in India and Pakistan, available in South Asian grocery stores in the Bost...

  7. Complementary and Alternative Medicine for the Management of Cervical Radiculopathy: An Overview of Systematic Reviews

    Directory of Open Access Journals (Sweden)

    Xu Wei

    2015-01-01

    Full Text Available Background. Complementary and alternative medicine (CAM is widely applied in the clinical practice of neck pain owing to cervical radiculopathy (CR. While many systematic reviews exist in CAM to improve CR, research is distributed across population, intervention, comparison, and setting. Objective. This overview aims to summarize the characteristics and evaluate critically the evidence from systematic reviews. Methods. A comprehensive literature search was performed in the six databases without language restrictions on February 24, 2015. We had identified relevant systematic reviews that examined the subjects with neck pain due to cervical radiculopathy undergoing CAM. Two authors independently appraised the methodological quality using the revised assessment of multiple systematic reviews instrument. Results. We had included eight systematic reviews. The effectiveness and safety of acupotomy, acupuncture, Jingfukang granule, manual therapies, and cervical spine manipulation were investigated. Based on available evidence, the systematic reviews supported various forms of CAM for CR. Nevertheless, the methodological quality for most of systematic reviews was low or moderate. In addition, adverse reactions of primary studies were infrequent. Conclusions. Current systematic reviews showed potential advantages to CAM for CR. Due to the frequently poor methodological quality of primary studies, the conclusions should be treated with caution for clinical practice.

  8. Relevance of Chronic Lyme Disease to Family Medicine as a Complex Multidimensional Chronic Disease Construct: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Liesbeth Borgermans

    2014-01-01

    Full Text Available Lyme disease has become a global public health problem and a prototype of an emerging infection. Both treatment-refractory infection and symptoms that are related to Borrelia burgdorferi infection remain subject to controversy. Because of the absence of solid evidence on prevalence, causes, diagnostic criteria, tools and treatment options, the role of autoimmunity to residual or persisting antigens, and the role of a toxin or other bacterial-associated products that are responsible for the symptoms and signs, chronic Lyme disease (CLD remains a relatively poorly understood chronic disease construct. The role and performance of family medicine in the detection, integrative treatment, and follow-up of CLD are not well studied either. The purpose of this paper is to describe insights into the complexity of CLD as a multidimensional chronic disease construct and its relevance to family medicine by means of a systematic literature review.

  9. How can we help family carers manage pain medicines for patients with advanced cancer? A systematic review of intervention studies.

    Science.gov (United States)

    Latter, Sue; Hopkinson, Jane B; Richardson, Alison; Hughes, Jane A; Lowson, Elizabeth; Edwards, Deborah

    2016-09-01

    Family carers play a significant role in managing pain and associated medicines for people with advanced cancer. Research indicates that carers often feel inadequately prepared for the tasks involved, which may impact on carers' and patients' emotional state as well as the achievement of optimal pain control. However, little is known about effective methods of supporting family carers with cancer pain medicines. To systematically identify and review studies of interventions to help carers manage medicines for pain in advanced cancer. To identify implications for practice and research. A systematic literature search of databases (MEDLINE, CINAHL, PsycINFO and AMED) was carried out to identify studies of pain medication management interventions that involved family carers of patients with advanced cancer, and reported specific outcomes for family carers. Patient pain outcomes were also sought. Studies were quality appraised; key aspects of study design, interventions and outcomes were compared and a narrative synthesis of findings developed. 8 studies were included; all had significant methodological limitations. The majority reported improvements in family carer knowledge and/or self-efficacy for managing pain medicines; no effect on patient pain outcomes; and no adverse effects. It was not possible to discern any association between particular intervention characteristics and family carer outcomes. Current evidence is limited, but overall suggests face-to-face educational interventions supported by written and/or other resources have potential to improve carers' knowledge and self-efficacy for pain management. Further research is needed to identify how best to help family carers manage pain medicines for patients with advanced cancer. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  10. World integrated medicine forum on the regulation of homoeopathic medicinal products: National and global strategies

    Directory of Open Access Journals (Sweden)

    Harleen Kaur

    2017-01-01

    Full Text Available The first World Integrated Medicine Forum on the regulation of homoeopathic medicinal products included 50 delegates from 25 countries to discuss the current state of regulation of homoeopathic medicinal products (HMPs. The stakeholders in attendance included government officials, manufacturers, pharmacopoeia organisations, pharmacists, and healthcare providers worldwide. The Minister of Ayurveda, Yoga, Unani, Siddha and Homoeopathy from India, who is likely the only high ranking national official in the world specifically dedicated to oversight of traditional medicines including Homoeopathy, was the keynote speaker for the meeting. The core presentations delivered information on the country-to-country variance in regulatory requirements for homoeopathic medicine manufacture and marketing. Different speakers addressed the current pharmacopeia structures in various countries, variance in premarket approval process, regulatory frameworks for homoeopathic medicines, labelling requirements, safety requirements, marketing approaches and good manufacturing practices. Debates focused on quality control testing, stability of intermediate stocks, shelf life of finished products, pre-market approval process and labelling and they shed light on regional differences in regulation. A lengthy discussion was held on the potential value of harmonisation of pharmacopoeias, manufacturing standards, safety evaluation and labelling. The group consensus was to meet again to pursue specific topics. Daily summaries of take-away points are provided at the end of each day's talk summaries. Much acclaim was won by the organisers for materialising this unique forum which proved to be an apt platform for rigorous discussions on lesser discussed, but very vital points such as regulations of HMPs, harmonisation of pharmacopeias and linking industry and regulators' sectors for unified efforts for global development of Homoeopathy.

  11. Cost-effectiveness analyses in orthopaedic sports medicine: a systematic review.

    Science.gov (United States)

    Nwachukwu, Benedict U; Schairer, William W; Bernstein, Jaime L; Dodwell, Emily R; Marx, Robert G; Allen, Answorth A

    2015-06-01

    As increasing attention is paid to the cost of health care delivered in the United States (US), cost-effectiveness analyses (CEAs) are gaining in popularity. Reviews of the CEA literature have been performed in other areas of medicine, including some subspecialties within orthopaedics. Demonstrating the value of medical procedures is of utmost importance, yet very little is known about the overall quality and findings of CEAs in sports medicine. To identify and summarize CEA studies in orthopaedic sports medicine and to grade the quality of the available literature. Systematic review. A systematic review of the literature was performed to compile findings and grade the methodological quality of US-based CEA studies in sports medicine. The Quality of Health Economic Studies (QHES) instrument and the checklist by the US Panel on Cost-effectiveness in Health and Medicine were used to assess study quality. One-sided Fisher exact testing was performed to analyze the predictors of high-quality CEAs. Twelve studies met inclusion criteria. Five studies examined anterior cruciate ligament reconstruction, 3 studies examined rotator cuff repair, 2 examined autologous chondrocyte implantation, 1 study examined hip arthroscopic surgery, and 1 study examined the operative management of shoulder dislocations. Based on study findings, operative intervention in sports medicine is highly cost-effective. The quality of published evidence is good, with a mean quality score of 81.8 (range, 70-94). There is a trend toward higher quality in more recent publications. No significant predictor of high-quality evidence was found. The CEA literature in sports medicine is good; however, there is a paucity of studies, and the available evidence is focused on a few procedures. More work needs to be conducted to quantify the cost-effectiveness of different techniques and procedures within sports medicine. The QHES tool may be useful for the evaluation of future CEAs. © 2014 The Author(s).

  12. Regulatory Consequences of "Brexit" for the Development of Medicinal Products.

    Science.gov (United States)

    Jackson, E L; Feldschreiber, P; Breckenridge, A

    2017-08-01

    The United Kingdom voted in a referendum in June 2016 to leave the European Union (EU) after 45 years of membership. Among the many political, social, and scientific consequences are those for the regulation of health care products. No longer will the efficacy, safety, and quality of medicines in the United Kingdom be subject to an EU regulatory framework. The European Medicines Agency (EMA), which is currently located in London, will move elsewhere in Europe. The pharmaceutical industry will reassess its commitment to the UK health scene. © 2017, ASCPT.

  13. Economic aspects of radionuclide production for nuclear medicine

    International Nuclear Information System (INIS)

    Le Gallic, Y.; Prospert, J.

    1980-03-01

    In a difficult economic situation it was considered advisable to inform users of certain financial aspects of radionuclide production for nuclear medicine. Two aspects of this vast and many-sided problem are developed here: - The cost price structure of different products (radiopharmaceutical and radioimmunological) which defines the size of the market consistent with a balanced budget. This aspect of the economic analysis seems all the more important as ORIS, although a non profit-making organization, has to balance its production costs. - The effects on the national economy of the nuclear medicine supply market. From this viewpoint it seemed interesting to examine the share-out of the French market between ORIS which is practically the only national producer and importers, as well as the balance of payments situation in this respect [fr

  14. Complementary and Alternative Medicine for Management of Premature Ejaculation: A Systematic Review.

    Science.gov (United States)

    Cooper, Katy; Martyn-St James, Marrissa; Kaltenthaler, Eva; Dickinson, Kath; Cantrell, Anna; Ren, Shijie; Wylie, Kevan; Frodsham, Leila; Hood, Catherine

    2017-03-01

    Premature ejaculation (PE) is defined as ejaculation within 1 minute (lifelong PE) or 3 minutes (acquired PE), inability to delay ejaculation, and negative personal consequences. Management includes behavioral and pharmacologic approaches. To systematically review effectiveness, safety, and robustness of evidence for complementary and alternative medicine in managing PE. Nine databases including Medline were searched through September 2015. Randomized controlled trials evaluating complementary and alternative medicine for PE were included. Studies were included if they reported on intravaginal ejaculatory latency time (IELT) and/or another validated PE measurement. Adverse effects were summarized. Ten randomized controlled trials were included. Two assessed acupuncture, five assessed Chinese herbal medicine, one assessed Ayurvedic herbal medicine, and two assessed topical "severance secret" cream. Risk of bias was unclear in all studies because of unclear allocation concealment or blinding, and only five studies reported stopwatch-measured IELT. Acupuncture slightly increased IELT over placebo in one study (mean difference [MD] = 0.55 minute, P = .001). In another study, Ayurvedic herbal medicine slightly increased IELT over placebo (MD = 0.80 minute, P = .001). Topical severance secret cream increased IELT over placebo in two studies (MD = 8.60 minutes, P medicine with selective serotonin reuptake inhibitors (SSRIs) favored SSRIs (MD = 1.01 minutes, P = .02). However, combination treatment with Chinese medicine plus SSRIs improved IELT over SSRIs alone (two studies; MD = 1.92 minutes, P medicine alone (two studies; MD = 2.52 minutes, P medicine, Ayurvedic herbal medicine, and topical severance secret cream in improving IELT and other outcomes. However, results are based on clinically heterogeneous studies of unclear quality. There are sparse data on adverse effects or potential for drug interactions. Further well-conducted randomized controlled trials

  15. Safety classification of herbal medicines used among pregnant women in Asian countries: a systematic review.

    Science.gov (United States)

    Ahmed, Mansoor; Hwang, Jung Hye; Choi, Soojeung; Han, Dongwoon

    2017-11-14

    High prevalence of herbal medicines used in pregnancy and the lack of information on their safety is a public concern. Despite this, no significant research has been done regarding potential adverse effects of using herbal medicines during pregnancy, especially among developing Asian countries. Cross-sectional studies were searched up to year 2016 on PubMed/Medline and EMBASE, the data were extracted and quality of studies was assessed using the quality appraisal tool. The findings are reported in accordance to the PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Classification on safety of identified herbal medicines was done based on current scientific literature. This study included eight cross-sectional studies (2729 participants) from seven different Asian countries, of which 1283 (47.01%) women used one or more herbal medicines during pregnancy. Peppermint (22.8%), aniseed (14.7%), olibanum (12.9%), flixweed seed (12.2%) and ginger (11.5%) were the most frequently used herbal medicines. Out of the 33 identified herbal medicines, 13 were classified as safe to use, five as use with caution, eight were potentially harmful to use in pregnancy and information on seven herbal medicines was not available in the current literature. Several herbal medicines identified in this review were classified to be potentially harmful or the information regarding safety in pregnancy was missing. It is recommended that contraindicated herbal medicines should be avoided and other herbals should be taken under supervision of a qualified health care practitioner. The classification regarding safety of herbal medicines in pregnancy can be utilized to create awareness on prevention of adverse effects.

  16. [History and criticism of systematic medicine in the works of Augusto Murri and his school].

    Science.gov (United States)

    Scandellari, C

    1994-01-01

    Augusto Murri's last book entitled Nosologia e Psicologia was published in 1924; in the same year his follower Antonio Gnudi delivered a very important commemorative speech for the 100th anniversary of the Società Medica Chirurgica of Bologna. Both works have great value for the understanding of both the history and the theories of so-called systematic medicine as well as the criticisms that led, through Maurizio Bufalini's ideas and the teaching of Augusto Murri and his school, to the birth, at Bologna, of scientific medicine.

  17. SYSTEMATIC APPROACH OF THE PRODUCT LIFECYCLE COMPONENTS

    Directory of Open Access Journals (Sweden)

    Constantin Adrian ALEXE

    2013-05-01

    Full Text Available Today, companies across numerous industries find themselves on the cusp of a product development revolution. The incorporation of software and electronics into mechanical-based products is driving a wave of new innovation as products become more like intelligent systems that are interactive, proactive, changeable and upgradable. With software and electronics driving so much new product value, leading companies have begun to view and develop their products as systems. Top companies take a systems based approach that requires simultaneous and connected development to occur between software, electronics and mechanical functions at the earliest design stages and continue throughout the product development cycle. The purpose of this article is to address the new vision of the PLM concept starting from the impact that intelligent systems, internet, globalization and collaborative engineering brings.

  18. Computer aided design of medicinal products based on interactive chemical/herbal ingredients - An R&D approach

    Science.gov (United States)

    Siontorou, Christina G.

    2012-12-01

    Herbal products have gained increasing popularity in the last decades, and are now broadly used to treat illness and improve health. Notwithstanding the public opinion, both, safety and efficacy, are major sources of dispute among the scientific community, mainly due to lack of (or scarcity or scattered) conclusive data linking a herbal constituent to pharmacological action in vivo, in a way that benefit overrides risk. This paper presents a methodological framework for addressing natural medicine in a systematic and holistic way with a view to providing medicinal products based on interactive chemical/herbal ingredients.

  19. Multimorbidity and out-of-pocket expenditure on medicines: a systematic review.

    Science.gov (United States)

    Sum, Grace; Hone, Thomas; Atun, Rifat; Millett, Christopher; Suhrcke, Marc; Mahal, Ajay; Koh, Gerald Choon-Huat; Lee, John Tayu

    2018-01-01

    Multimorbidity, the presence of two or more non-communicable diseases (NCD), is a costly and complex challenge for health systems globally. Patients with NCDs incur high levels of out-of-pocket expenditure (OOPE), often on medicines, but the literature on the association between OOPE on medicines and multimorbidity has not been examined systematically. A systematic review was conducted via searching medical and economics databases including Ovid Medline, EMBASE, EconLit, Cochrane Library and the WHO Global Health Library from year 2000 to 2016. Study quality was assessed using Newcastle-Ottawa Scale. PROSPERO: CRD42016053538. 14 articles met inclusion criteria. Findings indicated that multimorbidity was associated with higher OOPE on medicines. When number of NCDs increased from 0 to 1, 2 and ≥3, annual OOPE on medicines increased by an average of 2.7 times, 5.2 times and 10.1 times, respectively. When number of NCDs increased from 0 to 1, 2, ≥2 and ≥3, individuals spent a median of 0.36% (IQR 0.15%-0.51%), 1.15% (IQR 0.62%-1.64%), 1.41% (IQR 0.86%-2.15%), 2.42% (IQR 2.05%-2.64%) and 2.63% (IQR 1.56%-4.13%) of mean annual household net adjusted disposable income per capita, respectively, on annual OOPE on medicines. More multimorbidities were associated with higher OOPE on medicines as a proportion of total healthcare expenditures by patients. Some evidence suggested that the elderly and low-income groups were most vulnerable to higher OOPE on medicines. With the same number of NCDs, certain combinations of NCDs yielded higher medicine OOPE. Non-adherence to medicines was a coping strategy for OOPE on medicines. Multimorbidity of NCDs is increasingly costly to healthcare systems and OOPE on medicines can severely compromise financial protection and universal health coverage. It is crucial to recognise the need for better equity and financial protection, and policymakers should consider health system financial options, cost sharing policies and service

  20. Design of formulated products: a systematic methodology

    DEFF Research Database (Denmark)

    Conte, Elisa; Gani, Rafiqul; Ng, K.M.

    2011-01-01

    -based computer-aided methodology for design and verification of a class of chemical-based products (liquid formulations) is presented. This methodology is part of an integrated three-stage approach for design/verification of liquid formulations where stage-1 generates a list of feasible product candidates and....../or verifies a specified set through a sequence of predefined activities (work-flow). Stage-2 and stage-3 (not presented here) deal with the planning and execution of experiments, for product validation. Four case studies have been developed to test the methodology. The computer-aided design (stage-1...

  1. Clinical research activity in periodontal medicine: a systematic mapping of trial registers.

    Science.gov (United States)

    Monsarrat, Paul; Blaizot, Alessandra; Kémoun, Philippe; Ravaud, Philippe; Nabet, Cathy; Sixou, Michel; Vergnes, Jean-Noel

    2016-05-01

    The primary aim of the study was to systematically map registration records on periodontal medicine in clinical trial registers. The secondary aim was to assess the evolution of periodontal medicine in clinical periodontal research as a whole. We searched all registration records related to periodontology in the World Health Organization International Clinical Trials Registry Platform. For registration records classified in the field of periodontal medicine, we assigned the 2015 MeSH(®) term for the most precisely corresponding systemic condition. Fifty-seven systemic conditions have been hypothesized to be linked with periodontal diseases, covering nearly 2% of the diseases indexed in MeSH. In addition to diabetes, cardiovascular disease or preterm birth, other systemic conditions have been the subject of registration records, such as anaemia, liver diseases, dyspepsia or ankylosing spondylitis. A trend towards increasing diversification of systemic conditions has appeared over time. About a third of registration records in clinical periodontal research deals with periodontal medicine. Periodontal medicine now constitutes an important part of clinical periodontal research. Research activity in periodontal medicine has grown continuously since the early 2000s, and exploration of registers gives a useful up-to-date snapshot of this constantly evolving field of research. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Herbal medicine for insomnia: A systematic review and meta-analysis.

    Science.gov (United States)

    Leach, Matthew J; Page, Amy T

    2015-12-01

    Insomnia is a prevalent sleep disorder that can profoundly impact a person's health and wellbeing. Herbal medicine represents one of the most frequently used complementary and alternative treatments of insomnia. However, the safety and efficacy of herbal medicine for the treatment of this disorder is currently uncertain. In order to ascertain the evidence base for herbal medicine for insomnia, we systematically searched seventeen electronic databases and the reference lists of included studies for relevant randomised controlled trials (RCTs). Fourteen RCTs, involving a total of 1602 participants with insomnia, met the inclusion criteria. Four distinct orally administered herbal monopreparations were identified (i.e., valerian, chamomile, kava and wuling). There was no statistically significant difference between any herbal medicine and placebo, or any herbal medicine and active control, for any of the thirteen measures of clinical efficacy. As for safety, a similar or smaller number of adverse events per person were reported with kava, chamomile and wuling when compared with placebo. By contrast, a greater number of events per person were reported with valerian. While there is insufficient evidence to support the use of herbal medicine for insomnia, there is a clear need for further research in this area. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Implementation of Plasma Fractionation in Biological Medicines Production

    OpenAIRE

    Mousavi Hosseini, Kamran; Ghasemzadeh, Mehran

    2016-01-01

    Context The major motivation for the preparation of the plasma derived biological medicine was the treatment of casualties from the Second World War. Due to the high expenses for preparation of plasma derived products, achievement of self-sufficiency in human plasma biotechnological industry is an important goal for developing countries. Evidence Acquisition The complexity of the blood plasma was first revealed by the Nobel Prize laureate, Arne Tiselius and Theodor Svedberg, which resulted in...

  4. Traditional Chinese medicine for human papillomavirus (HPV) infections: A systematic review.

    Science.gov (United States)

    Lin, Jing; Chen, Lanting; Qiu, Xuemin; Zhang, Na; Guo, Qiting; Wang, Yan; Wang, Mingyan; Gober, Hans-Jürgen; Li, Dajin; Wang, Ling

    2017-07-24

    Human papillomavirus (HPV) infections are common and generally harmless, but persistent infections can bring health problems like cancer and genital warts. For the uninfected group, HPV vaccines provide safe and effective protection, but they're type-restricted and expensive. For those infected, so far there have been a handful of treatments for HPV-associated benign or malignant diseases, traditional Chinese medicine being one of them. This systematic review focuses on the application of traditional Chinese medicine in HPV infection and related diseases on the basis of clinical findings. Moreover it covers compositions and mechanisms based on in vitro laboratory methods and animal models. Traditional Chinese medicine improves clinical index in the treatment of cervical cancer and genital warts; the mechanisms behind the effectiveness might be the regulation of cell apoptosis, viral gene transcription and translation, cell signal transduction pathways, and immune function.

  5. Systematic reviews of complementary therapies – an annotated bibliography. Part 2: Herbal medicine

    Directory of Open Access Journals (Sweden)

    Hondras Maria

    2001-07-01

    Full Text Available Abstract Background Complementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy. This article is dealing with herbal medicine. Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of articles and books. To be included articles had to review prospective clinical trials of herbal medicines; had to describe review methods explicitly; had to be published; and had to focus on treatment effects. Information on conditions, interventions, methods, results and conclusions was extracted using a pre-tested form and summarized descriptively. Results From a total of 79 potentially relevant reviews pre-selected in the screening process 58 met the inclusion criteria. Thirty of the reports reviewed ginkgo (for dementia, intermittent claudication, tinnitus, and macular degeneration, hypericum (for depression or garlic preparations (for cardiovascular risk factors and lower limb atherosclerosis. The quality of primary studies was criticized in the majority of the reviews. Most reviews judged the available evidence as promising but definitive conclusions were rarely possible. Conclusions Systematic reviews are available on a broad range of herbal preparations prescribed for defined conditions. There is very little evidence on the effectiveness of herbalism as practised by specialist herbalists who combine herbs and use unconventional diagnosis.

  6. Herbal medicines for treating acute otitis media: A systematic review of randomised controlled trials.

    Science.gov (United States)

    Son, Mi Ju; Kim, Young-Eun; Song, Young Il; Kim, Yun Hee

    2017-12-01

    This systematic review aimed to assess the clinical evidence for the widespread use of herbal medicines in treating acute otitis media. Eleven electronic databases, including MEDLINE, EMBASE, and the CENTRAL were searched, without language limitations. All randomised controlled trials involving the use of herbal medicines, alone or in combination with conventional therapies, for acute otitis media were included. We identified 4956 studies, of which seven randomised clinical trials met the inclusion criteria. The overall risk of bias of the included trials was relatively high or unclear. Treatment with Longdan-xiegan decoction or Shenling-baizhu powder, combined with antibiotics, appeared to be more effective than treatment with antibiotics alone in terms of the proportion of patients with total symptom recovery. Moreover, combination treatment of Sinupret ® and antibiotics facilitated the recovery of middle ear conditions and hearing acuity. Despite some indications of potential symptom improvement, the evidence regarding the effectiveness and efficacy of herbal medicine for acute otitis media is inconclusive due to the poor quality of trials included. Moreover, we only analysed seven trials in this review. Therefore, to properly evaluate the effectiveness of herbal medicine for acute otitis media, systematic reviews based on more rigorously designed randomized trials are warranted in the future. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. [Safety monitoring of cell-based medicinal products (CBMPs)].

    Science.gov (United States)

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  8. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    OpenAIRE

    Vlachojannis, Christian; Zimmermann, Benno F.; Chrubasik-Hausmann, Sigrun

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate ...

  9. Complementary and Alternative Medicine for Cancer Pain: An Overview of Systematic Reviews

    Directory of Open Access Journals (Sweden)

    Yanju Bao

    2014-01-01

    Full Text Available Background and Objective. Now with more and more published systematic reviews of Complementary and Alternative Medicine (CAM on adult cancer pain, it is necessary to use the methods of overview of systematic review to summarize available evidence, appraise the evidence level, and give suggestions to future research and practice. Methods. A comprehensive search (the Cochrane Library, PubMed, Embase, and ISI Web of Knowledge was conducted to identify all systematic reviews or meta-analyses of CAM on adult cancer pain. And the evidence levels were evaluated using GRADE approach. Results. 27 systematic reviews were included. Based on available evidence, we could find that psychoeducational interventions, music interventions, acupuncture plus drug therapy, Chinese herbal medicine plus cancer therapy, compound kushen injection, reflexology, lycopene, TENS, qigong, cupping, cannabis, Reiki, homeopathy (Traumeel, and creative arts therapies might have beneficial effects on adult cancer pain. No benefits were found for acupuncture (versus drug therapy or shame acupuncture, and the results were inconsistent for massage therapy, transcutaneous electric nerve stimulation (TENS, and Viscum album L plus cancer treatment. However, the evidence levels for these interventions were low or moderate due to high risk of bias and/or small sample size of primary studies. Conclusion. CAM may be beneficial for alleviating cancer pain, but the evidence levels were found to be low or moderate. Future large and rigor randomized controlled studies are needed to confirm the benefits of CAM on adult cancer pain.

  10. Systematic review and gamma radiosensitivity of medicinal plants: development of protocol for quality control

    International Nuclear Information System (INIS)

    Oliveira, Ralph Santos

    2006-01-01

    The present study discusses the contribution of the adoption of more rigorous and objective criteria to the selection and analysis of information sources, leading to more scientific rigour when registering phytotherapic drugs. To this end, it is herein proposed the adoption of a previously tested and acknowledged methodology, namely the Systematic Revision, as a standard for phytotherapic drug analyses. In order to show differences brought about by the Systematic Revision during the registration procedures of phytotherapic drugs, the case of the Maytenus ilicifolia (known popularly in Brazil as 'espinheira-santa') is presented. As it is well known, the use of ionizing radiation is expanding, especially in medicine and pharmacy. Therefore, gamma radiation was applied to the microbiological quality control of phytotherapic matrices. Results indicated a positive contribution of Systematic Revision to the registration procedures of phytotherapic drugs, as well as the advantages of using gamma radiation to the microbiological quality control of phytotherapic matrices. (author)

  11. Medicinal and commercial uses of ostrich products in Tanzania.

    Science.gov (United States)

    Magige, Flora; Røskaft, Eivin

    2017-08-23

    Traditional communities have been utilizing animal products for numerous purposes and have for a long time contributed to the accumulation of world knowledge. Local people in Tanzania and elsewhere in Africa, have been using birds including ostriches as pets or their products such as meat, eggs as food; their body parts such as feathers, bones and hide for ornaments but more importantly have used such products in traditional medicine and rituals. Nevertheless, there is a general lack of information about the differences that exist between local people with different cultures, and the best use of such products to improve their livelihoods. This study aimed to determine the use of ostrich products among people residing around Serengeti National Park and explore the potential of improving livelihoods through game ranching. Use of the products was compared between that of agriculturalists with long hunting traditions in the Serengeti District to the west of Serengeti National Park (SNP) and the largely pastoral community in the Ngorongoro District to the east by using semistructured questionnaires in June 2006. A total of 115 respondents were interviewed, and the majority (74.5%) in the Serengeti district admitted that ostriches were mainly hunted for their products by snares, while in the Ngorongoro district, 98.2% of the respondents said that villagers only gathered products such as feathers and eggs. Ostriches were hunted for food, ornamentation, medical and economic purposes, and eggs and oil, which are believed to have medicinal properties, were used for the treatment of various ailments, including asthma. This indigenous knowledge of the medicinal value of ostrich products must be integrated with scientific knowledge to prove the supposed medical efficacy of the products. Ostrich products also had market value and were thus sold to the villagers. Since it has been found that ostrich products are commercially used, legal establishment of markets through game

  12. Quantitative genotoxicity assays for analysis of medicinal plants: A systematic review.

    Science.gov (United States)

    Sponchiado, Graziela; Adam, Mônica Lucia; Silva, Caroline Dadalt; Soley, Bruna Silva; de Mello-Sampayo, Cristina; Cabrini, Daniela Almeida; Correr, Cassyano Januário; Otuki, Michel Fleith

    2016-02-03

    Medicinal plants are known to contain numerous biologically active compounds, and although they have proven pharmacological properties, they can cause harm, including DNA damage. Review the literature to evaluate the genotoxicity risk of medicinal plants, explore the genotoxicity assays most used and compare these to the current legal requirements. A quantitative systematic review of the literature, using the keywords "medicinal plants", "genotoxicity" and "mutagenicity", was undertakenQ to identify the types of assays most used to assess genotoxicity, and to evaluate the genotoxicity potential of medicinal plant extracts. The database searches retrieved 2289 records, 458 of which met the inclusion criteria. Evaluation of the selected articles showed a total of 24 different assays used for an assessment of medicinal plant extract genotoxicity. More than a quarter of those studies (28.4%) reported positive results for genotoxicity. This review demonstrates that a range of genotoxicity assay methods are used to evaluate the genotoxicity potential of medicinal plant extracts. The most used methods are those recommended by regulatory agencies. However, based on the current findings, in order to conduct a thorough study concerning the possible genotoxic effects of a medicinal plant, we indicate that it is important always to include bacterial and mammalian tests, with at least one in vivo assay. Also, these tests should be capable of detecting outcomes that include mutation induction, clastogenic and aneugenic effects, and structural chromosome abnormalities. In addition, the considerable rate of positive results detected in this analysis further supports the relevance of assessing the genotoxicity potential of medicinal plants. Copyright © 2016. Published by Elsevier Ireland Ltd.

  13. Herbal medicinal products - Evidence and tradition from a historical perspective.

    Science.gov (United States)

    Jütte, Robert; Heinrich, Michael; Helmstädter, Axel; Langhorst, Jost; Meng, Günter; Niebling, Wilhelm; Pommerening, Tanja; Trampisch, Hans J

    2017-07-31

    Aside from the fully licensed herbal medicines there are products on the European pharmaceutical market which are registered by virtue of their longstanding traditional use. The normal registration procedure does not apply to them because presently they do not meet the legal requirements for a full license as set out in the relevant European Union Directive. One of these requirements, "proof of tradition", has so far been dealt with in different ways and fails to meet the criteria of good practice. This analysis is based on a selective literature search in PubMed and in databases of medical and pharmaceutical history, interviews with licensing experts, a consensus meeting attended by researchers with a background in general medicine, phytotherapy, medical and pharmaceutical history, biometry, ethnopharmacology, pharmacognosy and the pharmaceutical industry. The 2004 EU Directive, which governs the registration of Traditional Herbal Medicinal Products and demands proof of tradition, is a regulatory construct and, above all, the outcome of a political process that has ended in a pragmatic compromise. The concept of tradition applied in the Directive does not sufficiently reflect the semantic breadth of the term. The only condition defined is that a specific commercial preparation needs to have been on the market for 30 years (15 of them inside the EU). Such an approach does not make full scientific use of the evidence available because the information excerpted from historical sources, if adequately processed, may yield valuable insights. This applies to indications, modes of application, efficacy and product safety (innocuousness). Such criteria should enter in full into the benefit-risk-analysis of applied preparations, in the registration process as well as in the therapeutic practice. When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and

  14. Investigation of specificity ensuring of quality of biological medicinal products on example of drugs Cortexin and Retinalamin

    Directory of Open Access Journals (Sweden)

    N. O. Vetiutneva

    2013-06-01

    Full Text Available Biological medical products nowadays are one of the most promising area at the pharmaceutical market. Biopharmaceutical market has significant benefits such as fast and effective development of production facilities, the development of more effective and safer medical products. The aim of our research was, on the example of medical products Cortexin and Retinalamin, examine the specifics of quality of biological medicinal products in the chain from production to sale. The objects of study - original biological medicines Cortexin and Retinalamin. Comparative, systematic, analytical methods and reviews were used. Biological medical products have fundamental differences from synthetic medicines, due to their source - alive cells which are usually used in their production process. Each production cycle results in a unique finished pharmaceutical products and minimal differences in the modes of production can significantly effect on the properties of biological medical products. Therefore, even if the physical, chemical and biological properties of the product thoroughly studied and described, it does not guarantee therapeutic equivalence of two biological products which are manufactured in different conditions. One of the most important issues today is the problem of maintaining properties and quality of biological medicines. These issues are actively resolving on the native pharmaceutical market: quality control system are developing and implementing in accordance with international standards in order to maintain maximum efficiency of biological medicines and to protect consumers from defective products. Biological products require special conditions of storage and transportation. In order to save physical, chemical and therapeutic properties, strict compliance with the relevant conditions of packaging, transport and intermediate storage, related to deviations in temperature during transportation and storage is needed. The production process

  15. The Use of Herbal Medicine in Alzheimer's Disease—A Systematic Review

    Directory of Open Access Journals (Sweden)

    Leopoldo Luiz dos Santos-Neto

    2006-01-01

    Full Text Available The treatments of choice in Alzheimer's disease (AD are cholinesterase inhibitors and NMDA-receptor antagonists, although doubts remain about the therapeutic effectiveness of these drugs. Herbal medicine products have been used in the treatment of Behavioral and Psychological Symptoms of Dementia (BPSD but with various responses. The objective of this article was to review evidences from controlled studies in order to determine whether herbs can be useful in the treatment of cognitive disorders in the elderly. Randomized controlled studies assessing AD in individuals older than 65 years were identified through searches of MEDLINE, LILACS, Cochrane Library, dissertation Abstract (USA, ADEAR (Alzheimer's Disease Clinical Trials Database, National Research Register, Current Controlled trials, Centerwatch Trials Database and PsychINFO Journal Articles. The search combined the terms Alzheimer disease, dementia, cognition disorders, Herbal, Phytotherapy. The crossover results were evaluated by the Jadad's measurement scale. The systematic review identified two herbs and herbal formulations with therapeutic effects for the treatment of AD: Melissa officinalis, Salvia officinalis and Yi-Gan San and BDW (Ba Wei Di Huang Wan. Ginkgo biloba was identified in a meta-analysis study. All five herbs are useful for cognitive impairment of AD. M. officinalis and Yi-Gan San are also useful in agitation, for they have sedative effects. These herbs and formulations have demonstrated good therapeutic effectiveness but these results need to be compared with those of traditional drugs. Further large multicenter studies should be conducted in order to test the cost-effectiveness of these herbs for AD and the impact in the control of cognitive deterioration.

  16. Herbal Medicine for Xerostomia in Cancer Patients: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Park, Bongki; Noh, Hyeonseok; Choi, Dong-Jun

    2017-09-01

    Xerostomia (dry mouth) causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food. Many cancer patients have complained of xerostomia induced by cancer therapy. The aim of this systematic review is to assess the efficacy of herbal medicine for the treatment of xerostomia in cancer patients. Randomized controlled trials investigating the use of herbal medicines to treat xerostomia in cancer patients were included. We searched the following 12 databases without restrictions on time or language. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Twenty-five randomized controlled trials involving 1586 patients met the inclusion criteria. A total of 24 formulas were examined in the included trials. Most of the included trials were insufficiently reported in the methodology section. Five formulas were shown to significantly improve the salivary flow rate compared to comparators. Regarding the grade of xerostomia, all formulas with the exception of a Dark Plum gargle solution with normal saline were significantly effective in reducing the severity of dry mouth. Adverse events were reported in 4 trials, and adverse effects of herbal medicine were reported in 3 trials. We found herbal medicines had potential benefits for improving salivary function and reducing the severity of dry mouth in cancer patients. However, methodological limitations and a relatively small sample size reduced the strength of the evidence. More high-quality trials reporting sufficient methodological data are warranted to enforce the strength of evidence regarding the effectiveness of herbal medicines.

  17. Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews.

    Science.gov (United States)

    Ryan, Rebecca; Santesso, Nancy; Lowe, Dianne; Hill, Sophie; Grimshaw, Jeremy; Prictor, Megan; Kaufman, Caroline; Cowie, Genevieve; Taylor, Michael

    2014-04-29

    Many systematic reviews exist on interventions to improve safe and effective medicines use by consumers, but research is distributed across diseases, populations and settings. The scope and focus of such reviews also vary widely, creating challenges for decision-makers seeking to inform decisions by using the evidence on consumers' medicines use.This is an update of a 2011 overview of systematic reviews, which synthesises the evidence, irrespective of disease, medicine type, population or setting, on the effectiveness of interventions to improve consumers' medicines use. To assess the effects of interventions which target healthcare consumers to promote safe and effective medicines use, by synthesising review-level evidence. We included systematic reviews published on the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. We identified relevant reviews by handsearching databases from their start dates to March 2012. We screened and ranked reviews based on relevance to consumers' medicines use, using criteria developed for this overview. We used standardised forms to extract data, and assessed reviews for methodological quality using the AMSTAR tool. We used standardised language to summarise results within and across reviews; and gave bottom-line statements about intervention effectiveness. Two review authors screened and selected reviews, and extracted and analysed data. We used a taxonomy of interventions to categorise reviews and guide syntheses. We included 75 systematic reviews of varied methodological quality. Reviews assessed interventions with diverse aims including support for behaviour change, risk minimisation and skills acquisition. No reviews aimed to promote systems-level consumer participation in medicines-related activities. Medicines adherence was the most frequently-reported outcome, but others such as knowledge, clinical and service-use outcomes were also reported. Adverse events were less commonly

  18. Systematic review of emergency medicine clinical practice guidelines: Implications for research and policy.

    Science.gov (United States)

    Venkatesh, Arjun K; Savage, Dan; Sandefur, Benjamin; Bernard, Kenneth R; Rothenberg, Craig; Schuur, Jeremiah D

    2017-01-01

    Over 25 years, emergency medicine in the United States has amassed a large evidence base that has been systematically assessed and interpreted through ACEP Clinical Policies. While not previously studied in emergency medicine, prior work has shown that nearly half of all recommendations in medical specialty practice guidelines may be based on limited or inconclusive evidence. We sought to describe the proportion of clinical practice guideline recommendations in Emergency Medicine that are based upon expert opinion and low level evidence. Systematic review of clinical practice guidelines (Clinical Policies) published by the American College of Emergency Physicians from January 1990 to January 2016. Standardized data were abstracted from each Clinical Policy including the number and level of recommendations as well as the reported class of evidence. Primary outcomes were the proportion of Level C equivalent recommendations and Class III equivalent evidence. The primary analysis was limited to current Clinical Policies, while secondary analysis included all Clinical Policies. A total of 54 Clinical Policies including 421 recommendations and 2801 cited references, with an average of 7.8 recommendations and 52 references per guideline were included. Of 19 current Clinical Policies, 13 of 141 (9.2%) recommendations were Level A, 57 (40.4%) Level B, and 71 (50.4%) Level C. Of 845 references in current Clinical Policies, 67 (7.9%) were Class I, 272 (32.3%) Class II, and 506 (59.9%) Class III equivalent. Among all Clinical Policies, 200 (47.5%) recommendations were Level C equivalent, and 1371 (48.9%) of references were Class III equivalent. Emergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are expert opinion based. Emergency medicine appears to suffer from an evidence gap that should be prioritized in the national research agenda and considered by policymakers prior to developing future quality

  19. Analysis of evidence supporting the Federation of Bosnia and Herzegovina reimbursement medicines lists: role of the WHO Essential Medicines List, Cochrane systematic reviews and technology assessment reports.

    Science.gov (United States)

    Mahmić-Kaknjo, Mersiha; Marušić, Ana

    2015-07-01

    We compared recently introduced Basic Medicines Lists of the Federation of Bosnia and Herzegovina (BH) (FBH Basic Lists (FBLs)) with the World Health Organization (WHO) Essential Medicines List (EML) and the evidence supporting the inclusion of additional medicines on FBLs. The sources of data included the 18th edition of the EML and the following FBLs: 2013 Hospital List, 2013 A List in Outpatient Setting, and 2012 List financed by the Federal Solidarity Fund. For medicines found on FBLs but not on EML, we searched the Cochrane Database of Systematic Reviews (CSR) and public health technology assessment (HTA) reports for evidence. FBLs had 134 medicines and 17 combinations that were not on EML, as well as 9 medicines deleted and 4 rejected from EML. EML had 82 medicines and 10 combinations of medicines not included in FBLs. Out of 125 medicines on FBLs but not on EML, 52 (42%) had good CSR evidence supporting their inclusion (n = 38) or exclusion (n = 14). For the rest (n = 74), we found 24 favourable HTA reports. For the total of 89 medicines (27%) listed on FBLs, we found no evidence (EML, CSR, HTA reports) good enough to justify their inclusion in FBLs. In circumstances of scarce financial resources, greater reliance on well-established, proven list is crucial. Independent, unbiased, high-quality evidence such as WHO EML, CSR and HTA reports (national or international with local adaptations) should be used when deciding on medicine reimbursement.

  20. Anti-cancer natural products isolated from chinese medicinal herbs

    Directory of Open Access Journals (Sweden)

    Wu Guosheng

    2011-07-01

    Full Text Available Abstract In recent years, a number of natural products isolated from Chinese herbs have been found to inhibit proliferation, induce apoptosis, suppress angiogenesis, retard metastasis and enhance chemotherapy, exhibiting anti-cancer potential both in vitro and in vivo. This article summarizes recent advances in in vitro and in vivo research on the anti-cancer effects and related mechanisms of some promising natural products. These natural products are also reviewed for their therapeutic potentials, including flavonoids (gambogic acid, curcumin, wogonin and silibinin, alkaloids (berberine, terpenes (artemisinin, β-elemene, oridonin, triptolide, and ursolic acid, quinones (shikonin and emodin and saponins (ginsenoside Rg3, which are isolated from Chinese medicinal herbs. In particular, the discovery of the new use of artemisinin derivatives as excellent anti-cancer drugs is also reviewed.

  1. Chinese herbal medicine for idiopathic sudden sensorineural hearing loss: a systematic review of randomised clinical trials.

    Science.gov (United States)

    Su, C-X; Yan, L-J; Lewith, G; Liu, J-P

    2013-12-01

    Idiopathic sudden sensorineural hearing loss has great impact on quality of life. Many clinical trials using Chinese herbal medicine for idiopathic sudden sensorineural hearing loss have been conducted and reported beneficial results. However, there is no critical appraised evidence on efficacy and safety of Chinese herbal medicine for idiopathic sudden sensorineural hearing loss to inform clinical use. To assess the beneficial effect and safety of Chinese herbal medicine for idiopathic sudden sensorineural hearing loss. Systematic review of randomised clinical trials. Seven electronic databases and two trial registries were searched for all eligible trials from inception to January 2013. Two authors independently selected trials and extracted data. The Cochrane risk of bias tool was utilised to assess the methodological quality of the included trials. revman 5.2 software was applied for data analysis with effect estimate presented as risk ratio and mean difference with its 95% confidence interval. Forty-one randomised clinical trials involving 3560 participants were identified. Five kinds of Chinese herbal medicine were trialed. All trials compared conventional therapies of steroids, vasodilators, anticoagulants, nutritional supplements or hyperbaric oxygen with or without herbal medicine. No trial was identified that compared herbal medicine alone with placebo. No trial was identified that blinded the participants or the observers to their herbal medication. Only one trial adequately reported its method of randomisation. No trial reported the sample size calculated to show an effect. All trials had material other defects giving a high likelihood of bias. Because of the overall poor quality of all 41 trials, it was concluded that there was no level-one evidence to support the use of Chinese herbal medicine, alone or in addition to conventional therapies, to improve the hearing in adults with idiopathic sudden sensorineural hearing loss. Two trials reported adverse

  2. Microbial quality of some medicinal herbal products in Kashan, Iran

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    Mazroi Arani Navid

    2014-04-01

    Full Text Available Introduction: The use of medicinal plants has risen worldwide. In Iran, herbal waters and rose waters are of traditional medicinal products and as a result, they are widespreadly consumed. Therefore, diagnosis of microbial quality of these products is important. The aim of this study was to evaluate microbial quality of herbal extracts distributed in Kashan, Iran. Methods: In this descriptive study, 256 samples of herbal waters and 191 samples of rose waters (total samples of 447 distributed in Kashan during 2012 to 2013 were purchased and transferred to laboratory. Then microbial tests such as total aerobic bacterial count, mold and yeast count, total coliforms, and detection of Enterococcus, Pseudomonas and sulphite-reducing Clostridia were evaluated based on national standard of Iran. Results: Contamination with Pseudomonas and Enterococcus was observed in the herbal water samples. 196 cases (43.84% of the total samples, 113 cases (44.15% of the herbal waters and 83 cases (43.45% of the rose waters were usable based on the national standard of Iran. Neither herbal waters nor rosewater samples were contaminated by E.Coli and Sulphite-reducing clostridia. Additionally, none of the rosewater samples was contaminated by Coliforms and Pseudomonas. Conclusion: Based on the findings and due to the fact that these products are contaminated with aerobic mesophilic bacteria, mold and yeast, to minimize the risks we recommend to apply pasteurized temperature, high-quality packaging material and hygiene observance in processing time of herbal waters and rose waters.

  3. [Public production of medicines in Brazil: an overview].

    Science.gov (United States)

    de Oliveira, Egléubia Andrade; Labra, Maria Eliana; Bermudez, Jorge

    2006-11-01

    This paper analyzes the role of government production of medicines in Brazil, based on a review of the literature and public documents. It begins by examining the main characteristics of the national and international pharmaceutical industry and market dimensions, mainly in the public sector. The government view was examined through Ministry of Health documents. The article concludes with a diagnosis of the state-owned pharmaceutical industry in Brazil, showing a variety of difficulties faced by the laboratories due to political and institutional constraints, management deficiencies, shortage of qualified human resources, and low technological capability.

  4. Herbal medicinal products versus botanical-food supplements in the European market: state of art and perspectives.

    Science.gov (United States)

    Bilia, Anna Rita

    2015-01-01

    Botanical products marketed in Europe are diverse, classified as herbal medicinal products, dietary supplements, cosmetics, foods and beverages depending on the relevant applicable legislation. Many factors are taken into account in the classification of a botanical product (e.g. intended use, labeling, preparations and dosages) according to how it is placed on the market. Herbal medicinal products (HMPs) can only be sold in pharmacies, under the supervision of a pharmacist, and are marketed after full or simplified registration procedures according to their classification, i.e. as over-the-counter drugs (OTC) available without special restrictions and prescription only medicine (POM), which must be prescribed by a licensed medical practitioner. The dietary supplement segment is also sold in the market in dose form (such as capsules, tablets, ampoules of liquids, drops etc) and represents 15-20% of the botanical market at the European level with high variability among each country (i.e. in Italy it reaches up to 80%). In many cases the distinction between medicinal products and food supplements has generated borderline botanical-sourced products, which generally produce confusion and mislead the consumers. As a consequence, there is an urgent need of consumer education and in addition to collect comprehensive data and make this database systematically available to herbalists, nutritionists and medical specialists for a proper classification and harmonization of the use of botanical ingredients, and, as consequence, a correct use of these products.

  5. Medicinal Plants with Multiple Effects on Cardiovascular Diseases: A Systematic Review.

    Science.gov (United States)

    Rouhi-Boroujeni, Hojjat; Heidarian, Esfandiar; Rouhi-Boroujeni, Hamid; Deris, Fatemeh; Rafieian-Kopaei, Mahmoud

    2017-01-01

    Hyperlipidemia, obesity, hypertension, and diabetes are the most important risk factors for cardiovascular diseases. The aim of this systematic review article is to introduce the medicinal plants that exert significant clinical effects on hypertension, hyperlipidemia, obesity, and diabetes. In this review article, the international research databases including MEDLINE, Google scholar, EBSCO, Academic Search, Web of Science, SciVerse, Scopus (SCOPUS), EBSCO, Academic Search, Cochrane, Central Register of Controlled Trials (CENTRAL) and a Chinese database (China Network Knowledge Infrastructure [CNKI]) were searched using the key words hyperlipidemia, hypertension, diabetes, herbal, obesity, and phytomedicine, matched by MESH, from their respective inceptions up to March, 2016. The plants that were effective on one, two, three, or all of four diseases were determined. The doses, side effects, the most important pharmaceutically effective compounds, the used organs, and important points regarding usage were separately recorded. Also known clinically significant interactions were presented. 1023 articles were found to be about medicinal plants and hypertension, 1912 articles about medicinal plants and hyperlipidemia, 810 articles about medicinal plants and obesity, 1174 articles about medicinal plants and diabetes. Of 144 plants included in the analysis, 83 were found to be effective on hyperlipidemia, 100 on hypertension, 66 on obesity, and 72 on diabetes. 43 plants were found to be effective on two diseases, 14 on three diseases, and 34 on all four diseases. Three plants (Tomato, Cranberry and Pomegranate), in food and therapeutic doses, were found to be used to treat cardiovascular diseases especially in pre-eclampsia and hyperlipidemia in pregnancy. Regarding the findings of this study, we can argue that the medicinal plants, other than monotherapy, can be used as poly-therapy, to treat cardiovascular diseases. Copyright© Bentham Science Publishers; For any

  6. Systematic review on irrational use of medicines in China and Vietnam.

    Directory of Open Access Journals (Sweden)

    Wenhui Mao

    Full Text Available Irrational use of medicines has been an issue concerned all over the world and the outlooks in developing countries are more severe. This study aimed to assess the different patterns of irrational use of medicines and its influential factors in China and Vietnam.A systematic review was performed on both published and grey literatures in English, Chinese and Vietnamese languages between 1993 and 2013 based on the WHO framework. Quality assessment was conducted on the basis of the Critical Appraisal Skills Programme. Key indicators were analyzed to compare the irrational use of medicines in two countries.A total of 67 published works about China and 29 about Vietnam were included, the majority of which were cross-sectional prescription studies in both China and Vietnam. Irrational use of medicines was found in both the countries but issues with polypharmacy as well as overuse of antibiotics were more severe in Vietnam while overuse of injections was unique to China. Various patterns of irrational use were also indicated between urban and rural areas, and among different levels of hospitals. Rarely does literature focus on the analysis of influential factors of irrational use of medicines. While lack of proper knowledge from both providers and patients were the most recognized influential factors in both countries, economic incentives from pharmaceutical companies in China, and weak control and regulation over prescriptions in Vietnam were the main factors attributed to this issue.Severe irrational use of medicines has been abundantly evidenced in both China and Vietnam, highlighting the importance of policy interventions on the issue. However, limited evidence on the appropriateness or its compliance (conformity to guidelines of prescription has been found. In addition, convincing evidence on the underlying explanation of this issue is lacking, although economic incentives, health insurance coverage, and knowledge of service providers and users

  7. Systematic review on irrational use of medicines in China and Vietnam.

    Science.gov (United States)

    Mao, Wenhui; Vu, Huyen; Xie, Zening; Chen, Wen; Tang, Shenglan

    2015-01-01

    Irrational use of medicines has been an issue concerned all over the world and the outlooks in developing countries are more severe. This study aimed to assess the different patterns of irrational use of medicines and its influential factors in China and Vietnam. A systematic review was performed on both published and grey literatures in English, Chinese and Vietnamese languages between 1993 and 2013 based on the WHO framework. Quality assessment was conducted on the basis of the Critical Appraisal Skills Programme. Key indicators were analyzed to compare the irrational use of medicines in two countries. A total of 67 published works about China and 29 about Vietnam were included, the majority of which were cross-sectional prescription studies in both China and Vietnam. Irrational use of medicines was found in both the countries but issues with polypharmacy as well as overuse of antibiotics were more severe in Vietnam while overuse of injections was unique to China. Various patterns of irrational use were also indicated between urban and rural areas, and among different levels of hospitals. Rarely does literature focus on the analysis of influential factors of irrational use of medicines. While lack of proper knowledge from both providers and patients were the most recognized influential factors in both countries, economic incentives from pharmaceutical companies in China, and weak control and regulation over prescriptions in Vietnam were the main factors attributed to this issue. Severe irrational use of medicines has been abundantly evidenced in both China and Vietnam, highlighting the importance of policy interventions on the issue. However, limited evidence on the appropriateness or its compliance (conformity) to guidelines of prescription has been found. In addition, convincing evidence on the underlying explanation of this issue is lacking, although economic incentives, health insurance coverage, and knowledge of service providers and users have been implied

  8. Back to the Roots: Prediction of Biologically Active Natural Products from Ayurveda Traditional Medicine

    DEFF Research Database (Denmark)

    Polur, Honey; Joshi, Tejal; Workman, Christopher

    2011-01-01

    Ayurveda, the traditional Indian medicine is one of the most ancient, yet living medicinal traditions. In the present work, we developed an in silico library of natural products from Ayurveda medicine, coupled with structural information, plant origin and traditional therapeutic use. Following this...... basis of Ayurveda medicine and in drug repurposing....

  9. The role of complementary and alternative medicine in the treatment of eating disorders: A systematic review.

    Science.gov (United States)

    Fogarty, Sarah; Smith, Caroline A; Hay, Phillipa

    2016-04-01

    This systematic review critically appraises the role of complementary and alternative medicine in the treatment of those with an eating disorder. Sixteen studies were included in the review. The results of this review show that the role of complementary and alternative medicine in the treatment of those with an eating disorder is unclear and further studies should be conducted. A potential role was found for massage and bright light therapy for depression in those with Bulimia Nervosa and a potential role for acupuncture and relaxation therapy, in the treatment of State Anxiety, for those with an eating disorder. The role of these complementary therapies in treating eating disorders should only be provided as an adjunctive treatment only. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. The efficacy of Iranian herbal medicines in alleviating hot flashes: A systematic review

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    Masumeh Ghazanfarpour

    2016-03-01

    Full Text Available Background: Hot flashes are the most common symptoms experienced by women around the time of menopause. Many women are interested in herbal medicines because of fear of side effects of hormone therapy. Objective: The aim of this systematic review was to assess the effectiveness of Iranian herbal medicines in alleviating hot flashes. Materials and Methods: MEDLINE (1966 to January 2015, Scopus (1996 to January 2015, and Cochrane Central Register of Controlled Trials (The Cochrane Library, issue 1, 2015 were searched along with, SID, Iran Medex, Magiran, Medlib and Irandoc. Nineteen randomized controlled trials met the inclusion criteria. Results: Overall, studies showed that Anise (Pimpinella anisum, licorice (Glycyrrhizaglabra, Soy, Black cohosh, Red clover, Evening primrose, Flaxseed, Salvia officinalis, Passiflora ،itex Agnus Castus, Piascledine (Avacado plus soybean oil, St. John's wort (Hypericum perforatum, and valerian can alleviate the side effects of hot flashes. Conclusion: This research demonstrated the efficacy of herbal medicines in alleviating hot flashes, which are embraced both with people and health providers of Iran Therefore, herbal medicine can be seen as an alternative treatment for women experiencing hot flashes

  11. A systematic review of anti-obesity medicinal plants - an update

    OpenAIRE

    Hasani-Ranjbar, Shirin; Jouyandeh, Zahra; Abdollahi, Mohammad

    2013-01-01

    Obesity is the most prevalent health problem affecting all age groups, and leads to many complications in the form of chronic heart disease, diabetes mellitus Type 2 and stroke. A systematic review about safety and efficacy of herbal medicines in the management of obesity in human was carried out by searching bibliographic data bases such as, PubMed, Scopus, Google Scholar, Web of Science, and IranMedex, for studies reported between 30th December 2008 to 23rd April 2012 on human or animals, i...

  12. Medicinal plants with promising antileishmanial activity in Iran: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Masoud Soosaraei

    2017-09-01

    Conclusion: The most Iranian plants used as anti-leishmanial activity were Artemisia species, Allium sativum, Achilleamille folium, Peganum harmala and Thymus vulgaris. The present systematic and meta-analysis review provide valuable information about natural products with anti-Leishmania activity, which would be examined in the future experimental and clinical trials and herbal combination therapy.

  13. The public production of medicines compared to the National Policy of Medicines and the burden of disease in Brazil.

    Science.gov (United States)

    Figueiredo, Tatiana Aragão; Schramm, Joyce Mendes de Andrade; Pepe, Vera Lúcia Edais

    2017-09-28

    : The public production of medicines in Brazil by Government Pharmaceutical Laboratories has once again become the object of incentives, and Industrial Development Partnerships are one of the mechanisms adopted for the production of strategic medicines for the Brazilian Unified National Health System (SUS). Considering that burden-of-disease studies have been used as a tool to define priority and essential medicines, the article compares the product portfolios of the country's Official Pharmaceutical Laboratories (OPL) and the list of strategic medicines for the SUS and burden of disease in Brazil in 2008. Of the 205 strategic medicines for the SUS and 111 from the portfolios, 73% and 89%, respectively, are on the National List of Essential Medicines (RENAME 2014). Some strategic medicines for the SUS are already produced by OPL and feature the selection of cancer drugs and biologicals. The current study contributes to the discussion on the public production of medicines in light of the country's current industrial policy and highlights the need to define priority drugs and the role of OPL in guaranteeing access to them.

  14. The public production of medicines compared to the National Policy of Medicines and the burden of disease in Brazil

    Directory of Open Access Journals (Sweden)

    Tatiana Aragão Figueiredo

    2017-09-01

    Full Text Available Abstract: The public production of medicines in Brazil by Government Pharmaceutical Laboratories has once again become the object of incentives, and Industrial Development Partnerships are one of the mechanisms adopted for the production of strategic medicines for the Brazilian Unified National Health System (SUS. Considering that burden-of-disease studies have been used as a tool to define priority and essential medicines, the article compares the product portfolios of the country’s Official Pharmaceutical Laboratories (OPL and the list of strategic medicines for the SUS and burden of disease in Brazil in 2008. Of the 205 strategic medicines for the SUS and 111 from the portfolios, 73% and 89%, respectively, are on the National List of Essential Medicines (RENAME 2014. Some strategic medicines for the SUS are already produced by OPL and feature the selection of cancer drugs and biologicals. The current study contributes to the discussion on the public production of medicines in light of the country’s current industrial policy and highlights the need to define priority drugs and the role of OPL in guaranteeing access to them.

  15. A Systematic Methodology for Design of Emulsion Based Chemical Products

    DEFF Research Database (Denmark)

    Mattei, Michele; Kontogeorgis, Georgios; Gani, Rafiqul

    2012-01-01

    a hierarchical approach starting with the identification of the needs to be satisfied by the emulsified product and then building up the formulation by adding one-by-one the different classes of chemicals. A structured database together with dedicated property prediction models and evaluation criteria......A systematic methodology for emulsion based chemical product design is presented. The methodology employs a model-based product synthesis/design stage and a modelexperiment based further refinement and/or validation stage. In this paper only the first stage is presented. The methodology employs...

  16. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    Science.gov (United States)

    Vlachojannis, Christian

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  17. Selected non-timber forest products with medicinal applications from Jilin Province in China

    Science.gov (United States)

    Yao Ge Huang; Branka Barl; Gerald. Ivanochko

    2001-01-01

    This paper provides a brief account of the distribution, production, and use of some non-timber forest products such as medicinal plants, medicinal and nutraceutical mushrooms, pharmaceutical insects, and "wild" vegetables in Jilin Province, China. All materials featured in this paper are used in Traditional Chinese Medicine (TCM) inside and outside of China...

  18. A Friendly Relationship between Endophytic Fungi and Medicinal Plants: A Systematic Review

    Science.gov (United States)

    Jia, Min; Chen, Ling; Xin, Hai-Liang; Zheng, Cheng-Jian; Rahman, Khalid; Han, Ting; Qin, Lu-Ping

    2016-01-01

    Endophytic fungi or endophytes exist widely inside the healthy tissues of living plants, and are important components of plant micro-ecosystems. Over the long period of evolution, some co-existing endophytes and their host plants have established a special relationship with one and another, which can significantly influence the formation of metabolic products in plants, then affect quality and quantity of crude drugs derived from medicinal plants. This paper will focus on the increasing knowledge of relationships between endophytic fungi and medicinal plants through reviewing of published research data obtained from the last 30 years. The analytical results indicate that the distribution and population structure of endophytes can be considerably affected by factors, such as the genetic background, age, and environmental conditions of their hosts. On the other hand, the endophytic fungi can also confer profound impacts on their host plants by enhancing their growth, increasing their fitness, strengthening their tolerances to abiotic and biotic stresses, and promoting their accumulation of secondary metabolites. All the changes are very important for the production of bioactive components in their hosts. Hence, it is essential to understand such relationships between endophytic fungi and their host medicinal plants. Such knowledge can be well exploited and applied for the production of better and more drugs from medicinal plants. PMID:27375610

  19. Compensation and Production in Family Medicine by Practice Ownership

    Directory of Open Access Journals (Sweden)

    Alison C. Essary

    2016-02-01

    Full Text Available The increasing focus on high performance, patient-centered, team-based care calls for a strategy to evaluate cost-effective primary care. The trend toward physician practice consolidation further challenges the primary care health care system. Productivity measures establish provider value and help inform decision making regarding resource allocation in this evolving health care system. In this national survey of family medicine practices, physician assistant (PA productivity, as defined by mean annual patient encounters, exceeds that of both nurse practitioners (NPs and physicians in physician-owned practices and of NPs in hospital or integrated delivery system-owned practices. Total compensation, defined as salary, bonus, incentives, and honoraria for physicians, is significantly more compared to both PAs and NPs, regardless of practice ownership or productivity. Physician assistants and NPs earn equivalent compensation, regardless of practice ownership or productivity. Not only do these data support the value and role of PAs and NPs on the primary care team but also highlight differences in patient encounters between practice settings. Rural and underserved community practices, where physician-owned practices persist, also merit further consideration. Further research is needed to inform both organizational and policy decisions for the provision of high-quality, cost-effective, and accessible primary health care.

  20. Efficacy and Safety of Chinese Medicinal Herbs for the Treatment of Hyperuricemia: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Jianping Lin

    2016-01-01

    Full Text Available Background. Chinese medicinal herbs may be useful for the treatment of hyperuricemia, but there has been no systematic assessment of their efficacy and safety. Objectives. To systematically assess the efficacy and safety of Chinese medicinal herbs for the treatment of hyperuricemia. Methods. Six electronic databases were searched from their inception to December 2015. Randomized controlled clinical trials (RCTs were included. Cochrane criteria were applied to assess the risk of bias. Data analysis was performed using RevMan software version 5.2. Results. Eleven RCTs with 838 patients were included. There was no significant difference in serum uric acid between Chinese medicinal herbs and traditional Western medicine (SME: 0.19, 95% CI: −0.04 to 0.43; p=0.10. In terms of overall efficacy, the Chinese medicinal herbs were significantly superior to Western medicine (RR: 1.11; 95% CI: 1.04 to 1.17; p=0.0007. The Chinese medicinal herbs were better than Western medicine in reducing the adverse reactions (RR: 0.30; 95% CI: 0.15 to 0.62; p=0.001. And all these funnel plots showed unlikelihood of publishing bias. Conclusions. The results indicate that Chinese medicinal herbs may have greater overall efficacy with fewer adverse drug reactions, although the evidence is weak owing to the low methodological quality and the small number of the included trials.

  1. Complementary and alternative medicine for patients with chronic fatigue syndrome: A systematic review

    Directory of Open Access Journals (Sweden)

    Cao Huijuan

    2011-10-01

    Full Text Available Abstract Background Throughout the world, patients with chronic diseases/illnesses use complementary and alternative medicines (CAM. The use of CAM is also substantial among patients with diseases/illnesses of unknown aetiology. Chronic fatigue syndrome (CFS, also termed myalgic encephalomyelitis (ME, is no exception. Hence, a systematic review of randomised controlled trials of CAM treatments in patients with CFS/ME was undertaken to summarise the existing evidence from RCTs of CAM treatments in this patient population. Methods Seventeen data sources were searched up to 13th August 2011. All randomised controlled trials (RCTs of any type of CAM therapy used for treating CFS were included, with the exception of acupuncture and complex herbal medicines; studies were included regardless of blinding. Controlled clinical trials, uncontrolled observational studies, and case studies were excluded. Results A total of 26 RCTs, which included 3,273 participants, met our inclusion criteria. The CAM therapy from the RCTs included the following: mind-body medicine, distant healing, massage, tuina and tai chi, homeopathy, ginseng, and dietary supplementation. Studies of qigong, massage and tuina were demonstrated to have positive effects, whereas distant healing failed to do so. Compared with placebo, homeopathy also had insufficient evidence of symptom improvement in CFS. Seventeen studies tested supplements for CFS. Most of the supplements failed to show beneficial effects for CFS, with the exception of NADH and magnesium. Conclusions The results of our systematic review provide limited evidence for the effectiveness of CAM therapy in relieving symptoms of CFS. However, we are not able to draw firm conclusions concerning CAM therapy for CFS due to the limited number of RCTs for each therapy, the small sample size of each study and the high risk of bias in these trials. Further rigorous RCTs that focus on promising CAM therapies are warranted.

  2. Medicinal properties of ‘true’ cinnamon (Cinnamomum zeylanicum): a systematic review

    Science.gov (United States)

    2013-01-01

    Background In traditional medicine Cinnamon is considered a remedy for respiratory, digestive and gynaecological ailments. In-vitro and in-vivo studies from different parts of the world have demonstrated numerous beneficial medicinal effects of Cinnamomum zeylanicum (CZ). This paper aims to systematically review the scientific literature and provide a comprehensive summary on the potential medicinal benefits of CZ. Methods A comprehensive systematic review was conducted in the following databases; PubMed, Web of Science, SciVerse Scopus for studies published before 31st December 2012. The following keywords were used: “Cinnamomum zeylanicum”, “Ceylon cinnamon”, “True cinnamon” and “Sri Lankan cinnamon”. To obtain additional data a manual search was performed using the reference lists of included articles. Results The literature search identified the following number of articles in the respective databases; PubMed=54, Web of Science=76 and SciVerse Scopus=591. Thirteen additional articles were identified by searching reference lists. After removing duplicates the total number of articles included in the present review is 70. The beneficial health effects of CZ identified were; a) anti-microbial and anti-parasitic activity, b) lowering of blood glucose, blood pressure and serum cholesterol, c) anti-oxidant and free-radical scavenging properties, d) inhibition of tau aggregation and filament formation (hallmarks of Alzheimer’s disease), e) inhibitory effects on osteoclastogenesis, f) anti-secretagogue and anti-gastric ulcer effects, g) anti-nociceptive and anti-inflammatory activity, h) wound healing properties and i) hepato-protective effects. The studies reported minimal toxic and adverse effects. Conclusions The available in-vitro and in-vivo evidence suggests that CZ has many beneficial health effects. However, since data on humans are sparse, randomized controlled trials in humans will be necessary to determine whether these effects have public

  3. Complementary and alternative medicine for patients with chronic fatigue syndrome: A systematic review

    Science.gov (United States)

    2011-01-01

    Background Throughout the world, patients with chronic diseases/illnesses use complementary and alternative medicines (CAM). The use of CAM is also substantial among patients with diseases/illnesses of unknown aetiology. Chronic fatigue syndrome (CFS), also termed myalgic encephalomyelitis (ME), is no exception. Hence, a systematic review of randomised controlled trials of CAM treatments in patients with CFS/ME was undertaken to summarise the existing evidence from RCTs of CAM treatments in this patient population. Methods Seventeen data sources were searched up to 13th August 2011. All randomised controlled trials (RCTs) of any type of CAM therapy used for treating CFS were included, with the exception of acupuncture and complex herbal medicines; studies were included regardless of blinding. Controlled clinical trials, uncontrolled observational studies, and case studies were excluded. Results A total of 26 RCTs, which included 3,273 participants, met our inclusion criteria. The CAM therapy from the RCTs included the following: mind-body medicine, distant healing, massage, tuina and tai chi, homeopathy, ginseng, and dietary supplementation. Studies of qigong, massage and tuina were demonstrated to have positive effects, whereas distant healing failed to do so. Compared with placebo, homeopathy also had insufficient evidence of symptom improvement in CFS. Seventeen studies tested supplements for CFS. Most of the supplements failed to show beneficial effects for CFS, with the exception of NADH and magnesium. Conclusions The results of our systematic review provide limited evidence for the effectiveness of CAM therapy in relieving symptoms of CFS. However, we are not able to draw firm conclusions concerning CAM therapy for CFS due to the limited number of RCTs for each therapy, the small sample size of each study and the high risk of bias in these trials. Further rigorous RCTs that focus on promising CAM therapies are warranted. PMID:21982120

  4. Global Use of Traditional and Complementary Medicine in Childhood Cancer: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Caroline Diorio

    2017-12-01

    Full Text Available Purpose: Traditional and complementary medicine (T&CM strategies are commonly used in pediatric oncology. Patterns may vary based on country income. We systematically reviewed published studies describing T&CM use among pediatric oncology patients in low-income countries (LIC/LMIC, middle-income countries (UMIC, and high-income countries (HIC. Objectives included describing estimated prevalence of use, reasons for use, perceived effectiveness, modalities used, rates of disclosure, and reporting of delayed or abandoned treatment. Methods: MEDLINE, EMBASE, Global Health, CINAHL, PsycINFO, Allied and Complementary Medicine Database, Cochrane Database of Systematic Reviews, and ProceedingsFirst were searched. Inclusion criteria were primary studies involving children younger than the age of 18 years, undergoing active treatment of cancer, and any T&CM use. Exclusion criteria included no pediatric oncology–specific outcomes and studies involving only children off active treatment. Data were extracted by two reviewers using a systematic data extraction form determined a priori. Results: Sixty-five studies published between 1977 and 2015 were included, representing 61 unique data sets and 7,219 children from 34 countries. The prevalence of T&CM use ranged from 6% to 100%. Median rates of use were significantly different in LIC/LMIC (66.7% ± 19%, UMIC (60% ± 26%, and HIC (47.2% ± 20%; P = .02. Rates of disclosure differed significantly by country income, with higher median rates in HIC. Seven studies reported on treatment abandonment or delays. Conclusion: The use of T&CM in pediatric oncology is common worldwide, with higher median prevalence of use reported in LIC/LMIC. Further research is warranted to examine the impact on treatment abandonment and delay.

  5. A systematic review of clinical audit in companion animal veterinary medicine.

    Science.gov (United States)

    Rose, Nicole; Toews, Lorraine; Pang, Daniel S J

    2016-02-26

    Clinical audit is a quality improvement process with the goal of continuously improving quality of patient care as assessed by explicit criteria. In human medicine clinical audit has become an integral and required component of the standard of care. In contrast, in veterinary medicine there appear to have been a limited number of clinical audits published, indicating that while clinical audit is recognised, its adoption in veterinary medicine is still in its infancy. A systematic review was designed to report and evaluate the veterinary literature on clinical audit in companion animal species (dog, cat, horse). A systematic search of English and French articles using Proquest Dissertations and Theses database (February 6, 2014), CAB Abstracts (March 21, 2014 and April 4, 2014), Scopus (March 21, 2014), Web of Science Citation index (March 21, 2014) and OVID Medline (March 21, 2014) was performed. Included articles were those either discussing clinical audit (such as review articles and editorials) or reporting parts of, or complete, audit cycles. The majority of articles describing clinical audit were reviews. From 89 articles identified, twenty-one articles were included and available for review. Twelve articles were reviews of clinical audit in veterinary medicine, five articles included at least one veterinary clinical audit, one thesis was identified, one report was of a veterinary clinical audit website and two articles reported incomplete clinical audits. There was no indication of an increase in the number of published clinical audits since the first report in 1998. However, there was evidence of article misclassification, with studies fulfilling the criteria of clinical audit not appropriately recognised. Quality of study design and reporting of findings varied considerably, with information missing on key components, including duration of study, changes in practice implemented between audits, development of explicit criteria and appropriate statistical

  6. Complementary and alternative medicine use among women with breast cancer: a systematic review.

    Science.gov (United States)

    Wanchai, Ausanee; Armer, Jane M; Stewart, Bob R

    2010-08-01

    Patients with breast cancer use complementary and alternative medicine (CAM) despite the fact that no studies have shown altered disease progression attributable to CAM use. The purpose of this systematic review is to summarize research as it relates to CAM use among women with breast cancer. Among the many findings of the review, biologically based practices were noted as the types of CAM most used by women with breast cancer, followed by mind-body medicine, whole medical systems, and energy medicine. Sources of information about CAM use for women with breast cancer vary widely, including family, friends, mass media, healthcare providers, CAM providers, and self-help groups. Sociodemographic factors that appear to be related to CAM use were younger age, higher education, higher income, married status, involvement in a support group, and health insurance. The reasons for CAM use reported by women with breast cancer were to help healing, to promote emotional health, and to cure cancer. Oncology nurses should learn more about CAM use among women with breast cancer. Open communication about CAM use helps ensure that safe and holistic care is provided. Additional research in this particular area is needed.

  7. [Classification of cell-based medicinal products and legal implications: An overview and an update].

    Science.gov (United States)

    Scherer, Jürgen; Flory, Egbert

    2015-11-01

    In general, cell-based medicinal products do not represent a uniform class of medicinal products, but instead comprise medicinal products with diverse regulatory classification as advanced-therapy medicinal products (ATMP), medicinal products (MP), tissue preparations, or blood products. Due to the legal and scientific consequences of the development and approval of MPs, classification should be clarified as early as possible. This paper describes the legal situation in Germany and highlights specific criteria and concepts for classification, with a focus on, but not limited to, ATMPs and non-ATMPs. Depending on the stage of product development and the specific application submitted to a competent authority, legally binding classification is done by the German Länder Authorities, Paul-Ehrlich-Institut, or European Medicines Agency. On request by the applicants, the Committee for Advanced Therapies may issue scientific recommendations for classification.

  8. [The use of nanotechnology in medicinal products in the light of European Union law].

    Science.gov (United States)

    Jurewicz, Margin

    2014-12-01

    The purpose of EU regulations in relation to nanotechnology, according to the European Commission's Communication "Regulatory aspects of nanomaterials", is to allow the public to use innovative applications of nanotechnology while ensuring a high level of safety, health care and environmental protection. This article characterizes and comments on EU legislation in respect of medicinal products containing nanomaterials. Medicinal products manufactured using nanotechnology are subject to the optional centralized authorization procedure by the European Commission authorizations for the placing on the market throughout the EU; advanced therapy medicinal products containing nanomaterials are covered by the mandatory centralized procedure. Evaluation of medicines in centralized authorization mode for the marketing of medicinal products, including those containing nanomaterials, is carried out by the Committee on Medicinal Products for Human Use (CHMP) subject to the European Medicines Agency (EMA).

  9. Determination of counterfeit medicines by Raman spectroscopy: Systematic study based on a large set of model tablets.

    Science.gov (United States)

    Neuberger, Sabine; Neusüß, Christian

    2015-08-10

    In the last decade, counterfeit pharmaceutical products have become a widespread issue for public health. Raman spectroscopy which is easy, non-destructive and information-rich is particularly suitable as screening method for fast characterization of chemicals and pharmaceuticals. Combined with chemometric techniques, it provides a powerful tool for the analysis and determination of counterfeit medicines. Here, for the first time, a systematic study of the benefits and limitations of Raman spectroscopy for the analysis of pharmaceutical samples on a large set of model tablets, varying with respect to chemical and physical properties, was performed. To discriminate between the different mixtures, a combination of dispersive Raman spectroscopy performing in backscattering mode and principal component analysis was used. The discrimination between samples with different coatings, a varying amount of active pharmaceutical ingredients and a diversity of excipients were possible. However, it was not possible to distinguish between variations of the press power, mixing quality and granulation. As a showcase, the change in Raman signals of commercial acetylsalicylic acid effervescent tablets due to five different storage conditions was monitored. It was possible to detect early small chemical changes caused by inappropriate storage conditions. These results demonstrate that Raman spectroscopy combined with multivariate data analysis provides a powerful methodology for the fast and easy characterization of genuine and counterfeit medicines. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. [What doctors need to know about biosimilar medicinal products?].

    Science.gov (United States)

    Kes, Petar; Mesar, Ines; Bašić-Jukić, Nikolina; Rački, Sanjin

    2014-04-01

    Biological drug is a drug containing one or more active substances produced or secreted from a biological source. Some of them may be previously present in the human body, and examples include proteins such as insulin, growth hormone or erythropoetin. Biosimilar drug is a medical product that is a copy of the original approved drug whose patent has expired. Strict rules apply to similar biological medicines: 1) it is unable to support extrapolation of data on safety and efficacy between individual indications, except in the case of appropriate, science-based evidence; 2) biosimilar drugs must meet the requirements associated with testing the immunogenicity and safety monitoring afterthe introduction of the drug in clinical practice, including the risk management program; 3) each biosimilar drug has to be labeled under its own name in order to allow clear traceability of all medications; and 4) the principle of automatic substitution cannot apply to biosimilar drugs because they are not interchangeable.

  11. Medicinal and cosmetics soap production from Jatropha oil.

    Science.gov (United States)

    Shahinuzzaman, M; Yaakob, Zahira; Moniruzzaman, M

    2016-06-01

    Soap is the most useful things which we use our everyday life in various cleansing and cosmetics purposes. Jatropha oil is nonedible oil which has more benefits to soap making. It has also cosmetics and medicinal properties. But the presence of toxic Phorbol esters in Jatropha oil is the main constrains to use it. So it is necessary to search a more suitable method for detoxifying the Jatropha oil before the use as the main ingredient of soap production. This review implies a more suitable method for removing phorbol esters from Jatropha oil. Several parameters such as the % yield of pure Jatropha oil soap, TFM value of soap, total alkali content, free caustic alkalinity content, pH, the antimicrobial activity, and CMC value of general soap should be taken into consideration for soap from detoxified Jatropha oil. © 2016 Wiley Periodicals, Inc.

  12. The assessment of complementary and alternative medicine use among individuals with HIV: a systematic review and recommendations for future research.

    Science.gov (United States)

    Owen-Smith, Ashli; DePadilla, Lara; DiClemente, Ralph

    2011-09-01

    The use of complementary and alternative medicine (CAM), a group of health care practices and products that are not considered part of conventional medicine, has increased in recent years, particularly among individuals with human immune deficiency virus (HIV). Assessing the prevalence and predictors of CAM use among HIV-positive populations is important because some CAM therapies may adversely affect the efficacy of conventional HIV medications. Unfortunately, CAM use is not comprehensively or systematically assessed among HIV-positive populations. Therefore, the aim of the present study was to evaluate the quality of the instruments employed in observational studies assessing CAM use among HIV-positive populations by examining the degree to which these studies (1) evaluated the psychometric properties of their CAM instruments and (2) assessed the multidimensional nature of CAM use. A systematic review of studies was undertaken and specific review criteria were used to guide the inclusion of studies. Specifically, articles were included that were published in English and in a peer-reviewed journal between 1997 and 2007, recruited HIV-positive study participants, and assessed CAM use. Thirty-two (32) studies met these inclusion criteria. Results suggest that CAM assessment among HIV-positive populations continues to be problematic. For example, approximately 20% of the studies assessed the reliability and 3% assessed the validity of the CAM instrument employed. CAM assessment--regardless of the specific study population--is a complex and challenging task. However, CAM instruments will not become more refined over time in the absence of rigorous psychometric evaluation. Future research must assess reliability and validity and report these data in a clear and nuanced manner.

  13. Impact of Rhinitis on Work Productivity: A Systematic Review.

    Science.gov (United States)

    Vandenplas, Olivier; Vinnikov, Denis; Blanc, Paul D; Agache, Ioana; Bachert, Claus; Bewick, Michael; Cardell, Lars-Olaf; Cullinan, Paul; Demoly, Pascal; Descatha, Alexis; Fonseca, Joao; Haahtela, Tari; Hellings, Peter W; Jamart, Jacques; Jantunen, Juha; Kalayci, Ömer; Price, David; Samolinski, Boleslaw; Sastre, Joaquin; Tian, Longxiu; Valero, Antonio L; Zhang, Xinyi; Bousquet, Jean

    2017-10-07

    Allergic rhinitis (AR) is increasingly acknowledged as having a substantial socioeconomic impact associated with impaired work productivity, although available information remains fragmented. This systematic review summarizes recently available information to provide a quantitative estimate of the burden of AR on work productivity including lost work time (ie, absenteeism) and reduced performance while working (ie, presenteeism). A Medline search retrieved original studies from 2005 to 2015 pertaining to the impact of AR on work productivity. A pooled analysis of results was carried out with studies reporting data collected through the validated Work Productivity and Activity Impairment (WPAI) questionnaire. The search identified 19 observational surveys and 9 interventional studies. Six studies reported economic evaluations. Pooled analysis of WPAI-based studies found an estimated 3.6% (95% confidence interval [CI], 2.4; 4.8%) missed work time and 35.9% (95% CI, 29.7; 42.1%) had impairment in at-work performance due to AR. Economic evaluations indicated that indirect costs associated with lost work productivity are the principal contributor to the total AR costs and result mainly from impaired presenteeism. The severity of AR symptoms was the most consistent disease-related factor associated with a greater impact of AR on work productivity, although ocular symptoms and sleep disturbances may independently affect work productivity. Overall, the pharmacologic treatment of AR showed a beneficial effect on work productivity. This systematic review provides summary estimates of the magnitude of work productivity impairment due to AR and identifies its main determinant factors. This information may help guide both clinicians and health policy makers. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  14. Effects of Fermented Dairy Products on Skin: A Systematic Review.

    Science.gov (United States)

    Vaughn, Alexandra R; Sivamani, Raja K

    2015-07-01

    Fermented dairy products, such as yogurt, have been proposed as a natural source of probiotics to promote intestinal health. Growing evidence shows that modulation of the gastrointestinal tract microbiota can modulate skin disease as well. This systematic review was conducted to examine the evidence for the use of ingested fermented dairy products to modulate skin health and function. We also sought to review the effects of the topical application of dairy products. The PubMed and Embase databases were systematically searched for clinical studies involving humans only that examined the relationship between fermented dairy products and skin health. A total of 312 articles were found and a total of 4 studies met inclusion criteria. Three studies evaluated the effects of ingestion, while one evaluated the effects of topical application. All studies noted improvement with the use of fermented dairy. Overall, there is early and limited evidence that fermented dairy products, used both topically and orally, may provide benefits for skin health. However, existing studies are limited and further studies will be important to better assess efficacy and the mechanisms involved.

  15. Efficacy, tolerability and safety of cannabis-based medicines for chronic pain management - An overview of systematic reviews.

    Science.gov (United States)

    Häuser, W; Petzke, F; Fitzcharles, M A

    2018-03-01

    Medicinal cannabis has already entered mainstream medicine in some countries. This systematic review (SR) aimed at evaluating the efficacy, acceptability and safety of cannabis-based medicines for chronic pain management. Qualitative systematic review of SRs of randomized controlled trials with cannabis-based medicines for chronic pain management. The Cochrane databases of SRs, Database of Abstracts of Reviews of Effects and PubMed were searched for SR published in the period January 2009 to January 2017. Assessment of the methodological quality of SR was performed by the AMSTAR checklist. Out of 748 papers identified, 10 SRs met the inclusion criteria. The methodological quality was high in four and moderate in six SRs. There were inconsistent findings of four SRs on the efficacy of cannabis-based medicines in neuropathic pain and of one SR for painful spasms in multiple sclerosis. There were consistent results that there was insufficient evidence of any cannabis-based medicine for pain management in patients with rheumatic diseases (three SRs) and in cancer pain (two SRs). Cannabis-based medicines undoubtedly enrich the possibilities of drug treatment of chronic pain conditions. It remains the responsibility of the health care community to continue to pursue rigorous study of cannabis-based medicines to provide evidence that meets the standard of 21st century clinical care. We provide an overview of systematic reviews on the efficacy, tolerability and safety of cannabis-based medicines for chronic pain management. There are inconsistent findings of the efficacy of cannabinoids in neuropathic pain and painful spasms in multiple sclerosis. There are inconsistent results on tolerability and safety of cannabis-based medicines for any chronic pain. © 2017 European Pain Federation - EFIC®.

  16. A systematic review of anti-obesity medicinal plants - an update.

    Science.gov (United States)

    Hasani-Ranjbar, Shirin; Jouyandeh, Zahra; Abdollahi, Mohammad

    2013-06-19

    Obesity is the most prevalent health problem affecting all age groups, and leads to many complications in the form of chronic heart disease, diabetes mellitus Type 2 and stroke. A systematic review about safety and efficacy of herbal medicines in the management of obesity in human was carried out by searching bibliographic data bases such as, PubMed, Scopus, Google Scholar, Web of Science, and IranMedex, for studies reported between 30th December 2008 to 23rd April 2012 on human or animals, investigating the beneficial and harmful effects of herbal medicine to treat obesity. Actually we limited our search to such a narrow window of time in order to update our article published before December of 2008. In this update, the search terms were "obesity" and ("herbal medicine" or "plant", "plant medicinal" or "medicine traditional") without narrowing or limiting search items. Publications with available abstracts were reviewed only. Total publications found in the initial search were 651. Total number of publications for review study was 33 by excluding publications related to animals study.Studies with Nigella Sativa, Camellia Sinensis, Crocus Sativus L, Seaweed laminaria Digitata, Xantigen, virgin olive oil, Catechin enriched green tea, Monoselect Camellia, Oolong tea, Yacon syrup, Irvingia Gabonensi, Weighlevel, RCM-104 compound of Camellia Sinensis, Pistachio, Psyllium fibre, black Chinese tea, sea buckthorn and bilberries show significant decreases in body weight. Only, alginate-based brown seaweed and Laminaria Digitata caused an abdominal bloating and upper respiratory tract infection as the side effect in the trial group. No other significant adverse effects were reported in all 33 trials included in this article.In conclusion, Nigella Sativa, Camellia Synensis, Green Tea, and Black Chinese Tea seem to have satisfactory anti-obesity effects. The effect size of these medicinal plants is a critical point that should be considered for interpretation. Although there

  17. Inhibition of Th1 and Th17 Cells by Medicinal Plants and Their Derivatives: A Systematic Review.

    Science.gov (United States)

    Asadi-Samani, Majid; Bagheri, Nader; Rafieian-Kopaei, Mahmoud; Shirzad, Hedayatollah

    2017-08-01

    Searching for new natural drugs that are capable of targeting Th1 and Th17 may lead to development of more effective treatments for inflammatory and autoimmune diseases. Most of the natural drugs can be derived from plants that are used in traditional medicine and folk medicine. The aim of this systematic review is to identify and introduce plants or plant derivatives that are effective on inflammatory diseases by inhibiting Th1 and Th17 responses. To achieve this purpose, the search terms herb, herbal medicine, herbal drug, medicinal plant, phytochemical, traditional Chinese medicine, Ayurvedic medicine, natural compound, inflammation, inflammatory diseases, Th1, Th17, T helper 1 or T helper 17 were used separately in Title/Keywords/Abstract in Web of Science and PubMed databases. In articles investigating the effect of the medicinal plants and their derivatives in inhibiting Th1 and Th17 cells, the effects of eight extracts of the medicinal plants, 21 plant-based compounds and some of their derivatives, and eight drugs derived from the medicinal plants' compounds in inhibiting Th1 and Th17 cells were reviewed. The results showed that medicinal plants and their derivates are able to suppress Th17 and Th1 T cell functions as well as cytokine secretion and differentiation. The results can be used to produce herbal drugs that suppress Th, especially Th17, responses. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  18. Development of a Database for Study Data in Registration Applications for Veterinary Medicinal Products

    Directory of Open Access Journals (Sweden)

    Anke Finnah

    2017-02-01

    Full Text Available Objective: In the present study, the feasibility of a systematic record of clinical study data from marketing authorisation applications for veterinary medicinal products (VMP and benefits of the selected approach were investigated.Background: Drug registration dossiers for veterinary medicinal products contain extensive data from drug studies, which are not easily accessible to assessors.Evidentiary value: Fast access to these data including specific search tools could facilitate a meaningful use of the data and allow assessors for comparison of test and studies from different dossiers.Methods: First, pivotal test parameters and their mutual relationships were identified. Second, a data model was developed and implemented in a relational database management system, including a data entry form and various reports for database searches. Compilation of study data in the database was demonstrated using all available clinical studies involving VMPs containing the anthelmintic drug Praziquantel. By means of descriptive data analysis possibilities of data evaluation including graphical presentation were shown. Suitability of the database to support the performance of meta-analyses was tentatively validated.Results: The data model was designed to cover the specific requirements arising from study data. A total of 308 clinical studies related to 95 VMPs containing Praziquantel (single agent and combination drugs was selected for prototype testing. The relevant data extracted from these studies were appropriately structured and shown to be basically suitable for descriptive data analyses as well as for meta-analyses.Conclusion: The database-supported collection of study data would provide users with easy access to the continuously increasing pool of scientific information held by competent authorities. It enables specific data analyses. Database design allows expanding the data model to all types of studies and classes of drugs registered in veterinary

  19. Brazilian medicinal plants to treat upper respiratory tract and bronchial illness: systematic review and meta-analyses-study protocol.

    Science.gov (United States)

    Lopes, Luciane C; Silva, Maria Carolina O; Motta, Cristiane Bergamashi; Macho Quirós, Antonio; Biavatti, Maique Weber; de Oliveira, Jardel Corrêa; Guyatt, Gordon

    2014-07-23

    Respiratory illness, often associated with cough and sputum, is frequent. In Brazil, herbal medicines are often recommended as a first-line treatment for respiratory illness. There exists uncertainty regarding the effectiveness of these treatments. No systematic review has evaluated Brazilian medicinal plants (BMP) to treat upper respiratory tract and bronchial illness (URTI). We will conduct a systematic review and, if appropriate, a series of meta-analyses evaluating the safety and effectiveness of BMP for URTI. Eligible randomised controlled trials and observational studies will enrol adult or paediatric patients presenting with URTI treated by BMP approved by the Brazilian Health Surveillance Agency compared with placebo, no treatment or an alternative therapy. Our search will include the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Acute Respiratory Illness Group's Specialized Register; MEDLINE; EMBASE; CINAHL (Cumulative Index to Nursing and Allied Health Literature); Web of Science; AMED; LILACS; CAB abstracts; clinical trial.gov; the WHO Trial Register and the Brazilian thesis database (CAPES) without any language restrictions. Outcomes of interest are time to resolution of clinical symptoms and/or signs (cough, sputum production or activity limitations), severity of symptoms prior to resolution and major/minor adverse events. Teams of reviewers will, independently and in duplicate, screen titles and abstracts and the complete full text to determine eligibility. For eligible studies, reviewers will perform data abstraction and assess risk of bias of eligible trials. When appropriate, we will conduct meta-analyses. We will also assess the quality of body of evidence (confidence in estimates of effect) for each of the outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. The systematic review will be published in a peer-reviewed journal. Brief reports of review findings

  20. Fractal analysis in radiological and nuclear medicine perfusion imaging: a systematic review.

    Science.gov (United States)

    Michallek, Florian; Dewey, Marc

    2014-01-01

    To provide an overview of recent research in fractal analysis of tissue perfusion imaging, using standard radiological and nuclear medicine imaging techniques including computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, positron emission tomography (PET) and single-photon emission computed tomography (SPECT) and to discuss implications for different fields of application. A systematic review of fractal analysis for tissue perfusion imaging was performed by searching the databases MEDLINE (via PubMed), EMBASE (via Ovid) and ISI Web of Science. Thirty-seven eligible studies were identified. Fractal analysis was performed on perfusion imaging of tumours, lung, myocardium, kidney, skeletal muscle and cerebral diseases. Clinically, different aspects of tumour perfusion and cerebral diseases were successfully evaluated including detection and classification. In physiological settings, it was shown that perfusion under different conditions and in various organs can be properly described using fractal analysis. Fractal analysis is a suitable method for quantifying heterogeneity from radiological and nuclear medicine perfusion images under a variety of conditions and in different organs. Further research is required to exploit physiologically proven fractal behaviour in the clinical setting. • Fractal analysis of perfusion images can be successfully performed. • Tumour, pulmonary, myocardial, renal, skeletal muscle and cerebral perfusion have already been examined. • Clinical applications of fractal analysis include tumour and brain perfusion assessment. • Fractal analysis is a suitable method for quantifying perfusion heterogeneity. • Fractal analysis requires further research concerning the development of clinical applications.

  1. Traditional Chinese medicines in the management of cardiovascular diseases: a comprehensive systematic review.

    Science.gov (United States)

    Layne, Kerry; Ferro, Albert

    2017-01-01

    The aim was to perform a systematic review of the efficacy of traditional Chinese medicines (TCM) in cardiovascular disease. Electronic databases were searched up to 11 November 2015 for all randomized-controlled trials evaluating the effect of TCM in hypertension, ischaemic stroke, heart failure, coronary heart disease and type 2 diabetes mellitus. Pooled odds ratios (ORs) were calculated using a fixed-effects model. Four hypertension studies were eligible for statistical analysis and included 133 patients receiving TCM and 130 control patients. There were significant reductions in systolic blood pressure in patients receiving TCM, comparable to results achieved with pharmaceutical medicines. An OR of 3.781 (95% confidence interval 2.392, 5.977; P = 0.000) was observed for the anti-hypertensive effect of TCM. Significant heterogeneity was present (P = 0.011), with a tendency towards publication bias that did not reach significance (P = 0.05275). Outcome measures for other cardiovascular diseases were inconsistent. Certain TCM compounds appear to have significant anti-hypertensive effects, and although some are associated in some studies with improved outcomes in coronary heart disease, heart failure and type 2 diabetes mellitus, the data are inconsistent and will require large-scale randomized-controlled trials to allow full evaluation of any potential therapeutic benefit in these areas. © 2016 The British Pharmacological Society.

  2. [Systematic evaluation on clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine].

    Science.gov (United States)

    Yang, Zhi-min; Tang, Xiang-jiang; Lao, Ying-rong

    2005-07-01

    To analyze the quality of scientific research design of clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine, so as to objectively evaluate the therapeutic effect of TCM. According to principles of evidence-based medicine, clinical epidemiology/design measurement evaluation (DME), the "Table of Systematic Evaluation of Quality and Information Collection for TCM Clinical Research Literature" were established and used to evaluate clinical control trial literature related with treatment of Parkinson's disease with TCM published during 1979 to 2000. The method of randomization was not described in 66.7% of the literature. Although randomized design was declared in 33.3 %, problems or mistakes of randomized allocation still existed in them. No record about the state of dropped out or absconded cases in follow-up study and without any record of samples screening presented in all literature. There were some problems of key links concerning samples' homogeneity, outcome indexes selection, conclusion deduction and so on, which could also influence the quality and reliability of randomized controlled trials. Methodological design of clinical research of TCM on Parkinson's disease should be strengthened.

  3. Chinese Herbal Medicine for Aspirin Resistance: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Ai-ju Liu

    2014-01-01

    Full Text Available Aspirin resistance (AR is a prevalent phenomenon and leads to significant clinical consequences, but the current evidence for effective interventional strategy is insufficient. The objective of this systematic review is thus to assess the efficacy and safety of Chinese herbal medicine (CHM for AR. A systematical literature search was conducted in 6 databases until December 2012 to identify randomized controlled trials (RCTs of CHM for AR. As a result, sixteen RCTs with a total of 1011 subjects were identified, suggesting that the interests of the medical profession and the public in the use of CHM for AR have grown considerably in the recent years. Tongxinluo capsule and Danshen-based prescriptions were the most frequently used herbal prescriptions, while danshen root, milkvetch root, Leech, and Rosewood were the most frequently used single herbs. Despite the apparent reported positive findings, it is premature to determine the efficacy and safety of CHM for the treatment of AR due to poor methodological quality and insufficient safety data. However, CHMs appeared to be well tolerated in all included studies. Thus, CHM as a promising candidate is worthy of improvement and development for further clinical AR trials. Large sample-size and well-designed rigorous RCTs are needed.

  4. R&D implementation in a department of laboratory medicine and pathology: a systematic review based on pharmaceutical companies.

    Science.gov (United States)

    Feulefack, Joseph; Sergi, Consolato

    2015-01-01

    A systematic literature review on pharmaceutical companies may be a tool for guiding some procedures of R&D implementation in a department of Laboratory Medicine and Pathology. The use of pharmaceutical companies for this specific analysis arises from less variability of standards than healthcare facilities. In this qualitative and quantitative analysis, we focused on three useful areas of implementation, including R&D productivity, commercialization strategies, and expenditures determinants of pharmaceutical companies. Studies and reports of online databases from 1965 to 2014 were reviewed according to specific search terms. Initially, 218 articles and reports were found and examined, but only 91 were considered appropriate and used for further analysis.  We identified some suggested implementation strategies relevant for marketing to enhance companies' own R&D strategies; such as reliability of companies on "sourcing-in" R&D facilities and "think-tank" events. Regardless of the study and of the country, cash flow and profitability always positively influenced R&D expenditure, while sales and firm size did not. We consider that handling R&D determinants should require caution. It seems critical that implementation of R&D systems is directly related with productivity, if it reflects dual embodiment of efficiency and effectiveness. Scrutinizing the determinants of R&D expenditures emphasizes significant factors that are worth to highlight when planning an R&D investment strategy. Although there is no receipt fitting every situation, we think that health care plan makers may find relevant data in this systematic review in creating an initial implementation framework.

  5. The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

    Science.gov (United States)

    Kroes, Burt H

    2014-12-02

    In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply

  6. Advanced therapy medicinal products: current and future perspectives.

    Science.gov (United States)

    Hanna, Eve; Rémuzat, Cécile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health benefits, but also to substantially impact the pharmaceuticals budget. The aim of this study was to characterise the ATMPs in development and discuss future implications in terms of market access. Clinical trials were searched in the following databases: EudraCT (EU Drug Regulating Authorities Clinical Trials), ClinicalTrials.gov, and ICTRP (International Clinical Trials Registry Platform of the World Health Organization). Trials were classified by category of ATMP as defined by European regulation EC No. 1394/2007, as well as by development phase and disease area. The database search identified 939 clinical trials investigating ATMPs (85% ongoing, 15% completed). The majority of trials were in the early stages (Phase I, I/II: 64.3%, Phase II, II/III: 27.9%, Phase 3: 6.9%). Per category of ATMP, we identified 53.6% of trials for somatic cell therapies, 22.8% for tissue-engineered products, 22.4% for gene therapies, and 1.2% for combined products (incorporating a medical device). Disease areas included cancer (24.8%), cardiovascular diseases (19.4%), musculoskeletal (10.5%), immune system and inflammation (11.5%), neurology (9.1%), and others. Of the trials, 47.2% enrolled fewer than 25 patients. Due to the complexity and specificity of ATMPs, new clinical trial methodologies are being considered (e.g., small sample size, non-randomised trials, single-arm trials, surrogate endpoints, integrated protocols, and adaptive designs). Evidence generation post-launch will become unavoidable to address payers' expectations. ATMPs represent a fast-growing field of interest. Although most of the products are in an early development phase, the combined trial phase and the potential to cure severe chronic conditions suggest that ATMPs may reach the market earlier than

  7. Teamwork assessment in internal medicine: a systematic review of validity evidence and outcomes.

    Science.gov (United States)

    Havyer, Rachel D A; Wingo, Majken T; Comfere, Nneka I; Nelson, Darlene R; Halvorsen, Andrew J; McDonald, Furman S; Reed, Darcy A

    2014-06-01

    Valid teamwork assessment is imperative to determine physician competency and optimize patient outcomes. We systematically reviewed published instruments assessing teamwork in undergraduate, graduate, and continuing medical education in general internal medicine and all medical subspecialties. We searched MEDLINE, MEDLINE In-process, CINAHL and PsycINFO from January 1979 through October 2012, references of included articles, and abstracts from four professional meetings. Two content experts were queried for additional studies. Included studies described quantitative tools measuring teamwork among medical students, residents, fellows, and practicing physicians on single or multi-professional (interprofessional) teams. Instrument validity and study quality were extracted using established frameworks with existing validity evidence. Two authors independently abstracted 30 % of articles and agreement was calculated. Of 12,922 citations, 178 articles describing 73 unique teamwork assessment tools met inclusion criteria. Interrater agreement was intraclass correlation coefficient 0.73 (95 % CI 0.63-0.81). Studies involved practicing physicians (142, 80 %), residents/fellows (70, 39 %), and medical students (11, 6 %). The majority (152, 85 %) assessed interprofessional teams. Studies were conducted in inpatient (77, 43 %), outpatient (42, 24 %), simulation (37, 21 %), and classroom (13, 7 %) settings. Validity evidence for the 73 tools included content (54, 74 %), internal structure (51, 70 %), relationships to other variables (25, 34 %), and response process (12, 16 %). Attitudes and opinions were the most frequently assessed outcomes. Relationships between teamwork scores and patient outcomes were directly examined for 13 (18 %) of tools. Scores from the Safety Attitudes Questionnaire and Team Climate Inventory have substantial validity evidence and have been associated with improved patient outcomes. Review is limited to quantitative assessments of teamwork in internal

  8. Systematic Derivation of Static Analyses for Software Product Lines

    DEFF Research Database (Denmark)

    Midtgaard, Jan; Brabrand, Claus; Wasowski, Andrzej

    2014-01-01

    A recent line of work lifts particular verification and analysis methods to Software Product Lines (SPL). In an effort to generalize such case-by-case approaches, we develop a systematic methodology for lifting program analyses to SPLs using abstract interpretation. Abstract interpretation...... is a classical framework for deriving static analyses in a compositional, step-by-step manner. We show how to take an analysis expressed as an abstract interpretation and lift each of the abstract interpretation steps to a family of programs. This includes schemes for how to lift domain types, and combinators...... analysis for a simple imperative language....

  9. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain

    NARCIS (Netherlands)

    Rubinstein, Sidney M; van Middelkoop, Marienke; Kuijpers, Ton; Ostelo, Raymond; Verhagen, Arianne P; de Boer, Michiel R; Koes, Bart W; van Tulder, Maurits W

    2010-01-01

    The purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple databases up to

  10. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain

    NARCIS (Netherlands)

    S.M. Rubinstein (Sidney); M. van Middelkoop (Marienke); T. Kuijpers (Ton); R.W.J.G. Ostelo (Raymond); A.P. Verhagen (Arianne); M.R. de Boer (Michiel Robert); B.W. Koes (Bart); M.W. van Tulder (Maurits)

    2010-01-01

    textabstractThe purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple

  11. [SCIENTIFIC PRODUCTION ON THANATOLOGY IN NURSING JOURNALS: SYSTEMATIC REVIEW].

    Science.gov (United States)

    Santos Mendes, Andreia; Moraes Gibaut, Mariana De Almeida; De Oliva Menezes, Tânia Maria; Carneiro Mussi, Fernanda

    2014-10-01

    Analyze the scientific production on Thanatology published in nursing journals. Systematic review, with quantitative approach, that aimed the characterization of the articles with regard to the year and journal of publication, and its Qualis CAPES, thematic approach, methodological focus, description of training area and qualification of authors. According to the selection criteria of the sample, 36 articles whose publication period was between the years 1986 and 2011 were extracted for analysis. It was noted the predominance of studies published in journals with high quality strata (A1 and A2), use of qualitative method and nurses educators as authors. The focus of the studies encompassed six central themes, and the prevailing ones were: "Thanatology in the academic training" and "The nurse in face of the dying process of patients and families under their cares". It is clear that the issue still presents itself in a timid manner, requiring an increased production on the subject.

  12. Contribution of the spanish agency for medicines and healthcare products to the European committee for the evaluation of medicinal products for human use.

    Science.gov (United States)

    Alonso-Gutiérrez, A; Díaz-Ramos, P; Sulleiro-Avendaño, E; de Miguel-Marañón, M; Padilla-Gallego, M E; Sancho-López, A; Ruiz-Antúnez, S; Prieto-Yerro, C

    2015-05-01

    The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEMPS) has actively contributed to the committee on medicinal products for human use. The therapeutic areas in which AEMPS has the greatest presence are cardiovascular, sensory organs (mainly ophthalmology) and genitourinary/sexual hormones. The technical staff of AEMPS contributes their expertise and extensive experience to this task, as do the practitioners of the Spanish healthcare system who act as external experts, providing their clinical vision and bringing the daily clinical practice to the evaluation of medicinal products. As with other European decision spaces, the joint participation of the member states is not homogeneous, with a minority of countries still heading the majority of assessments for the committee on medicinal products for human use, although all member countries take part in the final decision. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  13. [Outline study on production place of Chinese medicine in Han dynasty].

    Science.gov (United States)

    Zhang, Rui-xian; Wang, Jing; Zhang, Wei; Zhang, Mu-qun

    2008-07-01

    The administrative area of Han dynasty was basically divided into 13 states. There were very little records about the place of medicine production in literatures. This article tried to outline the basic feature of region of medicine production from the available books of , , and .

  14. Use of herbal medicinal products among children and adolescents in Germany

    Science.gov (United States)

    2014-01-01

    Background Germany is a country with a high use of herbal medicinal products. Population-based data on the use of herbal medicinal products among children are lacking. The aim of this study is to investigate the prevalence, patterns and determinants of herbal medicine use among children and adolescents in Germany. Methods As data base served the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), a representative population based survey conducted 2003–2006 by the Robert Koch Institute. 17,450 boys and girls aged 0–17 years provided information on drug use in the preceding seven days. Herbal medicinal products were defined according to the European and German drug laws. SPSS Complex Sample method was used to estimate prevalence rates and factors associated with herbal medicine use. Results The prevalence rate of herbal medicinal product use amounts to 5.8% (95% confidence interval 5.3-6.3%). Use of herbal medicine declines along with increasing age and shows no difference between boys and girls in younger age groups. Teenage girls are more likely to use herbal medicines than teenage boys. Two thirds of herbal medicines are used for the treatment of coughs and colds; nearly half of herbal medicines are prescribed by medical doctors. Determinants of herbal medicinal product use are younger age, residing in South Germany, having a poor health status, having no immigration background and coming from a higher social class family. Children’s and parents-related health behavior is not found to be associated with herbal medicine use after adjusting for social class. Conclusions Use of herbal medicinal products among children and adolescents between the ages of 0 and 17 years in Germany is widely spread and shows relatively higher rates compared to international data. This study provides a reference on the use of herbal medicinal products for policy-makers, health professionals and parents. Further studies are needed to investigate the

  15. Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials.

    Science.gov (United States)

    Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. No failure risk rate per development phase is available for ATMPs. The discontinuation rate may prove helpful when assessing the

  16. Analysis of productivity costs in cancer: a systematic review

    Directory of Open Access Journals (Sweden)

    Jordi Gol-Montserrat

    2017-06-01

    Full Text Available ABSTRACTIntroductionThe concept of indirect costs – or productivity losses to both patients and their informal caregivers arising from an illness – started to gain more importance two decades ago with the intention of strengthening cost estimates prior to evaluating, which historically was performed only with direct cost data.ObjectiveThe aim of this study is to explore the methodological differences in estimating productivity costs in studies of cancer diseases, as well as providing an updated and comprehensive overview of the worldwide relevance of productivity costs of cancer.MethodsThe study is conducted using a systematic literature review.ResultsThe literature search resulted in 332 articles. After removing those not meeting eligibility criteria or duplicities, 27 articles were included in the qualitative analysis. It is observed that the weight of cost productivity is noticeable; in several cases, it may represent over 50% of the total. The most common method of estimation is the Human Capital method. However, certain heterogeneity is observed in the method of estimating, as well as in the resultant figures.ConclusionsMore efforts are needed to standardize calculations and allow for real comparisons between countries.

  17. Systematic review: Complementary and alternative medicine in the irritable bowel syndrome.

    LENUS (Irish Health Repository)

    Hussain, Z

    2012-02-03

    BACKGROUND: Complementary and alternative medical therapies and practices are widely employed in the treatment of the irritable bowel syndrome. AIM: To review the usage of complementary and alternative medicine in the irritable bowel syndrome, and to assess critically the basis and evidence for its use. METHODS: A systematic review of complementary and alternative medical therapies and practices in the irritable bowel syndrome was performed based on literature obtained through a Medline search. RESULTS: A wide variety of complementary and alternative medical practices and therapies are commonly employed by irritable bowel syndrome patients both in conjunction with and in lieu of conventional therapies. As many of these therapies have not been subjected to controlled clinical trials, some, at least, of their efficacy may reflect the high-placebo response rate that is characteristic of irritable bowel syndrome. Of those that have been subjected to clinical trials most have involved small poor quality studies. There is, however, evidence to support efficacy for hypnotherapy, some forms of herbal therapy and certain probiotics in irritable bowel syndrome. CONCLUSIONS: Doctors caring for irritable bowel syndrome patients need to recognize the near ubiquity of complementary and alternative medical use among this population and the basis for its use. All complementary and alternative medicine is not the same and some, such as hypnotherapy, forms of herbal therapy, specific diets and probiotics, may well have efficacy in irritable bowel syndrome. Above all, we need more science and more controlled studies; the absence of truly randomized placebo-controlled trials for many of these therapies has limited meaningful progress in this area.

  18. A systematic review of the pharmacokinetic and pharmacodynamic interactions of herbal medicine with warfarin.

    Directory of Open Access Journals (Sweden)

    Songie Choi

    Full Text Available The aim of this study was to systematically review data regarding pharmacokinetic (PK-pharmacodynamic (PD parameters from randomized controlled trials relating to interactions between herbal medicines and warfarin.Three electronic databases were searched to identify relevant trials. Two reviewers independently performed the study selection and data extraction. The risk of bias and reporting quality were also assessed independently by two reviewers using the Cochrane risk of bias tool and the consolidated standards of reporting trials (CONSORT. Outcomes were measured for all reported PK-PD parameters and adverse events.Nine randomized controlled trials met our inclusion criteria. Most of the included studies were unclear regarding the risk of bias and had a low quality of methodology. Using CONSORT, the reporting percentages for the articles ranged from 36.5% to 61.5% and the mean percentage for all articles was 45.6%. St John's wort and echinacea affected the PK parameters of warfarin. Ginseng, ginger, garlic, and cranberry had no significant effect on the PK parameters. American ginseng altered the PD parameters of warfarin. St John's wort, ginseng, Korea red ginseng, ginkgo, ginger, garlic, aged garlic, and echincea did not significantly alter the PD parameters. Studies of ginkgo and cranberry showed conflicting results on the PK parameters and PD parameters, respectively. The incidence of adverse events in all trials was low and no major adverse events were reported.It was difficult to determine whether ten herbal medicines had significant effects on the PK-PD parameters of warfarin. Low quality of evidence, different compounds within and different compositions of the herbs, and methodological limitations of the crossover study, which is a clinical study in which subjects receive a sequence of different interventions, made it difficult to form conclusions. Additional studies that remedy these vulnerabilities are necessary to verify these

  19. Emotional intelligence in medicine: a systematic review through the context of the ACGME competencies.

    Science.gov (United States)

    Arora, Sonal; Ashrafian, Hutan; Davis, Rachel; Athanasiou, Thanos; Darzi, Ara; Sevdalis, Nick

    2010-08-01

    Emotional intelligence (EI) involves the perception, processing, regulation and management of emotions. This article aims to systematically review the evidence for EI in medicine through the context of the Accreditation Council for Graduate Medical Education (ACGME) competencies. MEDLINE, EMBASE, PsycINFO, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials were searched for English-language articles published between January 1980 and March 2009. The grey literature was also searched and experts in the field contacted for additional studies. Two independent reviewers selected articles which reported empirical research studies about clinicians or medical students. Conceptual articles and opinion pieces and commentaries were excluded. Information about the measure used to assess EI, the study parameter or domain, and the educational or clinical outcome (with specific relation to the ACGME competencies) was extracted. The literature search identified 485 citations. An abstract review led to the retrieval of 24 articles for full-text assessment, of which 16 articles were included in the final review. Eleven studies focused on postgraduates, four on undergraduates and one on medical school applicants. Six out of seven studies found women to have higher EI than men. Higher EI was reported to positively contribute to the doctor-patient relationship (three studies), increased empathy (five studies), teamwork and communication skills (six studies), and stress management, organisational commitment and leadership (three studies). Measures of EI correlate with many of the competencies that modern medical curricula seek to deliver. Further research is required to determine whether training can improve EI and thus augment educational and clinical outcomes.

  20. [Application of risk-based approach for determination of critical factors in technology transfer of production of medicinal products].

    Science.gov (United States)

    Beregovykh, V V; Spitskiy, O R

    2014-01-01

    Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full- scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factorfor risk analysis having the most impact on quality attributes of a medicinal product. Further importantfactors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.

  1. Antiviral potential of medicinal plants against HIV, HSV, influenza, hepatitis, and coxsackievirus: A systematic review.

    Science.gov (United States)

    Akram, Muhammad; Tahir, Imtiaz Mahmood; Shah, Syed Muhammad Ali; Mahmood, Zahed; Altaf, Awais; Ahmad, Khalil; Munir, Naveed; Daniyal, Muhammad; Nasir, Suhaila; Mehboob, Huma

    2018-01-22

    Viral infections are being managed therapeutically through available antiviral regimens with unsatisfactory clinical outcomes. The refractory viral infections resistant to available antiviral drugs are alarming threats and a serious health concern. For viral hepatitis, the interferon and vaccine therapies solely are not ultimate solutions due to recurrence of hepatitis C virus. Owing to the growing incidences of viral infections and especially of resistant viral strains, the available therapeutic modalities need to be improved, complemented with the discovery of novel antiviral agents to combat refractory viral infections. It is widely accepted that medicinal plant heritage is nature gifted, precious, and fueled with the valuable resources for treatment of metabolic and infectious disorders. The aims of this review are to assemble the facts and to conclude the therapeutic potential of medicinal plants in the eradication and management of various viral diseases such as influenza, human immunodeficiency virus (HIV), herpes simplex virus (HSV), hepatitis, and coxsackievirus infections, which have been proven in diverse clinical studies. The articles, published in the English language since 1982 to 2017, were included from Web of Science, Cochrane Library, AMED, CISCOM, EMBASE, MEDLINE, Scopus, and PubMed by using relevant keywords including plants possessing antiviral activity, the antiviral effects of plants, and plants used in viral disorders. The scientific literature mainly focusing on plant extracts and herbal products with therapeutic efficacies against experimental models of influenza, HIV, HSV, hepatitis, and coxsackievirus were included in the study. Pure compounds possessing antiviral activity were excluded, and plants possessing activity against viruses other than viruses in inclusion criteria were excluded. Hundreds of plant extracts with antiviral effect were recognized. However, the data from only 36 families investigated through in vitro and in vivo

  2. Herbal medicines for the treatment of otitis media with effusion: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Son, Mi Ju; Choi, Songie; Kim, Young-Eun; Kim, Yun Hee

    2016-11-24

    This systematic review aimed to assess the clinical evidence supporting the use of herbal medicines (HMs) for the treatment of otitis media with effusion (OME). Systematic review and meta-analysis. MEDLINE, EMBASE, Cochrane Library, AMED, CINAHL and three trial registries were searched up to January 2015. We also searched five Korean medical databases (KoreaMed, RISS, OASIS, DBPIA and KISS) and three Chinese databases (CNKI, Wanfang and VIP). This study included randomised clinical trials that reported the effects of HM for OME. The primary outcome was the complete resolution of OME at 2 or 3 months post randomisation. Secondary outcomes included the partial or complete resolution at all possible time points and hearing test. Three authors independently screened the titles and abstracts, selected studies and extracted the data relating to trial quality, characteristics and results. A total of 2141 potentially relevant studies were identified, of which 17 randomised clinical trials met our inclusion criteria. Most were evaluated as having a high or unclear risk of bias. Tongqiao tablets, Tongqiao huoxue decoctions and Tsumura-Saireito were associated with a lower complete or partial resolution rate when compared with conventional medicines (CMs) (p=0.02, p=0.0001, and p=0.04, respectively), and similar outcomes were observed with Huanglong tonger pills, Erzhang decoctions and Shenling baizhu powder when combined with CM versus CM alone (p<0.00001, p=0.02, and p=0.05, respectively). Tongqiao huoxue decoction plus CM appeared to be more effective than CM in terms of improving the pure tone threshold levels (p=0.0007). Tsumura-Saireito was found to affect the proportion of patients with normalised tympanometry (p=0.03). Despite some indications of potential symptom improvement, the evidence regarding the effectiveness and efficacy of HMs for OME is of poor quality and therefore inconclusive. CRD42013005430. Published by the BMJ Publishing Group Limited. For

  3. Systematic review on traditional medicinal plants used for the treatment of malaria in Ethiopia: trends and perspectives.

    Science.gov (United States)

    Alebie, Getachew; Urga, Befikadu; Worku, Amha

    2017-08-01

    Ethiopia is endowed with abundant medicinal plant resources and traditional medicinal practices. However, available research evidence on indigenous anti-malarial plants is highly fragmented in the country. The present systematic review attempted to explore, synthesize and compile ethno-medicinal research evidence on anti-malarial medicinal plants in Ethiopia. A systematic web search analysis and review was conducted on research literature pertaining to medicinal plants used for traditional malaria treatment in Ethiopia. Data were collected from a total of 82 Ethiopian studies meeting specific inclusion criteria including published research articles and unpublished thesis reports. SPSS Version 16 was used to summarize relevant ethno-botanical/medicinal information using descriptive statistics, frequency, percentage, tables, and bar graphs. A total of 200 different plant species (from 71 families) used for traditional malaria treatment were identified in different parts of Ethiopia. Distribution and usage pattern of anti-malarial plants showed substantial variability across different geographic settings. A higher diversity of anti-malarial plants was reported from western and southwestern parts of the country. Analysis of ethno-medicinal recipes indicated that mainly fresh leaves were used for preparation of remedies. Decoction, concoction and eating/chewing were found to be the most frequently employed herbal remedy preparation methods. Notably, anti-malarial herbal remedies were administered by oral route. Information on potential side effects of anti-malarial herbal preparations was patchy. However, some anti-malarial plants were reported to have potentially serious side effects using different local antidotes and some specific contra-indications. The study highlighted a rich diversity of indigenous anti-malarial medicinal plants with equally divergent herbal remedy preparation and use pattern in Ethiopia. Baseline information gaps were observed in key geographic

  4. [Treatment of vascular dementia by Chinese herbal medicine: a systematic review of randomized controlled trials of clinical studies].

    Science.gov (United States)

    Jian, Wen-Jia; Shi, Jing; Tian, Jin-Zhou; Ni, Jing-Nian

    2015-01-01

    Chinese herbal medicine has been extensively used in the treatment of vascular dementia (VaD), but lacked systematic review on its efficacy and safety. So we conducted a systematic review to assess the efficacy and safety of Chinese herbal medicine in treating VaD. CNKI, CBM, PubMed, and Wiley Online Library were retrieved for randomized trials (RCTs) on Chinese herbal medicine treating VaD patients. Randomized parallel control trials by taking Chinese herbal medicine as one treatment method and placebos/cholinesterase inhibitors/Memantine hydrochloride as the control were included. Quality rating and data extraction were performed. RevMan5.2.0 Software was used for meta-analysis. Standardized mean difference (SMD) at 95% confidence interval (CI) was used to indicate effect indicators of results. Seven RCTs met the inclusive criteria. Totally 677 VaD patients were randomly assigned to the treatment group and the control group. Descriptive analyses were performed in inclusive trials. The cognitive function was assessed in all trials. Results showed Mini-Mental state examination (MMSE) score was better in the Chinese herbal medicine group than in the placebo group, but with no significant difference when compared with the donepezil group (P > 0.05). Adverse reactions were mainly manifested as gastrointestinal symptoms such as abdominal pain in the Chinese herbal medicine group. But they occurred more in the donepezil group than in the Chinese herbal medicine group. The methodological quality of included trials was poor with less samples. Results of different trials were lack of consistency. Present evidence is not sufficient to prove or disapprove the role of Chinese herbal medicine in improving clinical symptoms and outcome indicators of VaD patients. Their clinical efficacy and safety need to be supported by more higher quality RCTs.

  5. Conflicts of Interest in Medicine. A Systematic Review of Published and Scientifically evaluated Curricula

    Directory of Open Access Journals (Sweden)

    Weißkircher, Janosch

    2017-08-01

    Full Text Available Objective: Conflicts of interests resulting from interactions with pharmaceutical companies are pervasive in medicine and can result in an undue influence on physicians’ decision-making. The objective of this systematic review is to analyze published and scientifically evaluated curricula for medical students and residents regarding such conflicts of interest. We begin by describing the covered topics and teaching methods; afterwards we analyze the quality of the curricula using the published data on their evaluations and comparing the content with content recommended for such curricula.Methods: We searched Pubmed, PsycInfo, EMBASE, OECD, WISO, SOWI and googlescholar up to and including the 5th of September 2016. Publications describing curricula for residents or medical students on the topic of conflicts of interest in medicine and evaluating them for their effects on the participants’ learning were included. We analyzed the covered topics and the teaching methods used and compared them with recommendations by the American Medical Students’ Association (AMSA and Health Action International (HAI. Results: The literature search resulted in 20 publications that fulfilled our search criteria. In five trials, a control group was used, in no trial the participants were randomized to intervention or control group. 16/20 published curricula primarily covered marketing strategies by pharmaceutical companies, especially the interaction with pharmaceutical sales representatives (PSRs. Most curricula only covered a limited number of topics recommended by AMSA/HAI. The most frequent teaching method was a group discussion, which was used in 18/20 curricula; all curricula used at least one interactive teaching method. The evaluation of the curricula was heterogeneous in results as well as design. Some publications described a change of attitudes toward a stronger skepticism regarding interactions with pharmaceutical companies. Four publications

  6. Fulfilling the promise of personalized medicine? Systematic review and field synopsis of pharmacogenetic studies.

    Directory of Open Access Journals (Sweden)

    Michael V Holmes

    2009-12-01

    , small sample sizes, a mainly candidate gene approach, surrogate markers, an excess of nominally positive to truly positive associations and paucity of meta-analyses. Recommendations based on these findings should inform future study design to help realise the goal of personalised medicines. SYSTEMATIC REVIEW REGISTRATION NUMBER: Not Registered.

  7. Fulfilling the promise of personalized medicine? Systematic review and field synopsis of pharmacogenetic studies.

    Science.gov (United States)

    Holmes, Michael V; Shah, Tina; Vickery, Christine; Smeeth, Liam; Hingorani, Aroon D; Casas, Juan P

    2009-12-02

    sample sizes, a mainly candidate gene approach, surrogate markers, an excess of nominally positive to truly positive associations and paucity of meta-analyses. Recommendations based on these findings should inform future study design to help realise the goal of personalised medicines. SYSTEMATIC REVIEW REGISTRATION NUMBER: Not Registered.

  8. Product variety, product complexity and manufacturing operational performance: A systematic literature review

    DEFF Research Database (Denmark)

    Trattner, Alexandria Lee; Hvam, Lars; Herbert-Hansen, Zaza Nadja Lee

    measures are most affected by increased variety and complexity. This study presents a systematic literature review of the recent scholarly literature on variety, complexity and manufacturing operational performance (MOP). Results show that product variety has a consistently negative relationship with MOP......Manufacturing in the twenty-first century has been wrought with the struggle to satisfy the rising demand for greater product variety and more complex products while still maintaining efficient manufacturing operations. However, the literature lacks an overview of which operational performance...

  9. Challenges of E-learning in medicine: methods and results of a systematical exploration

    Directory of Open Access Journals (Sweden)

    Spreckelsen, Cord

    2006-11-01

    Full Text Available E-learning in medicine traditionally concentrates on case oriented or problem oriented learning scenarios, the development of multimedia courseware or the implementation of simulators. This paper aims at a systematic exploration of actual and new challenges for E-learning in the medical domain. The exploration is based on the analysis of the scientific discourse in the field of Medical Education. The analysis starts from text based sources: the concept hierarchy of the Medical Subject Headings, the profiles of the relevant scientific associations, and the scientific program of scientific conferences or annual meetings. These sources are subjected to conceptual analysis, supported by network visualization tools and supplemented by network theoretic indices (Betweeness Centrality. As a result, the main concerns of the Medical Education community and their modifications during the last six years can be identified. The analysis discovers new challenges, which result from central issues of Medical Education, namely from e.g. curricular and faculty development or the sustainable integration of postgraduate education and continuing medial education. The main challenges are: 1 the implementation of integrative conceptions of the application of learning management systems (LMS and 2 the necessity of combining aspects of organizational development, knowledge management and learning management within the scope of a comprehensive learning life cycle management.

  10. Classification of Insomnia Using the Traditional Chinese Medicine System: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Maggie Man-Ki Poon

    2012-01-01

    Full Text Available A systematic review was conducted to examine traditional Chinese medicine (TCM patterns commonly diagnosed in subjects with insomnia and clinical features associated with the TCM patterns, and an insomnia symptom checklist for TCM diagnostic purpose was developed based on the review. Two independent researchers searched the China Academic Journals Full-Text Database and 10 English databases. A total of 103 studies and 9499 subjects were analyzed. There was a wide variation in terminology relating to symptomatology and TCM pattern. We identified 69 patterns, with the top 3 patterns (i.e., deficiency of both the heart and spleen, hyperactivity of fire due to yin deficiency, and liver-qi stagnation transforming into fire and the top 10 patterns covering 51.8% and 77.4% of the 9499 subjects, respectively. There were 19 sleep-related, 92 non-sleep-related, 14 tongue, and 7 pulse features included as diagnostic criteria of the top 10 TCM patterns for insomnia. Excessive dreaming, dizziness, red tongue, and fine pulse were the most common sleep-related, non-sleep-related, tongue, and pulse features. Overlapping symptomatology between the TCM patterns was present. A standardized symptom checklist consisted of 92 items, including 13 sleep-related, 61 non-sleep-related, 11 tongue, and 7 pulse items, holds promise as a diagnostic tool and merits further validation.

  11. Integrative therapies for low back pain that include complementary and alternative medicine care: a systematic review.

    Science.gov (United States)

    Kizhakkeveettil, Anupama; Rose, Kevin; Kadar, Gena E

    2014-09-01

    Systematic review of the literature. To evaluate whether an integrated approach that includes different Complementary and Alternative Medicine (CAM) therapies combined or CAM therapies combined with conventional medical care is more effective for the management of low back pain (LBP) than single modalities alone. LBP is one of the leading causes of disability worldwide, yet its optimal management is still unresolved. The PRISMA Statement guidelines were followed. The Cochrane Back Review Group scale was used to rate the quality of the studies found. Twenty-one studies were found that met the inclusion criteria. The CAM modalities used in the studies included spinal manipulative therapy, acupuncture, exercise therapy, physiotherapy, massage therapy, and a topical ointment. Twenty studies included acupuncture and/or spinal manipulative therapy. Nine high quality studies showed that integrative care was clinically effective for the management of LBP. Spinal manipulative therapy combined with exercise therapy and acupuncture combined with conventional medical care or with exercise therapy appears to be promising approaches to the management of chronic cases of LBP. There is support in the literature for integrated CAM and conventional medical therapy for the management of chronic LBP. Further research into the integrated management of LBP is clearly needed to provide better guidance for patients and clinicians.

  12. [Evidence-based medicine in surgical practice - locating clinical studies and systematic reviews by searching the Medline database].

    Science.gov (United States)

    Grummich, K; Jensen, K; Obst, O; Seiler, C M; Diener, M K

    2014-12-01

    Every day approximately 75 clinical trials and 11 systematic reviews are published in the health-care intervention and medical field. Due to this growing number of publications it is a challenge for every practicing clinician to keep track with the latest research. The implementation of new and effective diagnostic and therapeutic interventions into daily clinical routine may thus be delayed. Conversely, ineffective or even harmful interventions might still be in use. Decision-making in evidence-based medicine (EBM) requires consideration of the most recent high quality evidence. Randomised controlled trials (RCTs) are regarded as the "gold standard" to prove the efficacy of surgical interventions in patient-oriented research. Systematic reviews combine results from RCTs by summarising single RCTs which answer a particular clinical question. Some basic knowledge in systematic literature searching is required and helpful for detecting relevant publications. This article shows various possibilities for locating clinical studies and systematic reviews in the database Medline on the basis of illustrative step-by-step instructions. RESULTS AND CONCLUSION. Depending on the aim and topic of the literature search, the time required for the task may vary. In routine practice, a systematic literature search is unrealistic in most cases. Clinicians in need of a quick update of current evidence on a certain clinical topic may make use of up-to-date systematic reviews. During a systematic literature search, different approaches and strategies might be necessary. Georg Thieme Verlag KG Stuttgart · New York.

  13. A systematic methodology for design of tailor-made blended products

    DEFF Research Database (Denmark)

    Yunus, Nor Alafiza Binti; Gernaey, Krist; Woodley, John

    2014-01-01

    A systematic methodology for design of tailor-made blended products has been developed. In tailor-made blended products, one identifies the product needs and matches them by blending different chemicals. The systematic methodology has four main tasks. First, the design problem is defined: the pro......, the methodology is highlighted through two case studies involving gasoline blends and lubricant base oils....

  14. Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.

    Science.gov (United States)

    Goedecke, Thomas; Morales, Daniel R; Pacurariu, Alexandra; Kurz, Xavier

    2018-03-01

    Evaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research. We searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non-European Union regulatory actions to safeguard public health published until March 2017. References from systematic reviews and articles from other known sources were added. Regulatory interventions, data sources, outcomes of interest, methodology and key findings were extracted. From 1246 screened articles, 229 were eligible for full-text review and 153 articles in English language were included in the descriptive analysis. Over a third of articles studied analgesics and antidepressants. Interventions most frequently evaluated are regulatory safety communications (28.8%), black box warnings (23.5%) and direct healthcare professional communications (10.5%); 55% of studies measured changes in drug utilization patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour or changes in clinical practice. Unintended consequences like switching therapies or spill-over effects were rarely evaluated. Two-thirds used before-after time series and 15.7% before-after cross-sectional study designs. Various analytical approaches were applied including interrupted time series regression (31.4%), simple descriptive analysis (28.8%) and descriptive analysis with significance tests (23.5%). Whilst impact evaluation of pharmacovigilance and product-specific regulatory interventions is increasing, the marked heterogeneity in study conduct and reporting highlights the need for scientific guidance to ensure robust methodologies are applied and systematic dissemination of results occurs. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of

  15. Consumer-oriented interventions for evidence-based prescribing and medicines use: an overview of systematic reviews.

    Science.gov (United States)

    Ryan, Rebecca; Santesso, Nancy; Hill, Sophie; Lowe, Dianne; Kaufman, Caroline; Grimshaw, Jeremy

    2011-05-11

    Numerous systematic reviews exist on interventions to improve consumers' medicines use, but this research is distributed across diseases, populations and settings. The scope and focus of reviews on consumers' medicines use also varies widely. Such differences create challenges for decision makers seeking review-level evidence to inform decisions about medicines use. To synthesise the evidence from systematic reviews on the effects of interventions which target healthcare consumers to promote evidence-based prescribing for, and medicines use, by consumers. We sought evidence on the effects on health and other outcomes for healthcare consumers, professionals and services. We included systematic reviews published on the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. We identified relevant reviews by handsearching both databases from start date to Issue 3 2008. We screened and ranked reviews based on relevance to consumers' medicines use, using criteria developed for this overview. Standardised forms were used to extract data, and reviews were assessed for methodological quality using the AMSTAR instrument. We used standardised language to summarise results within and across reviews; and a further synthesis step was used to give bottom-line statements about intervention effectiveness. Two review authors selected reviews, extracted and analysed data. We used a taxonomy of interventions to categorise reviews. We included 37 reviews (18 Cochrane, 19 non-Cochrane), of varied methodological quality.Reviews assessed interventions with diverse aims including support for behaviour change, risk minimisation, skills acquisition and information provision. No reviews aimed to promote systems-level consumer participation in medicines-related activities. Medicines adherence was the most commonly reported outcome, but others such as clinical (health and wellbeing), service use and knowledge outcomes were also reported. Reviews rarely

  16. Product-related Environmental Performance Indicators: a systematic literature review

    DEFF Research Database (Denmark)

    Issa, Isabela I.; Pigosso, Daniela Cristina Antelmi; McAloone, Tim C.

    2013-01-01

    structured approach to support EPIs selection is still lacking. This paper presents the efforts made in order to identify, classify and systematize the existing EPIs based on the systematic literature review. From the review, 261 EPIs were identified, classified, and then systematized in a digital database...

  17. Stable Isotope Systematics of Coalbed Gas during Desorption and Production

    Directory of Open Access Journals (Sweden)

    Martin Niemann

    2017-06-01

    Full Text Available The stable carbon isotope ratios of coalbed methane (CBM demonstrate diagnostic changes that systematically vary with production and desorption times. These shifts can provide decisive, predictive information on the behaviour and potential performance of CBM operations. Samples from producing CBM wells show a general depletion in 13C-methane with increasing production times and corresponding shifts in δ13C-CH4 up to 35.8‰. Samples from canister desorption experiments show mostly enrichment in 13C for methane with increasing desorption time and isotope shifts of up to 43.4‰. Also, 13C-depletion was observed in some samples with isotope shifts of up to 32.1‰. Overall, the magnitudes of the observed isotope shifts vary considerably between different sample sets, but also within samples from the same source. The δ13C-CH4 values do not have the anticipated signature of methane generated from coal. This indicates that secondary processes, including desorption and diffusion, can influence the values. It is also challenging to deconvolute these various secondary processes because their molecular and isotope effects can have similar directions and/or magnitudes. In some instances, significant alteration of CBM gases has to be considered as a combination of secondary alteration effects.

  18. Combatting Falsification and Counterfeiting Of Medicinal Products in the European Union

    DEFF Research Database (Denmark)

    Kohli, Vishv Priya

    The study of counterfeiting and falsification of medicinal products, from a legal perspective, is a relatively new area in the EU. Specific regulations that focus on falsification of medicines came as recently as 2011. Therefore, this discipline is also new for research. There are two primary obj...

  19. Training needs for chemists in nuclear medicine research and production

    International Nuclear Information System (INIS)

    Welch, M.J.

    1993-01-01

    The field Nuclear Medicine has expanded rapidly over the last two decades. Individuals with training in radiochemistry are needed in industry, medical centers and hospitals. Although basic training in organic chemistry, inorganic chemistry, biochemistry or pharmacy are required, radiochemistry knowledge is essential for all these individuals. Opportunities and training requirements in these areas will be discussed. (author) 7 refs.; 5 tabs

  20. The biosynthetic products of chinese insect medicine, Aspongopus chinensis

    Science.gov (United States)

    Luo, Xiao-Hong; Wang, Xiao-Zheng; Jiang, Hai-Long; Yang, Jun-Li; Crews, Phillip; Valeriote, Frederick A.; Wu, Quan-Xiang

    2012-01-01

    A new oxazole (1) was obtained from chinese insect medicine Aspongopus chinensis, along with three known N-acetyldopamine derivatives (2–4). Their structures were determined on the basis of NMR and ESI-MS analyses. The possible biosynthetic pathways of the isolated compounds are discussed. Cytotoxicities of those compounds against 10 selected cancer cells were measured in vitro. PMID:22430116

  1. Prehospital Blood Product Resuscitation for Trauma: A Systematic Review

    Science.gov (United States)

    Smith, Iain M.; James, Robert H.; Dretzke, Janine; Midwinter, Mark J.

    2016-01-01

    ABSTRACT Introduction: Administration of high ratios of plasma to packed red blood cells is a routine practice for in-hospital trauma resuscitation. Military and civilian emergency teams are increasingly carrying prehospital blood products (PHBP) for trauma resuscitation. This study systematically reviewed the clinical literature to determine the extent to which the available evidence supports this practice. Methods: Bibliographic databases and other sources were searched to July 2015 using keywords and index terms related to the intervention, setting, and condition. Standard systematic review methodology aimed at minimizing bias was used for study selection, data extraction, and quality assessment (protocol registration PROSPERO: CRD42014013794). Synthesis was mainly narrative with random effects model meta-analysis limited to mortality outcomes. Results: No prospective comparative or randomized studies were identified. Sixteen case series and 11 comparative studies were included in the review. Seven studies included mixed populations of trauma and non-trauma patients. Twenty-five of 27 studies provided only very low quality evidence. No association between PHBP and survival was found (OR for mortality: 1.29, 95% CI: 0.84–1.96, P = 0.24). A single study showed improved survival in the first 24 h. No consistent physiological or biochemical benefit was identified, nor was there evidence of reduced in-hospital transfusion requirements. Transfusion reactions were rare, suggesting the short-term safety of PHBP administration. Conclusions: While PHBP resuscitation appears logical, the clinical literature is limited, provides only poor quality evidence, and does not demonstrate improved outcomes. No conclusions as to efficacy can be drawn. The results of randomized controlled trials are awaited. PMID:26825635

  2. Huangqi injection (a traditional Chinese patent medicine for chronic heart failure: a systematic review.

    Directory of Open Access Journals (Sweden)

    Shufei Fu

    2011-05-01

    Full Text Available Chronic heart failure (CHF is a global public health problem. Therefore, novel and effective drugs that show few side-effects are needed. Early literature studies indicated that Huangqi injection is one of the most commonly used traditional Chinese patent medicines for CHF in China. As a large number of clinical studies has been carried out and published, it is essential to evaluate the effectiveness and safety of Huangqi injection. Therefore, we carried out this systematic review under the support of the framework of the Joint Sino-Italian Laboratory (JoSIL.To evaluate the efficacy and safety of Huangqi injection for CHF according to the available scientific knowledge.An extensive search including PubMed, EMBASE, CBM, the Cochrane Library and Chinese literature databases was performed up to July 2008. Clinical trials regarding Huangqi injection for the treatment of CHF were searched for, irrespective of languages. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration and STATA 9.2 were used for data analysis.After selection of 1,205 articles, 62 RCTs and quasi-RCTs conducted in China and published in Chinese journals were included in the review. The methodological quality of the trials was low. In most trials inclusion and exclusion criteria were not specified. Furthermore, only one study evaluated the outcomes for drug efficacy after an adequate period of time. For these reasons and because of the different baseline characteristics we did not conduct a meta-analysis.Although available studies are not adequate to draw a conclusion on the efficacy and safety of Huangqi injection (a traditional Chinese patent medicine, we hope that our work could provide useful experience on further studies on Huangqi injections. The overall level of TCM clinical research needs to be improved so that the efficacy of TCM can be evaluated by the international community and

  3. Introducing malaria rapid diagnostic tests in private medicine retail outlets: A systematic literature review.

    Science.gov (United States)

    Visser, Theodoor; Bruxvoort, Katia; Maloney, Kathleen; Leslie, Toby; Barat, Lawrence M; Allan, Richard; Ansah, Evelyn K; Anyanti, Jennifer; Boulton, Ian; Clarke, Siân E; Cohen, Jessica L; Cohen, Justin M; Cutherell, Andrea; Dolkart, Caitlin; Eves, Katie; Fink, Günther; Goodman, Catherine; Hutchinson, Eleanor; Lal, Sham; Mbonye, Anthony; Onwujekwe, Obinna; Petty, Nora; Pontarollo, Julie; Poyer, Stephen; Schellenberg, David; Streat, Elizabeth; Ward, Abigail; Wiseman, Virginia; Whitty, Christopher J M; Yeung, Shunmay; Cunningham, Jane; Chandler, Clare I R

    2017-01-01

    Many patients with malaria-like symptoms seek treatment in private medicine retail outlets (PMR) that distribute malaria medicines but do not traditionally provide diagnostic services, potentially leading to overtreatment with antimalarial drugs. To achieve universal access to prompt parasite-based diagnosis, many malaria-endemic countries are considering scaling up malaria rapid diagnostic tests (RDTs) in these outlets, an intervention that may require legislative changes and major investments in supporting programs and infrastructures. This review identifies studies that introduced malaria RDTs in PMRs and examines study outcomes and success factors to inform scale up decisions. Published and unpublished studies that introduced malaria RDTs in PMRs were systematically identified and reviewed. Literature published before November 2016 was searched in six electronic databases, and unpublished studies were identified through personal contacts and stakeholder meetings. Outcomes were extracted from publications or provided by principal investigators. Six published and six unpublished studies were found. Most studies took place in sub-Saharan Africa and were small-scale pilots of RDT introduction in drug shops or pharmacies. None of the studies assessed large-scale implementation in PMRs. RDT uptake varied widely from 8%-100%. Provision of artemisinin-based combination therapy (ACT) for patients testing positive ranged from 30%-99%, and was more than 85% in five studies. Of those testing negative, provision of antimalarials varied from 2%-83% and was less than 20% in eight studies. Longer provider training, lower RDT retail prices and frequent supervision appeared to have a positive effect on RDT uptake and provider adherence to test results. Performance of RDTs by PMR vendors was generally good, but disposal of medical waste and referral of patients to public facilities were common challenges. Expanding services of PMRs to include malaria diagnostic services may hold

  4. Introducing malaria rapid diagnostic tests in private medicine retail outlets: A systematic literature review.

    Directory of Open Access Journals (Sweden)

    Theodoor Visser

    Full Text Available Many patients with malaria-like symptoms seek treatment in private medicine retail outlets (PMR that distribute malaria medicines but do not traditionally provide diagnostic services, potentially leading to overtreatment with antimalarial drugs. To achieve universal access to prompt parasite-based diagnosis, many malaria-endemic countries are considering scaling up malaria rapid diagnostic tests (RDTs in these outlets, an intervention that may require legislative changes and major investments in supporting programs and infrastructures. This review identifies studies that introduced malaria RDTs in PMRs and examines study outcomes and success factors to inform scale up decisions.Published and unpublished studies that introduced malaria RDTs in PMRs were systematically identified and reviewed. Literature published before November 2016 was searched in six electronic databases, and unpublished studies were identified through personal contacts and stakeholder meetings. Outcomes were extracted from publications or provided by principal investigators.Six published and six unpublished studies were found. Most studies took place in sub-Saharan Africa and were small-scale pilots of RDT introduction in drug shops or pharmacies. None of the studies assessed large-scale implementation in PMRs. RDT uptake varied widely from 8%-100%. Provision of artemisinin-based combination therapy (ACT for patients testing positive ranged from 30%-99%, and was more than 85% in five studies. Of those testing negative, provision of antimalarials varied from 2%-83% and was less than 20% in eight studies. Longer provider training, lower RDT retail prices and frequent supervision appeared to have a positive effect on RDT uptake and provider adherence to test results. Performance of RDTs by PMR vendors was generally good, but disposal of medical waste and referral of patients to public facilities were common challenges.Expanding services of PMRs to include malaria diagnostic

  5. Undergraduate curricula in palliative medicine: a systematic analysis based on the palliative education assessment tool.

    LENUS (Irish Health Repository)

    Schiessi, C

    2013-01-01

    By law in 2013, palliative medicine will be integrated into the undergraduate curriculum as part of a mandatory training program and examinations at German medical schools. For this reason a national curriculum in palliative medicine has to be developed.

  6. Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

    Directory of Open Access Journals (Sweden)

    Janis eAncans

    2012-08-01

    Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

  7. Integrative medicine for managing the symptoms of lupus nephritis: A protocol for systematic review and meta-analysis.

    Science.gov (United States)

    Choi, Tae-Young; Jun, Ji Hee; Lee, Myeong Soo

    2018-03-01

    Integrative medicine is claimed to improve symptoms of lupus nephritis. No systematic reviews have been performed for the application of integrative medicine for lupus nephritis on patients with systemic lupus erythematosus (SLE). Thus, this review will aim to evaluate the current evidence on the efficacy of integrative medicine for the management of lupus nephritis in patients with SLE. The following electronic databases will be searched for studies published from their dates of inception February 2018: Medline, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), as well as 6 Korean medical databases (Korea Med, the Oriental Medicine Advanced Search Integrated System [OASIS], DBpia, the Korean Medical Database [KM base], the Research Information Service System [RISS], and the Korean Studies Information Services System [KISS]), and 1 Chinese medical database (the China National Knowledge Infrastructure [CNKI]). Study selection, data extraction, and assessment will be performed independently by 2 researchers. The risk of bias (ROB) will be assessed using the Cochrane ROB tool. This systematic review will be published in a peer-reviewed journal and disseminated both electronically and in print. The review will be updated to inform and guide healthcare practice and policy. PROSPERO 2018 CRD42018085205.

  8. Production and radioiodination of monoclonal antibodies and its applications in nuclear medicine

    International Nuclear Information System (INIS)

    Toledo e Souza, I.T. de; Okada, H.

    1988-12-01

    The basis of the monoclonal antibody production methodology, some immunological concepts which are important for the understanding of what is a Monoclonal Antibody, its radioiodination and acceptance as receptor-specific radiopharmaceuticals in nuclear medicine are reviewed. (author) [pt

  9. Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydopyrrolizidine alkaloids and aristolochic acid

    Science.gov (United States)

    In many countries, including the United States, herbal supplements, tisanes and vegetable products including traditional Chinese medicines are largely unregulated and their content is not registered, monitored or verified. Consequently potent plant toxins including dehydopyrrolizidine alkaloids and...

  10. Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydropyrrolizidine alkaloids and aristolochic acid

    Science.gov (United States)

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids ...

  11. A systematic review on barriers, facilities, knowledge and attitude toward evidence-based medicine in Iran

    Directory of Open Access Journals (Sweden)

    Morteza Ghojazadeh

    2015-03-01

    Full Text Available Introduction: Evidence-based medicine (EBM is the ability and skill in using and integration of the best up-to-date evidences. The aim of this study was a systematic review of barriers, facilities, knowledge and attitude of EBM in Iran. Methods: In this study, database and manual search was used with keywords such as, "evidence-based, EBM, evidence-based nursing, evidence-based practice, evidence-based care, evidence-based activities, evidence-based education" and their combination with the keywords of the barrier, facilitator, attitude, awareness, prospective, knowledge, practice and Iran. The databases of SID (Scientific information database, Magiran, MEDLIB, PubMed, Google scholar, IranMedex and CINAHL (Cumulative index to nursing and allied health literature were used for data collection. Results: Finally, 28 papers were included in this study. The lack of facilities, time and skill in research methodology were the most important barriers to EBM. The most and least important factors were orderly creating ample opportunity and detecting needs and problems. The degree of familiarity with the terminology of evidence-based performance was low (44.2%. The textbooks have been considered as the most significant source of obtaining information. The level of awareness, knowledge, and evidence-based performance was less than 50.0%. Conclusion: There are many various barriers in use of EBM and healthcare providers despite the positive attitude toward EBM had a low level knowledge in EBM setting. Consideration of the importance of EBM proper planning and effective intervention are necessary to removing the barriers and increase the knowledge of healthcare providers.

  12. Pharmacy led medicine reconciliation at hospital: A systematic review of effects and costs.

    Science.gov (United States)

    Hammad, Eman A; Bale, Amanda; Wright, David J; Bhattacharya, Debi

    Transition of patients care between settings presents an increased opportunity for errors and preventable morbidity. A number of studies outlined that pharmacy-led medicine reconciliation (MR) might facilitate safer information transfer and medication use. MR practice is not well standardized and often delivered in combination with other health care activities. The question regarding the effects and costs of pharmacy-led MR and the optimum MR practice is warranted of value. To review the evidence for the effects and costs/cost-effectiveness of complete pharmacy-led MR in hospital settings. A systematic review searching the following database was conducted up to the 13th December 2015; EMBASE & MEDLINE Ovid, CINAHL and the Cochrane library. Studies evaluating pharmacy-led MR performed fully from admission till discharges were included. Studies evaluated non-pharmacy-led MR at only one end of patient care or transfer was not included. Articles were screened and extracted independently by two investigators. Studies were divided into those in which: MR was the primary element of the intervention and labeled as "primarily MR" studies, or MR combined with non-MR care activities and labeled as "supplemented MR" studies. Quality assessment of studies was performed by independent reviewers using a pre-defined and validated tool. The literature search identified 4065 citations, of which 13 implemented complete MR. The lack of evidence precluded addressing the effects and costs of MR. The composite of optimum MR practice is not widely standardized and requires discussion among health professions and key organizations. Research focused on evaluating cost-effectiveness of pharmacy-led MR is lacking. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. General sale of non-prescription medicinal products

    DEFF Research Database (Denmark)

    Lind, Johanna Lena Maria; Schafheutle, Ellen; Hägg, Annika Nordén

    2016-01-01

    BACKGROUND: The number of non-prescription medicines (NPMs) available for self-medication is increasing within the European Union (EU). This can enhance the autonomy of individuals but is also connected with risks. Under an existing EU Directive, Sweden has only recently deregulated and made NPMs...... available in non-pharmacy outlets; The United Kingdom (UK) is a more established NPM market; both are guided by the same EU directives. OBJECTIVE: The aim of this study was to compare specific requirements under the legislation, rationales and outcomes regarding the sale of NPMs through non-pharmacy outlets...... between Sweden and the UK. METHOD: The main method was analysis of legislative text and policy documents, conducted in 2012. RESULTS: Both countries had specified medicines available to the public in non-pharmacy outlets, but with restrictions on different factors, e.g. placement and package size...

  14. Regulatory structures for gene therapy medicinal products in the European Union.

    Science.gov (United States)

    Klug, Bettina; Celis, Patrick; Carr, Melanie; Reinhardt, Jens

    2012-01-01

    Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. The majority of gene or cell therapy product development is carried out by academia, hospitals, and small- and medium-sized enterprises (SMEs). Thus, acknowledging the particular needs of these types of sponsors, the legislation also provides incentives for product development tailored to them. The European Medicines Agency (EMA) and, in particular, its Committee for Advanced Therapies (CAT) provide a variety of opportunities for early interaction with developers of ATMPs to enable them to have early regulatory and scientific input. An important tool to promote innovation and the development of new medicinal products by micro-, small-, and medium-sized enterprises is the EMA's SME initiative launched in December 2005 to offer financial and administrative assistance to smaller companies. The European legislation also foresees the involvement of stakeholders, such as patient organizations, in the development of new medicines. Considering that gene therapy medicinal products are developed in many cases for treatment of rare diseases often of monogenic origin, the involvement of patient organizations, which focus on rare diseases and genetic and congenital disorders, is fruitful. Two such organizations are represented in the CAT. Research networks play another important role in the development of gene therapy medicinal products. The European Commission is funding such networks through the EU Sixth Framework Program. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Effects and treatment methods of acupuncture and herbal medicine for premenstrual syndrome/premenstrual dysphoric disorder: systematic review

    Science.gov (United States)

    2014-01-01

    Background During their reproductive years about 10% of women experience some kind of symptoms before menstruation (PMS) in a degree that affects their quality of life (QOL). Acupuncture and herbal medicine has been a recent favorable therapeutic approach. Thus we aimed to review the effects of acupuncture and herbal medicine in the past decade as a preceding research in order to further investigate the most effective Korean Medicine treatment for PMS/PMDD. Methods A systematic literature search was conducted using electronic databases on studies published between 2002 and 2012. Our review included randomized controlled clinical trials (RCTs) of acupuncture and herbal medicine for PMS/PMDD. Interventions include acupuncture or herbal medicine. Clinical information including statistical tests was extracted from the articles and summarized in tabular form or in the text. Study outcomes were presented as the rate of improvement (%) and/or end-of-treatment scores. Results The search yielded 19 studies. In screening the RCTs, 8 studies in acupuncture and 11 studies in herbal medicine that matched the criteria were identified. Different acupuncture techniques including traditional acupuncture, hand acupuncture and moxibustion, and traditional acupuncture technique with auricular points, have been selected for analysis. In herbal medicine, studies on Vitex Agnus castus, Hypericum perforatum, Xiao yao san, Elsholtzia splendens, Cirsium japonicum, and Gingko biloba L. were identified. Experimental groups with Acupuncture and herbal medicine treatment (all herbal medicine except Cirsium japonicum) had significantly improved results regarding PMS/PMDD. Conclusions Limited evidence supports the efficacy of alternative medicinal interventions such as acupuncture and herbal medicine in controlling premenstrual syndrome and premenstrual dysphoric disorder. Acupuncture and herbal medicine treatments for premenstrual syndrome and premenstrual dysphoric disorder showed a 50% or

  16. 21st century natural product research and drug development and traditional medicines.

    Science.gov (United States)

    Ngo, Linh T; Okogun, Joseph I; Folk, William R

    2013-04-01

    Natural products and related structures are essential sources of new pharmaceuticals, because of the immense variety of functionally relevant secondary metabolites of microbial and plant species. Furthermore, the development of powerful analytical tools based upon genomics, proteomics, metabolomics, bioinformatics and other 21st century technologies are greatly expediting identification and characterization of these natural products. Here we discuss the synergistic and reciprocal benefits of linking these 'omics technologies with robust ethnobotanical and ethnomedical studies of traditional medicines, to provide critically needed improved medicines and treatments that are inexpensive, accessible, safe and reliable. However, careless application of modern technologies can challenge traditional knowledge and biodiversity that are the foundation of traditional medicines. To address such challenges while fulfilling the need for improved (and new) medicines, we encourage the development of Regional Centres of 'omics Technologies functionally linked with Regional Centres of Genetic Resources, especially in regions of the world where use of traditional medicines is prevalent and essential for health.

  17. Leadership mentoring in nursing research, career development and scholarly productivity: A systematic review.

    Science.gov (United States)

    Hafsteinsdóttir, Thóra B; van der Zwaag, Angeli M; Schuurmans, Marieke J

    2017-10-01

    Although nursing has been an academic discipline for decades, the infrastructure for nursing research in many countries is still fragile and struggling. Postdoctoral nurses have difficulties developing sustaining careers in nursing research due to lack of career opportunities. Considerable research has been conducted on leadership and mentoring in various areas of nursing. We aimed to systematically review the literature investigating leadership programs and mentoring for postdoctoral nurse researchers, as well as the influence of leadership and mentoring on research productivity, research career development, leadership knowledge and skills, the nurses' health and well-being, staff relationships, work culture and collaboration, salaries and postdoctoral nurses' experiences. A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was conducted. The electronic databases PubMed, CINAHL and EMBASE were searched without time limits for eligible studies up to January 2016. Reference lists of included articles were also searched manually and authors were contacted to inquire about other relevant papers. Two authors independently assessed eligibility of studies for inclusion. Titles and abstracts were matched with the inclusion criteria: studies investigating leadership and mentoring programs for postdoctoral nurses and leadership and mentoring influencing research productivity, and career development; and leadership knowledge and skills and other outcomes. The quality of the studies was appraised using the Centre for Evidence-Based Medicine for surveys, the Critical Appraisal Skill Program Qualitative Appraisal Checklist for qualitative studies, and a critical appraisal list for mixed methods studies. Any disagreements were resolved by consensus. Data were extracted by two reviewers. We screened 1775 titles and abstracts, resulting in 15 studies, which included quantitative, descriptive, qualitative and mixed

  18. Proposal for new European pharmaceutical legislation to permit access to custom-made anti-sense oligonucleotide medicinal products.

    Science.gov (United States)

    Johnston, John D; Feldschreiber, Peter

    2014-06-01

    Current European pharmaceutical legislation is not adequate to meet advances in science and technologies that will lead to rapid development of custom-made medicines. Using existing legislation for custom-made medical devices as a template and anti-sense oligonucleotides as model medicinal products, we propose new European pharmaceutical legislation to permit timely access to custom-made anti-sense oligonucleotide medicinal products. The proposals may be more widely applicable to other medicinal products. © 2013 The British Pharmacological Society.

  19. Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites' marketing of stem cell therapies.

    Science.gov (United States)

    Murdoch, Blake; Zarzeczny, Amy; Caulfield, Timothy

    2018-02-28

    To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market. Systematic website analysis. Global. US and English-language bias due to methodology. Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits). 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of

  20. Human resource development contributes to the creation of outstanding regenerative medicine products

    Directory of Open Access Journals (Sweden)

    Fusako Nishigaki

    2017-12-01

    Full Text Available Regenerative medicine is currently the focus of global attention. Countries all around the world are actively working to create new regenerative treatment modalities through pioneering research and novel technologies. This is wonderful news for patients who could not be treated with existing medical options. New venture businesses and companies are being established in regenerative medicine and their rapid industrialization is anticipated. However, to ensure high-quality products, human resources qualified in research and development and the manufacturing of these products are essential. The Forum for Innovative Regenerative Medicine (FIRM conducted a questionnaire of its industry members to examine the training and hiring of people in research and development, product creation, manufacturing, and more. Regenerative medicine is a brand new field; thus, many different businesses will need to cooperate together. People with a broad range of technical skills, abilities, and knowledge will be in demand, with various levels of expertise, from basic to advanced.

  1. Bar-HRM for Authentication of Plant-Based Medicines: Evaluation of Three Medicinal Products Derived from Acanthaceae Species.

    Science.gov (United States)

    Osathanunkul, Maslin; Madesis, Panagiotis; de Boer, Hugo

    2015-01-01

    Medicinal plants are used as a popular alternative to synthetic drugs, both in developed and developing countries. The economic importance of the herbal and natural supplement industry is increasing every year. As the herbal industry grows, consumer safety is one issue that cannot be overlooked. Herbal products in Thai local markets are commonly sold without packaging or labels. Plant powders are stored in large bags or boxes, and therefore buying local herbal products poses a high risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. Here DNA barcoding was used in combination with High Resolution Melting analysis (Bar-HRM) to authenticate three medicinal Acanthaceae species (Acanthus ebracteatus, Andrographis paniculata and Rhinacanthus nasutus) commonly used in Thailand. The rbcL barcode was selected for use in primers design for HRM analysis to produce standard melting profiles of the selected species. Melting data from the HRM assay using the designed rbcL primers showed that the three chosen species could be distinguished from each other. HRM curves of all fifteen test samples indicated that three of tested products did not contain the indicated species. Two closely related species (A. paniculata and R. nasutus), which have a high level of morphological similarity, were interchanged with one another in three tested products. Incorrect information on packaging and labels of the tested herbal products was the cause of the results shown here. Morphological similarity among the species of interest also hindered the collection process. The Bar-HRM method developed here proved useful in aiding in the identification and authentication of herbal species in processed samples. In the future, species authentication through Bar-HRM could be used to promote consumer trust, as well as raising the quality of herbal products.

  2. Teaching-skills training programs for family medicine residents: systematic review of formats, content, and effects of existing programs.

    Science.gov (United States)

    Lacasse, Miriam; Ratnapalan, Savithiri

    2009-09-01

    To review the literature on teaching-skills training programs for family medicine residents and to identify formats and content of these programs and their effects. Ovid MEDLINE (1950 to mid-July 2008) and the Education Resources Information Center database (pre-1966 to mid-July 2008) were searched using and combining the MeSH terms teaching, internship and residency, and family practice; and teaching, graduate medical education, and family practice. The initial MEDLINE and Education Resources Information Center database searches identified 362 and 33 references, respectively. Titles and abstracts were reviewed and studies were included if they described the format or content of a teaching-skills program or if they were primary studies of the effects of a teaching-skills program for family medicine residents or family medicine and other specialty trainees. The bibliographies of those articles were reviewed for unidentified studies. A total of 8 articles were identified for systematic review. Selection was limited to articles published in English. Teaching-skills training programs for family medicine residents vary from half-day curricula to a few months of training. Their content includes leadership skills, effective clinical teaching skills, technical teaching skills, as well as feedback and evaluation skills. Evaluations mainly assessed the programs' effects on teaching behaviour, which was generally found to improve following participation in the programs. Evaluations of learner reactions and learning outcomes also suggested that the programs have positive effects. Family medicine residency training programs differ from all other residency training programs in their shorter duration, usually 2 years, and the broader scope of learning within those 2 years. Few studies on teaching-skills training, however, were designed specifically for family medicine residents. Further studies assessing the effects of teaching-skills training in family medicine residents are

  3. Measuring medicine-related experiences from the patient perspective: a systematic review.

    Science.gov (United States)

    Katusiime, Barbra; Corlett, Sarah; Reeve, Joanne; Krska, Janet

    2016-01-01

    There is an increasing drive to measure and so improve patients' experiences and outcomes of health care. This also applies to medicines, given their ubiquity as health care interventions. Patients' experiences of using medicines vary, and instruments which measure these are seen as an essential component to improve care. We aimed to identify generic measures of patients' experiences of using prescription medicines and to examine their properties and suitability for use in research or practice. Multiple electronic databases were searched: MEDLINE, Embase, PsycINFO, PsycARTICLES, CINHAL Plus, PROQOLID ® , and Google Scholar. We identified, critically appraised, and summarized generic questionnaires assessing one or more aspects of the medicine use experience among adult patients using prescription medicines for chronic conditions, and the process of questionnaire development, degree of patient involvement, and/or validation processes. Fifteen questionnaires were included. Of these, nine measures were multidimensional, covering various aspects of medicine use. Six instruments covered only a single domain, assessing a specific facet of using medicines. Domains covered were the following: effectiveness; convenience, practicalities, and/or managing medicines; information, knowledge, and/or understanding; side effects; relationships and/or communication with health professionals; impact on daily living and/or social life; general satisfaction; attitudes; beliefs, concerns, and/or perceptions; medical follow-up and/or adherence-related issues; treatment- and/or medicine-related burden, perceived control, or autonomy; self-confidence about medicine use; availability and accessibility; and medicine-related quality of life. None of the identified questionnaires covered all domains. Instruments varied in the extent of patient involvement in both their development and validation. There is a scarcity of psychometrically sound, comprehensive, and generic measures of experiences

  4. Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

    Science.gov (United States)

    Beall, Reed F; Nickerson, Jason W; Kaplan, Warren A; Attaran, Amir

    2016-01-01

    Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration's Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product's device patents and medicine patents. Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3-15.2 years). Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes "evergreening" depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic

  5. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs.

    LENUS (Irish Health Repository)

    Dunne, Suzanne S

    2015-07-01

    Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient\\/consumer perspectives of generic medicines.

  6. Natural Fostering in Fritillaria cirrhosa: Integrating herbal medicine production with biodiversity conservation

    Directory of Open Access Journals (Sweden)

    Xiwen Li

    2012-02-01

    Full Text Available Protected areas are generally regarded as a power tool to conserve biodiversity. Nonetheless, few protected areas could address three crucial problems simultaneously, namely funding, public participation and rural living. Here, we introduced a new protective approach, Natural Fostering, which integrated herbal medicine production with community conservation. The principles of Natural Fostering adopted species–species interaction at community level. Most effective chemical components of herbal medicine are derived from such interaction. Fritillaria cirrhosa was selected as an economic botany, one of herbal medicines, to carry out Natural Fostering. Community habitats, herbal medicine production, funding and income of local family were investigated to verify the feasibility of Natural Fostering for biodiversity. We found the density of plant populations and the annual average personal income of rural people increased. F. cirrhosa production could provide sufficient funds for sustainable conservation. Local people gradually changed their life style of wild collection and overgrazing, instead of herbal medicine production. The fostering area set up a good sustainable economic cycle. Natural Fostering can be presented as an effective and pragmatic way to conserve biological diversity and sustainable utilization of traditional medicinal resources.

  7. Definition of Health 2.0 and Medicine 2.0 : A systematic review

    NARCIS (Netherlands)

    Sivera Berben; T. van de Belt; Lisette Schoonhoven; L. Engelen

    2010-01-01

    During the last decade, the Internet has become increasingly popular and is now an important part of our daily life. When new "Web 2.0" technologies are used in health care, the terms "Health 2.0" or "Medicine 2.0" may be used. The objective was to identify unique definitions of Health 2.0/Medicine

  8. Manual therapy with or without physical medicine modalities for neck pain: a systematic review

    NARCIS (Netherlands)

    D'Sylva, Jonathan; Miller, Jordan; Gross, Anita; Burnie, Stephen J.; Goldsmith, Charles H.; Graham, Nadine; Haines, Ted; Brønfort, Gert; Hoving, Jan L.

    2010-01-01

    Manual therapy interventions are often used with or without physical medicine modalities to treat neck pain. This review assessed the effect of 1) manipulation and mobilisation, 2) manipulation, mobilisation and soft tissue work, and 3) manual therapy with physical medicine modalities on pain,

  9. [Risk-benefit evaluation of medicinal products. An element of Health Technology Assessment].

    Science.gov (United States)

    Hart, D

    2005-02-01

    This paper aims to further develop and specify the method and the process of risk-benefit evaluation for determining the safety of medicinal products in national and European pharmaceutical law. The term "safety" (Unbedenklichkeit=the relationship between efficacy and harmfulness) is one of the central categories of national and European pharmaceutical law. The guaranteeing of the safety of pharmaceuticals is not a static but a dynamic and process oriented objective. It aims to preserve what has been approved on the one hand, and to increase the standard of safety by innovation on the other. A medicinal product is only found to be safe if the result of the risk-benefit evaluation is a positive risk-benefit balance. Safety must be guaranteed permanently through the entire lifecycle of the medicinal product. One must differentiate between absolute safety, which is related to the individual product, and relative safety, which is related to already available medicinal products of the same indication. The process of risk-benefit evaluation is determined by the indication of the medicinal product. The different types of medicinal products or their different mechanisms of action require different risk-benefit evaluations. The established, estimated and evaluated benefit has to be compared with the established, estimated and evaluated risks of the medicinal product. The comparative risk-benefit evaluation requires a procedural optimisation of benefits as well as minimisation of risks and a reciprocal optimisation of both requirements. If the comparison of the benefits and risks of the product results in a negative risk-benefit balance, the product is rated absolutely unsafe. The product is relatively unsafe if its standard of safety is lower than that of already available pharmaceuticals of the same indication and the existing safety gap (increased benefit or lesser risks) is deemed considerable. Differences in benefit and/or differences in risk between the medicinal

  10. Ethical responsibilities of pharmacists when selling complementary medicines: a systematic review.

    Science.gov (United States)

    Salman Popattia, Amber; Winch, Sarah; La Caze, Adam

    2018-04-01

    The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines. International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists' practices or perceptions, consumers' expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists' responsibilities in selling complementary medicines were included in the review. Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict. There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines. © 2018 Royal Pharmaceutical Society.

  11. [Publish or perish: the scientific productivity of academics in the field of occupational medicine].

    Science.gov (United States)

    Franco, G

    2009-01-01

    A new Italian law aiming at improving and supporting research productivity establishes that evaluation of academic products is a requisite for accessing research funds,for acting as examiner for recruitments and for individual financial benefits. To analyse the scientific products of full professors of Occupational Medicine in Italian Universities in order to provide a framework for discussing a standard of productivity with objective metric parameters. Research products of the 40 full professors of Occupational Medicine indexed in the National Library of Medicine PubMed database were identified. By means of l0 different indicators, including the total number of papers, the papers published in journals included in the Journal Citation Reports (JCR), total Impact Factor (IF), the individual productivity of the last 5 years was measured. In the last 5 years 503 scientific products were published, 231 of which in JCR-indexed journals, with a mean individual IF = 16.741. The total number of papers indexed in PubMed, the number of papers included in JCR-indexed journals and the number of papers included in JCR-indexed journal of Public, Environmental & Occupational Health were associated with the overall number of authors (p total number of papers is inversely associated with age (p productivity authors have an elevated number of products both in JCR-indexed journals (targeted to a small number of specialists in the field) and in PubMed-indexed journal (addressed to the broad audience of occupational health professionals). The productivity standard of academics of Occupational Medicine should take into account the overall research products within the Public Health field. In addition, the standard should be shared with that of academics of Hygiene and of Forensic medicine in order to address the recruitment policy in the Public Health field

  12. The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines.

    Science.gov (United States)

    Carvalho, Ana Cecília Bezerra; Lana, Túlio Nader; Perfeito, João Paulo Silvério; Silveira, Dâmaris

    2018-02-15

    the herbal medicinal products (HMP) market is expanding in the world, an expansion that has not occurred in Brazil when considering the number of licensed products. Despite being a megadiverse country, the number of HMP licensed in Brazil is small, and the number of HMP obtained from native species is even smaller. A new legislation for herbal products licensing, which divides the products into two categories, Herbal Medicine (HM) and Traditional Herbal Product (THP) was launched in Brazil focusing on traditional use, as well as a law regulating the use of biodiversity and traditional knowledge. to evaluate the situation of HMP licensed in Brazil and to make a comparison with the data obtained in 2008 and 2011, discussing the evolution of the licensed products and the possible impacts of the new legislation. a survey was carried out in the Brazilian Health Regulatory Agency (Anvisa) database to verify the HMP licensed in Brazil in September 2016. The data obtained were compared with two surveys previously published. There are 332 single, and 27 combined HM, totaling 359 HM licensed in Brazil. There is no THP notified in Anvisa's system yet. There are 214 HM classified as nonprescription (OTC), while 145 are sold under prescription, one of them with prescription retention. There are 101 plant species licensed as active in HM in Brazil, 39 of which are native, adapted or cultivated. The most licensed plant species is Mikania glomerata Spreng., with 25 HM licensed. The article includes tables with plant species that have derivatives licensed as simple and combined HM, their therapeutic classification, the native plant species indication and the distribution of the companies by Brazilian regions. There are few licensed HM in Brazil, and this number has been decreasing in recent years. It is expected that the data obtained, together with the changes promoted in sanitary and environmental rules, will help to develop and regulate HMP chain in Brazil. Copyright © 2017

  13. Evaluation of medicinal interventions for the management of oral submucous fibrosis: a systematic review of the literature.

    Science.gov (United States)

    Awan, Kamran Habib; Patil, Shankargouda; Habib, Syed Rashid; Pejcic, Ana; Zain, Rosnah Binti

    2014-11-01

    Oral submucous fibrosis is a chronic, progressive scarring disease associated with both significant morbidity including pain and limited mouth opening and an increased risk for malignancy. This systematic review evaluated the different medicinal (i.e. nonsurgical) interventions available for the management of oral submucous fibrosis. An automated literature searches of online databases from January 1960 to December 2013 were performed and only studies with high level of evidence based on the guidelines of the Oxford Centre for evidence-based medicine were selected. Thirteen studies (3 randomized controlled trials and 10 clinical trials/controlled clinical trials) were included and drugs like steroids, hyaluronidase, human placenta extracts, chymotrypsin and collagenase, pentoxifylline, nylidrin hydrochloride, iron and multivitamin supplements including lycopene were used. There is a clear lack of evidence on the available drug treatment for oral submucous fibrosis and further high quality randomized controlled trials are needed to evaluate the different therapeutic agents.

  14. Measuring medicine-related experiences from the patient perspective: a systematic review

    Directory of Open Access Journals (Sweden)

    Katusiime B

    2016-10-01

    Full Text Available Barbra Katusiime,1 Sarah Corlett,1 Joanne Reeve,2 Janet Krska1 1Medway School of Pharmacy, The Universities of Kent and Greenwich, Chatham, Maritime, Kent, UK; 2Warwick Medical School, University of Warwick, Coventry, UK Background: There is an increasing drive to measure and so improve patients’ experiences and outcomes of health care. This also applies to medicines, given their ubiquity as health care interventions. Patients’ experiences of using medicines vary, and instruments which measure these are seen as an essential component to improve care. We aimed to identify generic measures of patients’ experiences of using prescription medicines and to examine their properties and suitability for use in research or practice. Methods: Multiple electronic databases were searched: MEDLINE, Embase, PsycINFO, PsycARTICLES, CINHAL Plus, PROQOLID®, and Google Scholar. We identified, critically appraised, and summarized generic questionnaires assessing one or more aspects of the medicine use experience among adult patients using prescription medicines for chronic conditions, and the process of questionnaire development, degree of patient involvement, and/or validation processes. Results: Fifteen questionnaires were included. Of these, nine measures were multidimensional, covering various aspects of medicine use. Six instruments covered only a single domain, assessing a specific facet of using medicines. Domains covered were the following: effectiveness; convenience, practicalities, and/or managing medicines; information, knowledge, and/or understanding; side effects; relationships and/or communication with health professionals; impact on daily living and/or social life; general satisfaction; attitudes; beliefs, concerns, and/or perceptions; medical follow-up and/or adherence-related issues; treatment- and/or medicine-related burden, perceived control, or autonomy; self-confidence about medicine use; availability and accessibility; and medicine

  15. Non-Prescription Medicinal Products Exclusively Dispensed in Pharmacies in Portugal

    Directory of Open Access Journals (Sweden)

    Elisabete Gonçalves

    2016-04-01

    Full Text Available Self-medication is a process through which the individual assumes a greater degree of responsibility for the management of a minor health problem, by acquiring a medicine that is accessible without the need to obtain a medical prescription. Access to health care is undergoing important changes in the European Union. In the presence of factors such as aging populations and economic constraints on health systems, greater emphasis to the efficient use of health resources has been given. Self-care, which comprises self-medication assumes, in this context, an important role by encouraging individuals to take greater responsibility for their own health and wellbeing, choose healthy life choices, consult the pharmacist when appropriate and to establish whether and when medical treatment should be sought. In order to promote the rational use of medicinal products, the subcategory of non-prescription medicinal products exclusively dispensed in pharmacies has gained expression in different European countries. As the name implies, this category includes medicines that, by their nature and given the framework of the condition for which they are intended, are considered safe for dispensing without the requirement of a prescription, possess some attribute that makes them elective for dispensing under the supervision of a health professional, in this case the pharmacist, in order to promote safety and efficiency in their use. The different Member States have advanced at different times with the implementation of this category of classification regarding the dispensing to the public of medicines. Portugal introduced in 2013 this category of medicines in its legal framework. If, on one hand, the big drivers for the classification of more medicines in categories non-prescription medicinal products and non-prescription medicinal products exclusively dispensed in pharmacies have been the greater empowerment of the patient regarding the management of his health and

  16. Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies.

    Science.gov (United States)

    Hamilton, William L; Doyle, Cormac; Halliwell-Ewen, Mycroft; Lambert, Gabriel

    2016-12-01

    Falsified medicines are deliberately fraudulent drugs that pose a direct risk to patient health and undermine healthcare systems, causing global morbidity and mortality. To produce an overview of anti-falsifying public health interventions deployed at international, national and local scales in low and middle income countries (LMIC). We conducted a systematic search of the PubMed, Web of Science, Embase and Cochrane Central Register of Controlled Trials databases for healthcare or pharmaceutical policies relevant to reducing the burden of falsified medicines in LMIC. Our initial search identified 660 unique studies, of which 203 met title/abstract inclusion criteria and were categorised according to their primary focus: international; national; local pharmacy; internet pharmacy; drug analysis tools. Eighty-four were included in the qualitative synthesis, along with 108 articles and website links retrieved through secondary searches. On the international stage, we discuss the need for accessible pharmacovigilance (PV) global reporting systems, international leadership and funding incorporating multiple stakeholders (healthcare, pharmaceutical, law enforcement) and multilateral trade agreements that emphasise public health. On the national level, we explore the importance of establishing adequate medicine regulatory authorities and PV capacity, with drug screening along the supply chain. This requires interdepartmental coordination, drug certification and criminal justice legislation and enforcement that recognise the severity of medicine falsification. Local healthcare professionals can receive training on medicine quality assessments, drug registration and pharmacological testing equipment. Finally, we discuss novel technologies for drug analysis which allow rapid identification of fake medicines in low-resource settings. Innovative point-of-purchase systems like mobile phone verification allow consumers to check the authenticity of their medicines. Combining anti

  17. Medicinal plants--prophylactic and therapeutic options for gastrointestinal and respiratory diseases in calves and piglets? A systematic review.

    Science.gov (United States)

    Ayrle, Hannah; Mevissen, Meike; Kaske, Martin; Nathues, Heiko; Gruetzner, Niels; Melzig, Matthias; Walkenhorst, Michael

    2016-06-06

    Gastrointestinal and respiratory diseases in calves and piglets lead to significant economic losses in livestock husbandry. A high morbidity has been reported for diarrhea (calves ≤ 35%; piglets ≤ 50%) and for respiratory diseases (calves ≤ 80%; piglets ≤ 40%). Despite a highly diverse etiology and pathophysiology of these diseases, treatment with antimicrobials is often the first-line therapy. Multi-antimicrobial resistance in pathogens results in international accordance to strengthen the research in novel treatment options. Medicinal plants bear a potential as alternative or additional treatment. Based on the versatile effects of their plant specific multi-component-compositions, medicinal plants can potentially act as 'multi-target drugs'. Regarding the plurality of medicinal plants, the aim of this systematic review was to identify potential medicinal plant species for prevention and treatment of gastrointestinal and respiratory diseases and for modulation of the immune system and inflammation in calves and piglets. Based on nine initial sources including standard textbooks and European ethnoveterinary studies, a total of 223 medicinal plant species related to the treatment of gastrointestinal and respiratory diseases was identified. A defined search strategy was established using the PRISMA statement to evaluate 30 medicinal plant species starting from 20'000 peer-reviewed articles published in the last 20 years (1994-2014). This strategy led to 418 references (257 in vitro, 84 in vivo and 77 clinical trials, thereof 48 clinical trials in veterinary medicine) to evaluate effects of medicinal plants and their efficacy in detail. The findings indicate that the most promising candidates for gastrointestinal diseases are Allium sativum L., Mentha x piperita L. and Salvia officinalis L.; for diseases of the respiratory tract Echinacea purpurea (L.) MOENCH, Thymus vulgaris L. and Althea officinalis L. were found most promising, and Echinacea purpurea (L

  18. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

    Science.gov (United States)

    Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

    2015-01-01

    In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

  19. Risk assessment on the use of herbal medicinal products containing pyrrolizidine alkaloids.

    Science.gov (United States)

    Allgaier, Clemens; Franz, Stephanie

    2015-11-01

    Pyrrolizidine alkaloids (PA) are common plantal toxins directed against insect herbivores. Unsaturated PAs are known to be hepatotoxic. Many of the PAs are in addition mutagenic and some may possibly be carcinogenic for humans. The risk of an exposure to PAs associated with their occurrence in herbal medicinal products and in foodstuff is under current discussion. The present risk assessment for herbal medicinal products containing PAs is based on a margin of safety derivation for foodstuff indicating that a life-long exposure to maximally 0.007 μg/kg bw/day is not expected to be associated with safety concerns. This approach offers a possibility to estimate the potential risk of PA-containing herbal medicinal products irrespective of the route of administration. It assumes PA levels in the final herbal medicinal product below 0.01 ppm and considers for dermal administration a 100% skin penetration of the PAs reflecting a worst-case scenario. As a result, the calculated margins of safety show a potential exposure using herbal medicinal products 70-, 45.5-, and 19.3-fold lower on a one-day base and 608-, 396-, and 168- fold lower on a one-year base for adults, children aged 12 years, and children aged 4 years, respectively, than the thresholds considered acceptable for foodstuff. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Modeling belowground biomass of black cohosh, a medicinal forest product.

    Science.gov (United States)

    James Chamberlain; Gabrielle Ness; Christine Small; Simon Bonner; Elizabeth Hiebert

    2014-01-01

    Tens of thousands of kilograms of rhizomes and roots of Actaea racemosa L., a native Appalachian forest perennial, are harvested every year and used for the treatment of menopausal conditions. Sustainable management of this and other wild-harvested non-timber forest products requires the ability to effectively and reliably inventory marketable plant...

  1. Callus production and regeneration of the medicinal plant Papaver ...

    African Journals Online (AJOL)

    Administrator

    2011-09-19

    Sep 19, 2011 ... and morphinan alkaloids production in two species of opium poppy. Biomed. Biotechnol. 1(2): 70-78. Murashige T, Skoog F (1962). A revised medium for rapid growth and bioassays with tobacco tissue cultures. Physiol. Plant, 15: 473-497. Rao AQ, Hussain SS, Shahzad MS, Bokhari SYA, Raza MH, Rakha ...

  2. Nigerian Journal of Natural Products and Medicine: Contact

    African Journals Online (AJOL)

    Principal Contact. J. M.Agbedahunsi Ph.D. Editor in Chief Drug Research and Production Unit, Faculty of Pharmacy Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, NIGERIA. Phone: +2348034093594. Fax: +234 36 231 733. Email: jagbedah@oauife.edu.ng ...

  3. Impact of family medicine clerkships in undergraduate medical education: a systematic review

    Science.gov (United States)

    Turkeshi, Eralda; Michels, Nele R; Hendrickx, Kristin; Remmen, Roy

    2015-01-01

    Objective Synthesise evidence about the impact of family medicine/general practice (FM) clerkships on undergraduate medical students, teaching general/family practitioners (FPs) and/or their patients. Data sources Medline, ERIC, PsycINFO, EMBASE and Web of Knowledge searched from 21 November to 17 December 2013. Primary, empirical, quantitative or qualitative studies, since 1990, with abstracts included. No country restrictions. Full text languages: English, French, Spanish, German, Dutch or Italian. Review methods Independent selection and data extraction by two authors using predefined data extraction fields, including Kirkpatrick’s levels for educational intervention outcomes, study quality indicators and Best Evidence Medical Education (BEME) strength of findings’ grades. Descriptive narrative synthesis applied. Results Sixty-four included articles: impact on students (48), teaching FPs (12) and patients (8). Sample sizes: 16-1095 students, 3-146 FPs and 94-2550 patients. Twenty-six studies evaluated at Kirkpatrick level 1, 26 at level 2 and 6 at level 3. Only one study achieved BEME’s grade 5. The majority was assessed as grade 4 (27) and 3 (33). Students reported satisfaction with content and process of teaching as well as learning in FM clerkships. They enhanced previous learning, and provided unique learning on dealing with common acute and chronic conditions, health maintenance, disease prevention, communication and problem-solving skills. Students’ attitudes towards FM were improved, but new or enhanced interest in FM careers did not persist without change after graduation. Teaching FPs reported increased job satisfaction and stimulation for professional development, but also increased workload and less productivity, depending on the setting. Overall, student’s presence and participation did not have a negative impact on patients. Conclusions Research quality on the impact of FM clerkships is still limited, yet across different settings and

  4. Generation of mesenchymal stem cells as a medicinal product in organ transplantation.

    Science.gov (United States)

    Verbeek, Richard

    2013-02-01

    Mesenchymal stem cells (MSCs) are emerging as an alternative treatment in solid-organ transplantation. The use of MSCs as a therapeutic product requires the translation of basic research protocols into a production process under good manufacturing practice (GMP) to obtain a safe product of high quality. This requires a different mindset from the academic setting of changing protocols into a well defined, controlled and documented process. This review describes some of the challenges faced by culturing MSCs as a medicinal product. Clinical-grade MSCs are used in the clinical trials and proved to be safe as a medicinal product. Because of the differences in the type of MSCs and in the production process, clinical outcome is not always comparable. New standardized methods in the culture condition such as the use of alternatives for fetal bovine serum (FBS), standardized plating densities or the use of bioreactors may further standardize the production process. To generate MSCs as a medicinal product in organ transplantation, regulation requires that MSCs have to be generated under GMP. During the whole production process, all critical steps should be known and described. Further steps should be taken to optimize and standardize the production process.

  5. Medicinal herbs as possible sources of anti-inflammatory products

    Directory of Open Access Journals (Sweden)

    Andreia Corciovă

    2017-12-01

    Full Text Available Plants constitute an inexhaustible source of bioactive compounds that can be valuable for research in the chemistry field of anti-inflammatory compounds. This review describes several plants from international and national flora that have been shown to have anti-inflammatory activity in various clinical trials. The paper includes: general aspects regarding the vegetal source, compounds responsible for anti-inflammatory activity, mechanism of action and clinical trials carried out with extracts or products containing standardized extracts.

  6. Impact of nanotechnology on public health : production of medicines

    OpenAIRE

    Dimer, Frantiescoli Anversa; Friedrich, Rossana Barcellos; Beck, Ruy Carlos Ruver; Guterres, Silvia Stanisçuaski; Pohlmann, Adriana Raffin

    2013-01-01

    Several studies have described the benefits of nanoscience and nanotechnology (N&N) in different sectors such as agriculture, energy, environmental preservation, and public health. The rapid evolution of N&N can be shown through a panoramic analysis of scientific papers and patents. In the area of public health, it is estimated that the global market for nanotechnology products will expand to 160 billion U.S. dollars in 2015. The Brazilian government has also strengthened its innovative poten...

  7. Systematic review and meta-analysis of cannabinoids in palliative medicine.

    Science.gov (United States)

    Mücke, Martin; Weier, Megan; Carter, Christopher; Copeland, Jan; Degenhardt, Louisa; Cuhls, Henning; Radbruch, Lukas; Häuser, Winfried; Conrad, Rupert

    2018-02-05

    We provide a systematic review and meta-analysis on the efficacy, tolerability, and safety of cannabinoids in palliative medicine. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, PubMed, Scopus, and http://clinicaltrials.gov, and a selection of cancer journals were searched up until 15th of March 2017. Of the 108 screened studies, nine studies with a total of 1561 participants were included. Overall, the nine studies were at moderate risk of bias. The quality of evidence comparing cannabinoids with placebo was rated according to Grading of Recommendations Assessment, Development, and Evaluation as low or very low because of indirectness, imprecision, and potential reporting bias. In cancer patients, there were no significant differences between cannabinoids and placebo for improving caloric intake (standardized mean differences [SMD]: 0.2 95% confidence interval [CI]: [-0.66, 1.06] P = 0.65), appetite (SMD: 0.81 95% CI: [-1.14, 2.75]; P = 0.42), nausea/vomiting (SMD: 0.21 [-0.10, 0.52] P = 0.19), >30% decrease in pain (risk differences [RD]: 0.07 95% CI: [-0.01, 0.16]; P = 0.07), or sleep problems (SMD: -0.09 95% CI: [-0.62, 0.43] P = 0.72). In human immunodeficiency virus (HIV) patients, cannabinoids were superior to placebo for weight gain (SMD: 0.57 [0.22; 0.92]; P = 0.001) and appetite (SMD: 0.57 [0.11; 1.03]; P = 0.02) but not for nausea/vomiting (SMD: 0.20 [-0.15, 0.54]; P = 0.26). Regarding side effects in cancer patients, there were no differences between cannabinoids and placebo in symptoms of dizziness (RD: 0.03 [-0.02; 0.08]; P = 0.23) or poor mental health (RD: -0.01 [-0.04; 0.03]; P = 0.69), whereas in HIV patients, there was a significant increase in mental health symptoms (RD: 0.05 [0.00; 0.11]; P = 0.05). Tolerability (measured by the number of withdrawals because of adverse events) did not differ significantly in cancer (RD: 1.15 [0.80; 1.66]; P = 0.46) and HIV patients (RD: 1.87 [0.60; 5

  8. Micropropagation: a tool for the production of high quality plant-based medicines.

    Science.gov (United States)

    Debnath, Mousumi; Malik, C P; Bisen, P S

    2006-02-01

    Medicinal plants are the most important source of life saving drugs for the majority of the world's population. The biotechnological tools are important to select, multiply and conserve the critical genotypes of medicinal plants. Plant tissue culture techniques offer an integrated approach for the production of standardized quality phytopharmaceutical through mass-production of consistent plant material for physiological characterization and analysis of active ingredients. Micropropagation protocols for cloning of some medicinal plants such as Catharanthus roseus (Apocynaceae), Chlorophytum borivilianum (Liliaceae), Datura metel (Solanaceae), and Bacopa monnieri (Scrophulariaceae) have been developed. Regeneration occurred via organogenesis and embryogenesis in response to auxins and cytokinins. The integrated approaches of our culture systems will provide the basis for the future development of novel, safe, effective, and high-quality products for consumers.

  9. Exploring anti-TB leads from natural products library originated from marine microbes and medicinal plants.

    Science.gov (United States)

    Liu, Xueting; Chen, Caixia; He, Wenni; Huang, Pei; Liu, Miaomiao; Wang, Qian; Guo, Hui; Bolla, Krishna; Lu, Yan; Song, Fuhang; Dai, Huanqin; Liu, Mei; Zhang, Lixin

    2012-10-01

    Multidrug-resistant tuberculosis (MDR-TB) and TB-HIV co-infection have become a great threat to global health. However, the last truly novel drug that was approved for the treatment of TB was discovered 40 years ago. The search for new effective drugs against TB has never been more intensive. Natural products derived from microbes and medicinal plants have been an important source of TB therapeutics. Recent advances have been made to accelerate the discovery rate of novel TB drugs including diversifying strategies for environmental strains, high-throughput screening (HTS) assays, and chemical diversity. This review will discuss the challenges of finding novel natural products with anti-TB activity from marine microbes and plant medicines, including biodiversity- and taxonomy-guided microbial natural products library construction, target- and cell-based HTS, and bioassay-directed isolation of anti-TB substances from traditional medicines.

  10. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].

    Science.gov (United States)

    Jost, Nils; Schüssler-Lenz, Martina; Ziegele, Bettina; Reinhardt, Jens

    2015-11-01

    The aim of scientific advice is to support pharmaceutical developers in regulatory and scientific questions, thus facilitating the development of safe and efficacious new medicinal products. Recent years have shown that the development of advanced therapy medicinal products (ATMPs) in particular needs a high degree of regulatory support. On one hand, this is related to the complexity and heterogeneity of this group of medicinal products and on the other hand due to the fact that mainly academic research institutions and small- and medium-sized enterprises (SMEs) are developing ATMPs. These often have limited regulatory experience and resources. In 2009 the Paul-Ehrlich-Institut (PEI) initiated the Innovation Office as a contact point for applicants developing ATMPs. The mandate of the Innovation Office is to provide support on regulatory questions and to coordinate national scientific advice meetings concerning ATMPs for every phase in drug development and especially with view to the preparation of clinical trial applications. On the European level, the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicinal Agency (EMA) offers scientific advice. This article describes the concepts of national and EMA scientific advice concerning ATMPs and summarizes the experience of the last six years.

  11. Systems biology technologies enable personalized traditional Chinese medicine: a systematic review.

    Science.gov (United States)

    Wang, Xijun; Zhang, Aihua; Sun, Hui; Wang, Ping

    2012-01-01

    Traditional Chinese medicine (TCM), an alternative medicine, focuses on the treatment of human disease via the integrity of the close relationship between body and syndrome analysis. It remains a form of primary care in most Asian countries and its characteristics showcase the great advantages of personalized medicine. Although this approach to disease diagnosis, prognosis and treatment has served the medical establishment well for thousands of years, it has serious shortcomings in the era of modern medicine that stem from its reliance on reductionist principles of experimentation and analysis. In this way, systems biology offers the potential to personalize medicine, facilitating the provision of the right care to the right patient at the right time. We expect that systems biology will have a major impact on future personalized therapeutic approaches which herald the future of medicine. Here we summarize current trends and critically review the potential limitations and future prospects of such treatments. Some characteristic examples are presented to highlight the application of this groundbreaking platform to personalized TCM as well as some of the necessary milestones for moving systems biology of a state-of-the-art nature into mainstream health care.

  12. Ten-year trends in family medicine residency productivity and staffing: impact of electronic health records, resident duty hours, and the medical home.

    Science.gov (United States)

    Lesko, Sarah; Hughes, Lauren; Fitch, Wes; Pauwels, Judith

    2012-02-01

    Electronic health records (EHRs), resident duty hour restrictions, and Patient-centered Medical Home (PCMH) innovations have all impacted the clinical practices of residency programs over the past decade. The University of Washington Family Medicine Network (UWFMN) residencies have collaborated for 10 years in collecting and comparing data regarding the productivity and operations of their training programs to identify the program-level effects of such changes. Based on five survey results from 2000 to 2010, this study examines changes in faculty and resident productivity and staffing models of UWFMN residency training clinics using a standardized methodology, specifically describing the productivity impact of EHR changes and duty hour restrictions and the implementation of the PCMH by residencies. Data were systematically collected via standardized questionnaire, evaluated for quality, clarified, and then analyzed. Resident productivity decreased over the 10-year interval, with resident total yearly patient visits down 17.2%. Core family medicine faculty productivity was highly variable among programs, and nonphysician provider visits increased. Faculty part-time status increased. Front office, medical assistant, and nursing staffing grew significantly, but other administrative staff decreased, resulting in minimal change in total non-provider staffing. A majority of programs engaged in PCMH initiatives in 2010 and had implemented an EHR. Physician productivity in UWFMN residency programs decreased for all resident physicians from 2000 to 2010, likely due to a combination of decreased resident duty hours and other clinical practice changes. Productivity trends have implications for the structure and training requirements for family medicine residency programs.

  13. Quality transitivity and traceability system of herbal medicine products based on quality markers.

    Science.gov (United States)

    Liu, Changxiao; Guo, De-An; Liu, Liang

    2018-03-06

    Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

  14. Recent progress of research on medicinal mushrooms, foods, and other herbal products used in traditional Chinese medicine

    Directory of Open Access Journals (Sweden)

    Kuo-Hsiung Lee

    2012-04-01

    Full Text Available This article will review selected herbal products used in traditional Chinese medicine, including medicinal mushrooms (巴西蘑菇 bā xī mó gū; Agaricus blazei, 雲芝 yún zhī; Coriolus versicolor, 靈芝 líng zhī; Ganoderma lucidum, 香蕈 xiāng xùn; shiitake, Lentinus edodes, 牛樟芝 niú zhāng zhī; Taiwanofungus camphoratus, Cordyceps (冬蟲夏草 dōng chóng xià cǎo, pomegranate (石榴 shí liú; Granati Fructus, green tea (綠茶 lǜ chá; Theae Folium Non Fermentatum, garlic (大蒜 dà suàn; Allii Sativi Bulbus, turmeric (薑黃 jiāng huáng; Curcumae Longae Rhizoma, and Artemisiae Annuae Herba (青蒿 qīng hāo; sweet wormwood. Many of the discussed herbal products have gained popularity in their uses as dietary supplements for health benefits. The review will focus on the active constituents of the herbs and their bioactivities, with emphasis on the most recent progress in research for the period of 2003 to 2011.

  15. Product development public-private partnerships for public health: a systematic review using qualitative data.

    Science.gov (United States)

    De Pinho Campos, Katia; Norman, Cameron D; Jadad, Alejandro R

    2011-10-01

    Almost a decade ago, public health initiated a number of innovative ventures to attract investments from multinational drug companies for the development of new drugs and vaccines to tackle neglected diseases (NDs). These ventures - known as product development public-private partnerships (PD PPPs) - represent the participation of the public and private actors toward the discovery and development of essential medicines to reduce the suffering of over one billion people worldwide living with NDs. This systematic review aimed to identify empirical-based descriptive articles to understand critical elements in the partnership process, and propose a framework to shed light on future guidelines to support better planning, design and management of existing and new forms of PPPs for public health. Ten articles met the inclusion criteria and were analyzed and synthesized using qualitative content analysis. The findings show that the development stage of PD PPPs requires a careful initiation and planning process including discussion on values and shared goals, agreement on mutual interests & equality of power relation, exchange of expertise & resources, stakeholder engagement, and assessment of the local health capacity. The management stage of PD PPPs entails transparency, extensive communication and participatory decision-making among partner organizations. This review illustrates the difficulties, challenges and effective responses during the partnering process. This model of collaboration may offer a way to advance population health at present, while creating streams of innovation that can yield future social and financial dividends in enhancing the public's health more widely. Copyright © 2011 Elsevier Ltd. All rights reserved.

  16. Cyclotron Production of Radionuclides for Nuclear Medicine at Academic Centers

    Science.gov (United States)

    Lapi, Suzanne

    2016-09-01

    The increase in use of radioisotopes for medical imaging has led to the development of new accelerator targetry and separation techniques for isotope production. For example, the development of longer-lived position emitting radionuclides has been explored to allow for nuclear imaging agents based on peptides, antibodies and nanoparticles. These isotopes (64Cu, 89Zr, 86Y) are typically produced via irradiation of solid targets on smaller cyclotrons (10-25 MeV) at academic or hospital based facilities. Recent research has further expanded the toolbox of PET tracers to include additional isotopes such as 52Mn, 55Co, 76Br and others. The smaller scale of these types of facilities can enable the straightforward involvement of students, thus adding to the next generation of nuclear science leaders. Research pertaining to development of robust and larger scale production technologies including solid target systems and remote systems for transport and purification of these isotopes has enabled both preclinical and clinical imaging research for many diseases. In particular, our group has focused on the use of radiolabeled antibodies for imaging of receptor expression in preclinical models and in a clinical trial of metastatic breast cancer patients.

  17. Could the products of Indian medicinal plants be the next alternative for the treatment of infections?

    Directory of Open Access Journals (Sweden)

    B Nandagopal

    2011-01-01

    Full Text Available Indian medicinal plants are now recognized to have great potential for preparing clinically useful drugs that could even be used by allopathic physicians. Traditionally, practitioners of Indian medicine have used plant products in powder, syrup or lotion forms, without identification, quantification and dose regulation, unlike their allopathic counterparts. The present review explores the immense potential of the demonstrated effect of Indian medicinal plants on microbes, viruses and parasites. In the present context, with the available talent in the country like pharmaceutical chemists, microbiologists, biotechnologists and interested allopathic physicians, significant national effort towards identification of an "active principle" of Indian medicinal plants to treat human and animal infections should be a priority.

  18. The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

    2017-01-01

    Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

  19. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  20. Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

    International Nuclear Information System (INIS)

    Jordan, Scott A.; Cunningham, David G.; Marles, Robin J.

    2010-01-01

    Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantity and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.

  1. Local production of pharmaceuticals in Africa and access to essential medicines: 'urban bias’ in access to imported medicines in Tanzania and its policy implications

    Science.gov (United States)

    2014-01-01

    Background International policy towards access to essential medicines in Africa has focused until recently on international procurement of large volumes of medicines, mainly from Indian manufacturers, and their import and distribution. This emphasis is now being challenged by renewed policy interest in the potential benefits of local pharmaceutical production and supply. However, there is a shortage of evidence on the role of locally produced medicines in African markets, and on potential benefits of local production for access to medicines. This article contributes to filling that gap. Methods This article uses WHO/HAI data from Tanzania for 2006 and 2009 on prices and sources of a set of tracer essential medicines. It employs innovative graphical methods of analysis alongside conventional statistical testing. Results Medicines produced in Tanzania were equally likely to be found in rural and in urban areas. Imported medicines, especially those imported from countries other than Kenya (mainly from India) displayed 'urban bias’: that is, they were significantly more likely to be available in urban than in rural areas. This finding holds across the range of sample medicines studied, and cannot be explained by price differences alone. While different private distribution networks for essential medicines may provide part of the explanation, this cannot explain why the urban bias in availability of imported medicines is also found in the public sector. Conclusions The findings suggest that enhanced local production may improve rural access to medicines. The potential benefits of local production and scope for their improvement are an important field for further research, and indicate a key policy area in which economic development and health care objectives may reinforce each other. PMID:24612518

  2. Estimated costs of production and potential prices for the WHO Essential Medicines List.

    Science.gov (United States)

    Hill, Andrew M; Barber, Melissa J; Gotham, Dzintars

    2018-01-01

    There are persistent gaps in access to affordable medicines. The WHO Model List of Essential Medicines (EML) includes medicines considered necessary for functional health systems. A generic price estimation formula was developed by reviewing published analyses of cost of production for medicines and assuming manufacture in India, which included costs of formulation, packaging, taxation and a 10% profit margin. Data on per-kilogram prices of active pharmaceutical ingredient exported from India were retrieved from an online database. Estimated prices were compared with the lowest globally available prices for HIV/AIDS, tuberculosis (TB) and malaria medicines, and current prices in the UK, South Africa and India. The estimation formula had good predictive accuracy for HIV/AIDS, TB and malaria medicines. Estimated generic prices ranged from US$0.01 to US$1.45 per unit, with most in the lower end of this range. Lowest available prices were greater than estimated generic prices for 214/277 (77%) comparable items in the UK, 142/212 (67%) in South Africa and 118/298 (40%) in India. Lowest available prices were more than three times above estimated generic price for 47% of cases compared in the UK and 22% in South Africa. A wide range of medicines in the EML can be profitably manufactured at very low cost. Most EML medicines are sold in the UK and South Africa at prices significantly higher than those estimated from production costs. Generic price estimation and international price comparisons could empower government price negotiations and support cost-effectiveness calculations.

  3. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain.

    Science.gov (United States)

    Rubinstein, Sidney M; van Middelkoop, Marienke; Kuijpers, Ton; Ostelo, Raymond; Verhagen, Arianne P; de Boer, Michiel R; Koes, Bart W; van Tulder, Maurits W

    2010-08-01

    The purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple databases up to December 22, 2008. Randomised controlled trials (RCTs) of adults with chronic non-specific LBP, which evaluated at least one clinically relevant, patient-centred outcome measure were included. Two authors working independently from one another assessed the risk of bias using the criteria recommended by the CBRG and extracted the data. The data were pooled when clinically homogeneous and statistically possible or were otherwise qualitatively described. GRADE was used to determine the quality of the evidence. In total, 35 RCTs (8 SMT, 20 acupuncture, 7 herbal medicine), which examined 8,298 patients, fulfilled the inclusion criteria. Approximately half of these (2 SMT, 8 acupuncture, 7 herbal medicine) were thought to have a low risk of bias. In general, the pooled effects for the studied interventions demonstrated short-term relief or improvement only. The lack of studies with a low-risk of bias, especially in regard to SMT precludes any strong conclusions; however, the principal findings, which are based upon low- to very-low-quality evidence, suggest that SMT does not provide a more clinically beneficial effect compared with sham, passive modalities or any other intervention for treatment of chronic low-back pain. There is evidence, however, that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Although there are some good results for individual herbal medicines in short-term individual trials, the lack of homogeneity across studies did not allow for a pooled estimate of the effect. In general, these results are in agreement with other recent systematic reviews on

  4. Acupuncture plus Herbal Medicine for Alzheimer's Disease: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Zhou, Simin; Dong, Lanlan; He, Yuan; Xiao, Hong

    2017-01-01

    Alzheimer's disease (AD) is associated with the unprecedented aging tendency in our world population and has become a significant health issue. The use of Traditional Chinese Medicine to treat AD has been increasing in recent years. The objective of this meta-analysis is to evaluate the effectiveness of combining acupuncture with herbal medicine to treat AD. Randomized controlled trials (RCTs) of acupuncture plus herbals versus treatment with western drugs for AD were retrieved from 11 databases. The data were extracted by two authors; dichotomous data were expressed as odds ratio (ORs) and 95% confidence intervals (CIs), while continuous data were calculated by mean differences (MDs) with 95% CIs. Although the combined analysis of the score of Activity of Daily Life (ADL) scale MD was [Formula: see text]3.59 (95% CI [Formula: see text]7.18-0.01, [Formula: see text]), which indicates there was no statistically significant difference between the two treatments at reducing the ADL scale score, the pooled results of 12 trials indicated that acupuncture plus Chinese herbal medicine was better than western drugs at improving the effectiveness rate (OR 2.24, 95% CI 1.40-3.56), the combined evidence of 11 articles showed that acupuncture plus Chinese herbal medicine was more effective than western drugs at improving the scores for the Mini Mental State Examination (MMSE) scale (2.10, 95% CI 0.69-3.51, [Formula: see text]) and the traditional Chinese medicine symptom (MD 5.07, 95% CI 3.90-6.25, [Formula: see text]). From the current research results, acupuncture plus herbal medicine may have advantages over western drugs for treating AD. Nevertheless, well-designed RCTs with a larger sample size are required in the future.

  5. How current Clinical Practice Guidelines for low back pain reflect Traditional Medicine in East Asian Countries: a systematic review of Clinical Practice Guidelines and systematic reviews.

    Directory of Open Access Journals (Sweden)

    Hyun-Woo Cho

    Full Text Available OBJECTIVES: The aims of this study were to investigate whether there is a gap between evidence of traditional medicine (TM interventions in East-Asian countries from the current Clinical Practice Guidelines (CPGs and evidence from current systematic reviews and meta-analyses (SR-MAs and to analyze the impact of this gap on present CPGs. METHODS: We examined 5 representative TM interventions in the health care systems of East-Asian countries. We searched seven relevant databases for CPGs to identify whether core CPGs included evidence of TM interventions, and we searched 11 databases for SR-MAs to re-evaluate current evidence on TM interventions. We then compared the gap between the evidence from CPGs and SR-MAs. RESULTS: Thirteen CPGs and 22 SR-MAs met our inclusion criteria. Of the 13 CPGs, 7 CPGs (54% mentioned TM interventions, and all were for acupuncture (only one was for both acupuncture and acupressure. However, the CPGs did not recommend acupuncture (or acupressure. Of 22 SR-MAs, 16 were for acupuncture, 5 for manual therapy, 1 for cupping, and none for moxibustion and herbal medicine. Comparing the evidence from CPGs and SR-MAs, an underestimation or omission of evidence for acupuncture, cupping, and manual therapy in current CPGs was detected. Thus, applying the results from the SR-MAs, we moderately recommend acupuncture for chronic LBP, but we inconclusively recommend acupuncture for (subacute LBP due to the limited current evidence. Furthermore, we weakly recommend cupping and manual therapy for both (subacute and chronic LBP. We cannot provide recommendations for moxibustion and herbal medicine due to a lack of evidence. CONCLUSIONS: The current CPGs did not fully reflect the evidence for TM interventions. As relevant studies such as SR-MAs are conducted and evidence increases, the current evidence on acupuncture, cupping, and manual therapy should be rigorously considered in the process of developing or updating the CPG system.

  6. Capture-mark-recapture as a tool for estimating the number of articles available for systematic reviews in critical care medicine.

    Science.gov (United States)

    Lane, Daniel; Dykeman, Jonathan; Ferri, Mauricio; Goldsmith, Charles H; Stelfox, Henry T

    2013-08-01

    Systematic reviews are an important knowledge synthesis tool for critical care medicine clinicians and researchers. With new literature available each day, reviewers must balance identifying all relevant literature against timely synthesis. We therefore sought to apply capture-mark-recapture, a novel methodology, to estimate the population of articles available for a systematic review of effective patient rounding practices in critical care medicine. Capture-mark-recapture was applied retrospectively to estimate the population of articles available for a systematic review of 4 bibliographic databases. All research studies (no methodology restrictions) of patient rounding practices in critical care medicine were included. Estimates of article population size were calculated for search of the bibliographic databases, selection of articles for full-text review, and selection of articles for inclusion in the systematic review. Capture-mark-recapture estimated a population of 28839 articles (95% confidence interval [CI], 12393-70990) for search of the bibliographic databases, 169 articles (95% CI, 152-202) for full-text review, and 48 articles (95% CI, 39-131) for inclusion in the systematic review. These estimates suggest that our search identified 15% (4462/28839) of the population of potentially available articles for the search of the bibliographic databases, 79% (133/169) of articles for full-text review, and 79% (38/48) of articles for inclusion in the systematic review. The capture-mark-recapture technique can be applied to systematic reviews in critical care medicine with heterogeneous study methodologies to estimate the population of articles available. Capture-mark-recapture may help clinicians who use systematic reviews to estimate search completeness and researchers who perform systematic reviews to develop more efficient literature search strategies. Copyright © 2013 Elsevier Inc. All rights reserved.

  7. Research and Development for Botanical Products in Medicinals and Food Supplements Market

    Directory of Open Access Journals (Sweden)

    Marco Miroddi

    2013-01-01

    Full Text Available Botanical products sold in the health area are generally intended as drugs, medicinal products, food supplements or substances for therapeutic use. Use of botanicals for improving or to care human health has evolved independently in different countries worldwide. Regulatory issues regarding botanical products designed for the food supplements or medicinal market and their influence on research and development are discussed. European Union (EU and United States (US policies regulating these products are focused with comments on the legislations delivered during the last ten years and differences existing in rules between these countries are emphasized. Research and development on botanical products nowdays strongly influenced by the product destination in the market. Addressed and differentiated research for either food supplements or medicinal markets is necessary to purchase data really useful for assessment of safe and effective use for both the categories. The main objective is to catalyze interest of academic and companies' researchers on crucial aspects to be taken into account in the research for the development of botanical products.

  8. Research and development for botanical products in medicinals and food supplements market.

    Science.gov (United States)

    Miroddi, Marco; Mannucci, Carmen; Mancari, Ferdinando; Navarra, Michele; Calapai, Gioacchino

    2013-01-01

    Botanical products sold in the health area are generally intended as drugs, medicinal products, food supplements or substances for therapeutic use. Use of botanicals for improving or to care human health has evolved independently in different countries worldwide. Regulatory issues regarding botanical products designed for the food supplements or medicinal market and their influence on research and development are discussed. European Union (EU) and United States (US) policies regulating these products are focused with comments on the legislations delivered during the last ten years and differences existing in rules between these countries are emphasized. Research and development on botanical products nowdays strongly influenced by the product destination in the market. Addressed and differentiated research for either food supplements or medicinal markets is necessary to purchase data really useful for assessment of safe and effective use for both the categories. The main objective is to catalyze interest of academic and companies' researchers on crucial aspects to be taken into account in the research for the development of botanical products.

  9. Chinese Herbal Medicine Combined with Conventional Therapy for Blood Pressure Variability in Hypertension Patients: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Zhuo Chen

    2015-01-01

    Full Text Available Objective. The aim of this systematic review is to evaluate effect of Chinese medicine combined with conventional therapy on blood pressure variability (BPV in hypertension patients. Methods. All randomized clinical trials (RCTs comparing Chinese medicine with no intervention or placebo on the basis of conventional therapy were included. Data extraction, analyses, and quality assessment were performed according to the Cochrane standards. Results. We included 13 RCTs and assessed risk of bias for all the trials. Chinese medicine has a significant effect in lowering blood pressure (BP, reducing BPV in the form of standard deviation (SD or coefficient of variability (CV, improving nighttime BP decreased rate, and reversing abnormal rhythm of BP. Conclusions. Chinese medicine was safe and showed beneficial effects on BPV in hypertension patients. However, more rigorous trials with high quality are warranted to give high level of evidence before recommending Chinese medicine as an alternative or complementary medicine to improve BPV in hypertension patients.

  10. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

    Science.gov (United States)

    Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

    2017-12-05

    The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  11. Traditional herbal medicine use among hypertensive patients in sub-Saharan Africa: a systematic review.

    Science.gov (United States)

    Liwa, Anthony C; Smart, Luke R; Frumkin, Amara; Epstein, Helen-Ann B; Fitzgerald, Daniel W; Peck, Robert N

    2014-06-01

    Hypertension is increasingly common in sub-Saharan Africa, and rates of hypertension control are low. Use of traditional herbal medicines (THM) is common among adults in sub-Saharan Africa and may affect hypertension therapy. We searched Ovid MEDLINE, Ovid EMBASE, and Web of Knowledge in June 2013 to find studies about THM use among hypertensive patients living in sub-Saharan Africa. Two independent reviewers evaluated titles and abstracts. Qualifying references were reviewed in full text. Data were extracted using a standardized questionnaire. Four hundred and eighty-one references were retrieved, and four articles from two countries met criteria for inclusion. The prevalence of THM use was 25-65% (average 38.6%). THM was the most common type of complementary and alternative medicines used by patients (86.7-96.6%). Among THM users, 47.5% concomitantly used both allopathic medicine and THM. Increased age (phistory of hypertension (OR 1.78) were positively associated with THM use, while belief that hypertension is preventable was negatively associated with THM use (OR 0.57). More than one-third of adults with hypertension in sub-Saharan Africa use THM. Half of these patients use THM concurrently with allopathic medicine. Healthcare workers in sub-Saharan Africa must discuss THM use with their hypertensive patients. More research is urgently needed to define the impact of THM use on hypertension control and outcomes in sub-Saharan Africa.

  12. Herbal Medicine as an Alternative Treatment in Autism Spectrum Disorder: A Systematic Review.

    Science.gov (United States)

    Gasparotto, Francielly Mourao; Liveror, Francislaine Aparecida; Tolouei Menegati, Sara Emilia Lima; Junior, Arquimedes Gasparotto

    2017-12-27

    This review focuses on the efficacy and safety of herbal medicines in the management of autism spectrum disorder (ASD) in humans and animals. PubMed, Scopus, Google Scholar, Web of Science, and Science Direct databases were searched up to October 30, 2016. The key terms used were "ASD", "Asperger", "autism", "healing plants", "herbal medicine", and "medicinal plants". In each database, the searches consisted of each of the three key terms describing the disorder and subtypes plus each of the terms describing the therapy. All human and animal studies on the effects of herbs with the key outcome of change in autism symptoms were included. In vitro studies were excluded. From the publications perused in the initial database, 3157 results were identified, reviewed and a total of 23 studies were included. Preclinical studies using critically validated models were conducted, with some promising preliminary results. Data availability on controlled clinical studies is currently very limited. The use of different methodologies and the very small number of patients raise doubts about the effects of these preparations. Available data do not yet allow us to suggest the effectiveness of herbal medicines as an add-on in the treatment of ASD symptoms. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  13. Definition of Health 2.0 and Medicine 2.0: a systematic review.

    NARCIS (Netherlands)

    Belt, T. van den; Engelen, L.J.; Berben, S.A.A.; Schoonhoven, L.J.

    2010-01-01

    BACKGROUND: During the last decade, the Internet has become increasingly popular and is now an important part of our daily life. When new "Web 2.0" technologies are used in health care, the terms "Health 2.0" or "Medicine 2.0" may be used. OBJECTIVE: The objective was to identify unique definitions

  14. Are agricultural and natural sources of bio-products important for modern regenerative medicine? A review

    Directory of Open Access Journals (Sweden)

    Maciej Nowacki

    2017-05-01

    Evolving trends in agriculture are likely to play a key role in the future development of a number of systemic and local medical procedures within tissue engineering and regenerative medicine. This is in addition to the use of bio-products derived from the natural environment which are found to deliver positive results in the treatment of prospective patients.

  15. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Science.gov (United States)

    2010-08-17

    ... parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized... the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and...

  16. Complementary and Alternative Medicine: The Mozart Effect on Childhood Epilepsy--A Systematic Review

    Science.gov (United States)

    Brackney, Dana E.; Brooks, Jessica L.

    2018-01-01

    This systematic review examines the effectiveness of Mozart's music in decreasing seizures in children with epilepsy (Mozart Effect) using the Johns Hopkins Nursing Evidence-Based Practice rating scale©. A search for articles with "Mozart Effect," "child*," and "epilepsy" was conducted in CINAHL Complete, Science…

  17. Treatment of cholecystitis with Chinese herbal medicines: A systematic review of the literature

    Science.gov (United States)

    Dong, Zhi-Yong; Wang, Guan-Liang; Liu, Xing; Liu, Jia; Zhu, De-Zeng; Ling, Chang-Quan

    2012-01-01

    AIM: To analyze the literature on the use of Chinese herbal medicines for the treatment of cholecystitis. METHODS: The literature on treatment of cholecystitis with traditional Chinese medicines (TCM) was analyzed based on the principles and methods described by evidence-based medicine (EBM). Eight databases including MEDLINE, EMbase, Cochrane Central (CCTR), four Chinese databases (China Biological Medicine Database, Chinese National Knowledge Infrastructure Database, Database of Chinese Science and Technology Periodicals, Database of Chinese Ministry of Science and Technology) and Chinese Clinical Registry Center, were searched. Full text articles or abstracts concerning TCM treatment of cholecystitis were selected, categorized according to study design, the strength of evidence, the first author’s hospital type, and analyzed statistically. RESULTS: A search of the literature published from 1977 through 2009 yielded 1468 articles in Chinese and 9 in other languages; and 93.92% of the articles focused on clinical studies. No article was of level I evidence, and 9.26% were of level II evidence. The literature cited by Science Citation Index (SCI), MEDLINE and core Chinese medical journals accounted for 0.41%, 0.68% and 7.29%, respectively. Typically, the articles featured in case reports of illness, examined from the perspective of EBM, were weak in both quality and evidence level, which inconsistently conflicted with the fact that most of the papers were by authors from Level-3 hospitals, the highest possible level evaluated based on their comprehensive quality and academic authenticity in China. CONCLUSION: The published literature on TCM treatment of cholecystitis is of low quality and based on low evidence, and cognitive medicine may functions as a useful supplementary framework for the evaluation. PMID:22529700

  18. The use of traditional medicine in maternity care among African women in Africa and the diaspora: a systematic review.

    Science.gov (United States)

    Shewamene, Zewdneh; Dune, Tinashe; Smith, Caroline A

    2017-08-02

    There is a paucity of literature describing traditional health practices and beliefs of African women. The purpose of this study was to undertake a systematic review of the use of traditional medicine (TM) to address maternal and reproductive health complaints and wellbeing by African women in Africa and the diaspora. A literature search of published articles, grey literature and unpublished studies was conducted using eight medical and social science databases (CINAHL, EMBASE, Infomit, Ovid Medline, ProQuest, PsychINFO, PubMed and SCOPUS) from the inception of each database until 31 December 2016. Critical appraisal was conducted using a quality assessment tool (QAT). A total of 20 studies conducted in 12 African countries representing 11,858 women were included. No literature was found on African women in the diaspora related to maternal use of TM or complementary and alternative medicine (CAM). The prevalence of TM use among the African women was as high as 80%. The most common TM used was herbal medicine for reasons related to treatment of pregnancy related symptoms. Frequent TM users were pregnant women with no formal education, low income, and living far from public health facilities. Lack of access to the mainstream maternity care was the major determining factor for use of TM. TM is widely used by African women for maternal and reproductive health issues due to lack of access to the mainstream maternity care. Further research is required to examine the various types of traditional and cultural health practices (other than herbal medicine), the beliefs towards TM, and the health seeking behaviors of African women in Africa and the diaspora.

  19. A systematic review and meta-analysis of traditional insect Chinese medicines combined chemotherapy for non-surgical hepatocellular carcinoma therapy.

    Science.gov (United States)

    Shi, Zhaofeng; Song, Tiebing; Wan, Yi; Xie, Juan; Yan, Yiquan; Shi, Kekai; Du, Yongping; Shang, Lei

    2017-06-28

    On the background of high morbidity and mortality of hepatocellular carcinoma (HCC) and rapid development of traditional Chinese medicine (TCM), we conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to assess the clinical effectiveness and safety of traditional insect Chinese medicine and related preparation for non-surgical HCC. RCTs were searched based on standardized searching rules in mainstream medical databases from the inception up to May 2016. Ultimately, a total of 57 articles with 4,651 patients enrolled in this meta-analysis. We found that traditional insect Chinese medicine and related preparation combined chemotherapy show significantly effectiveness and safety in objective response rate (P traditional insect Chinese medicine and related preparations could be recommended as auxiliary therapy combined chemotherapy for HCC therapy.

  20. Systematic Problem Solving in Production: The NAX Approach

    DEFF Research Database (Denmark)

    Axelsdottir, Aslaug; Nygaard, Martin; Edwards, Kasper

    2017-01-01

    This paper outlines the NAX problem solving approach developed by a group of problem solving experts at a large Danish Producer of medical equipment. The company, “Medicmeter” is one of Denmark’s leading companies when it comes to lean and it has developed a strong problem solving culture. The main...... steps of the approach are to extensively gather direct detailed process knowledge at the actual process, assemble a team that systematically builds on each other ideas, apply team thinking in a structured way to get a rapid and very deep understanding of the problem, and conducting a structured...

  1. [Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

    Science.gov (United States)

    Niimi, Shingo

    2015-01-01

    Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

  2. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe

    Directory of Open Access Journals (Sweden)

    Andreas M. Farkas

    2017-05-01

    Full Text Available In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs. We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP, or gene therapy medicinal product (GTMP] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA and other Committees [Committee for Advanced Therapies (CAT and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%. ATMPs ODDs were primarily GTMPs (48.7% and SCTMPs (43.3%. TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP. Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three have received a marketing authorization (MAA and a 10-year market exclusivity. Strimvelis also completed their

  3. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.

    Science.gov (United States)

    Farkas, Andreas M; Mariz, Segundo; Stoyanova-Beninska, Violeta; Celis, Patrick; Vamvakas, Spiros; Larsson, Kristina; Sepodes, Bruno

    2017-01-01

    In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP), or gene therapy medicinal product (GTMP)] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA) and other Committees [Committee for Advanced Therapies (CAT) and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%). ATMPs ODDs were primarily GTMPs (48.7%) and SCTMPs (43.3%). TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD) ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP). Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three) have received a marketing authorization (MAA) and a 10-year market exclusivity. Strimvelis also completed their PIP

  4. A systematic apporach to service oriented product development

    DEFF Research Database (Denmark)

    Matzen, Detlef

    Throughout the last years, manufacturing industry has experienced a trend towards a higher level of operational integration with their customers, i.e. manufacturers differentiate their offer from competitors by combining physical and software products with service plans and service support...... for the creation of these Product/Service-Systems (PSS). The contribution builds on the foundations of engineering design and product development research performed at the Section of Engineering Design and Product Development at The Technical University of Denmark, also dubbed the Copenhagen school. Service...

  5. Systematic validation of medicinally important genus epimedium species based on microsatellite markers

    International Nuclear Information System (INIS)

    Yousif, Z.

    2015-01-01

    Epimedium is taxonomically complicated in terms of identification and availability of limited phenotypical markers. Therefore in the present study, 36 SSR primers markers were used for 44 individuals belonging to 13 medicinal species of the Epimedium genus and one out group species Vancouveria hexandra W. J. Hooker to resolve their existing taxonomic problems. A total of 164 alleles by genomic SSR were detected. The markers were presented between 2-10 alleles per locus. Jacard index cluster analysis revealed two main and four subclusters. Principle component analysis indicated that genetic variability is analogous to geographical variability. It has been concluded that medicinally important species of the genus Epimedium possesses sufficient genetic variation for effective resolution of the existing taxonomic problems in combination of morphological markers. (author)

  6. A systematic review of counterfeit and substandard medicines in field quality surveys

    OpenAIRE

    Alghannam, Abdulaziz; Evans,Sara; Schifano,Fabrizio; Aslanpour,Zoe

    2014-01-01

    Abdulaziz Fahad Abdulaziz Alghannam, Zoe Aslanpour, Sara Evans, Fabrizio Schifano Department of Pharmacy, University of Hertfordshire, Hatfield, Hertfordshire, United Kingdom Objectives: Counterfeit and substandard medicines pose a great threat to public health and the economy worldwide. Reports suggest their prevalence is increasing and can no longer be ignored. A detailed account on the current nature of the problem and identification of knowledge limitations in terms of geographical locat...

  7. A Systematic Review of Herbal Medicine for Chemotherapy Induced Peripheral Neuropathy

    Science.gov (United States)

    Noh, Hyeonseok

    2018-01-01

    Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients. The aim of this review was to assess the effectiveness of herbal medicine in preventing and treating CIPN. Methods Randomised controlled trials were included in this review. Extracting and assessing the data independently, two authors searched 13 databases. Results Twenty-eight trials involving 2174 patients met the inclusion criteria. Although there were some exceptions, the methodological quality was typically low. Seventeen trials reported the incidence rate of CIPN assessed by various tools and 14 showed a significant difference regarding the decrease of the incidence rate between the two groups. For clinical improvement, 12 trials reported it using various tools and 10 showed a significant difference between two groups. Two cases of adverse events occurred in one trial; the other nine trials reported no adverse events. Conclusions We found that herbal medicines in combination with and/or without other therapies potentially have preventive or therapeutic effects on CIPN. However, conclusions cannot be drawn because of the generally low quality of the methodology, the clinical heterogeneity, and the small sample size for each single herbal medicine. Trials that are more rigorous and report sufficient methodological data are needed. PMID:29636782

  8. Chinese herbal medicine in treatment of polyhydramnios:a meta-analysis and systematic review.

    Science.gov (United States)

    Zhou, Fen; Hao, Yu-fang; Chen, Yan; Wang, Tong

    2013-06-01

    To compare the efficacy of Chinese herbal medicine (therapy A) or Chinese herbal medicine plus indomethacin (therapy B) with that of indomethacin alone (therapy C) in treating polyhydramnios. Literatures published up to April 2012 were retrieved from PubMed, Embase and Cochrane library, Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific and Technological Periodical Database (VIP), Wangfang, and Traditional Chinese Medicine online. Two researchers collected data independently. The assessment of methodological quality was based on Cochrane handbook and the materials were analyzed with software RevMan 5.1.2. The outcome measure index was relative risk or difference of mean value (95% confidence interval). The following outcomes were evaluated (1) general clinical improvement rate; (2) maximum vertical pocket depth; (3) amniotic fluid index (AFI) value; (4) rate of fetal ductus arteriosus constriction; (5) incidence of adverse events. Based on the search strategy, 5 trails involving 1017 patients were finally included. Compared with therapy C, therapy A decreased the rate of fetal ductus arteriosus constriction (Ppolyhydramnios (Ppolyhydramnios. However, the exact effect needs to be confirmed with well-designed large-scale clinical trials.

  9. Application of plant cell and tissue culture for the production of phytochemicals in medicinal plants.

    Science.gov (United States)

    Pant, Bijaya

    2014-01-01

    Approximately 80% of the world inhabitants depend on the medicinal plants in the form of traditional formulations for their primary health care system well as in the treatment of a number of diseases since the ancient time. Many commercially used drugs have come from the information of indigenous knowledge of plants and their folk uses. Linking of the indigenous knowledge of medicinal plants to modern research activities provides a new reliable approach, for the discovery of novel drugs much more effectively than with random collection. Increase in population and increasing demand of plant products along with illegal trade are causing depletion of medicinal plants and many are threatened in natural habitat. Plant tissue culture technique has proved potential alternative for the production of desirable bioactive components from plants, to produce the enough amounts of plant material that is needed and for the conservation of threatened species. Different plant tissue culture systems have been extensively studied to improve and enhance the production of plant chemicals in various medicinal plants.

  10. Computer-based HIV adherence promotion interventions: a systematic review: Translation Behavioral Medicine

    OpenAIRE

    Claborn, Kasey R.; Fernandez, Anne; Wray, Tyler; Ramsey, Susan

    2015-01-01

    Researchers have instituted a range of methodologies to increase access to HIV adherence interventions. This article reviews studies published through January 2014 utilizing computer-based delivery of such interventions to persons living with HIV. A systematic review of five databases identified ten studies (three RCTs, three pilot studies, three feasibility studies, and one single-group trial) that met the inclusion criteria. Descriptions of the interventions’ content and characteristics are...

  11. Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland.

    Science.gov (United States)

    Koski, Sari M; Laitinen-Parkkonen, Pirjo; Airaksinen, Marja

    2015-01-01

    The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied. Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products. Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent. Copyright © 2013 John Wiley & Sons, Ltd.

  12. Medicinal plants and natural products in amelioration of arsenic toxicity: a short review.

    Science.gov (United States)

    Bhattacharya, Sanjib

    2017-12-01

    Chronic arsenic toxicity (arsenicosis) is considered a serious public health menace worldwide, as there is no specific, safe, and efficacious therapeutic management of arsenicosis. To collate the studies on medicinal plants and natural products with arsenic toxicity ameliorative effect, active pre-clinically and/or clinically. Literature survey was carried out by using Google, Scholar Google and Pub-Med. Only the scientific journal articles found on the internet for last two decades were considered. Minerals and semi-synthetic or synthetic analogs of natural products were excluded. Literature study revealed that 34 medicinal plants and 14 natural products exhibited significant protection from arsenic toxicity, mostly in preclinical trials and a few in clinical studies. This research could lead to development of a potentially useful agent in clinical management of arsenicosis in humans.

  13. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    Science.gov (United States)

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  14. The univocal identification and safe dispensation of medicinal products across Europe – challenges and solution proposal

    Directory of Open Access Journals (Sweden)

    Stroetmann, Karl A.

    2017-12-01

    Full Text Available Problem: The Smart Open Services for European Patients (epSOS the exchange of electronic Patient Summaries and ePrescriptions between selected member states of the European Union (EU. This project basically solved the ‘communication’ or message transfer problem. However, it encountered a serious ‘delivery’ problem: the safe dispensation of a medicinal product noted in a prescription from a given country by a retail pharmacist in another country. The reason for this was that the specified medicine could in many instances not univocally be identified – the same name may identify a product with a different active ingredient, or the product with identical composition may carry a different name in the other country. If the prescribed medicine had not been authorised for marketing in the other country, information on its attributes may not be available. This rendered dispensation by the pharmacist impossible, even where substitution would, in principle, be allowed and possible.Objectives: This paper reports on the goal, activities and achievements of the openMedicine project towards development of a digital solution and its implementation to meet this identification and the resulting delivery challenge. European-wide and cross-Atlantic endeavours to enhance pharmacovigilance by being able to match adverse event reports filed under different drug names which provide, however, for the same active ingredient(s were developed upon. And the need for and benefits of being able to trace for clinical purposes, e.g. the longer-term treatment with the same active ingredient, even when the name of the prescribed medicine changed several times, were explored.Methodological approach: The openMedicine project was funded by the European Commission (EC on behalf of member states to analyse this European-wide problem. Work benefitted from the epSOS project and work by the European Medicines Agency (EMA, the USA Federal Drug Agency (FDA, and standard

  15. The Chain Information Model: a systematic approach for food product development

    NARCIS (Netherlands)

    Benner, M.

    2005-01-01

    The chain information model has been developed to increase the success rate of new food products. The uniqueness of this approach is that it approaches the problem from a chain perspective and starts with the consumer. The model can be used to analyse the production chain in a systematic way. This

  16. Dairy products and colorectal cancer risk : a systematic review and meta-analysis of cohort studies

    NARCIS (Netherlands)

    Aune, D.; Lau, R.; Chan, D.S.M.; Vieira, R.; Greenwood, D.C.; Kampman, E.; Norat, T.

    2012-01-01

    Background: Previous studies of the association between intake of dairy products and colorectal cancer risk have indicated an inverse association with milk, however, the evidence for cheese or other dairy products is inconsistent. Methods: We conducted a systematic review and meta-analysis to

  17. Dairy products and colorectal cancer risk: a systematic review and meta-analysis of cohort studies.

    NARCIS (Netherlands)

    Aune, D.; Lau, R.; Chan, D.S.; Vieira, R.; Greenwood, D.C.; Kampman, E.; Norat, T.

    2012-01-01

    BACKGROUND: Previous studies of the association between intake of dairy products and colorectal cancer risk have indicated an inverse association with milk, however, the evidence for cheese or other dairy products is inconsistent. METHODS: We conducted a systematic review and meta-analysis to

  18. [Phenotypic and genotypic characterization of probiotic bacterial strains used in medicinal products].

    Science.gov (United States)

    Wiatrzyk, Aldona; Polak, Maciej; Czajka, Urszula; Krysztopa-Grzybowska, Katarzyna; Lutyńska, Anna

    2013-01-01

    The optimization of quality testing strategy of products containing probiotics might allow to general improvement of its safer use in humans. The goal of the study was the evaluation of quality expressed by identity, colony forming unit (CFU) and antibiotic sensitivity ofprobiotics used in medicinal products available in Poland using the appropriate and validated procedures. The medicinal products containing L. rhamnosus, L. acidophilus, L. delbrueckii subsp. bulgaricus and B. animalis subsp. lactis, L. helveticus, and L. gasseri were tested for species identity performed with validated rep-PCR (BOXA 1R) method. The antimicrobial susceptibility of working seeds and strains isolated to 26 antibiotics were tested by disk diffusion and E-test methods using relevant references as recommended by EUCAST. The numbers of probiotic strains, expressed as cfu count per package, was done using plating plunge method. All strains tested, except B. lactis, were found to be resistant to trimethoprim-sulphamethoxazole, nalidixic acid, metronidazole, and colistin. B. lactis was resistant to aminoglycosides. L. rhamnosus strains were found to be resistant to vancomycin, (MIC > 256 microg/ml) similarly to ATCC strains (L. rhamnosus GG 53103 and 244). The sensitivity to other antibiotics was strain specific. The rep-PCR method was found species and strain specific. All products tested fulfilled declared countent as measured by cfu count/package. Quality of medicinal products containing probiotics was found undoubted and confirmed. The optimized strategy of quality monitoring of probiotics used in medicinal products can be used in dietary supplements and foodstuffs intended for particular nutritional uses.

  19. A systematic review of complementary and alternative medicine interventions for the management of cancer-related fatigue.

    Science.gov (United States)

    Finnegan-John, Jennifer; Molassiotis, Alex; Richardson, Alison; Ream, Emma

    2013-07-01

    Fatigue, experienced by patients during and following cancer treatment, is a significant clinical problem. It is a prevalent and distressing symptom yet pharmacological interventions are used little and confer limited benefit for patients. However, many cancer patients use some form of complementary and alternative medicine (CAM), and some evidence suggests it may relieve fatigue. A systematic review was conducted to appraise the effectiveness of CAM interventions in ameliorating cancer-related fatigue. Systematic searches of biomedical, nursing, and specialist CAM databases were conducted, including Medline, Embase, and AMED. Included papers described interventions classified as CAM by the National Centre of Complementary and Alternative Medicine and evaluated through randomized controlled trial (RCT) or quasi-experimental design. Twenty studies were eligible for the review, of which 15 were RCTs. Forms of CAM interventions examined included acupuncture, massage, yoga, and relaxation training. The review identified some limited evidence suggesting hypnosis and ginseng may prevent rises in cancer-related fatigue in people undergoing treatment for cancer and acupuncture and that biofield healing may reduce cancer-related fatigue following cancer treatments. Evidence to date suggests that multivitamins are ineffective at reducing cancer-related fatigue. However, trials incorporated within the review varied greatly in quality; most were methodologically weak and at high risk of bias. Consequently, there is currently insufficient evidence to conclude with certainty the effectiveness or otherwise of CAM in reducing cancer-related fatigue. The design and methods employed in future trials of CAM should be more rigorous; increasing the strength of evidence should be a priority.

  20. Benefits and Harms in Pivotal Trials of Oral Centrally Acting Antiobesity Medicines: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Onakpoya, Igho J; Collins, Dylan R J; Bobrovitz, Niklas J H; Aronson, Jeffrey K; Heneghan, Carl J

    2018-03-01

    To evaluate the benefits and harms of oral centrally acting antiobesity medicinal products in pivotal trials. The European Medicines Agency and Federal Drug Administration websites, PubMed, and ClinicalTrials.gov were searched to identify pivotal trials used to gain marketing authorizations. Pivotal phase III trials on which marketing authorizations were based were included. The data were analyzed by using Cochrane Review Manager (RevMan), and quality assessments for each outcome were performed by using the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE). Five products (16 trials with 24,555 participants) were included. Significantly more participants who took the antiobesity products achieved ≥ 5% reduction in body weight (risk ratio [RR] 2.39; 95% CI: 2.09-2.74; GRADE = low). However, the products significantly increased the risk of adverse events (RR 1.12; 95% CI: 1.07-1.17; GRADE = very low) and the risk of discontinuation because of adverse events (RR 1.52; 95% CI: 1.33-1.74; GRADE = low). There were no significant differences for most outcomes between currently approved and withdrawn products. Although oral centrally acting antiobesity products generate modest weight losses, they also increase the risks of adverse events and discontinuations because of adverse events. The premarketing benefit-to-harm profiles of currently available products and products that were later withdrawn because of harms are similar. Targeted study designs, better outcomes reporting, and improved postmarketing monitoring of harms are needed. © 2018 The Obesity Society.

  1. Systematic Computer-Aided Framework for Sustainable Chemical Product Design

    DEFF Research Database (Denmark)

    Cignitti, Stefano; Zhang, Lei; Kalakul, Sawitree

    for CAPD, including the accuracy of the property estimation, molecular structure generation, inclusion of sustainability, process and application targets and needs in the problem formulation. CAPD has been widely utilized for the synthesis of several types of products, such as solvents, polymers, fuels...... and environmental impact. In step (3), the CAPD formulation is converted into a mixed-integer nonlinear program (MINLP) by set-up of constraints, objective and boundaries defined in step (2). In step (4), the MINLP is solved through a decomposed approach [3]. The decomposed approach breaks down the MINLP problem...... and formulated products [2]. However, for product design problems where the process needs and sustainability possess demanding constraints, the complexity of the problem is increased as the relation between product property, sustainability and process criteria is difficult to mathematically define. In this work...

  2. The Use of Traditional Media for Public Communication about Medicines: A Systematic Review of Characteristics and Outcomes.

    Science.gov (United States)

    Catalan-Matamoros, Daniel; Peñafiel-Saiz, Carmen

    2017-12-18

    A systematic review was conducted to identify, appraise, and synthesize data from original research investigating the use of traditional media for public communication about medicines. Databases were searched for studies conducting quantitative or qualitative analyses between the years 2007 and 2017. Data extraction and assessment of the quality of the resulting studies was conducted by one reviewer and checked for accuracy by a second reviewer. A total of 57 studies met the inclusion criteria. Studies were grouped as follows: "newspapers and other print media" (n = 42), "television" (n = 9), and "radio and a combination of media" (n = 6). Content analysis (n = 34) was the most frequent research design, followed by surveys or interviews (n = 14) and randomized controlled trials (RCTs) (n = 9). Advertising, public awareness, and health administration were the most common themes, and the medicines most analyzed were vaccines, particularly human papillomavirus (HPV) and influenza. Studies conducted in the United States were the most frequent, followed by other high-income countries such as Canada and the United Kingdom. The lack of consistent studies of the effects of media campaigns stresses the importance of the use of standardized research methodologies. Theoretical and practical implications of the findings for further research are discussed.

  3. Trends in research productivity of residents applying for orthopedic sports medicine fellowship.

    Science.gov (United States)

    DeFroda, Steven F; Shah, Kalpit N; Safdar, Omar; Mulcahey, Mary K

    2018-02-01

    Though there are no research requirements to match into an orthopaedic sports medicine fellowship, many applicants are productive in research endeavors during residency. We hypothesize that the number of publications by Orthopaedic sports medicine applicants are increasing. A list of current and recent sports medicine fellows was compiled from publicly accessible information on sports medicine fellowship websites. Articles published while the fellow was a resident were identified via publicly available search engines. The following information was collected: year of fellowship and years of residency, fellowship program, geographic location of fellowship program, total number of publications (noting specifically first and last author publications), number of publications in high impact orthopaedic journals (AJSM, JBJS Am, JSES, or Arthroscopy). Overall, 189 fellowship-matched surgeons from 2010 - 2017 were identified. There were 746 publications (average of 3.95 per fellow), with 218 (29.2%) in high impact orthopaedic journals. Surgeons who completed their fellowship during the 2016-17 academic year, published on average 5.42 publications per fellow. Fellowship applicants in the Northeast region had the highest number of total publications (359 publications, 48.1% of all publications; 6.41 publications per fellow). Applicants were listed most often as middle authors (462 publications, 61.9%). There has been an overall increase in the number of publications among sports medicine fellowship applicants in the last several academic years. Fellowship programs in the northeast United States tended to match applicants with a higher number of publications.

  4. Application of Metabolomics to Quality Control of Natural Product Derived Medicines.

    Science.gov (United States)

    Lee, Kyung-Min; Jeon, Jun-Yeong; Lee, Byeong-Ju; Lee, Hwanhui; Choi, Hyung-Kyoon

    2017-11-01

    Metabolomics has been used as a powerful tool for the analysis and quality assessment of the natural product (NP)-derived medicines. It is increasingly being used in the quality control and standardization of NP-derived medicines because they are composed of hundreds of natural compounds. The most common techniques that are used in metabolomics consist of NMR, GC-MS, and LC-MS in combination with multivariate statistical analyses including principal components analysis (PCA) and partial least squares-discriminant analysis (PLS-DA). Currently, the quality control of the NP-derived medicines is usually conducted using HPLC and is specified by one or two indicators. To create a superior quality control framework and avoid adulterated drugs, it is necessary to be able to determine and establish standards based on multiple ingredients using metabolic profiling and fingerprinting. Therefore, the application of various analytical tools in the quality control of NP-derived medicines forms the major part of this review. Veregen ® (Medigene AG, Planegg/Martinsried, Germany), which is the first botanical prescription drug approved by US Food and Drug Administration, is reviewed as an example that will hopefully provide future directions and perspectives on metabolomics technologies available for the quality control of NP-derived medicines.

  5. A Systematic Review of the Quality of IV Fluid Therapy in Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    William W. Muir

    2017-08-01

    Full Text Available ObjectiveTo evaluate the quality of the veterinary literature investigating IV fluid therapy in dogs, cats, horses, and cattle.DesignSystematic review.ProceduresThe preferred reporting of items for systematic review and meta-analysis protocols (PRISMA-P was employed for systematic review of all relevant IV fluid therapy manuscripts published from January 1969 through December 2016 in the Commonwealth Agricultural Bureaux International (CABI database. Independent grading systems used to evaluate manuscripts included the updated CONsolidated Standards of Reporting Trials 2012 checklist, risk of bias for animal intervention studies, criteria for levels of evidence, and methodological quality (Jadad scale. The quality of articles published before and after 2010 was compared.ResultsOne hundred and thirty-nine articles (63 dogs, 7 cats, 39 horses, 30 cattle from 7,258 met the inclusion criteria. More than 50% of the manuscripts did not comply with minimal requirements for reporting randomized controlled trials. The most non-compliant items included identification of specific predefined objectives or a hypothesis, identification of trial design, how sample size was determined, randomization, and blinding procedures. Most studies were underpowered and at risk for selection, performance, and detection bias. The overall quality of the articles improved for articles published after 2010.Conclusion and clinical relevanceMost of the veterinary literature investigating the administration of IV fluid therapy in dogs, cats, horses, and cattle is descriptive, does not comply with standards for evidence, or provide adequate translation to clinical practice. Authors should employ and journal editors should enforce international consensus recommendations and guidelines for publication of data from animal experiments investigating IV fluid therapy.

  6. Time-motion studies of internal medicine residents' duty hours: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Leafloor CW

    2015-11-01

    Full Text Available Cameron W Leafloor,1 Heather A Lochnan,2,3,6 Catherine Code,2,4 Erin J Keely,2,3,6 Deanna M Rothwell,5,6 Alan J Forster,2,4–6 Allen R Huang2,6,7 1Faculty of Medicine, 2Department of Medicine, 3Division of Endocrinology and Metabolism, 4Division of General Internal Medicine, 5Performance Measurement and Innovation, 6Ottawa Hospital Research Institute, 7Division of Geriatric Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada Background: Since the mid-1980s, medical residents' long duty hours have been under scrutiny as a factor affecting patient safety and the work environment for the residents. After several mandated changes in duty hours, it is important to understand how residents spend their time before proposing and implementing future changes. Time-motion methodology may provide reliable information on what residents do while on duty.Purpose: The purpose of this study is to review all available literature pertaining to time-motion studies of internal medicine residents while on a medicine service and to understand how much of their time is apportioned to various categories of tasks, and also to determine the effects of the Accreditation Council for Graduate Medical Education (ACGME-mandated duty hour changes on resident workflow in North America.Methods: Electronic bibliographic databases were searched for articles in English between 1941 and April 2013 reporting time-motion studies of internal medicine residents rotating through a general medicine service.Results: Eight articles were included. Residents spent 41.8% of time in patient care activities, 18.1% communicating, 13.8% in educational activities, 19.7% in personal/other, and 6.6% in transit. North American data showed the following changes after the implementation of the ACGME 2003 duty hours standard: patient care activities from 41.8% to 40.8%, communication activities from 19.0% to 22.3%, educational activities from 17.7% to 11.6%, and personal

  7. Methodological quality and reporting of generalized linear mixed models in clinical medicine (2000-2012): a systematic review.

    Science.gov (United States)

    Casals, Martí; Girabent-Farrés, Montserrat; Carrasco, Josep L

    2014-01-01

    Modeling count and binary data collected in hierarchical designs have increased the use of Generalized Linear Mixed Models (GLMMs) in medicine. This article presents a systematic review of the application and quality of results and information reported from GLMMs in the field of clinical medicine. A search using the Web of Science database was performed for published original articles in medical journals from 2000 to 2012. The search strategy included the topic "generalized linear mixed models","hierarchical generalized linear models", "multilevel generalized linear model" and as a research domain we refined by science technology. Papers reporting methodological considerations without application, and those that were not involved in clinical medicine or written in English were excluded. A total of 443 articles were detected, with an increase over time in the number of articles. In total, 108 articles fit the inclusion criteria. Of these, 54.6% were declared to be longitudinal studies, whereas 58.3% and 26.9% were defined as repeated measurements and multilevel design, respectively. Twenty-two articles belonged to environmental and occupational public health, 10 articles to clinical neurology, 8 to oncology, and 7 to infectious diseases and pediatrics. The distribution of the response variable was reported in 88% of the articles, predominantly Binomial (n = 64) or Poisson (n = 22). Most of the useful information about GLMMs was not reported in most cases. Variance estimates of random effects were described in only 8 articles (9.2%). The model validation, the method of covariate selection and the method of goodness of fit were only reported in 8.0%, 36.8% and 14.9% of the articles, respectively. During recent years, the use of GLMMs in medical literature has increased to take into account the correlation of data when modeling qualitative data or counts. According to the current recommendations, the quality of reporting has room for improvement regarding the

  8. Are agricultural and natural sources of bio-products important for modern regenerative medicine? A review.

    Science.gov (United States)

    Nowacki, Maciej; Nowacka, Katarzyna; Kloskowski, Tomasz; Pokrywczyńska, Marta; Tyloch, Dominik; Rasmus, Marta; Warda, Karolina; Drewa, Tomasz

    2017-05-11

    [b] Abstract Introduction and objectives[/b]. As tissue engineering and regenerative medicine have continued to evolve within the field of biomedicine, the fundamental importance of bio-products has become increasingly apparent. This true not only in cases where they are derived directly from the natural environment, but also when animals and plants are specially bred and cultivated for their production. [b]Objective.[/b] The study aims to present and assess the global influence and importance of selected bio-products in current regenerative medicine via a broad review of the existing literature. In particular, attention is paid to the matrices, substances and grafts created from plants and animals which could potentially be used in experimental and clinical regeneration, or in reconstructive procedures. [b]Summary.[/b] Evolving trends in agriculture are likely to play a key role in the future development of a number of systemic and local medical procedures within tissue engineering and regenerative medicine. This is in addition to the use of bio-products derived from the natural environment which are found to deliver positive results in the treatment of prospective patients.

  9. Restrictions on the conduct of advertising of medicinal products in Poland and their violations.

    Science.gov (United States)

    Czerw, Aleksandra; Marek, Ewelina Maria

    2013-01-01

    Similarly to other European countries, the Polish pharmaceutical market is in the phase of maturity characterized by limited speed of increase in sales. In connection with escalation of the competitive struggle, being the result of globalization and development of enterprises producing generic medications, the most important aim for pharmaceutical companies has been to maintain profitability on the right level. To perform this task, companies producing medications have to carry out proper marketing actions. The marketing elements include, apart from the product, the price and the distribution, also promotion which is inextricably linked with advertising. It is a special type of information message that aims at evoking a specific consumer's attitude and belief. Advertising of medicinal products is subject to detailed legislative and non-legislative regulations. The aim of the article is to present legal regulations within the scope of advertising of medicinal products and violations of these regulations based on example decisions of the Main Pharmaceutical Inspector issued in the years 2008-2010. Abundant rulings of the Main Pharmaceutical Inspector prove that both advertisements addressed to public attention and those addressed to specialists often diverge from the criteria determined by the Pharmaceutical Law. In the face of still increasing violations of the provisions of the Pharmaceutical Law act, it seems that introducing a ban on advertising or any possible financial sanctions is not a sufficient punishment for advertisers. Thus, an introduction of other, more rigorous legal regulations as a deterrent for those involved in illegal advertising of medicinal products ought to be considered.

  10. Medical application of nuclear science: nuclear medicine and production of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Cornet, L.

    1997-01-01

    Nuclear science in attendance on medicine or from Radium to Radiopharmaceuticals. By a brief historical reminder of the evolution of the radioactivity and development of nuclear science, we could see a very early interest and application of the radioactivity in the medical field. Main steps: Detection of natural radioactivity/Discovery of artificial radioactivity/First treatment of leukaemia and thyroid/First nuclear reactor/First radioisotope laboratory in hospital/First scintigraphy/First radiopharmaceutical/First cyclotron and cyclotron products/First immunoscintigraphy/Biotechnology and radioisotope/Evolution of technics [equipment for diagnosis (imaging, scintigraphy) and therapy]/Evolution of production technics and concept of products (generators of Technetium) and machines, reactor, cyclotron/Evolution of importance and interest of nuclear medicine/Creation of international association of nuclear medicine and producers (example ARPR)/Evolution of safety and pharmaceuticals regulation. After the sixties, period extremely rich in invention of products, characterized by a high fertility specially due to a non-restrictive regulation in terms of safety and pharmaceutical consideration, the evolution of technics, the importance of costs (investment, research, healthcare and the evolution of the regulations) have smoothly but continuously transformed the contexts and different actors. Consequences and facts: Rationalization and standardization of the catalogues, total integration of radiopharmaceuticals into the pharmaceutical laws, stop of nuclear research reactors, increase of number of cyclotrons, transformation of size and role of the producers and nuclear centers, risk in supply of some raw materials like Molybdenum, medical nuclear application as a worldwide business

  11. Oral Chinese Herbal Medicine for Treatment of Dilated Cardiomyopathy: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Yu-Shuo Zhu

    2016-01-01

    Full Text Available Dilated cardiomyopathy (DCM is one of the main causes of heart failure and could increase death, hospitalization, and rehospitalization rate. The effect of conventional medicine treatment (CMT is limited; meanwhile, the combination of CMT and Oral Chinese Herbal Medicine (OCHM represents exciting adjunctive therapies. In this study, we ascertained the therapeutic effect of OCHM in combination with CMT for dilated cardiomyopathy by using meta-analysis methods for controlled clinical trials. We searched studies from five databases and extracted data from these studies. We also assessed the methodological quality of the included studies. We evaluated the following outcome measures to estimate the prognosis in patients with DCM: left ventricular ejection fraction (LVEF, left ventricular end-diastolic dimension (LVEDD, stroke volume (SV, brain natriuretic peptide (BNP, 6-minute walk test (6MWT, and overall efficacy. The result showed that OCHM combined with CMT for the improvement of therapeutic effect in DCM patients. However, the evidence remains weak due to the small sample size, high clinical heterogeneity, and poor methodological quality of the included trials. Further, large sample size and well-designed trials are needed.

  12. Addressing the challenge of high-priced prescription drugs in the era of precision medicine : A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

    NARCIS (Netherlands)

    Gronde, T.V. (Toon van der); C.A. Uyl-de Groot (Carin); Pieters, T. (Toine)

    2017-01-01

    markdownabstractCONTEXT: Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. METHOD: A systematic review of Pubmed, the

  13. Addressing the challenge of high-priced prescription drugs in the era of precision medicine : a systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

    NARCIS (Netherlands)

    van der Gronde, T.; Uyl-de Groot, Carin A; Pieters, A.H.L.M.|info:eu-repo/dai/nl/188785833

    2017-01-01

    Context. Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. Method. A systematic review of Pubmed, the Financial Times,

  14. THE PRODUCTION OF MEDICINES IN ROMANIA AFTER 1990. WHAT'S THE REASON FOR IMPORTS?

    Directory of Open Access Journals (Sweden)

    Unita Lucian

    2011-12-01

    Full Text Available Since 1990, Romania turned itself slowly but surely, from a large drugs producer, which has used to supplydrugs to the whole former Council for Mutual Economic Assistance Member States, and with a net positive trade balance in medicine sector, into a large drugs importer, trying hardly to attract investors which could produce medicines not only for the Romanian domestic market, but also for all other Eastern European markets, Ukraine, Russia and Turkey. This paper focuses on the empirical analisys of the medicines production sector in Romania after 1990, aiming to emphasises the factors which have mostly affected this industry, in correlation with different interests and reasons which determined the increasing imports of drugs during the last years, by underlying at the same time, the role of the new public authority in charge of supervising the distribution and import of medicines in Romania, The National Medicines Administration (NMA. The paper relevance relies in the fact that Romania registered during the last years drug imports of an average of 1.7 billion euros, while the drug exports were only around 0,1 billions euros, according to the computations made on the data provided by the Romanian Institute of National Statistics (INS. The most imported products are patent drugs, which are more expensive than those produced by the domestic manufactured. At the same time, Romania registered an increase of the pharmaceutical market of around 20% only since its EU integration, this market proven to be largely driven by expensive products. Our research conducted to the conclusion that the Romanian resort authorities have to immediately adopt measures meant to limit consumption of expensive drugs, on the one side, and to reinforce the domestic manufacturers on the other side, even by attracting major investors in this sector. We have also identified that there is a large competitiveness for Romanian medicine products on the international market, due

  15. [A contribution to the development of advertising in pharmacy II. Historical development of regulation of advertising of medicinal products].

    Science.gov (United States)

    Vranová, Vilma

    2012-10-01

    The article deals with the development of regulation of advertising of medicinal products in the Czech Lands of the Habsburg Monarchy and Czechoslovakia in the years 1775-1938. Advertising medicines had and has its specifics and its regulation had been addressed by specific standards and linked to other health laws and regulations. Regulation of advertising of medicinal products has undergone a long process from the initial total ban on advertising to the establishment of clear rules, some of which, such as restrictions on advertising prescription-only medicines only to the professional healthcare press, are still valid.

  16. Role of Medicinal Plants and Natural Products on Osteoporotic Fracture Healing

    Directory of Open Access Journals (Sweden)

    Mohd Azri Abd Jalil

    2012-01-01

    Full Text Available Popularly known as “the silent disease” since early symptoms are usually absent, osteoporosis causes progressive bone loss, which renders the bones susceptible to fractures. Bone fracture healing is a complex process consisting of four overlapping phases—hematoma formation, inflammation, repair, and remodeling. The traditional use of natural products in bone fractures means that phytochemicals can be developed as potential therapy for reducing fracture healing period. Located closely near the equator, Malaysia has one of the world’s largest rainforests, which are homes to exotic herbs and medicinal plants. Eurycoma longifolia (Tongkat Ali, Labisia pumila (Kacip Fatimah, and Piper sarmentosum (Kaduk are some examples of the popular ethnic herbs, which have been used in the Malay traditional medicine. This paper focuses on the use of natural products for treating fracture as a result of osteoporosis and expediting its healing.

  17. Role of medicinal plants and natural products on osteoporotic fracture healing.

    Science.gov (United States)

    Abd Jalil, Mohd Azri; Shuid, Ahmad Nazrun; Muhammad, Norliza

    2012-01-01

    Popularly known as "the silent disease" since early symptoms are usually absent, osteoporosis causes progressive bone loss, which renders the bones susceptible to fractures. Bone fracture healing is a complex process consisting of four overlapping phases-hematoma formation, inflammation, repair, and remodeling. The traditional use of natural products in bone fractures means that phytochemicals can be developed as potential therapy for reducing fracture healing period. Located closely near the equator, Malaysia has one of the world's largest rainforests, which are homes to exotic herbs and medicinal plants. Eurycoma longifolia (Tongkat Ali), Labisia pumila (Kacip Fatimah), and Piper sarmentosum (Kaduk) are some examples of the popular ethnic herbs, which have been used in the Malay traditional medicine. This paper focuses on the use of natural products for treating fracture as a result of osteoporosis and expediting its healing.

  18. Induced production of mycotoxins in an endophytic fungus from the medicinal plant Datura stramonium L.

    Science.gov (United States)

    Sun, Jieyin; Awakawa, Takayoshi; Noguchi, Hiroshi; Abe, Ikuro

    2012-10-15

    Epigenetic modifiers, including DNA methyltransferase (DNMT) or histone deacetylase (HDAC) inhibitors, are useful to induce the expression of otherwise dormant biosynthetic genes under standard laboratory conditions. We isolated several endophytic fungi from the medicinal plant Datura stramonium L., which produces pharmaceutically important tropane alkaloids, including scopolamine and hyoscyamine. Although none of the endophytic fungi produced the tropane alkaloids, supplementation of a DNMT inhibitor, 5-azacytidine, and/or a HDAC inhibitor, suberoylanilide hydroxamic acid, to the culture medium induced the production of mycotoxins, including alternariol, alternariol-5-O-methyl ether, 3'-hydroxyalternariol-5-O-methyl ether, altenusin, tenuazonic acid, and altertoxin II, by the endophytic fungus Alternaria sp. This is the first report of a mycotoxin-producing endophytic fungus from the medicinal plant D. stramonium L. This work demonstrates that treatments with epigenetic modifiers induce the production of mycotoxins, thus providing a useful tool to explore the biosynthetic potential of the microorganisms. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. First identification of natural products from the African medicinal plant Zamioculcas zamiifolia - A drought resistant survivor through millions of years.

    Science.gov (United States)

    Le Moullec, Angharad; Juvik, Ole Johan; Fossen, Torgils

    2015-10-01

    Zamioculcas zamiifolia, an unusually drought resistant medicinal plant native to tropical east Africa and subtropical southeast Africa, including the countries Kenya, Malawi, Mozambique, South-Africa, Tanzania and Zimbabwe, is described as a living fossil which may have evolved as early as 42 million years ago. It belongs to the notoriously toxic family Araceae giving it, through association, a reputation for being toxic; despite little or no systematic evidence exists to support this claim. As an ancient plant it has sustained substantial climate changes and attacks from millions of generations of pathogenic microorganisms, which encouraged search for novel natural products from this source. Seven natural products have been characterized from leaves and petioles of Z. zamiifolia, including the novel main compound of the leaves, apigenin 6-C-(6″-(3-hydroxy-3-methyl-glutaroyl)-ß-glucopyranoside). The structure determinations were based on extensive use of 2D NMR spectroscopic techniques and high-resolution mass spectrometry. Initial toxicological experiment on extracts from Z. zamiifolia using brine shrimp lethality assay did not indicate lethality to the shrimps providing disproving evidence for the assumption of Z. zamiifolia's toxic character. Copyright © 2015 Elsevier B.V. All rights reserved.

  20. Complementary and Alternative Medicine: The Mozart Effect on Childhood Epilepsy-A Systematic Review.

    Science.gov (United States)

    Brackney, Dana E; Brooks, Jessica L

    2018-02-01

    This systematic review examines the effectiveness of Mozart's music in decreasing seizures in children with epilepsy (Mozart Effect) using the Johns Hopkins Nursing Evidence-Based Practice rating scale © . A search for articles with "Mozart Effect," "child*," and "epilepsy" was conducted in CINAHL Complete, Science Direct, Cochrane, and PubMed databases. Eight studies were selected based on the exclusion and inclusion criteria after removal of duplicates ( n = 17) and others ( n = 46). Studies included were English language, peer reviewed, published between April 2010 and February 2017, and available in full text with an abstract. Quasi-experimental studies demonstrate that the Mozart Effect May reduce epileptiform discharges or seizures in children and has potential as an adjunct to medical management of seizure activity or alone when medication or surgery is not accepted. A causal relationship between the music of Mozart and decreased seizure activity has yet to be demonstrated.

  1. How well are GIC product labels related to current systematic review evidence?

    Science.gov (United States)

    Mickenautsch, Steffen

    2011-11-01

    Systematic reviews have been recommended as providing the best source of evidence to guide clinical decisions in dentistry. They appraise evidence from trials focused on investigating clinical effects of dental material categories, such as conventional glass-ionomer cements (GIC) or resin-modified GIC. In contrast, the general dental practitioner is introduced to these categories of materials in the form of branded or private product labels that are marketed during dental conventions or through advertisements. Difficulties may arise in recognizing material categories that have been subjected to systematic reviews, because of the multitude of product labels on the current market. Thus, the value and relevance of published systematic review evidence concerning the material categories represented by these labels may remain obscure. Based on a systematic literature search, this article identifies glass-ionomer cement product labels used during clinical trials which, in turn, were subsequently reviewed in systematic review articles (published between 15 April 2009 and 14 April 2011). This article further clarifies how these product labels relate to the systematic review conclusions. The results show that the conventional and resin-modified glass-ionomer cements that were used in most trials were marketed by GC and 3M ESPE, respectively. The conventional GICs used in most of the reviewed trials were Fuji III and Fuji IX, while Vitremer was the most commonly used resin-modified GIC. Evidence from the reviewed trials suggests that GIC provides beneficial effects for preventive and restorative dentistry. However, more trials of higher internal validity are needed in order to confirm (or disprove) these findings. Only GIC products of branded labels and none of private labels were identified, suggesting that private label GIC products have little or no research back-up. Dental products, such as glass-ionomers cements (GIC), can only be judged as effective when they are based

  2. Translating cell-based regenerative medicines from research to successful products: challenges and solutions.

    Science.gov (United States)

    Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Egloff, Matthieu; Snykers, Sarah; Salinas, Gabriella Franco; Thomas, Robert; Girling, Alan; Lilford, Richard; Clermont, Gaelle; Kemp, Paul

    2014-08-01

    The Tissue Engineering & Regenerative Medicine International Society-Europe (TERMIS-EU) Industry Committee as well as its TERMIS-Americas (AM) counterpart intend to address the specific challenges and needs facing the industry in translating academic research into commercial products. Over the last 3 years, the TERMIS-EU Industry Committee has worked with commercial bodies to deliver programs that encourage academics to liaise with industry in proactive collaborations. The TERMIS-EU 2013 Industry Symposium aimed to build on this commercial agenda by focusing on two topics: Operations Management (How to move a process into the good manufacturing practice [GMP] environment) and Clinical Translation (Moving a GMP process into robust trials). These topics were introduced by providing the synergistic business perspective of partnering between the multiple regenerative medicine stakeholders, throughout the life cycle of product development. Seven industry leaders were invited to share their experience, expertise, and strategies. Due to the complex nature of regenerative medicine products, partnering for their successful commercial development seems inevitable to overcome all obstacles by sharing experiences and expertise of all stakeholders. When ideally implemented, the "innovation quotient" of a virtual team resulting from the combination of internal and external project teams can be maximized through maximizing the three main dimensions: core competences, technology portfolio, and alliance management.

  3. Nutritional supplements and herbal medicines for women with polycystic ovary syndrome; a systematic review and meta-analysis.

    Science.gov (United States)

    Arentz, Susan; Smith, Caroline A; Abbott, Jason; Bensoussan, Alan

    2017-11-25

    Polycystic ovary syndrome (PCOS) is a common, reproductive endocrinopathy associated with serious short and long term health risks. Many women with PCOS use ingestible complementary medicines. This systematic review examined the effect on menstrual regulation and adverse effects from randomised controlled trials. Randomised controlled trials (RCTs) that compared herbal or nutritional supplements to placebo or active controls in women with PCOS were eligible for inclusion. Electronic databases were searched to July 2017. Study selection and assessment of quality were conducted independently by two review authors. Twenty four studies (1406 women) investigating seven nutritional supplements and four herbal medicines were included. No one study was assessed as having a low risk of bias. Four trials reported on the primary endpoint menstrual regulation. There was no evidence on improved menstrual regularity for calcium plus vitamin D compared to Metformin (RR: 0.66, 95% CI 0.35 to 1.23, p = 0.19), reduced amenorrhoea for Camellia sinensis compared to placebo (RR: 0.17, 95% CI 0.02 to 1.72, p = 0.13) and no difference in the number of menses per month for Cinnamomum sp. against placebo (MD 0.05, 95% CI -0.36 to 1.36, p = 0.26). Adverse effects were investigated in seven studies (164 women). Mild adverse effects were found for Cinnamomum sp. compared to placebo (17 women, RR: 0.36, 95% CI 0.03 to 0.70, p = 0.03). No difference was found for adverse effects between inositol, B complex vitamins, vitamin D, chromium and placebo. Improved reproduction, metabolic hormones and hyperandrogenism was found for inositol and improved cholesterol for omega three fish oils. There is no high quality evidence to support the effectiveness of nutritional supplements and herbal medicine for women with PCOS and evidence of safety is lacking. High quality trials of nutritional supplements and herbal medicines examining menstrual regulation and adverse effects in women with PCOS

  4. Bibliometric analysis of systematics production in Latin America

    International Nuclear Information System (INIS)

    Michan Aguirre, Layla

    2011-01-01

    I compare six bibliographic databases with information on Latin American systematics: Biosis, CAB, periodica, SCI, scopus and Zoological record. the databases are characterized and compared considering their content, temporal, typological, geographical, thematical coverage, kind of access and new taxon description, to identify which and how many should be used to be more representative. Of the 1363 journals analyzed, 36.5% are found in more than one database and 63.46% are recorded in a single one. zoological record contains 63421 documents, Biosis 19079, CAB 14363, periodica 11185, SCI 3257 and scopus 916. CAB and ZR are the oldest databases, the average number of articles published per year was 6417 for Biosis, 433 for ZR, 361 for periodica, 145 for CAB, 91 for SCI and 30 for Scopus. According to the network analysis, there are stronger relations between SCI and Biosis, which share at least 16% of titles, CAB and Biosis share 15%, Biosis and ZR 14%, and CAB and ZR 11%. Based on the cladogram obtained from a parsimony analysis on the shared journals, the strongest relation is between Biosis and SCI; periodica has the largest number of exclusive journals with 285. ZR has 72.9% of published articles with descriptions of new taxa and an average of 322 a year, CAB 54.6% with 82, and periodica 24.6% with 90. None of databases meets the characteristics to be used as a single source of information, therefore it would be appropriate to use different combinations according to the aim of the analysis. biosis has the most comprehensive information on any current taxon, zoological record and CAB have a broader temporal coverage and include mainly animals or plants, respectively. SCI has the largest number of documents in mainstream journals, with references, citations and bibliometric indicators. periodica has the largest number of documents and temporal coverage published in the area. The cladogram proved to be an optimal visualization tool to represent the main features of

  5. Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

    Science.gov (United States)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-05-01

    On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.

  6. Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market – Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014

    Science.gov (United States)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A.; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-01-01

    On September 11, 2014, a workshop entitled ‘Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market’ was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT. PMID:26195933

  7. A strategy for intensive production of molybdenum-99 isotopes for nuclear medicine using CANDU reactors.

    Science.gov (United States)

    Morreale, A C; Novog, D R; Luxat, J C

    2012-01-01

    Technetium-99m is an important medical isotope utilized worldwide in nuclear medicine and is produced from the decay of its parent isotope, molybdenum-99. The online fueling capability and compact fuel of the CANDU(®)(1) reactor allows for the potential production of large quantities of (99)Mo. This paper proposes (99)Mo production strategies using modified target fuel bundles loaded into CANDU fuel channels. Using a small group of channels a yield of 89-113% of the weekly world demand for (99)Mo can be obtained. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. [Approval of clinical trials of immunobiological medicinal products at the Paul Ehrlich Institute].

    Science.gov (United States)

    Krafft, H; Cichutek, K

    2005-02-01

    The GCP Directive 2001/20/EG has been implemented in Germany by the 12th Law Amending the Drug Law of 6 August 2004, thereby introducing new regulations for the performance of clinical trials. The amount of the required documentation has increased, but the assessment and the approval of clinical trials as well as scientific advice procedures (national or by the EMEA) allow the early discussion of many details of the development and the non-clinical and clinical testing of the medicinal product with the experts of the Paul Ehrlich Institute (PEI). This might shorten the times required for later marketing authorisation procedures. To facilitate these new tasks, the PEI has created a new central section "Approval of Clinical Trials", which is responsible for the assessment of the clinical trial applications and will coordinate the procedures within the institute. The main topics of clinical trial applications and the particularities of biological/biotechnological medicinal products such as allergens, blood products, vaccines, sera/mAb and products for cell and gene therapy as well as the differences from chemically defined products are discussed.

  9. Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid.

    Science.gov (United States)

    Stegelmeier, Bryan L; Brown, Ammon W; Welch, Kevin D

    2015-12-01

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids and other potential carcinogens can contaminate these products. As herbal and food supplement producers are left to their own means to determine the safety and purity of their products prior to marketing, disturbingly often good marketing practices currently in place are ignored and content is largely undocumented. Historical examples of poisoning and health issues relating to plant material containing dehydopyrrolizidine alkaloids and aristolochic acids were used as examples to demonstrate the risk and potential toxicity of herbal products, food supplements, or traditional medicines. More work is needed to educate consumers of the potential risk and require the industry to be more responsible to verify the content and insure the safety of their products. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

  10. Marketing medicines: charting the rise of modern therapeutics through a systematic review of adverts in UK medical journals (1950-1980).

    Science.gov (United States)

    Green, A Richard; Haddad, Peter M; Aronson, Jeffrey K

    2018-02-14

    To examine how pharmaceutical products that were first marketed between 1950 and 1980 were promoted to physicians through advertisements and briefly review advertising regulations and accuracy of the advertisements in the light of modern knowledge. We systematically reviewed advertisements promoting drugs for specific therapeutic areas, namely central nervous system disorders (anxiety and sleep disorders, depression, psychoses, and Parkinson's disease), respiratory disorders, cardiovascular disorders, and gastrointestinal disorders. We examined about 800 issues of the British Medical Journal (1950-1980) and about 150 issues of World Medicine (1965-1984). Advertising material was minimally regulated until the mid-1970s. Many drugs were marketed with little preclinical or clinical knowledge and some with the expectation that prescribers would obtain further data. The peak of advertising occurred in parallel with the surge in the release of novel drugs during the 1960s, but declined markedly after the mid-1970s. Advertisements generally contained little useful prescribing information. The period we investigated saw the release of many novel pharmaceuticals in the therapeutic areas we examined, and many (or their class successors) still play important therapeutic roles, including benzodiazepines, tricyclic antidepressants, phenothiazines, levodopa, selective and non-selective β-adrenoceptor antagonists, thiazide diuretics, β-adrenoceptor agonists, and histamine H 2 receptor antagonists. Advertising pharmaceuticals in the BMJ and World Medicine in 1950-1980 was poorly regulated and often lacked rigour. However, advertisements were gradually modified in the light of increasing clinical pharmacological knowledge, and they reflect an exciting period for the introduction of many drugs that continue to be of benefit today. © 2018 The British Pharmacological Society.

  11. Addressing the leadership gap in medicine: residents' need for systematic leadership development training.

    Science.gov (United States)

    Blumenthal, Daniel M; Bernard, Ken; Bohnen, Jordan; Bohmer, Richard

    2012-04-01

    All clinicians take on leadership responsibilities when delivering care. Evidence suggests that effective clinical leadership yields superior clinical outcomes. However, few residency programs systematically teach all residents how to lead, and many clinicians are inadequately prepared to meet their day-to-day clinical leadership responsibilities. The purpose of this article is twofold: first, to make the case for the need to refocus residency education around the development of outstanding "frontline" clinical leaders and, second, to provide an evidence-based framework for designing formal leadership development programs for residents. The authors first present a definition of clinical leadership and highlight evidence that effective frontline clinical leadership improves both clinical outcomes and satisfaction for patients and providers. The authors then discuss the health care "leadership gap" and describe barriers to implementing leadership development training in health care. Next, they present evidence that leaders are not just "born" but, rather, can be "made," and offer a set of best practices to facilitate the design of leadership development programs. Finally, the authors suggest approaches to mitigating barriers to implementing leadership development programs and highlight the major reasons why health care delivery organizations, residency programs, and national accreditation bodies must make comprehensive leadership education an explicit goal of residency training.

  12. Medicinal uses, pharmacology, and phytochemistry of Convolvulaceae plants with central nervous system efficacies: A systematic review.

    Science.gov (United States)

    Chen, Guang-Tong; Lu, Yun; Yang, Min; Li, Jian-Lin; Fan, Bo-Yi

    2018-01-22

    Central nervous system (CNS) disorders play a major impact on individual lives and place a severe strain on health care resources. Convolvulaceae is a family comprising approximately 1,600-1,700 species grouped in 55-60 genera, and many species are reported to have an effect on CNS functions. A systematic review of the literature studies was carried out to summarize available evidences on Convolvulaceae plants with CNS efficacies. This review is based on various data sources such as Google Scholar, Web of Science, Scopus, PubMed, and Wanfang Data. A total of 200 related articles were included in this review. According to the research result, 54 Convolvulaceae species are suggested to display CNS efficacies historically, and 46 species have been evaluated for their CNS efficacies. In addition, 67 compounds from 16 Convolvulaceae species are recognized to possess CNS efficacies. Despite great progress made through pharmacology and phytochemistry studies on CNS active Convolvulaceae species, more exploratory research is needed to gain a better understanding of the CNS efficacies of this plant family. Copyright © 2018 John Wiley & Sons, Ltd.

  13. Chinese Herbal Medicine for Postpartum Depression: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Yongle Li

    2016-01-01

    Full Text Available Background. Postpartum depression (PPD does great harm to women following childbirth. The aim of this study was to conduct a systematic review of the literature to assess the efficacy and safety of CHM for the treatment of PPD. Methods. Published or ongoing registered trials were searched for from the inception of the various databases to December 31, 2015. Data extraction and methodology assessment were conducted independently by two researchers. RevMan 5.3 software was used to analyze the data. Results. Forty-seven registered clinical trials (RCTs were identified and reviewed. The results showed CHM alone or in combination with routine treatments could reduce HAMD score, EPDS score, incidence of adverse events, TESS, and SERS. CHM combined with routine treatment was more effective in increasing serum estradiol levels and reducing progesterone levels than routine treatment alone. Meanwhile, pooled data revealed that MRLQS combined with routine treatments or MRLQS plus MSHS combined with routine treatments were more effective than other therapeutic methods in TCM. MRLQS plus MSHS alone was found to be an effective alternative when compared to routine treatments. Conclusions. This review suggested that CHM was safe and effective in the treatment of PPD. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more rigorously designed trials are warranted.

  14. [Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2016].

    Science.gov (United States)

    Müntener, C R; Müntener, C; Kupper, J; Naegeli, H; Gassner, B

    2017-11-01

    A total of 253 reports of adverse reactions to veterinary medicinal products were received during the year 2016 representing a decrease of 13% compared to the previous year (292 reports). The majority of the reports described reactions affecting companion animals (178 dogs and 32 cats) as well as cattle (17 reports) and horses (10 reports). Most of the reactions reported were linked to the use of antiparasitics (145 reports), hormone products (26 reports) and antiinfectives (10 reports). 32 reports were generated from consultations with Tox Info Suisse in Zürich and involved mainly the excessive intake of flavoured tablets and, in some cases, the use of reconverted products (applied to another species than that authorized). Five signals were identified from the reports, which resulted in revisions of the product information in the sections addressing contraindications or adverse reactions.

  15. Systematic approach to inclusive lepton pair production in hadronic collisions

    International Nuclear Information System (INIS)

    Lam, C.S.; Tung, W.

    1978-01-01

    Strong-interaction dynamics as probed by lepton pair production in hadronic collisions is naturally separated from kinematics by using suitably defined structure functions. In the first part of this paper, general properties of invariant structure functions and a variety of ''helicity'' structure functions for this process are studied, and their use discussed. An exact parallelism to the case of deep-inelastic lepton-hadron scattering is set up. In the second part, a series of parton-model relations between the structure functions, reflecting the basic Drell-Yan on-shell quark-antiquark annihilation picture (but independent of details of parton distributions), is derived. These relations serve the dual purposes of (i) supplementing the model-independent structure-function formalism and rendering it useful for analyzing data of limited scope initially, and (ii) providing unambiguous tests of various aspects of the underlying quark-parton model when more detailed data become available

  16. Application of electrophoton capture (EPC) analysis based on gas discharge visualization (GDV) technique in medicine: a systematic review.

    Science.gov (United States)

    Korotkov, Konstantin G; Matravers, Peter; Orlov, Dmitry V; Williams, Bernard O

    2010-01-01

    The objective of this study was to evaluate the scale and scope of implementing electrophoton capture (EPC) analysis based on gas discharge visualization (GDV) technique in diverse medical applications and psychophysiology; to identify the range of applications in medicine; and to show in which areas the procedure can be useful to health professionals. The design of the study is a systematic review. The database included articles published in peer-reviewed journals, proceedings of the international scientific congress "Science, Information, Spirit" (2003-2007), articles from the International Union of Medical and Applied Bioelectrography database, and proceedings of other conferences devoted to EPC or GDV, bioelectrography, and biophotonics. Search restrictions were human subjects, English or Russian language, and publication date from 2003 to 2007. All randomized controlled studies (RCTs) and systematic research reports (SRRs) were evaluated using Scottish Intercollegiate Guidelines Network and Jadad checklists. The search yielded 136 articles addressing four different fields of medical and psychophysiologic applications of EPC (GDV). Among them were 26 SRR, 19 RCT, 18 case reports or case series, and 13 cohort studies. Thirteen (13) RCTs and 19 SRRs were rated "high" on the two conventional checklists. (1) The software and equipment EPC/GDV-complex is a convenient and easy-to-use device, easily allows examining patients with various pathologies and, therefore, offers a wide range of applications. (2) The GDV method has shown itself to be very fast (i.e., it is an "express-method" for studying states of the human organism). (3) Our review has revealed that GDV method can be implemented as an express method for assessment of treatment procedure effectiveness, evaluating emotional and physical conditions of people, and in many other fields.

  17. Natural Products from Chinese Medicines with Potential Benefits to Bone Health

    Directory of Open Access Journals (Sweden)

    Chun-Tao Che

    2016-02-01

    Full Text Available Osteoporosis is a progressive, systemic bone disorder characterized by loss of bone mass and microstructure, leading to reduced bone strength and increased risk of fracture. It is often associated with reduced quality of life and other medical complications. The disease is common in the aging population, particularly among postmenopausal women and patients who receive long-term steroidal therapy. Given the rapid growth of the aging population, increasing life expectancy, the prevalence of bone loss, and financial burden to the healthcare system and individuals, demand for new therapeutic agents and nutritional supplements for the management and promotion of bone health is pressing. With the advent of global interest in complementary and alternative medicine and natural products, Chinese medicine serves as a viable source to offer benefits for the improvement and maintenance of bone health. This review summarizes the scientific information obtained from recent literatures on the chemical ingredients of Chinese medicinal plants that have been reported to possess osteoprotective and related properties in cell-based and/or animal models. Some of these natural products (or their derivatives may become promising leads for development into dietary supplements or therapeutic drugs.

  18. External Application of Traditional Chinese Medicine for Venous Ulcers: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Xin Li

    2015-01-01

    Full Text Available Objective. To evaluate the effectiveness of external application of traditional Chinese medicine (EA-TCM on venous ulcers. Methods. Seven databases were searched until April 2015 for randomized controlled trials (RCTs of EA-TCM for venous ulcers. Risk of bias was assessed using Cochrane Handbook guidelines. Study outcomes were presented as risk ratios (RRs for dichotomous data or mean differences (MDs for continuous data. Results. Sixteen of 193 potentially relevant trials met the inclusion criteria; however, their methodological qualities were low. Comparison of the same intervention strategies revealed significant differences in total effectiveness rates between EA-TCM and conventional therapy groups (RR = 1.22, 95% confidence interval [CI] = 1.16–1.29, and P<0.00001. Compared to conventional therapy, EA-TCM combined with conventional therapy had a superior total effectiveness rate (RR = 1.11, 95% CI = 1.04–1.19, and P=0.003. There were no significant differences in recurrence rates during followup and final pain measurements between the experimental and those in the control groups (RR = 0.86, 95% CI = 0.31–2.39, and P=0.85; MD −0.75, 95% CI = −2.15–0.65, and P=0.29. Conclusion. The evidence that EA-TCM is an effective treatment for venous ulcers is encouraging, but not conclusive due to the low methodological quality of the RCTs. Therefore, more high-quality RCTs with larger sample sizes are required.

  19. Reliability of Manual Pulse Diagnosis Methods in Traditional East Asian Medicine: A Systematic Narrative Literature Review.

    Science.gov (United States)

    Bilton, Karen; Zaslawski, Chris

    2016-08-01

    Little evidence shows the reliability of Chinese medicine pulse diagnosis. Regularly used in modern practice, it is believed to gather important diagnostic information. However, in the current evidence-based healthcare system, basing clinical decisions on unproven methods is problematic and obviously questions the relevancy of the procedure. Therefore, the literature on reliability of practitioners implementing the method was reviewed. Major medical databases and reference lists of identified articles were searched. All studies published in English that investigated manual pulse diagnosis applied to the radial artery by human testers were considered. Twelve eligible studies were included; three evaluated intra- and inter-rater pulse diagnosis reliability, and nine assessed inter-rater reliability. Acceptable levels of intra- and inter-rater reliability were achieved with operationally defined methods. Poor reliability was related to unclear definitions and terminology existing within the classical definitions, and with standardized systems to persisting imprecise descriptions that can be interpreted differently. Reliability of pulse qualities was influenced by sensation complexity and the amount of sensory input provided to the testers' fingers by the impulse. Consistent study limitations included small sample sizes; the possibility that testers' prior knowledge confounded the data; and, most notably, the fact that many studies did not consider intra-rater reliability. Assessing the effectiveness of interventions in clinical practice is guided by comparisons of markers to baseline. The absence of intra-rater results may therefore raise methodologic concerns for these types of studies. Strategies for future studies include using pulse methods with concrete operational definitions; investigating intra- and inter-rater reliability for extrapolation to clinical practice; similar training and experience in the method to control for tester variance; maintaining

  20. Productization and Commercialization of IT-Enabled Higher Education in Computer Science: A Systematic Literature Review

    Science.gov (United States)

    Kankaanpää, Irja; Isomäki, Hannakaisa

    2013-01-01

    This paper reviews research literature on the production and commercialization of IT-enabled higher education in computer science. Systematic literature review (SLR) was carried out in order to find out to what extent this area has been studied, more specifically how much it has been studied and to what detail. The results of this paper make a…

  1. DNA barcoding: a tool for standardization of herbal medicinal products (HMPS) of lamiaceae from pakistan

    International Nuclear Information System (INIS)

    Zahra, N.B.; Shinwari, Z.K.

    2016-01-01

    There has been a considerable interest worldwide in traditional and alternative medicine, particularly herbal products over the past few decades but the adulteration or contamination of herbal medicinal products (HMPs) is a potential threat to consumer safety. The fact highlights the importance of an effective and accurate science integrated method for taxonomic identification of the medicinal plants and their HMPs. DNA barcoding is a molecular technique which has made it possible to identify the herbs and to find the adulterants in HMPs. The current study was designed on DNA barcoding of medicinal plants of family Lamiaceae for their correct identification and to fix the problem of adulteration for protecting consumers from health risks associated with product substitution and contamination. Many Lamiaceae species are used as traditional medicines, as culinary herbs, spices and as source of essential oils. HMPs representing 32 Lamiaceae plant samples were purchased/collected from three herbal stores (Pansar stores) in Islamabad and a herbal pharmaceutical industry. We selected three plastid loci rbcL, matK and psbA-trnH to barcode these HMPs. MEGABLAST sequence comparison was performed to verify the taxonomic identity of the samples. We found four mislabeled samples and two product substitutions. The overall amplification success for rbcL and matK was 87% and 81% while psbA-trnH showed 69%. matK and psbA-trnH were able to distinguish the species relatively better with 40% success rate than rbcL (16%). On the whole we generated a total of 22 genus-level barcodes (78%) and 12 species-level barcodes (44%). The species-level identification was considerably low due to insufficient reference data and selection of plastid markers. Therefore, it is recommended to develop herbal barcode library for adequate availability of reference sequence data and addition of nuclear markers. DNA barcoding can help the regulatory authorities to devise a mechanism for quality control and

  2. Crowdsourcing--harnessing the masses to advance health and medicine, a systematic review.

    Science.gov (United States)

    Ranard, Benjamin L; Ha, Yoonhee P; Meisel, Zachary F; Asch, David A; Hill, Shawndra S; Becker, Lance B; Seymour, Anne K; Merchant, Raina M

    2014-01-01

    Crowdsourcing research allows investigators to engage thousands of people to provide either data or data analysis. However, prior work has not documented the use of crowdsourcing in health and medical research. We sought to systematically review the literature to describe the scope of crowdsourcing in health research and to create a taxonomy to characterize past uses of this methodology for health and medical research. PubMed, Embase, and CINAHL through March 2013. Primary peer-reviewed literature that used crowdsourcing for health research. Two authors independently screened studies and abstracted data, including demographics of the crowd engaged and approaches to crowdsourcing. Twenty-one health-related studies utilizing crowdsourcing met eligibility criteria. Four distinct types of crowdsourcing tasks were identified: problem solving, data processing, surveillance/monitoring, and surveying. These studies collectively engaged a crowd of >136,395 people, yet few studies reported demographics of the crowd. Only one (5 %) reported age, sex, and race statistics, and seven (33 %) reported at least one of these descriptors. Most reports included data on crowdsourcing logistics such as the length of crowdsourcing (n = 18, 86 %) and time to complete crowdsourcing task (n = 15, 71 %). All articles (n = 21, 100 %) reported employing some method for validating or improving the quality of data reported from the crowd. Gray literature not searched and only a sample of online survey articles included. Utilizing crowdsourcing can improve the quality, cost, and speed of a research project while engaging large segments of the public and creating novel science. Standardized guidelines are needed on crowdsourcing metrics that should be collected and reported to provide clarity and comparability in methods.

  3. Evaluation of phytochemicals from medicinal plants of Myrtaceae family on virulence factor production by Pseudomonas aeruginosa.

    Science.gov (United States)

    Musthafa, Khadar Syed; Sianglum, Wipawadee; Saising, Jongkon; Lethongkam, Sakkarin; Voravuthikunchai, Supayang Piyawan

    2017-05-01

    Virulence factors regulated by quorum sensing (QS) play a critical role in the pathogenesis of an opportunistic human pathogen, Pseudomonas aeruginosa in causing infections to the host. Hence, in the present work, the anti-virulence potential of the medicinal plant extracts and their derived phytochemicals from Myrtaceae family was evaluated against P. aeruginosa. In the preliminary screening of the tested medicinal plant extracts, Syzygium jambos and Syzygium antisepticum demonstrated a maximum inhibition in QS-dependent violacein pigment production by Chromobacterium violaceum DMST 21761. These extracts demonstrated an inhibitory activity over a virulence factor, pyoverdin, production by P. aeruginosa ATCC 27853. Gas chromatography-mass spectrometric (GC-MS) analysis revealed the presence of 23 and 12 phytochemicals from the extracts of S. jambos and S. antisepticum respectively. Three top-ranking phytochemicals, including phytol, ethyl linoleate and methyl linolenate, selected on the basis of docking score in molecular docking studies lowered virulence factors such as pyoverdin production, protease and haemolytic activities of P. aeruginosa to a significant level. In addition, the phytochemicals reduced rhamnolipid production by the organism. The work demonstrated an importance of plant-derived compounds as anti-virulence drugs to conquer P. aeruginosa virulence towards the host. © 2017 APMIS. Published by John Wiley & Sons Ltd.

  4. [Scientific production in clinical medicine and international collaboration networks in South American countries].

    Science.gov (United States)

    Huamaní, Charles; González A, Gregorio; Curioso, Walter H; Pacheco-Romero, José

    2012-04-01

    International collaboration is increasingly used in biomedical research. To describe the characteristics of scientific production in Latin America and the main international collaboration networks for the period 2000 to 2009. Search for papers generated in Latin American countries in the Clinical Medicine database of ISI Web of Knowledge v.4.10 - Current Contents Connect. The country of origin of the corresponding author was considered the producing country of the paper. International collaboration was analyzed calculating the number of countries that contributed to the generation of a particular paper. Collaboration networks were graphed to determine the centrality of each network. Twelve Latin American countries participated in the production of 253,362 papers. The corresponding author was South American in 79% of these papers. Sixteen percent of papers were on clinical medicine and 36% of these were carried out in collaboration. Brazil had the highest production (22,442 papers) and the lower percentage of international collaboration (31%). North America accounts for 63% of collaborating countries. Only 8% of collaboration is between South American countries. Brazil has the highest tendency to collaborate with other South American countries. Brazil is the South American country with the highest scientific production and indicators of centrality in South America. The most common collaboration networks are with North American countries.

  5. Methodological quality and reporting of generalized linear mixed models in clinical medicine (2000-2012: a systematic review.

    Directory of Open Access Journals (Sweden)

    Martí Casals

    Full Text Available BACKGROUND: Modeling count and binary data collected in hierarchical designs have increased the use of Generalized Linear Mixed Models (GLMMs in medicine. This article presents a systematic review of the application and quality of results and information reported from GLMMs in the field of clinical medicine. METHODS: A search using the Web of Science database was performed for published original articles in medical journals from 2000 to 2012. The search strategy included the topic "generalized linear mixed models","hierarchical generalized linear models", "multilevel generalized linear model" and as a research domain we refined by science technology. Papers reporting methodological considerations without application, and those that were not involved in clinical medicine or written in English were excluded. RESULTS: A total of 443 articles were detected, with an increase over time in the number of articles. In total, 108 articles fit the inclusion criteria. Of these, 54.6% were declared to be longitudinal studies, whereas 58.3% and 26.9% were defined as repeated measurements and multilevel design, respectively. Twenty-two articles belonged to environmental and occupational public health, 10 articles to clinical neurology, 8 to oncology, and 7 to infectious diseases and pediatrics. The distribution of the response variable was reported in 88% of the articles, predominantly Binomial (n = 64 or Poisson (n = 22. Most of the useful information about GLMMs was not reported in most cases. Variance estimates of random effects were described in only 8 articles (9.2%. The model validation, the method of covariate selection and the method of goodness of fit were only reported in 8.0%, 36.8% and 14.9% of the articles, respectively. CONCLUSIONS: During recent years, the use of GLMMs in medical literature has increased to take into account the correlation of data when modeling qualitative data or counts. According to the current recommendations, the

  6. Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007-15: Report from the Medical Products Agency.

    Science.gov (United States)

    Svedlund, Erika; Larsson, Maria; Hägerkvist, Robert

    2017-06-01

    In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. Adverse drug reactions reported to the Swedish Medical Product Agency during 2007-15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval.

  7. Development of antibacterial conjugates using sulfamethoxazole with monocyclic terpenes: A systematic medicinal chemistry based computational approach.

    Science.gov (United States)

    Swain, Shasank S; Paidesetty, Sudhir K; Padhy, Rabindra N

    2017-03-01

    To develop 6 conjugate agents of the moribund antibiotic sulfamethoxazole (SMZ) joined to 6 individual monoterpenes, followed by protocols of medicinal chemistry as potent antibacterials, against multidrug resistant (MDR) human gruesome pathogenic bacteria. Antibacterial activities of the proposed conjugates were ascertained by the 'prediction of activity spectra of substances' (PASS) program. Drug-likeness parameters and toxicity profiles of conjugates were standardized with the Lipinski rule of five, using cheminformatic tools, Molsoft, molinspiration, OSIRIS and ProTox. Antibacterial activities of individual chemicals and conjugates were examined by targeting the bacterial folic acid biosynthesis enzyme, dihydropteroate synthases (DHPSs) of bacteria, Bacillus anthracis, Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae and Mycobacterium tuberculosis, with 3D structures of DHPSs from protein data bank. According to the PASS program, biological spectral values of conjugate-2, conjugate-5 and conjugate-6 were ascertained effective with 'probably active' or 'Pa' value > 0.5, for anti-infective and antituberculosic activities. Using molecular docking against 5 cited bacterial DHPSs, effective docking scores of 6 monoterpenes in the specified decreasing order (kcal/mol): -9.72 (eugenol against B. anthracis), -9.61 (eugenol against S. pneumoniae), -9. 42 (safrol, against B. anthracis), -9.39 (thymol, against M. tuberculosis), -9.34 (myristicin, against S. pneumoniae) and -9.29 (thymol, against B. anthracis); whereas the lowest docking score of SMZ was -8.46kcal/mol against S. aureus DHPS. Similarly, effective docking scores of conjugates were as specified (kcal/mol.): -10.80 (conjugate-4 consisting SMZ+safrol, against M. tuberculosis), -10.78 (conjugate-5 consisting SMZ+thymol, against M. tuberculosis), -10.60 (conjugate-5 against B. anthracis), -10.26 (conjugate-2 consisting SMZ+ eugenol, against M. tuberculosis), -10.25 (conjugate-5, against S

  8. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 4: observational studies.

    Science.gov (United States)

    Manchikanti, Laxmaiah; Singh, Vijay; Smith, Howard S; Hirsch, Joshua A

    2009-01-01

    Evidence-based medicine (EBM) stresses the examination of evidence from clinical research and describes it as a shift in medical paradigms, in contrast to intuition, unsystematic clinical experience, and pathophysiologic rationale. While the importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy, much of the medical research is observational. There is competition, contrast, and a feeling of inferiority and uselessness for observational studies, created by a lack of understanding of medical research. However, observational studies and randomized clinical trials (RCTs) can be viewed as the steps of observation and experimentation that form the basis of the scientific methodology. Further, rational healthcare practices require knowledge about the etiology and pathogenesis, diagnosis, prognosis, and treatment of disorders. The reporting of observational research is often not detailed and clear enough with insufficient quality and poor reporting, which hampers the assessment of strengths and weaknesses of the study and the generalizability of the mixed results. Thus, design, implementation, and reporting of observational studies is crucial. The biased interpretation of results from observational studies, either in favor of or opposed to a treatment, and lack of proper understanding of observational studies, leads to a poor appraisal of the quality. Similar to the Consolidated Standards of Reporting Trials (CONSORT) statement for the reporting of randomized trials, the Strengthening of the Reporting of Observational Studies in Epidemiology (STROBE) statement was developed with recommendations to improve the quality of reporting observational studies. The STROBE statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Multiple types of observational studies are conducted; however, 3 types have been highlighted in the

  9. Randomized controlled trials covering pharmaceutical care and medicines management: A systematic review of literature.

    Science.gov (United States)

    Babar, Zaheer-Ud-Din; Kousar, Rozina; Murtaza, Ghulam; Azhar, Saira; Khan, Shujaat Ali; Curley, Louise

    2017-06-19

    To review the effects of pharmaceutical care on hospitalizations, mortality and clinical outcomes in patients. Systematic searches were conducted in MEDLINE, EMBASE and International Pharmaceutical Abstracts (IPA) databases to identify studies that were published between 2004 and January 2017. Studies included in this review were randomized controlled trials (RCTs) that spanned across both community and hospital settings. Using strict inclusion/exclusion criteria studies were included if they reported level 1 or 2 outcomes in the hierarchy of outcome measure i.e. clinical and surrogate outcomes (e.g. blood pressure (BP) control, blood glucose level, cholesterol BMI). Each study was assessed for quality using the Jadad scoring system. Fifty-four RCTs were included in the present review. Forty-six of these studies ranked high quality according to the Jadad scoring system. Studies were categorized into their general condition groups. Interventions in patients with diabetes, depression, respiratory disorders, cardiovascular disorders, epilepsy, osteoporosis, and interventions in older adults were identified. In the majority of studies pharmaceutical care was found to lead to significant improvements in clinical outcomes and/or hospitalizations when compared to the non-intervention group. Some conditions had a large number of RCTs, for example for cardiovascular conditions and in diabetes. Statistically significant improvements were seen in the majority of the studies included for both of these conditions, with studies indicating positive clinical outcomes and/or hospitalizations rates. Within the cardiovascular condition, a subset of studies, focusing on cardiac heart failure and coronary heart disease, had more mixed results. In other conditions the number of RCTs conducted was small and the evidence did not show improvements after pharmaceutical care, i.e. in depression, osteoporosis, and epilepsy. The majority of interventions were face to face interactions with

  10. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

    Science.gov (United States)

    Ancans, Janis

    2012-01-01

    Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

  11. A systematic review of the traits and cognitions associated with use of and belief in complementary and alternative medicine (CAM).

    Science.gov (United States)

    Galbraith, Niall; Moss, Tim; Galbraith, Victoria; Purewal, Satvinder

    2018-02-22

    Complementary and alternative medicine (CAM) use is widespread despite the controversy over its effectiveness. Although previous reviews have examined the demographics and attitudes of CAM users, there is no existing review on the traits or cognitions which characterise either CAM users or those who believe in CAM effectiveness. The current systematic review set out to address these gaps in the literature by applying a narrative synthesis. A bibliographic search and manual searches were undertaken and key authors were contacted. Twenty-three papers were selected. The trait openness to experience was positively associated with CAM use but not CAM belief. Absorption and various types of coping were also positively associated with CAM use and belief. No other trait was reliably associated with CAM use or belief. Intuitive thinking and ontological confusions were positively associated with belief in CAM effectiveness; intuitive thinking was also positively associated with CAM use. Studies researching cognitions in CAM use/belief were mostly on non-clinical samples, whilst studies on traits and CAM use/belief were mostly on patients. The quality of studies varied but unrepresentative samples, untested outcome measures and simplistic statistical analyses were the most common flaws. Traits and cognition might be important correlates of CAM use and also of faith in CAM.

  12. Medium selection for exopolysaccharide and biomass production in submerged cultures of culinary-medicinal mushrooms from Turkey

    NARCIS (Netherlands)

    Kizilcik, M.; Yamaç, M.; Griensven, van L.J.L.D.

    2010-01-01

    The present study investigates the exopolysaccharide (EPS) and biomass production of 18 strains of 15 species of culinary-medicinal higher Basidiomycetes in submerged culture under four different media. Gloeophyllum abietinum and Schizophyllum commune produced the highest EPS and biomass

  13. [Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2015].

    Science.gov (United States)

    Müntener, C; Kupper, J; Naegeli, H; Gassner, B

    2016-11-01

    A total of 292 adverse reactions to veterinary medicinal products were reported during the year 2015. This represents an increase of 9% compared to the previous year (268 reports). Similar to previous years, most of the reactions reported were linked to the use of antiparasitics (55.1%), non-steroidal anti-inflammatory products (8.9%) or antiinfectives (9.3%). The affected animal species were primarily dogs (198 reports) and cats (42 reports), followed by cattle (31 reports) and horses (8 reports). Additional 42 reports were provided within the frame of consultations with Tox Info Suisse in Zürich and involved mainly the excessive intake of flavored tablets. Eight signals were identified from the reports received or the periodic safety update reports. They resulted in revisions of the product information in sections addressing contraindications, adverse reactions or withdrawal times.

  14. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

    DEFF Research Database (Denmark)

    Gluud, Christian; Kubiak, Christine; Whitfield, Kate

    2012-01-01

    In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.......In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe....

  15. Studies On Sterilization Process For Some Traditional Products Of Herbal Medicine By Gamma Radiation

    International Nuclear Information System (INIS)

    Hoang Phuong Thao; Nguyen Van Binh; Tran Bang Diep; Hoang Dang Sang; Nguyen Thuy Huong Trang; Pham Duy Duong; Tran Minh Quynh

    2014-01-01

    Herbal eyebright products and their raw materials have been irradiated with 1, 2, 3 and 5 kGy by Co-60 gamma radiation source at Hanoi Irradiation Center (VINATOM) for sterilization. Initial bioburdens were under the limitation levels established for the traditional medicines according to the decree of 16/2011/TT-BYT issued by Vietnam Health Ministry. These values for both bacteria and fungus slightly increased during storage to three months, reach to about 10 3 and 10 2 CFU/g for bacteria and mold, respectively. However, there are no microbial colony could be observed in the samples irradiated with dose higher than 3 kGy, suggested that the radiation dose of 3 kGy was enough for sterilization of eyebright raw powders and products. At higher radiation dose of 5 kGy, the moisture and vitamin A content of the samples were insignificantly changed. These mean the radiation treatment with lower dose did not influenced on the quality of eyebright products, and radiation treatment can be applied to prolong the storage of not only eyebright, but also other traditional medicines. (author)

  16. Evidences of Herbal Medicine-Derived Natural Products Effects in Inflammatory Lung Diseases

    Directory of Open Access Journals (Sweden)

    Fernanda Paula R. Santana

    2016-01-01

    Full Text Available Pulmonary inflammation is a hallmark of many respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD, and acute respiratory syndrome distress (ARDS. Most of these diseases are treated with anti-inflammatory therapy in order to prevent or to reduce the pulmonary inflammation. Herbal medicine-derived natural products have been used in folk medicine and scientific studies to evaluate the value of these compounds have grown in recent years. Many substances derived from plants have the biological effects in vitro and in vivo, such as flavonoids, alkaloids, and terpenoids. Among the biological activities of natural products derived from plants can be pointed out the anti-inflammatory, antiviral, antiplatelet, antitumor anti-allergic activities, and antioxidant. Although many reports have evaluated the effects of these compounds in experimental models, studies evaluating clinical trials are scarce in the literature. This review aims to emphasize the effects of these different natural products in pulmonary diseases in experimental models and in humans and pointing out some possible mechanisms of action.

  17. Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders.

    Science.gov (United States)

    Currò, Diego; Ianiro, Gianluca; Pecere, Silvia; Bibbò, Stefano; Cammarota, Giovanni

    2017-06-01

    Functional bowel disorders (FBD), mainly irritable bowel syndrome (IBS) and functional constipation (FC, also called chronic idiopathic constipation), are very common worldwide. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, although less common, has a strong impact on patients' quality of life, as well as being highly expensive for our healthcare. A definite cure for those disorders is still yet to come. Over the years, several therapeutic approaches complementary or alternative to traditional pharmacological treatments, including probiotics, prebiotics, synbiotics, fibre and herbal medicinal products, have been investigated for the management of both groups of diseases. However, most available studies are biased by several drawbacks, including small samples and poor methodological quality. Probiotics, in particular Saccharomyces boulardii and Lactobacilli (among which Lactobacillus rhamnosus), synbiotics, psyllium, and some herbal medicinal products, primarily peppermint oil, seem to be effective in ameliorating IBS symptoms. Synbiotics and fibre seem to be beneficial in FC patients. The probiotic combination VSL#3 may be effective in inducing remission in patients with mild-to-moderate ulcerative colitis, in whom Escherichia coli Nissle 1917 seems to be as effective as mesalamine in maintaining remission. No definite conclusions can be drawn as to the efficacy of fibre and herbal medicinal products in IBD patients due to the low number of studies and the lack of randomized controlled trials that replicate the results obtained in the individual studies conducted so far. Thus, further, well-designed studies are needed to address the real role of these therapeutic options in the management of both FBD and IBD. This article is part of a themed section on Principles of Pharmacological Research of Nutraceuticals. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.11/issuetoc.

  18. A single European pharmaceutical market: Does maximum harmonization enhance medicinal product innovation?

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata

    2013-01-01

    The pharmaceutical sector in the European Union is innovative, but not innovative enough to compete on the world market. This article addresses this issue from the perspective of market harmonization, since the European Commission perceives – according to the ‘European 2020 Flagship Initiative...... – Innovation Union’ – market fragmentation to be one of the major causes of the lack of innovation. In order to establish if maximum harmonization benefits innovation, two distinct legal regimes in the pharmaceutical sector will be compared. The general rules for medicinal products are weighed against...

  19. Comparison of the backward overhead medicine ball throw to power production in college football players.

    Science.gov (United States)

    Mayhew, Jerry L; Bird, Michael; Cole, Mary L; Koch, Alex J; Jacques, Jeff A; Ware, John S; Buford, Brittney N; Fletcher, Kate M

    2005-08-01

    The purpose of this study was to determine the relationship of the backward overhead medicine ball (BOMB) throw to power production in college football players. Forty National Collegiate Athletic Association Division II college football players were studied at the end of an 8-week off-season conditioning program for power output determined from a countermovement vertical jump on a force plate and for maximal distance in the standing BOMB throw. Although the reliability of the BOMB test was high (interclass correlation coefficient = 0.86), there was a significant learning effect across 3 trials (p football players.

  20. An alternate approach to the production of radioisotopes for nuclear medicine applications.

    Science.gov (United States)

    D'Auria, John M; Keller, Roderich; Ladouceur, Keith; Lapi, Suzanne E; Ruth, Thomas J; Schmor, Paul

    2013-03-01

    There is a growing need for the production of radioisotopes for both diagnostic and therapeutic medical applications. Radioisotopes that are produced using the (n,γ) or (γ,n) reactions, however, typically result in samples with low specific activity (radioactivity∕gram) due to the high abundance of target material of the same element. One method to effectively remove the isotopic impurity is electro-magnetic mass separation. An Ion Source Test Facility has been constructed at TRIUMF to develop high-intensity, high-efficiency, reliable ion sources for purification of radioactive isotopes, particularly those used in nuclear medicine. In progress studies are presented.

  1. [Marketing of medicinal products in the European Community. The Mutual Recognition and Decentralised Procedures].

    Science.gov (United States)

    Bachmann, Peter

    2008-07-01

    The Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), which were first established in late 2005, can be regarded as the backbone for marketing authorisation of medicinal products in the European Community (EC) and the European Economic Area (EEA). Both procedures are compared and advantages and disadvantages are discussed. However, the focus is more related to current developments than the detailed comparison of both procedures. The role of the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) and the decision making process in relation to the MRP and DCP is also discussed.

  2. Access to advanced therapy medicinal products in the EU: where do we stand?

    Science.gov (United States)

    Mahalatchimy, A

    2011-05-01

    The European Union has a public health strategy and will generally ensure in all its policies and activities a "high level of human health protection". The new Regulation (EC) n 1394/2007 on advanced therapy medicinal products (ATMP), stems from this global policy and aims to harmonise access to the ATMP market. A real will for the harmonisation is clearly expressed in legal texts and enforced in the implementable procedures and requirements. However, several barriers remain. On the one hand, the scope of the ATMP Regulation is limited. On the other hand, Member States benefit from a wide margin of action.

  3. Refurbishing of a Freeze Drying Machine, used in Nuclear Medicine for Radiopharmaceuticals Production

    International Nuclear Information System (INIS)

    Gaytan-Gallardo, E.; Desales-Galeana, G.

    2006-01-01

    The refurbishing of a freeze drying machine used in the radiopharmaceuticals production, applied in nuclear medicine in the Radioactive Materials Department of the Nuclear Research National Institute in Mexico (ININ in Spanish), is presented. The freeze drying machine was acquired in the 80's decade and some components started having problems. Then it was necessary to refurbish this equipment by changing old cam-type temperature controllers and outdated recording devices, developing a sophisticated software system that substitutes those devices. The system is composed by a freeze drying machine by Hull, AC output modules for improved temperature control, a commercial data acquisition card, and the software system

  4. Advanced Therapy Medicinal Products (ATMPand exemptions to the Regulation 1394/2007: how confident can we be? An exploratory analysis.

    Directory of Open Access Journals (Sweden)

    Philippe eVan Wilder

    2012-02-01

    Full Text Available The market authorisation procedure for medicinal products for human use is relying on their demonstrated efficacy, safety and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP has been authorised through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products.An appropriate ATMP- Regulation is dealing with ATMP requirements.Two exemptions are foreseen to the ATMP-Regulation: a. Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by 30 December 2012. b.the hospital exemption rule for non routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.

  5. Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis.

    Science.gov (United States)

    Van Wilder, Philippe

    2012-01-01

    The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP) has been authorized through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products. An appropriate ATMP - Regulation is dealing with ATMP requirements. Two exemptions are foreseen to the ATMP Regulation: (a) Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by December 30, 2012. (b) The hospital exemption rule for non-routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.

  6. Consumers' acceptance and preferences for nutrition-modified and functional dairy products: A systematic review.

    Science.gov (United States)

    Bimbo, Francesco; Bonanno, Alessandro; Nocella, Giuseppe; Viscecchia, Rosaria; Nardone, Gianluca; De Devitiis, Biagia; Carlucci, Domenico

    2017-06-01

    This systematic literature review collects and summarizes research on consumer acceptance and preferences for nutrition-modified and functional dairy products, to reconcile, and expand upon, the findings of previous studies. We find that female consumers show high acceptance for some functional dairy products, such as yogurt enriched with calcium, fiber and probiotics. Acceptance for functional dairy products increases among consumers with higher diet/health related knowledge, as well as with aging. General interest in health, food-neophobia and perceived self-efficacy seem also to contribute shaping the acceptance for functional dairy products. Furthermore, products with "natural" matches between carriers and ingredients have the highest level of acceptance among consumers. Last, we find that brand familiarity drives consumers with low interest in health to increase their acceptance and preference for health-enhanced dairy products, such as probiotic yogurts, or those with a general function claim. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. The ban on smokeless tobacco products is systematically violated in Chennai, India

    DEFF Research Database (Denmark)

    Vidhubala, E.; Pisinger, C.; Basumallik, B.

    2016-01-01

    on the sachets. Results: Totally 65 STPs were collected; 26 distinct products and 23 brands. All products were claimed to be 'tobacco' by the shop keepers. Sixty-five percent of the products informed to contain tobacco and 15.4% to contain pan masala. Five sachets did not inform about the content; 30.8% did...... not have a pictorial warning; a text warning was printed on 80.8%, but only two products had the messages in Tamil; 70% had promotional messages printed, and 57% had their registration numbers printed. Conclusion: The ban on STP is being systematically violated in Chennai. STP are cheap and easily...... available and due to promotional laudatory messages and lacking information about the content and warning of health damage, the consumers are left with the perception that they buy more or less harmless product. The Indian Government must introduce policies to control production, import, and sale of illicit...

  8. Nurse prescribing of medicines in Western European and Anglo-Saxon countries: a systematic review of the literature.

    Science.gov (United States)

    Kroezen, Marieke; van Dijk, Liset; Groenewegen, Peter P; Francke, Anneke L

    2011-05-27

    A growing number of countries are introducing some form of nurse prescribing. However, international reviews concerning nurse prescribing are scarce and lack a systematic and theoretical approach. The aim of this review was twofold: firstly, to gain insight into the scientific and professional literature describing the extent to and the ways in which nurse prescribing has been realised or is being introduced in Western European and Anglo-Saxon countries; secondly, to identify possible mechanisms underlying the introduction and organisation of nurse prescribing on the basis of Abbott's theory on the division of professional labor. A comprehensive search of six literature databases and seven websites was performed without any limitation as to date of publication, language or country. Additionally, experts in the field of nurse prescribing were consulted. A three stage inclusion process, consisting of initial sifting, more detailed selection and checking full-text publications, was performed independently by pairs of reviewers. Data were synthesized using narrative and tabular methods. One hundred and twenty-four publications met the inclusion criteria. So far, seven Western European and Anglo-Saxon countries have implemented nurse prescribing of medicines, viz., Australia, Canada, Ireland, New Zealand, Sweden, the UK and the USA. The Netherlands and Spain are in the process of introducing nurse prescribing. A diversity of external and internal forces has led to the introduction of nurse prescribing internationally. The legal, educational and organizational conditions under which nurses prescribe medicines vary considerably between countries; from situations where nurses prescribe independently to situations in which prescribing by nurses is only allowed under strict conditions and supervision of physicians. Differences between countries are reflected in the jurisdictional settlements between the nursing and medical professions concerning prescribing. In some

  9. Nurse prescribing of medicines in Western European and Anglo-Saxon countries: a systematic review of the literature

    Directory of Open Access Journals (Sweden)

    Groenewegen Peter P

    2011-05-01

    Full Text Available Abstract Background A growing number of countries are introducing some form of nurse prescribing. However, international reviews concerning nurse prescribing are scarce and lack a systematic and theoretical approach. The aim of this review was twofold: firstly, to gain insight into the scientific and professional literature describing the extent to and the ways in which nurse prescribing has been realised or is being introduced in Western European and Anglo-Saxon countries; secondly, to identify possible mechanisms underlying the introduction and organisation of nurse prescribing on the basis of Abbott's theory on the division of professional labor. Methods A comprehensive search of six literature databases and seven websites was performed without any limitation as to date of publication, language or country. Additionally, experts in the field of nurse prescribing were consulted. A three stage inclusion process, consisting of initial sifting, more detailed selection and checking full-text publications, was performed independently by pairs of reviewers. Data were synthesized using narrative and tabular methods. Results One hundred and twenty-four publications met the inclusion criteria. So far, seven Western European and Anglo-Saxon countries have implemented nurse prescribing of medicines, viz., Australia, Canada, Ireland, New Zealand, Sweden, the UK and the USA. The Netherlands and Spain are in the process of introducing nurse prescribing. A diversity of external and internal forces has led to the introduction of nurse prescribing internationally. The legal, educational and organizational conditions under which nurses prescribe medicines vary considerably between countries; from situations where nurses prescribe independently to situations in which prescribing by nurses is only allowed under strict conditions and supervision of physicians. Conclusions Differences between countries are reflected in the jurisdictional settlements between the

  10. The production of radionuclides for nuclear medicine from a compact, low-energy accelerator system.

    Science.gov (United States)

    Webster, William D; Parks, Geoffrey T; Titov, Dmitry; Beasley, Paul

    2014-05-01

    The field of nuclear medicine is reliant on radionuclides for medical imaging procedures and radioimmunotherapy (RIT). The recent shut-downs of key radionuclide producers have highlighted the fragility of the current radionuclide supply network, however. To ensure that nuclear medicine can continue to grow, adding new diagnostic and therapy options to healthcare, novel and reliable production methods are required. Siemens are developing a low-energy, high-current - up to 10 MeV and 1 mA respectively - accelerator. The capability of this low-cost, compact system for radionuclide production, for use in nuclear medicine procedures, has been considered. The production of three medically important radionuclides - (89)Zr, (64)Cu, and (103)Pd - has been considered, via the (89)Y(p,n), (64)Ni(p,n) and (103)Rh(p,n) reactions, respectively. Theoretical cross-sections were generated using TALYS and compared to experimental data available from EXFOR. Stopping power values generated by SRIM have been used, with the TALYS-generated excitation functions, to calculate potential yields and isotopic purity in different irradiation regimes. The TALYS excitation functions were found to have a good agreement with the experimental data available from the EXFOR database. It was found that both (89)Zr and (64)Cu could be produced with high isotopic purity (over 99%), with activity yields suitable for medical diagnostics and therapy, at a proton energy of 10MeV. At 10MeV, the irradiation of (103)Rh produced appreciable quantities of (102)Pd, reducing the isotopic purity. A reduction in beam energy to 9.5MeV increased the radioisotopic purity to 99% with only a small reduction in activity yield. This work demonstrates that the low-energy, compact accelerator system under development by Siemens would be capable of providing sufficient quantities of (89)Zr, (64)Cu, and (103)Pd for use in medical diagnostics and therapy. It is suggested that the system could be used to produce many other

  11. Modelling study on production cross sections of {sup 111}In radioisotopes used in nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Kara, Ayhan; Korkut, Turgay [Sinop Univ. (Turkey). Faculty of Engineering; Yigit, Mustafa [Aksaray Univ. (Turkey). Faculty of Science and Arts; Tel, Eyyup [Osmaniye Korkut Ata Univ. (Turkey). Faculty of Science and Arts

    2015-07-15

    Radiopharmaceuticals are radioactive drugs used for diagnosis or treatment in a tracer quantity with no pharmacological action. The production of radiopharmaceuticals is carried out in the special research centers generally using by the cyclotron systems. Indium-111 is one of the most useful radioisotopes used in nuclear medicine. In this paper, we calculated the production cross sections of {sup 111}In radioisotope via {sup 111-114}Cd(p,xn) nuclear reactions up to 60 MeV energy. In the model calculations, ALICE/ASH, TALYS 1.6 and EMPIRE 3.2 Malta nuclear reaction code systems were used. The model calculation results were compared to the experimental literature data and TENDL-2014 (TALYS-based) data.

  12. Animals and their products utilized as medicines by the inhabitants surrounding the Ranthambhore National Park, India

    Directory of Open Access Journals (Sweden)

    Jaroli DP

    2006-11-01

    Full Text Available Abstract The present ethnozoological study describes the traditional knowledge related to the use of different animals and animal-derived products as medicines by the inhabitants of villages surrounding the Ranthambhore National Park of India (Bawaria, Mogya, Meena, which is well known for its very rich biodiversity. The field survey was conducted from May to July 2005 by performing interviews through structured questionnaires with 24 informants (16 men and 8 women, who provided information regarding therapeutic uses of animals. A total of 15 animals and animal products were recorded and they are used for different ethnomedical purposes, including tuberculosis, asthma, paralysis, jaundice, earache, constipation, weakness, snake poisoning. The zootherapeutic knowledge was mostly based on domestic animals, but some protected species like the collared dove (Streptopelia sp., hard shelled turtle (Kachuga tentoria, sambhar (Cervus unicolor were also mentioned as important medicinal resources. We would suggest that this kind of neglected traditional knowledge should be included into the strategies of conservation and management of faunistic resources in the investigated area.

  13. Medicinal mushroom Ganoderma lucidum in the production of special beer types

    Directory of Open Access Journals (Sweden)

    Leskošek-Čukalović Ida I.

    2009-01-01

    Full Text Available Mushrooms like Ganoderma lucidum have been used for thousands of years as a traditional medicine in the Far East. Ganoderma received wide popularity as an eating mushroom with high nutritive value, but even more as medical fungi. It has been used for the treatment of various diseases: hepatitis, hypertension, insomnia, and even cancer. Due to its extraordinary action, it is often called 'Elixir of life', 'Food of gods' and 'Mushroom of universe'. The intracellular and extracellular polysaccharides (b-glucane inhibit the growth of several types of cancer. Mushroom produces triterpenes of which especially ganoderic acid showed cytotoxicity on primary tumor liver cells, inhibition of histamine release, hepatoprotective effect, stimulation of the immune system functions, inhibition of the aggregation of blood plates, etc. On the other hand, beer as a purely natural beverage obtained in the process of fermentation, contains a number of ingredients which are important for human organism, and in moderate usage has favorable reaction on the general health condition of the body. As such, beer is a very good basis for the development of a number of new products with defined pharmacodynamics influence. In this work, we have investigated the possibilities of using extracts of mushroom Ganoderma lucidum in the production of special beer types. The composition of mushroom, properties of the most important active ingredients, extraction procedures, and sensory characteristics of the beers on the basis of such extracts were determined. The most important parameters of quality and possibility of adjustments using extracts of different medicinal herbs were investigated.

  14. Investigations of residue of veterinary medicines and environmental contaminants during production cycle of Petrovska klobasa as part of compulsory parameters for food safety

    Directory of Open Access Journals (Sweden)

    Janković Vesna

    2012-01-01

    Full Text Available A significant factor in the protection of consumer health is the systematic and constant implementation of control for the presence of residue of biologically active substances and their metabolites in raw materials and in primary products of animal origin. As regards meat, an essential aspect of security is definitely the control of possible residue of veterinary medicines and environmental contaminants. In that respect, the objective of the national project entitled „Development of technology for drying and fermentation of the sausage petrovačka kobasica (Petrovská klobása - registered geographic origin under controlled conditions“, Number TR - 20037, was to protect the product petrovačka kobasica (Petrovská klobása with the appropriate appellation. A part of the compulsory investigations also included the establishing of the presence of residue of veterinary medicines and environmental contaminants in raw materials and in the finished product, which was also the aim of this work. [Projekat Ministarstva nauke Republike Srbije, br. TR-20037: Petrovská klobása - oznaka geografskog porekla u kontrolisanim uslovima

  15. Systematic model for lean product development implementation in an automotive related company

    Directory of Open Access Journals (Sweden)

    Daniel Osezua Aikhuele

    2017-07-01

    Full Text Available Lean product development is a major innovative business strategy that employs sets of practices to achieve an efficient, innovative and a sustainable product development. Despite the many benefits and high hopes in the lean strategy, many companies are still struggling, and unable to either achieve or sustain substantial positive results with their lean implementation efforts. However, as the first step towards addressing this issue, this paper seeks to propose a systematic model that considers the administrative and implementation limitations of lean thinking practices in the product development process. The model which is based on the integration of fuzzy Shannon’s entropy and Modified Technique for Order Preference by Similarity to the Ideal Solution (M-TOPSIS model for the lean product development practices implementation with respective to different criteria including management and leadership, financial capabilities, skills and expertise and organization culture, provides a guide or roadmap for product development managers on the lean implementation route.

  16. Chinese Medicinal Herbs in the Treatment of Upper Airway Cough Syndrome: A Systematic Review of Randomized, Controlled Trials.

    Science.gov (United States)

    Jiang, Hongli; Liu, Wei; Li, Guanhong; Fan, Tao; Mao, Bing

    2016-03-01

    Context • Upper airway cough syndrome (UACS), previously called postnasal drip syndrome (PNDS), has been considered universally to be one of the most common causes of chronic cough. As an important part of complementary and alternative therapy, traditional Chinese medicine (TCM) has found an exact curative therapy for chronic cough through clinical practice for thousands of years. Objective • The aim of the current review was to investigate systematically the beneficial and adverse effects of Chinese medicinal herbs (CMH) in the treatment of UACS. Design • The research team performed searches in 11 main databases from respective inception to October 31, 2015, supplemented with manual retrieval of other data. Only randomized, controlled trials (RCTs) reporting on the effectiveness of CMH in patients with UACS were included. Descriptive and quantitative data on the studies' designs, population demographics, interventions, outcomes, and methodological quality were extracted and tabulated. Methodological quality was assessed using the Cochrane risk-of-bias system and the quality of the evidence was evaluated using the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) system. Participants • The reviewed studies included 1355 participants-720 in the CMH groups and 635 in the control groups-of both genders, from various professional and ethnic groups, and with a wide range of ages. They all had a duration of cough symptoms of longer than 8 wk and a clinical diagnosis of chronic cough induced by UACS that was supported by appropriate physical findings. Outcome Measures • The primary outcomes included (1) TCM recovery rate and (2) TCM cough symptom score. TCM's curative effect was calculated as the cumulative percentage of the symptom-score reduction (PSSR), estimated between baseline and postintervention. The cough symptom scores were graded according to the Chinese Criteria Guiding Principle of Clinical Research on New Drugs of TCM, with

  17. Systematic review automation technologies

    Science.gov (United States)

    2014-01-01

    Systematic reviews, a cornerstone of evidence-based medicine, are not produced quickly enough to support clinical practice. The cost of production, availability of the requisite expertise and timeliness are often quoted as major contributors for the delay. This detailed survey of the state of the art of information systems designed to support or automate individual tasks in the systematic review, and in particular systematic reviews of randomized controlled clinical trials, reveals trends that see the convergence of several parallel research projects. We surveyed literature describing informatics systems that support or automate the processes of systematic review or each of the tasks of the systematic review. Several projects focus on automating, simplifying and/or streamlining specific tasks of the systematic review. Some tasks are already fully automated while others are still largely manual. In this review, we describe each task and the effect that its automation would have on the entire systematic review process, summarize the existing information system support for each task, and highlight where further research is needed for realizing automation for the task. Integration of the systems that automate systematic review tasks may lead to a revised systematic review workflow. We envisage the optimized workflow will lead to system in which each systematic review is described as a computer program that automatically retrieves relevant trials, appraises them, extracts and synthesizes data, evaluates the risk of bias, performs meta-analysis calculations, and produces a report in real time. PMID:25005128

  18. From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU.

    Science.gov (United States)

    Pellegrini, Graziella; Lambiase, Alessandro; Macaluso, Claudio; Pocobelli, Augusto; Deng, Sophie; Cavallini, Gian Maria; Esteki, Roza; Rama, Paolo

    2016-06-01

    In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was established in different facilities and the clinical application in several hospitals. Advanced therapy medicinal products, including stem cells, are unique products with different challenges than other drugs: some uncertainties, in addition to benefit, cannot be avoided. This review will focus on all recent developments in the stem cell-based corneal therapy.

  19. A systematic methodology for the design of continuous active pharmaceutical ingredient production processes

    DEFF Research Database (Denmark)

    Cervera Padrell, Albert Emili; Gani, Rafiqul; Kiil, Søren

    2011-01-01

    Continuous pharmaceutical manufacturing (CPM) has emerged as a powerful technology to obtain higher reaction yields and improved separation efficiencies, potentially leading to simplified process flowsheets, reduced total costs, lower environmental impacts, and safer and more flexible production...... and representation, as well as on how to employ this knowledge for process (re-)design. The aim of this paper is to introduce a methodology that systematically identifies already existing PSE methods and tools which can assist in the design of CPM processes. This methodology has been applied to a process...... for the production of an API developed by H. Lundbeck A/S, demonstrating the mentioned potential benefits that CPM can offer....

  20. Systematic substrate adoption methodology (SAM) for future flexible, generic pharmaceutical production processes

    DEFF Research Database (Denmark)

    Singh, Ravendra; Godfrey, Andy; Gregertsen, Björn

    2013-01-01

    (APIs) for early delivery campaigns. Of these candidates only a few will be successful such that further development is required to scale-up the process. Systematic computer-aided methods and tools are required for faster manufacturing of these API candidates. In this work, a substrate adoption......The discovery of an effective and safe pharmaceutical product is based on success in clinical trials. Often, several candidate compounds targeting the same disease area are tested in order to identify the most efficacious products. This involves the manufacture of small quantities of compounds...... from the pharmaceutical industry. Use of computer-aided methods and tools as part of the methodology is also highlighted....

  1. Publication Productivity of Faculty of Medicine, Mansoura University Indexed in PubMed.

    Science.gov (United States)

    Helal, Rm; Abou-ElWafa, Hs; El-Gilany, Ah

    2014-09-01

    Analysis of PubMed publications as an indicator of the research productivity of individual countries, regions, or institutions has recently become a field of interest. The aim was to assess the past trends in PubMed-indexed medical publications from Mansoura Faculty of Medicine and to have an idea about the current situation in medical research. PubMed was searched for publications affiliated to Mansoura from the end of the calendar year 2012 and earlier. Of 2798 papers related to Mansoura, 1756 publications were included in the analysis, and 1042 publications were excluded (false positives). The highest number of publications was in 2011 (10.6%, 187/1756) followed by 2012 (10.2%, 179/1756). There was an increase of the publication rate over 5-years period until it reaches 47.0% (826/1756) during the period from 2008 to 2012. The main high-producing department was Urology and Nephrology, which accounted for 35.9% (631/1756) of the total publications followed by Pediatrics and Parasitology. The median number of authors participated in the researches was four ranging from 1 to 23. Most of the publications were in the form of intervention/clinical trials (38.4%, 662/1756) followed by descriptive/cross-sectional study (38.3%, 659/1756). The median of the impact factor was 1.99 ranging from 0.27 to 53.3. The publication productivity of Mansoura Faculty of Medicine showed fluctuating pattern from the end of the calendar year 2012 and earlier. Future prospects for increasing research productivity should be considered to increase the number and quality of publications and academic staff participating in high-quality international researches.

  2. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.

    Science.gov (United States)

    Cavagnaro, Joy; Silva Lima, Beatriz

    2015-07-15

    The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. Production layout improvement by using line balancing and Systematic Layout Planning (SLP) at PT. XYZ

    Science.gov (United States)

    Buchari; Tarigan, U.; Ambarita, M. B.

    2018-02-01

    PT. XYZ is a wood processing company which produce semi-finished wood with production system is make to order. In the production process, it can be seen that the production line is not balanced. The imbalance of the production line is caused by the difference in cycle time between work stations. In addition, there are other issues, namely the existence of material flow pattern is irregular so it resulted in the backtracking and displacement distance away. This study aimed to obtain the allocation of work elements to specific work stations and propose an improvement of the production layout based on the result of improvements in the line balancing. The method used in the balancing is Ranked Positional Weight (RPW) or also known as Helgeson Birnie method. While the methods used in the improvement of the layout is the method of Systematic Layout Planning (SLP). By using Ranked Positional Weight (RPW) obtained increase in line efficiency becomes 84,86% and decreased balance delay becomes 15,14%. Repairing the layout using the method of Systematic Layout Planning (SLP) also give good results with a reduction in path length becomes 133,82 meters from 213,09 meters previously or a decrease of 37.2%.

  4. Analytical product study of germanium-containing medicine by different ICP-MS applications.

    Science.gov (United States)

    Krystek, Petra; Ritsema, Rob

    2004-01-01

    For several years organo-germanium containing medicine has been used for special treatments of e.g. cancer and AIDS. The active substances contain germanium as beta-carboxyethylgermanium sesquioxide ((GeCH2CH2COOH)203/"Ge-132"), spirogermanium, germanium-lactate-citrate or unspecified forms. For humans, germanium is not essential and in general the toxicity of the mentioned organo-germanium compounds is low. Acute and chronic toxic effects of inorganic germanium dioxide have been demonstrated. It is obvious that especially inorganic germanium has a higher potential of negative effects. Therefore, a widespread analytical product control is indispensable. Inductively coupled plasma mass spectrometry (ICP-MS) is the preferred technique and different applications were developed for controlling various parameters: (i) A speciation method using high performance liquid chromatography (HPLC) coupled with quadrupole (Q-) ICP-MS was developed for the identification of organo-germanium species in medicine. (ii) The nuclear magnetic resonance (NMR) technique was applied to confirm the molecular structure and to determine the molecule concentration. (iii) The total concentration of germanium in the medicine was determined in the diluted sample by high resolution (HR-) ICP-MS. (iv) For a general overview, a multi-element screening method of 56 elements with HR-ICP-MS was developed. The semi-quantitative mode was used for quantification and elements of higher abundance are reported. (v) Investigations about matrix-based interferences on masses of isotopes, which are generally determinable without remarkable problems. Isotopes like e.g. 85Rb, 88Sr, 89y, 90Zr, 93Nb and the isotopes of Ba are strongly interfered by different Ge-based molecules and need to be analysed in a higher resolution mode than used for other common matrices.

  5. The Microbial Quality Aspects and Decontamination Approaches for the Herbal Medicinal Plants and Products: An in-Depth Review.

    Science.gov (United States)

    Ghisleni, Daniela Dal Molim; Braga, Marina de Souza; Kikuchi, Irene Satiko; Braşoveanu, Mirela; Nemţanu, Monica R; Dua, Kamal; Pinto, Terezinha de Jesus Andreoli

    2016-01-01

    The present review article provides an overview of the published literature concerning microbial quality of medicinal plants and products and their decontamination methods. It is important to analyze different aspects regarding the cultivation, growing, harvesting, storage, manufacturing, and decontamination of medicinal plant products. Herbal medicinal plants bear a massive microbial load leading to contamination and mycotoxin, which needs to be considered, and properly controlled using suitable sterilization and decontamination methods. The main focus of this review is on the definition, advantages, disadvantages and applications of decontamination methods, particularly to show that one must consider the characteristics of the initial sample to be decontaminated. The effects of various methods (ozone, plasma, irradiation) on medicinal herbs and products treated for microbiological decontamination are dependent on factors related to microbial load (i.e., nature and amount of initial contamination), herb/product matrix (i.e., complexity of chemical composition, physical state - solid or liquid) and treatment conditions (i.e., time, irradiation dose, absence or presence of oxygen). In addition, it is important to accept some loss of the chemical compounds, while decreasing microbial load to acceptable limits according to official herbal pharmacopoeias and literature, thus ensuring a final product with quality, safety and therapeutic efficacy. The conclusion, which comes from this contribution, is that herbal medicine has more contaminants than a chemically welldefined drug, thus, good manufacturing practices should be followed.

  6. Animal-derived natural products of Sowa Rigpa medicine: Their pharmacopoeial description, current utilization and zoological identification.

    Science.gov (United States)

    Yeshi, Karma; Morisco, Paolo; Wangchuk, Phurpa

    2017-07-31

    The Bhutanese Sowa Rigpa medicine (BSM) uses animal parts in the preparation of numerous polyingredient traditional remedies. Our study reports the taxonomical identification of medicinal animals and the description of traditional uses in English medical terminologies. To taxonomically identify the medicinal animals and their derived natural products used as a zootherapeutic agents in BSM. First, the traditional textbooks were reviewed to generate a list of animal products described as ingredients. Second, animal parts that are currently used in Bhutan were identified. Third, the ethnopharmacological uses of each animal ingredients were translated into English medical terminologies by consulting Traditional Physicians, clinical assistants, pharmacognosists, and pharmacists in Bhutan. Fourth, the animal parts were taxonomically identified and their Latin names were confirmed by crosschecking them with online animal databases and relevant scientific literature. The study found 73 natural products belonging to 29 categories derived from 45 medicinal animals (36 vertebrates and 9 invertebrates), comprising of 9 taxonomic categories and 30 zoological families. Out of 116 formulations currently produced, 87 of them contain one or more extracts and products obtained from 13 medicinal animals to treat more than 124 traditionally classified illnesses. Only five animal ingredients were found available in Bhutan and rest of the animal parts are being imported from India. Out of 73 natural products described in the traditional textbooks, only 13 of them (some omitted and few substituted by plants) are currently included in 87 formulations of BSM. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  7. Non-timber forest products marketing systems and market players in southwest Virginia: crafts, medicinal and herbal, and specialty wood products

    Science.gov (United States)

    S.M. Greene; A.L. Hammett; S. Kant

    2000-01-01

    Non-timber forest products (NTFPs) are important in rural southwest Virginia as a source of household income. Marketing system of crafts, medicinal and herbal, and specialty wood products are studied using exploratory and qualitative research methods. Fifty market players at various levels in marketing chains are interviewed to get the information on elements of...

  8. Systematic Methodology for Design of Tailor-Made Blended Products: Fuels and Other Blended Products

    DEFF Research Database (Denmark)

    Yunus, Nor Alafiza Binti

    A tailor-made blended liquid product is defined as a formulation of various chemicals in the liquid state to obtain a liquid mixture with a specific set of desired characteristics and qualities. Examples of blended liquid products are synthetic fuels and lubricants. This type of products is very ...... methodology and tools was tested through two case studies. In the first case study, two different gasoline blend problems have been solved. In the second case study, four different lubricant design problems have been solved....

  9. [Scientific productivity standards and the National Automous University of Mexico School of Medicine].

    Science.gov (United States)

    Martínez, Federico; Palomares, Alejandra; Piña, Enrique

    2004-01-01

    The scientific production at theNational Autonomous University of Mexico (Universidad Nacional Autónoma de México, UNAM) School of Medicine was analyzed during the period from 1999 to 2002. We found the following: 1) 94.83% of total international scientific papers was recovered; 2) mean impact factor had a value of 2.5, ca. the value reported by CONACYT, México, for the period 1998-2002; 3) percentage of corresponding authors was 58.83%, 27.80% of papers were national collaborations, 9.83% were international collaborations, and 3.37% corresponded to personal publications; 4) by using corresponding author and collaborations, academic leaders were identified; 5) there are differences among academic departments, and 6) basic research from the UNAM School of Medicine contributes 14% of national research and teaches ca. 2,450 students per year. It is proposed that this type of analysis should be used to establish the politics of science.

  10. Kitchen chemistry: A scoping review of the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions.

    Science.gov (United States)

    Van Hout, Marie Claire

    2014-01-01

    Misuse of pharmaceuticals is of increasing drug policy and public health concern. A scoping review was conducted on the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions. The research question was broad: What is known from the existing literature about the diversion of pharmaceuticals for non-medicinal use and for home production of drug solutions? The scoping process centred on the systematic selection, collection, and summarization of extant knowledge within this broad thematic remit. One hundred and thirty-four records were grouped into discrete thematic categories namely: non medicinal use and tampering with pharmaceuticals, oral misuse of codeine cough syrups, homemade drug solutions, and home-produced drug-related harms in the narrative review design. Forms of abuse of codeine cough syrup include mixtures with alcohol or soft drinks ('Purple Drank'), with kratom leaves ('Kratom cocktails'), or chemically altered to extract dextromorphan ('Lemon Drop'). Production of homemade opiates ('Cheornaya', 'Kolyosa', Himiya', 'Braun', 'Krokodil'), methamphetamine ('Vint', 'Pervitin'), methcathinone ('Jeff'), and cathinone ('Boltushka') are described. Displacement patterns between the non-medical use of pharmaceuticals, commercial, and homemade drugs appear dependent on availability of opiates, prescribing practices, supervision of substitution drug dosing, availability of cheap ingredients, policing, and awareness of harms. Adverse health and social consequences relate to the use of unknown and contaminated (end) substances, injecting practices, redosing, medical complications, and death. The review highlights a public health imperative requiring a multidisciplinary approach to quantify potential impact and required integrated policy responses incorporating international regulation, enforcement, health surveillance and service delivery. Copyright © 2014 John Wiley & Sons, Ltd.

  11. [Vigilance for veterinary medicinal products: declarations of adverse reactions in the year 2009].

    Science.gov (United States)

    Müntener, C R; Bruckner, L; Stürer, A; Althaus, F R; Caduff-Janosa, P

    2010-12-01

    During the year 2009, 134 reports of suspected adverse drug reactions (ADRs) to veterinary medicinal products (VMPs) were received (106 in the year 2008). The distribution according to species and drug classes remained in line with previous years. Companion animals were involved in most of the reports (46 % dogs, 19 % cats), followed by cattle or calves (22 %). Antiparasitic drugs made the biggest part with 30 % of the reports, followed by antiinfectives (19 %) and hormones (13 %). Some reactions following their use are specifically discussed. 95 additional enquiries about ADRs of VMPs were received by the Swiss Toxicological Information Centre in Zürich. Most of them concerned dogs or cats and antiparasitics or anti-inflammatory drugs. In the vaccinovigilance program, a total of 1020 reports were received, of which 1000 were related to the vaccination against blue tongue disease. The most frequently reported adverse reactions were aborts, mastitis or alterations of milk quality and they are specifically discussed.

  12. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

    Science.gov (United States)

    de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

    2018-03-21

    A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.

    Science.gov (United States)

    Barrow, Paul

    2016-09-01

    SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2) guideline on detection of toxicity to reproduction for medicinal products. The current ICH guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new guideline will be adopted even outside the ICH regions. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Contamination of herbal medicinal products marketed in Kaduna metropolis with selected pathogenic bacteria.

    Science.gov (United States)

    Abba, Danladi; Inabo, Helen I; Yakubu, Sabo E; Olonitola, Olayeni S

    2008-10-25

    The study aimed to evaluate the bacterial contamination of powdered herbal medicinal preparations sourced from identified herbal retail outlets in different parts of Kaduna metropolis. The assessments of the contamination of the herbal products were carried out using standard procedures: total aerobic bacterial plate count, measurement of some physical parameters, isolation and characterization of selected bacterial pathogens etc. The results showed that out of a total of 150, 70 (46.67%) herbal remedies were contaminated with Salmonella typhi, twenty nine (19.33%) with Shigella spp. Eighty eight (58.67%) and 98 (65.33%) were contaminated with Escherichia coli and Staphylococcus aureus, respectively. The total aerobic plate count results showed that the highest average count of > 5x10(7) cfu/g was found in 89 (59.33%) of the preparations, while average plate count of < or = 5x10(7) cfu/g was found in 42 (28%) and no bacterial count was obtained in 19 (12.67%) of the preparations. Correlation was positive (P = 0.01; r = +0.109) between the physical parameters tested and the bacterial load. Antibacterial activities result of some common antibiotics showed that all the antibiotics had activities on the test bacterial isolates at various minimum inhibitory concentrations. Most traditionally prepared herbal medications in Kaduna state are likely to be contaminated with a wide variety of potentially pathogenic bacteria. The quality assurance of these products should be thoroughly enforced and monitored in the production and distribution of herbal preparations.

  15. Advanced Therapy Medicinal Products in type I diabetes mellitus: technological and regulatory challenges

    Directory of Open Access Journals (Sweden)

    Camila Leal-Lopes

    2018-02-01

    Full Text Available Introduction: Type 1 Diabetes mellitus (T1DM is an autoimmune disorder which arises from the destruction of insulin-producing pancreatic β-cells. Currently, Brazil’s advanced therapy medicinal products (ATMP, developed for clinical research and therapeutic purposes, take place in the so-called Cellular Technology Centers (CTC, according to the Resolution nº. 9/2011 of the Collegiate Board of Directors (RDC, enacted by the National Health Surveillance Agency (Anvisa. Objective: This study was conducted with the main objective of describing and discussing the development of ATMP for T1DM treatment. Method: A qualitative research, narrative review and critical discussion of the literature were under taken. Results: ATMP promote new therapeutic approaches for Diabetes, holding great potential to restore the patients’ endogenous insulin secretion, improving their life quality, overcoming the chronic complications of Diabetes and reducing the socioeconomic burden. Nowadays, ATMP in T1DM comprise: a cell therapy; b gene therapy products; c tissue engineering and d ATMPassociated to biopharmaceutical products. Conclusions: Further research should contribute to stimulate public and private organizations to effectively act towards reducing the impact of Diabetes on individuals and the society as a whole. It is essential that Brazilian legislation closely follows the biotechnological developments, supporting the scientific progress and benefiting T1DM patients with modern and cutting-edge therapies.

  16. Do ultra-orphan medicinal products warrant ultra-high prices? A review

    Directory of Open Access Journals (Sweden)

    Picavet E

    2013-06-01

    Full Text Available Eline Picavet,1 David Cassiman,2 Steven Simoens1 1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; 2Department of Hepatology, University Hospital Leuven, Leuven, Belgium Abstract: Ultra-orphan medicinal products (ultra-OMPs are intended for the treatment, prevention, or diagnosis of ultra-rare diseases, ie, life-threatening or chronically debilitating diseases that affect less than one per 50,000 individuals. Recently, high prices for ultra-OMPs have given rise to debate on the sustainability and justification of these prices. The aim of this article is to review the international scientific literature on the pricing of ultra-OMPs and to provide an overview of the current knowledge on the drivers of ultra-OMP pricing. The pricing process of ultra-OMPs is a complex and nontransparent issue. Evidence in the literature seems to indicate that ultra-OMPs are priced according to rarity and what the manufacturer believes the market will bear. Additionally, there appears to be a trend between the price of an ultra-OMP and the number of available alternatives. Patients, third-party payers, and pharmaceutical companies could benefit from more transparent pricing strategies. With a view to containing health care costs, it is likely that cost-sharing strategies, such as performance-based risk sharing arrangements, will become increasingly more important. However, it is vital that any measures for price control are consistent with the intended goals of the incentives to promote the development of new OMPs. Ideally, a balance must be struck between attaining affordable prices for ultra-OMPs and securing a realistic return on investment for the pharmaceutical industry. Keywords: ultra-orphan medicinal product, ultra-rare disease, pricing

  17. Systematical estimation of GPM-based global satellite mapping of precipitation products over China

    Science.gov (United States)

    Zhao, Haigen; Yang, Bogang; Yang, Shengtian; Huang, Yingchun; Dong, Guotao; Bai, Juan; Wang, Zhiwei

    2018-03-01

    As the Global Precipitation Measurement (GPM) Core Observatory satellite continues its mission, new version 6 products for Global Satellite Mapping of Precipitation (GSMaP) have been released. However, few studies have systematically evaluated the GSMaP products over mainland China. This study quantitatively evaluated three GPM-based GSMaP version 6 precipitation products for China and eight subregions referring to the Chinese daily Precipitation Analysis Product (CPAP). The GSMaP products included near-real-time (GSMaP_NRT), microwave-infrared reanalyzed (GSMaP_MVK), and gauge-adjusted (GSMaP_Gau) data. Additionally, the gauge-adjusted Integrated Multi-Satellite Retrievals for Global Precipitation Measurement Mission (IMERG_Gau) was also assessed and compared with GSMaP_Gau. The analyses of the selected daily products were carried out at spatiotemporal resolutions of 1/4° for the period of March 2014 to December 2015 in consideration of the resolution of CPAP and the consistency of the coverage periods of the satellite products. The results indicated that GSMaP_MVK and GSMaP_NRT performed comparably and underdetected light rainfall events (products, these validation results will supply helpful references for both end users and algorithm developers. However, the study findings need to be confirmed over a longer future study period when the longer-period IMERG retrospectively-processed data are available.

  18. Productivity estimation in economic evaluations of occupational health and safety interventions: a systematic review.

    Science.gov (United States)

    Steel, Jonas; Godderis, Lode; Luyten, Jeroen

    2018-02-06

    Objectives Occupational health and safety (OHS) interventions` effect on worker productivity is an essential, but complex element of the value of these programs. The trustworthiness of economic evaluation studies, aiming to provide guidance to decision-makers in the field of OHS, depends at least partly on how accurately productivity changes are measured. We aim to review the methods used to estimate productivity changes in recently published economic evaluations of OHS interventions. Methods We performed systematic searches of economic evaluations of OHS programs published between 2007 and 2017 and reviewed these studies` methods to quantify the programs` impact on worker productivity Results Of the 90 identified studies, 44 used a human capital approach, 17 a friction cost approach, 13 stated productivity in natural units (eg, a cost-per-absence-day-avoided), 7 made use of compensation expenses, 4 used output-based methods, 4 an "ad hoc" approach, and 1 study did not state its method. Different approaches were combined in 19 studies. Within these methods, we observed a wide diversity in their precise implementation, especially regarding the measurement and valuation of absenteeism and presenteeism. Conclusions Productivity is a key element of the economic attractiveness of investing in OHS. Economic evaluation studies of OHS would benefit from more methodological standardization in their approach to quantifying productivity change. Future research should better account for the methodological uncertainty that occurs in estimating it in order to demonstrate the impact that particular choices and approaches to productivity estimation can have on cost-effectiveness results.

  19. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

    Science.gov (United States)

    Zhu, You-Ping

    2017-06-01

    This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

  20. USE OF FRESH PARTS OF MEDICINAL PLANTS FOR HEALTH AND PRODUCTION IN LIVESTOCK – A NEW CONCEPT OF FARMING

    Directory of Open Access Journals (Sweden)

    Shibabrata Pattanayak

    2013-06-01

    Full Text Available Farm animals are reared for production to meet up the demand for animal protein in human. Various modern medicines are extensively used for production as well as treatment and prevention of diseases of animals, which can ultimately reach us through food chain. Herbs are now considered as an important source of alternative medicines. The Ayurvedic medicines prepared by manufacturers contain processed plant parts and added with preservative and other chemicals in many cases. The present way of research on herbal medicine follows the path of identification of active principles from the extracts of preserved parts of medicinal plants after testing of their efficacy in laboratory. This concept of research have the limitation of loss of many aromatic and other phytochemicals present in the living plant, which may have very important role when used together. Animals maintained in modern farm may be given relief from modern medicines in minor and moderate ailments, cure of problems related with their production with the validated fresh plant medicine available from the plants cultivated adjacent to the farm area. Consulting the reports of ethno-botanical study, a preliminary list of medicinal plant is prepared which are having antipyretic, analgesic, wound healing, immunostimulant, hepato-protective, fertility enhancing, pregnancy assisting, lactation assisting, anthelmintic, astringent, expectorant, purgative and anti-flatulent, nutriceutical, antiseptic, anti-dermatitis, anti-dysenteric and anti-enteric, hematenic, stomachic, diuretic and kidney stone removing effects and insecticidal or insect repelling effects. This list may be enriched further and plants may be selected for a farm from these groups according to the agro-climatic condition of the area, disease prevalence, problems encountered during farming practice and other requirements of the farm. Validation of reported effects of the plants is to be performed in fresh condition, so that parts

  1. Effects of assessing the productivity of faculty in academic medical centres: a systematic review

    Science.gov (United States)

    Akl, Elie A.; Meerpohl, Joerg J.; Raad, Dany; Piaggio, Giulia; Mattioni, Manlio; Paggi, Marco G.; Gurtner, Aymone; Mattarocci, Stefano; Tahir, Rizwan; Muti, Paola; Schünemann, Holger J.

    2012-01-01

    Background: Many academic medical centres have introduced strategies to assess the productivity of faculty as part of compensation schemes. We conducted a systematic review of the effects of such strategies on faculty productivity. Methods: We searched the MEDLINE, Healthstar, Embase and PsycInfo databases from their date of inception up to October 2011. We included studies that assessed academic productivity in clinical, research, teaching and administrative activities, as well as compensation, promotion processes and satisfaction. Results: Of 531 full-text articles assessed for eligibility, we included 9 articles reporting on eight studies. The introduction of strategies for assessing academic productivity as part of compensation schemes resulted in increases in clinical productivity (in six of six studies) in terms of clinical revenue, the work component of relative-value units (these units are nonmonetary standard units of measure used to indicate the value of services provided), patient satisfaction and other departmentally used standards. Increases in research productivity were noted (in five of six studies) in terms of funding and publications. There was no change in teaching productivity (in two of five studies) in terms of educational output. Such strategies also resulted in increases in compensation at both individual and group levels (in three studies), with two studies reporting a change in distribution of compensation in favour of junior faculty. None of the studies assessed effects on administrative productivity or promotion processes. The overall quality of evidence was low. Interpretation: Strategies introduced to assess productivity as part of a compensation scheme appeared to improve productivity in research activities and possibly improved clinical productivity, but they had no effect in the area of teaching. Compensation increased at both group and individual levels, particularly among junior faculty. Higher quality evidence about the benefits

  2. The use of complementary and alternative medicine products in preceding two days among Finnish parents - a population survey

    Directory of Open Access Journals (Sweden)

    Hämeen-Anttila Katri P

    2011-11-01

    Full Text Available Abstract Background The use of complementary and alternative medicines (CAM has been extensively studied globally among adult and paediatric populations. Parents, as a group, had not been studied to assess their knowledge and attitude to CAM and general medicine use. This study is necessary since parents' attitude to medicine use is known to influence their child's attitude to medicine use later in life. We therefore aim to assess the extent and types of CAM use among Finnish parents, and to determine the factors that promote the CAM use. Also, we aim to determine parents' attitude to general medicine use. Methods Children less than 12 years old, as of spring 2007, were identified from the database of the Finnish Population Register Centre and were selected by random sampling. The parents of these children were identified and a questionnaire was sent to them. Only the parent who regularly takes care of the child's medicine was requested to fill the questionnaire. Cross-tabulations and Chi-square test were used to determine the associations between categorical variables. CAMs were defined as natural products that are not registered as medicines, such as homeopathic preparations, dietary food supplements, and traditional medicinal products. Results The response rate of the survey was 67% (n = 4032. The use of CAM was 31% in the preceding two days. The most commonly used CAM products were vitamins and minerals, followed by fish oils and fatty acids. Prescription and OTC medicines were used concomitantly with CAM by one-third of the parents. CAM was frequently used by parents over 30 years (33%, female parents (32%, highly educated parents (35%, and parents with high monthly net income (3000-3999 euros, 34%. The users of CAM had more negative attitudes towards medicines than non-users of CAM. Conclusions Our findings are in accordance with those of previous studies that women over 30 years of age with a high education and income typically use CAMs

  3. Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China.

    Science.gov (United States)

    Yuan, Bao-Zhu

    2015-12-01

    Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new "interim guidelines" for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs.

  4. Regulation of advanced therapy medicinal products in Europe and the role of academia.

    Science.gov (United States)

    Pearce, Kim F; Hildebrandt, Martin; Greinix, Hildegard; Scheding, Stefan; Koehl, Ulrike; Worel, Nina; Apperley, Jane; Edinger, Matthius; Hauser, Andrea; Mischak-Weissinger, Eva; Dickinson, Anne M; Lowdell, Mark W

    2014-03-01

    Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to ensure their free movement within the European Union while guaranteeing the highest level of health protection for patients. Academic good manufacturing practice (GMP) centers are major contributors in the development of ATMPs and this study assessed the impact of regulations on them. European academic and non-industrial facilities (n = 747) were contacted, and a representative sample of 50 replied to a detailed questionnaire. Experienced centres were further selected in every Member State (MS) for semi-structured interviews. Indicators of ATMP production and development success were statistically assessed, and opinions about directive implementation were documented. Facilities experienced in manufacturing cell therapy transplant products are the most successful in developing ATMPs. New centres lacking this background struggle to enter the field, and there remains a shortage of facilities in academia participating in translational research. This is compounded by heterogeneous implementation of the regulations across MS. GMP facilities successfully developing ATMPs are present in all MS. However, the implementation of regulations is heterogeneous between MS, with substantial differences in the definition of ATMPs and in the approved manufacturing environment. The cost of GMP compliance is underestimated by research funding bodies. This is detrimental to development of new ATMPs and commercialization of any that are successful in early clinical trials. Academic GMP practitioners should strengthen their political visibility and contribute to the development of functional and effective European Union legislation in this field. Copyright © 2014 International Society for Cellular Therapy. All rights reserved.

  5. Development of a productive research culture in emergency medicine: Report of the outcomes of a research forum.

    Science.gov (United States)

    Taylor, David McD; Cohen, Donna R; Epstein, Joseph; Freeman, Peter; Gosbell, Andrew D; Judkins, Simon; Mowatt, Elizabeth J M; O'Reilly, Gerard M; Vinen, John

    2016-02-01

    In recent years, the Australasian College for Emergency Medicine (ACEM) has increasingly focused on the need for high-quality research in emergency medicine (EM). One important initiative was the establishment of the ACEM Foundation, which among other responsibilities, is required to support clinical research through the provision of research funding and other measures. In February 2015, the Foundation held a Research Forum that was attended by the leading EM researchers from Australasia. The Forum aimed to determine how a productive research culture could be developed within the ACEM. Nine key objectives were determined including that research should be a core business of the ACEM and a core activity of the EM workforce, and that EM research should be sustainable and adequately supported. This report describes the background and conduct of the Forum, its recommendations and the way in which they could be implemented. © 2015 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  6. Impact of animal health and welfare planning on medicine use, herd health and production in European organic dairy farms

    DEFF Research Database (Denmark)

    Ivemeyer, S; Smolders, G; Brinkmann, J

    2012-01-01

    medicine use through animal health and welfare planning (AHWP). Medicine use (excluding complementary treatments such as homeopathic remedies) was assessed as the total number of treatments and as the number of treatments of various disease categories (udder, fertility, metabolism, locomotion and others......Achieving and maintaining high herd health and welfare status and low veterinary medicine inputs are important aims in organic livestock farming. Therefore, an on-farm intervention study (CORE Organic ANIPLAN) was conducted on 128 organic dairy farms in seven European countries aiming at minimising...... be regarded as a feasible approach to minimising medicine use without the impairment of production and herd health under several organic dairy farming conditions in Europe....

  7. Simulation of multispectral multisource for device of consumer and medicine products analysis

    Science.gov (United States)

    Korolev, Timofey K.; Peretyagin, Vladimir S.

    2017-06-01

    One of the results of intensive development of led technology was the creation of a multi-component, managed devices and illumination/irradiation used in various fields of production (e.g., food industry analysis, food quality). The use of LEDs has become possible due to their structure determining spatial, energy, electrical, thermal and other characteristics. However, the development of the devices for illumination/irradiation require closer attention in the case if you want to provide precise illumination to the area of analysis, located at a specified distance from the radiation source. The present work is devoted to the development and modelling of a specialized source of radiation intended for solving problems of analysis of food products, medicines and water for suitability in drinking. In this work, we provided a mathematical model of spatial and spectral distribution of irridation from the source of infrared radiation ring structure. When you create this kind of source, you address factors such spectral component, the power settings, the spatial and energy components of the diodes.

  8. Efficacy of cosmetic products in cellulite reduction: systematic review and meta-analysis.

    Science.gov (United States)

    Turati, F; Pelucchi, C; Marzatico, F; Ferraroni, M; Decarli, A; Gallus, S; La Vecchia, C; Galeone, C

    2014-01-01

    The number of original articles investigating the efficacy of cosmetic products in cellulite reduction increased rapidly in the last decade; however, to our knowledge, no systematic review and meta-analysis has been performed so far. We conducted a systematic review of in vivo studies on humans adopting the PRISMA guidelines. Moreover, we used a meta-analytic approach to estimate the overall effect of cosmetic creams in cellulite treatment from controlled trials with more than 10 patients per arm, using thigh circumference reduction as the outcome measure. Medline and Embase were searched up to August 2012 to identify eligible studies. Twenty-one original studies were included in the present systematic review. All studies were clinical trials, most of them recruited women only and 67% had an intra-patient study design. About half of the active cosmetic creams tested only contained one active ingredient among xanthenes, herbals or retinoids. The other studies tested cosmetic creams with more complex formulations and most of them included xanthenes. A total of seven controlled trials satisfied the inclusion criteria for the meta-analysis. The pooled mean difference of thigh circumference reduction between the treated and the controlled group was -0.46 cm (95% confidence intervals, CI: -0.85, -0.08), with significant heterogeneity between studies (P cellulite reduction and supports a moderate efficacy in thigh circumference reduction. © 2013 European Academy of Dermatology and Venereology.

  9. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

    Science.gov (United States)

    Gronde, Toon van der; Uyl-de Groot, Carin A; Pieters, Toine

    2017-01-01

    Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

  10. Relationship between Organizational Culture and the Use of Psychotropic Medicines in Nursing Homes: A Systematic Integrative Review.

    Science.gov (United States)

    Sawan, Mouna; Jeon, Yun-Hee; Chen, Timothy F

    2018-03-01

    Psychotropic medicines are commonly used in nursing homes, despite marginal clinical benefits and association with harm in the elderly. Organizational culture is proposed as a factor explaining the high-level use of psychotropic medicines. Schein describes three levels of culture: artifacts, espoused values, and basic assumptions. This integrative review aimed to investigate the facets and role of organizational culture in the use of psychotropic medicines in nursing homes. Five databases were searched for qualitative, quantitative, and mixed method empirical studies up to 13 February 2017. Articles were included if they examined an aspect of organizational culture according to Schein's theory and the use of psychotropic medicines in nursing homes for the management of behavioral and sleep disturbances in residents. Article screening and data extraction were performed independently by one reviewer and checked by the research team. The integrative review method, an approach similar to the method of constant comparison analysis was utilized for data analysis. Twenty-four studies met the inclusion criteria: 13 used quantitative methods, 9 used qualitative methods, 1 was quasi-qualitative, and 1 used mixed methods. Included studies were found to only address two aspects of organizational culture in relation to the use of psychotropic medicines: artifacts and espoused values. No studies addressed the basic assumptions, the unsaid taken-for-granted beliefs, which provide explanations for in/consistencies between the ideal use of psychotropic medicines and the actual use of psychotropic medicines. Previous studies suggest that organizational culture influences the use of psychotropic medicines in nursing homes; however, what is known is descriptive of culture only at the surface level, that is the artifacts and espoused values. Hence, future research that explains the impact of the basic assumptions of culture on the use of psychotropic medicines is important.

  11. Sales effects of product health information at points of purchase: a systematic review.

    Science.gov (United States)

    van 't Riet, Jonathan

    2013-03-01

    Information about healthy and unhealthy nutrients is increasingly conveyed at the point of purchase. Many studies have investigated the effects of product health information on attitudes and intentions, but the empirical evidence becomes sketchier when the focus of research is actual purchase behaviour. The present paper provides an overview of empirical evidence on the effectiveness of product health information for food products at the point of purchase. A systematic literature review was conducted. Only studies were included that assessed the effect of product health information at the point of purchase on actual purchase behaviour, using data provided by stores' sales records or obtained by investigating customer receipts as the primary outcome measure. The included studies' target group comprised supermarket clientele. Several studies found no significant effects of product health information on actual purchase behaviour. Interventions were more likely to be effective when they lasted for a longer time, when they included additional intervention components, and when they targeted the absence of unhealthy nutrients instead of or in addition to the presence of healthy nutrients. No strong evidence for the effectiveness of product health information was found. The effect of intervention duration, additional promotional activities and targeting of healthy v. unhealthy nutrients should be closely examined in future studies.

  12. Estimating productivity costs using the friction cost approach in practice: a systematic review.

    Science.gov (United States)

    Kigozi, Jesse; Jowett, Sue; Lewis, Martyn; Barton, Pelham; Coast, Joanna

    2016-01-01

    The choice of the most appropriate approach to valuing productivity loss has received much debate in the literature. The friction cost approach has been proposed as a more appropriate alternative to the human capital approach when valuing productivity loss, although its application remains limited. This study reviews application of the friction cost approach in health economic studies and examines how its use varies in practice across different country settings. A systematic review was performed to identify economic evaluation studies that have estimated productivity costs using the friction cost approach and published in English from 1996 to 2013. A standard template was developed and used to extract information from studies meeting the inclusion criteria. The search yielded 46 studies from 12 countries. Of these, 28 were from the Netherlands. Thirty-five studies reported the length of friction period used, with only 16 stating explicitly the source of the friction period. Nine studies reported the elasticity correction factor used. The reported friction cost approach methods used to derive productivity costs varied in quality across studies from different countries. Few health economic studies have estimated productivity costs using the friction cost approach. The estimation and reporting of productivity costs using this method appears to differ in quality by country. The review reveals gaps and lack of clarity in reporting of methods for friction cost evaluation. Generating reporting guidelines and country-specific parameters for the friction cost approach is recommended if increased application and accuracy of the method is to be realized.

  13. Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product.

    Science.gov (United States)

    Lee, Kyoung Hoon; Lee, Jihun; Bae, Jin Soo; Kim, Yeon Jung; Kang, Hyun Ah; Kim, Sung Hwan; Lee, So Jung; Lim, Ki Jung; Lee, Jung Woo; Jung, Soon Kwan; Chang, Shin Jae

    2018-02-22

    CT-P10 (TruximaTM) was recently approved as the world's first rituximab biosimilar product in the European Union (EU) and South Korea. To demonstrate biosimilarity of CT-P10 with the reference medicinal product (RMP), extensive 3-way similarity assessment has been conducted between CT-P10, EU-Rituximab and US-Rituximab, focusing on the physicochemical and biological quality attributes. A multitude of state-of-the-art analyses revealed that CT-P10 has identical primary and higher order structures compared to the original product. Purity/impurity profiles of CT-P10 measured by the levels of aggregates, fragments, non-glycosylated form and process-related impurities were also found to be comparable with those of RMPs. In terms of the post-translational modification, CT-P10 contains slightly less N-terminal pyro-glutamate variant, which has been known not to affect product efficacy or safety. Oligosaccharide profiling has revealed that, although CT-P10 contains the same conserved glycan species and relative proportion with the RMPs, the content of total afucosylated glycan in CT-P10 was slightly higher than in EU- or US-Rituximab. Nevertheless, the effect of the observed level of afucosylation in CT-P10 drug product on Fc receptor binding affinity or antibody-dependent cell-mediated cytotoxicity was found to be negligible based on the spiking study with highly afucosylated sample. Arrays of biological assays representative of known and putative mechanisms of action for rituximab have shown that biological activities of CT-P10 are within the quality range of RMPs. Recent results of clinical studies have further confirmed that the CT-P10 exhibits equivalent clinical efficacy and safety profiles compared to EU- and US-Rituximab. The current 3-way similarity assessment together with clinical study results confidently demonstrate that CT-P10 is highly similar with EU- and US-Rituximab in terms of physicochemical properties, biological activities, efficacy, and safety for

  14. Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

    Directory of Open Access Journals (Sweden)

    Bate R

    2012-07-01

    Full Text Available Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA or the World Health Organization (WHO prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50% than Indian cities (26.57%, but they also experienced a higher failure rate (14.21% than Indian cities (7.83%. The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high

  15. Conservation and sustainable use of medicinal and aromatic products in North America: Are there really lessons to be learned?

    Science.gov (United States)

    A. L. Hammett; James L. Chamberlain

    2002-01-01

    This paper discusses the legacy of nontimber forest products (NTFPs) and, more specifically, medicinal plant use in North America. It also discusses briefly MAP markets both in North America and throughout the world, and describes the constraints to the sustainable use and development of MAP resources. Lastly, the paper relates some lessons that may be appropriate for...

  16. 78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

    Science.gov (United States)

    2013-08-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug...

  17. [Analysis on influential factors in China's exports of primary and semi-finished products of traditional Chinese medicine to ASEAN].

    Science.gov (United States)

    Qian, Yun-Xu; Yang, Yue; Zhao, Wei; Bi, Kai-Shun

    2014-04-01

    Two regression models, based on panel data over the period of 2000-2011, are built and used to analyze what factors determine China's exports of primary and semi-finished products of traditional Chinese medicine to ASEAN. The results indicate that, China GDP, the ratio of ASEAN to China GDP per capita, average export price, the ratio of state-owned assets to total assets, have a significant positive influence on the export volumes of primary products of Chinese medicine. At the same time, RMB appreciation, the ratio of three kinds of foreign-invested assets to total assets, China-ASEAN Early Harvest Program, ASEAN-China Free Trade Area have a significant negative influence. In respect of the export volumes of semi-finished products of Chinese medicine, the significant influential factors are ASEAN GDP and the ratio of ASEAN to China GDP per capita. The former is positive and the latter is negative. In order to optimize the commodity composition of experts, it is needed to increase export volumes of both primary and semi-finished products of Chinese medicine. According to the analysis above, some proposals are put forward, such as, improving the performance of foreign capital, playing an exemplary and leading role in technological innovation by state-owned enterprises, taking advantage of bargaining power of suppliers, increasing outward foreign direct investment.

  18. Use of medicines and other products for therapeutic purposes among children in Brazil.

    Science.gov (United States)

    Pizzol, Tatiane da Silva Dal; Tavares, Noemia Urruth Leão; Bertoldi, Andréa Dâmaso; Farias, Mareni Rocha; Arrais, Paulo Sergio Dourado; Ramos, Luiz Roberto; Oliveira, Maria Auxiliadora; Luiza, Vera Lucia; Mengue, Sotero Serrate

    2016-12-01

    To assess the prevalence of the use of medicines and other products for therapeutic purposes in the Brazilian pediatric population and test whether demographic, socioeconomic and health factors are associated with use. A cross-sectional population-based study (National Survey on Access, Use and Promotion of Rational Use of Medicines - PNAUM), including 7,528 children aged 12 or younger, living in urban areas in Brazil. Medicine use to treat chronic or acute diseases was reported by the primary caregiver present at the household interview. Associations between independent variables and medicine use were investigated by Poisson regression. The overall prevalence of medicine use was 30.7% (95%CI 28.3-33.1). The prevalence of medicine use for chronic diseases was 5.6% (95%CI 4.7-6.7) and for acute conditions, 27.1% (95%CI 24.8-29.4). The factors significantly associated with overall use were five years old or under, living in the Northeast region, having health insurance and using health services in the last 12 months (emergency visits and hospitalizations). The following were associated with drug use for chronic diseases: age ≥ 2 years, Southeast and South regions, and use of health services. For drug use in treating acute conditions, the following associated factors were identified: ≤ 5 years, North, Northeast or Midwest regions, health insurance, and one or more emergency visits. The most commonly used drugs among children under two years of age were paracetamol, ascorbic acid, and dipyrone; for children aged two years or over they were dipyrone, paracetamol, and amoxicillin. The use of medicine by children is considerable, especially in treating acute medical conditions. Children using drugs for chronic diseases have a different demographic profile from those using drugs for acute conditions in relation to gender, age, and geographic region. Estimar a prevalência de uso de medicamentos e outros produtos com finalidade terapêutica na população pedi

  19. Herbal medicine for management of the behavioural and psychological symptoms of dementia (BPSD): A systematic review and meta-analysis.

    Science.gov (United States)

    Hyde, Anna J; May, Brian H; Dong, Lin; Feng, Mei; Liu, Shaonan; Guo, Xinfeng; Zhang, Anthony Lin; Lu, Chuanjian; Xue, Charlie Changli

    2017-02-01

    Management of the behavioural and psychological symptoms of dementia remains a challenge worldwide. Herbal medicines may play a role in the development of new interventions. To determine effects of herbal medicines for management of the behavioural and psychological symptoms of dementia, meta-analysis was conducted of 31 controlled trials (3613 participants). Frequently tested herbal medicines were the Ginkgo biloba leaf extract EGb 761 (seven studies) and the multi-ingredient formula Yokukansan (eight studies). Sixteen studies tested other herbal medicines. Improvements were detected in Neuropsychiatric Inventory scores in EGb 761 groups compared to placebo (MD -3.46 [-5.94, -0.98]; I 2 = 93%; n = 1757) and Yokukansan groups compared to no treatment (SMD -0.53 [-0.86, -0.21]; I 2 = 0%; n = 150). Cognitive scores were improved in EGb 761 groups while Yokukansan did not appear to affect cognitive function. Of the other herbal medicines, there were improvements in the behavioural and psychological symptoms of dementia and cognitive outcomes in two of four placebo-controlled studies. EGb 761 and Yokukansan appeared safe and well tolerated. Adverse effects and dropouts were not reported consistently for the other herbal medicines. Weaknesses of these included short durations, small sample sizes, lack of blinding and other risks of bias. Well-designed studies are needed to further investigate the reported effects of these interventions on the behavioural and psychological symptoms of dementia.

  20. Systematization of the major stages of the client in certain branches of construction production

    Directory of Open Access Journals (Sweden)

    Kuzmina Tatyana

    2016-01-01

    Full Text Available The article contains substantiation of the need for investment and construction projects in various sectors of the construction production. On the basis of domestic and foreign experience it describes the concept of the client (customer and his functions and tasks in the implementation of such projects. It also systematizes the main stages of the customer’s activities, which are presented as a preparation for the construction, development of construction sites, monitoring the progress of the construction, commis-sioning and commissioning of facilities. There is also a determination of time intervals at each stage, the final formula for calculating the duration of the investment project due to the given the shared stages. The article also gives optimization variants in some sectors of construction production.

  1. Preliminary investigation of the possibility for implementation of modified pharmacopoeial HPLC methods for quality control of metronidazole and ciprofloxacin in medicinal products used in veterinary medicine

    Directory of Open Access Journals (Sweden)

    Marjan Piponski

    2015-03-01

    Full Text Available Quality control of veterinary medicine products containing two different frequently used antibiotics metronidazole and ciprofloxacin hydrochloride, was considered and performed, using modified pharmacopoeial HPLC methods. Three different HPLC systems were used: Varian ProStar, Perkin Elmer Series and UPLC Shimadzu Prominence XR. The chromatographic columns used were LiChropher RP Select B 75 mm x 4 mm with 5 μm particles and Discovery C18 100 mm x 4,6 mm with 5 μm particles. Chromatographic methods used for both analytes were compendial, with minor modifications made for experimental purposes. Minor modifications of the pharmacopoeia prescribed chromatographic conditions, in both cases, led to better chromatographic parameters, good resolution and shorter analysis times. Optimized methods can be used for: determination of metronidazole in gel formulation, for its simultaneous quantification with preservatives present in the formulation and even for identification and quantification of its specified impurity, 2-methyl-5-nitroimidazole; determination of ciprofloxacin hydrochloride in film coated tablets and eye drops and identification and quantification of its specified impurities. These slightly modified and optimized pharmacopoeial methods for quality control of metronidazole and ciprofloxacin dosage forms used in veterinary medicine can be successfully applied in laboratories for quality control of veterinary medicines.

  2. Indole-3-acetic acid production by endophytic Streptomyces sp. En-1 isolated from medicinal plants.

    Science.gov (United States)

    Lin, Lan; Xu, Xudong

    2013-08-01

    Plant-associated actinobacteria are rich sources of bioactive compounds including indole-derived molecules such as phytohormone indole-3-acetic acid (IAA). In view of few investigations concerning the biosynthesis of IAA by endophytic actinobacteria, this study evaluated the potential of IAA production in endophytic streptomycete isolates sourced from medicinal plant species Taxus chinensis and Artemisia annua. By HPLC analysis of IAA combined with molecular screening approach of iaaM, a genetic determinant of streptomycete IAA synthesis via indole-3-acetamide (IAM), our data showed the putative operation of IAM-mediated IAA biosynthesis in Streptomyces sp. En-1 endophytic to Taxus chinensis. Furthermore, using the co-cultivation system of model plant Arabidopsis thaliana and streptomycete, En-1 was found to be colonized intercellularly in the tissues of Arabidopsis, an alternative host, and the effects of endophytic En-1 inoculation on the model plant were also assayed. The phytostimulatory effects of En-1 inoculation suggest that IAA-producing Streptomyces sp. En-1 of endophytic origin could be a promising candidate for utilization in growth improvement of plants of economic and agricultural value.

  3. Berry Leaves: An Alternative Source of Bioactive Natural Products of Nutritional and Medicinal Value.

    Science.gov (United States)

    Ferlemi, Anastasia-Varvara; Lamari, Fotini N

    2016-06-01

    Berry fruits are recognized, worldwide, as "superfoods" due to the high content of bioactive natural products and the health benefits deriving from their consumption. Berry leaves are byproducts of berry cultivation; their traditional therapeutic use against several diseases, such as the common cold, inflammation, diabetes, and ocular dysfunction, has been almost forgotten nowadays. Nevertheless, the scientific interest regarding the leaf composition and beneficial properties grows, documenting that berry leaves may be considered an alternative source of bioactives. The main bioactive compounds in berry leaves are similar as in berry fruits, i.e., phenolic acids and esters, flavonols, anthocyanins, and procyanidins. The leaves are one of the richest sources of chlorogenic acid. In various studies, these secondary metabolites have demonstrated antioxidant, anti-inflammatory, cardioprotective, and neuroprotective properties. This review focuses on the phytochemical composition of the leaves of the commonest berry species, i.e., blackcurrant, blackberry, raspberry, bilberry, blueberry, cranberry, and lingonberry leaves, and presents their traditional medicinal uses and their biological activities in vitro and in vivo.

  4. Berry Leaves: An Alternative Source of Bioactive Natural Products of Nutritional and Medicinal Value†

    Science.gov (United States)

    Ferlemi, Anastasia-Varvara; Lamari, Fotini N.

    2016-01-01

    Berry fruits are recognized, worldwide, as “superfoods” due to the high content of bioactive natural products and the health benefits deriving from their consumption. Berry leaves are byproducts of berry cultivation; their traditional therapeutic use against several diseases, such as the common cold, inflammation, diabetes, and ocular dysfunction, has been almost forgotten nowadays. Nevertheless, the scientific interest regarding the leaf composition and beneficial properties grows, documenting that berry leaves may be considered an alternative source of bioactives. The main bioactive compounds in berry leaves are similar as in berry fruits, i.e., phenolic acids and esters, flavonols, anthocyanins, and procyanidins. The leaves are one of the richest sources of chlorogenic acid. In various studies, these secondary metabolites have demonstrated antioxidant, anti-inflammatory, cardioprotective, and neuroprotective properties. This review focuses on the phytochemical composition of the leaves of the commonest berry species, i.e., blackcurrant, blackberry, raspberry, bilberry, blueberry, cranberry, and lingonberry leaves, and presents their traditional medicinal uses and their biological activities in vitro and in vivo. PMID:27258314

  5. Paving the way to personalized medicine: production of some theragnostic radionuclides at Brookhaven National Laboratory

    International Nuclear Information System (INIS)

    Srivastava, S.C.

    2011-01-01

    This paper introduces a relatively novel paradigm that involves specific individual radionuclides or radionuclide pairs that have emissions that allow pre-therapy low-dose imaging plus higher-dose therapy in the same patient. We have made an attempt to sort out and organize a number of such theragnostic radionuclides and radionuclide pairs that may potentially bring us closer to the age-long dream of personalized medicine for performing tailored low-dose molecular imaging (SPECT/CT or PET/CT) to provide the necessary pre-therapy information on biodistribution, dosimetry, the limiting or critical organ or tissue, and the maximum tolerated dose (MTD), etc. If the imaging results then warrant it, it would be possible to perform higher-dose targeted molecular therapy in the same patient with the same radiopharmaceutical. A major problem that remains yet to be fully resolved is the lack of availability, in sufficient quantities, of a majority of the best candidate theragnostic radionuclides in a no-carrier-added (NCA) form. A brief description of the recently developed new or modified methods at BNL for the production of four theragnostic radionuclides, whose nuclear, physical, and chemical characteristics seem to show great promise for personalized cancer therapy are described.

  6. Berry Leaves: An Alternative Source of Bioactive Natural Products of Nutritional and Medicinal Value

    Directory of Open Access Journals (Sweden)

    Anastasia-Varvara Ferlemi

    2016-06-01

    Full Text Available Berry fruits are recognized, worldwide, as “superfoods” due to the high content of bioactive natural products and the health benefits deriving from their consumption. Berry leaves are byproducts of berry cultivation; their traditional therapeutic use against several diseases, such as the common cold, inflammation, diabetes, and ocular dysfunction, has been almost forgotten nowadays. Nevertheless, the scientific interest regarding the leaf composition and beneficial properties grows, documenting that berry leaves may be considered an alternative source of bioactives. The main bioactive compounds in berry leaves are similar as in berry fruits, i.e., phenolic acids and esters, flavonols, anthocyanins, and procyanidins. The leaves are one of the richest sources of chlorogenic acid. In various studies, these secondary metabolites have demonstrated antioxidant, anti-inflammatory, cardioprotective, and neuroprotective properties. This review focuses on the phytochemical composition of the leaves of the commonest berry species, i.e., blackcurrant, blackberry, raspberry, bilberry, blueberry, cranberry, and lingonberry leaves, and presents their traditional medicinal uses and their biological activities in vitro and in vivo.

  7. Teaching dairy production medicine to entry-level veterinarians: the summer dairy institute model.

    Science.gov (United States)

    Nydam, Charles W; Nydam, Daryl V; Guard, Charles L; Gilbert, Robert O

    2009-01-01

    Food supply veterinarians who intend to enter dairy cattle practice or other related career activities are in need of up-graded skills to better serve the dairy industry as it continues to evolve. The time available for students to increase their abilities within the conventional professional curriculum is scarce, especially as those with food-supply interests are a minority of students competing for time and resources. The dairy industry has need of skilled veterinarians who are not only well versed in their traditional capabilities, but who also have an understanding of the complete picture of that industry as a "farm-to-fork" experience. Society at large also stands to benefit from the presence of skilled dairy veterinarians contributing to the production of safe, affordable dairy foodstuffs in a manner deemed sustainable and humane. Veterinarians in practice can and do acquire the necessary skills to make themselves relevant to their clients and consumers; however, better preparation of entry-level veterinarians could increase their value to their employers, clients, themselves, and society in a more timely manner. Cornell University's College of Veterinary Medicine developed the Summer Dairy Institute to provide an avenue for advancing the skills of new veterinarians as a means to address the current and future needs of the dairy industry. This article describes the need for, concept of, and experience with that program.

  8. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation.

    Science.gov (United States)

    de Wilde, Sofieke; Veltrop-Duits, Louise; Hoozemans-Strik, Merel; Ras, Thirza; Blom-Veenman, Janine; Guchelaar, Henk-Jan; Zandvliet, Maarten; Meij, Pauline

    2016-06-01

    Since the implementation of the European Union (EU) regulation for advanced therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing authorization approval in the EU. Recognizing the major developments in the ATMP field, starting mostly in academic institutions, we investigated which hurdles were experienced in the whole pathway of ATMP development towards clinical care. Quality interviews were executed with different stakeholders in The Netherlands involved in the ATMP development field, e.g. academic research groups, national authorities and patient organizations. Based on the hurdles mentioned in the interviews, questionnaires were subsequently sent to the academic principal investigators (PIs) and ATMP good manufacturing practice (GMP) facility managers to quantify these hurdles. Besides the familiar regulatory routes of marketing authorization (MA) and hospital exemption (HE), a part of the academic PIs perceived that ATMPs should become available by the Tissues and Cells Directive or did not anticipate on the next development steps towards implementation of their ATMP towards regular clinical care. The main hurdles identified were: inadequate financial support, rapidly evolving field, study-related problems, lacking regulatory knowledge, lack of collaborations and responsibility issues. Creating an academic environment stimulating and planning ATMP development and licensing as well as investing in expanding the relevant regulatory knowledge in academic institutions seems a prerequisite to develop ATMPs from bench to patient. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  9. Lanthanides in Nuclear Medicine. The Production of Terbium-149 by Heavy Ion Beams

    CERN Document Server

    Dmitriev, S N; Zaitseva, N G; Maslov, O D; Molokanova, L G; Starodub, G Ya; Shishkin, S V; Shishkina, T V

    2001-01-01

    Among radioactive isotopes of lanthanide series elements, finding the increasing using in nuclear medicine, alpha-emitter {149}Tb (T_{1/2} = 4.118 h; EC 76.2 %; beta^+ 7.1 %; alpha 16.7 %) is considered as a perspective radionuclide for radioimmunotherapy. The aim of the present work is to study experimental conditions of the {149}Tb production in reactions Nd({12}C, xn){149}Dy (4.23 min; beta^+, EC)\\to {149}Tb when the Nd targets have been irradiated by heavy ions of carbon. On the basis of results of formation and decay of {149}Dy\\to{149}Tb evaluation of the {149}Tb activity, is made which can be received under optimum conditions (enriched {142}Nd target, {12}C ions with the energy 120 MeV and up to current 100 mu A, time of irradiating 8-10 hours). Under these conditions {149}Tb can be obtained up to 30 GBq (up to 0.8 Ci).

  10. [Practical Use Evaluation of Aluminum Packaging for Medicinal Products Based on Universal Design].

    Science.gov (United States)

    Ohtani, Kazuya; Hidaka, Takashi; Marubashi, Koichi; Takagi, Hirokazu; Kamimura, Naoki

    2015-01-01

    Many pharmacists have requested optimization of aluminum packaging of medicinal products in terms of usability. To improve operational efficiency of aluminum packaging, we used Universal Design (UD)-based approach, which enables products to be used properly and consistently regardless of users. The UD-pack used in this research is composed of a film that can be easily opened and torn linear. Here, we compared the UD-pack to conventional aluminum packaging by evaluating the practical use of each under the cooperation of 24 pharmacists. Following opening and removal of contents of one sample for both types of packaging, monitors were asked which type was easier to use in each case. Also, monitors were to repeat the opening and removal of contents of five samples in a row, and were asked the same question. Monitors were recorded by digital camera to measure the time required to finish the procedure for five samples in a row. After opening one sample, approximately 83% of monitors preferred the UD-pack, and after opening five samples, all (100%) preferred the UD-pack. Regarding the time required for opening five samples and removing the contents measured by analyzing the recorded video, the UD-pack significantly reduced the time required for all monitors. The average time ratio of the UD-pack to conventional aluminum packaging was approximately 59%, and no significant difference was observed between male and female pharmacists. Our results indicate the UD-pack improves ease of opening and removal of contents and increases efficiency of dispensing in a clinical setting compared with conventional aluminum packaging.

  11. The availability of reliable information about medicines in Serbia for health professionals summary of product characteristics

    Directory of Open Access Journals (Sweden)

    Đukić Ljiljana C.

    2015-01-01

    Full Text Available Introduction Today, there are many drugs for the treatment of a large number of indicator areas. Significant financial resources are invested in research with the aim of introducing reliable therapeutics to therapy. Therefore, it is necessary to provide health care professionals exact information about new therapies. The overall process of scientific data, ideas and information exchange is possible through numerous communications of modern IT tools. Methodology According to the Law, key information on registered drug is included in the Summary of Product Characteristics (SPC for health professionals, which is harmonized with EU directives and regulations (SmPC.Protocol content and structure of the information provided in SPC is determined in the guidelines of the EU, therefore, a unique set of data is established for all the drugs registered in Serbia. Topic This paper presents the key segments of SPC, with special reference to the description of the regulations that are required for data related to indications, mechanism of action, dosage, contraindications, side effects, interactions and other important information regarding the profile of the drug, which are standardized and harmonized with the structure of identical documents which operate at the EU level, or EMEA. Conclusions SPC is the regulatory determined technical document on medicinal products in the RS in which there are listed scientifically proven, clinical and pharmacological data and information on the profile of the drug, which are essential for health professionals - doctors and pharmacists in the implementation of pharmacotherapy in our society. This document is the starting point for the development of applied Pharmacoinformatics and it includes a range of activities important for the development of appropriate manuals and makes available data and information for monitoring indicators of the national policy on drugs and modern effective drugs treatment.

  12. New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation.

    Science.gov (United States)

    Martinac, Adrijana Ilić; Tomić, Sinisa; Simicić, Mirna

    2010-09-01

    Variations 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.

  13. Contamination of food products with Mycobacterium avium paratuberculosis: a systematic review.

    Science.gov (United States)

    Eltholth, M M; Marsh, V R; Van Winden, S; Guitian, F J

    2009-10-01

    Although a causal link between Mycobacterium avium subspecies paratuberculosis (MAP) and Crohn's disease has not been proved, previous studies suggest that the potential routes of human exposure to MAP should be investigated. We conducted a systematic review of literature concerning the likelihood of contamination of food products with MAP and the likely changes in the quantity of MAP in dairy and meat products along their respective production chains. Relevant data were extracted from 65 research papers and synthesized qualitatively. Although estimates of the prevalence of Johne's disease are scarce, particularly for non-dairy herds, the available data suggest that the likelihood of contamination of raw milk with MAP in most studied regions is substantial. The presence of MAP in raw and pasteurized milk has been the subject of several studies which show that pasteurized milk is not always MAP-free and that the effectiveness of pasteurization in inactivating MAP depends on the initial concentration of the agent in raw milk. The most recent studies indicated that beef can be contaminated with MAP via dissemination of the pathogen in the tissues of infected animals. Currently available data suggests that the likelihood of dairy and meat products being contaminated with MAP on retail sale should not be ignored.

  14. A Systematic Optimization Design Method for Complex Mechatronic Products Design and Development

    Directory of Open Access Journals (Sweden)

    Jie Jiang

    2018-01-01

    Full Text Available Designing a complex mechatronic product involves multiple design variables, objectives, constraints, and evaluation criteria as well as their nonlinearly coupled relationships. The design space can be very big consisting of many functional design parameters, structural design parameters, and behavioral design (or running performances parameters. Given a big design space and inexplicit relations among them, how to design a product optimally in an optimization design process is a challenging research problem. In this paper, we propose a systematic optimization design method based on design space reduction and surrogate modelling techniques. This method firstly identifies key design parameters from a very big design space to reduce the design space, secondly uses the identified key design parameters to establish a system surrogate model based on data-driven modelling principles for optimization design, and thirdly utilizes the multiobjective optimization techniques to achieve an optimal design of a product in the reduced design space. This method has been tested with a high-speed train design. With comparison to others, the research results show that this method is practical and useful for optimally designing complex mechatronic products.

  15. Systematic review of pneumococcal disease costs and productivity loss studies in Latin America and the Caribbean.

    Science.gov (United States)

    Bahia, Luciana; Toscano, Cristiana M; Takemoto, Maíra Libertad Soligo; Araujo, Denizar Vianna

    2013-07-02

    Pneumococcal disease is an important cause of morbidity and mortality associated with significant economic burden for healthcare systems and society. To systematically review pneumococcal disease cost of illness and productivity loss studies in the Latin America and Caribbean (LAC) region. A search of relevant databases was performed till November 2011. A broad and sensitive search strategy was used consisting of medical subject headings (MeSH) terms for pneumococcal disease, healthcare costs and productivity loss studies. No language restriction was applied. Only papers from LAC region and child population were analyzed. Additional exclusion criteria included duplicate studies, and insufficient information about methods. A total of 1241 citations were retrieved. After applying the exclusion criteria, only 16 studies remained for analysis. There were 4 papers from Brazil, 3 from Argentina, 2 from Colombia, 2 from Mexico, 1 from Uruguay, 1 from Chile, and 3 analyzing a group of LAC countries. Only 4 were cost-of-illness studies, 11 were cost-effectiveness studies of pneumococcal vaccine and 1 study of the pneumococcal burden of disease. Methods used for quantifying health resource utilization and costing methods varied significantly among studies, as well as data sources considered. Productivity losses were considered in 8 studies, all of which used the human capital approach method. Pneumococcal disease cost estimates varied significantly depending on the pneumococcal syndromes considered, methods used, study perspective and type of costs included. This systematic review reinforced the importance of standardization of methods for cost studies that can allow comparison and reproducibility in other settings. These estimates can be useful for future economic analysis conducted to support the decision making process on the introduction of new vaccines in LAC. However, caution must be taken, as methodological aspects of studies will result in estimates with varying

  16. Herbal medicine IMOD suppresses LPS-induced production of proinflammatory cytokines in human dendritic cells

    NARCIS (Netherlands)

    Mirzaee, Saeedeh; Drewniak, Agata; Sarrami-Forooshani, Ramin; Kaptein, Tanja M.; Gharibdoost, Farhad; Geijtenbeek, Teunis B. H.

    2015-01-01

    Traditional medicines that stimulate or modulate the immune system can be used as innovative approaches to treat immunological diseases. The herbal medicine IMOD has been shown to strongly modulate immune responses in several animal studies as well as in clinical trials. However, little is known

  17. SOCIO-ETHICAL ISSUES IN PERSONALIZED MEDICINE: A SYSTEMATIC REVIEW OF ENGLISH LANGUAGE HEALTH TECHNOLOGY ASSESSMENTS OF GENE EXPRESSION PROFILING TESTS FOR BREAST CANCER PROGNOSIS.

    Science.gov (United States)

    Ali-Khan, Sarah E; Black, Lee; Palmour, Nicole; Hallett, Michael T; Avard, Denise

    2015-01-01

    There have been multiple calls for explicit integration of ethical, legal, and social issues (ELSI) in health technology assessment (HTA) and addressing ELSI has been highlighted as key in optimizing benefits in the Omics/Personalized Medicine field. This study examines HTAs of an early clinical example of Personalized Medicine (gene expression profile tests [GEP] for breast cancer prognosis) aiming to: (i) identify ELSI; (ii) assess whether ELSIs are implicitly or explicitly addressed; and (iii) report methodology used for ELSI integration. A systematic search for HTAs (January 2004 to September 2012), followed by descriptive and qualitative content analysis. Seventeen HTAs for GEP were retrieved. Only three (18%) explicitly presented ELSI, and only one reported methodology. However, all of the HTAs included implicit ELSI. Eight themes of implicit and explicit ELSI were identified. "Classical" ELSI including privacy, informed consent, and concerns about limited patient/clinician genetic literacy were always presented explicitly. Some ELSI, including the need to understand how individual patients' risk tolerances affect clinical decision-making after reception of GEP results, were presented both explicitly and implicitly in HTAs. Others, such as concern about evidentiary deficiencies for clinical utility of GEP tests, occurred only implicitly. Despite a wide variety of important ELSI raised, these were rarely explicitly addressed in HTAs. Explicit treatment would increase their accessibility to decision-makers, and may augment HTA efficiency maximizing their utility. This is particularly important where complex Personalized Medicine applications are rapidly expanding choices for patients, clinicians and healthcare systems.

  18. The global impact of non-communicable diseases on macro-economic productivity: a systematic review.

    Science.gov (United States)

    Chaker, Layal; Falla, Abby; van der Lee, Sven J; Muka, Taulant; Imo, David; Jaspers, Loes; Colpani, Veronica; Mendis, Shanthi; Chowdhury, Rajiv; Bramer, Wichor M; Pazoki, Raha; Franco, Oscar H

    2015-05-01

    Non-communicable diseases (NCDs) have large economic impact at multiple levels. To systematically review the literature investigating the economic impact of NCDs [including coronary heart disease (CHD), stroke, type 2 diabetes mellitus (DM), cancer (lung, colon, cervical and breast), chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD)] on macro-economic productivity. Systematic search, up to November 6th 2014, of medical databases (Medline, Embase and Google Scholar) without language restrictions. To identify additional publications, we searched the reference lists of retrieved studies and contacted authors in the field. Randomized controlled trials, cohort, case-control, cross-sectional, ecological studies and modelling studies carried out in adults (>18 years old) were included. Two independent reviewers performed all abstract and full text selection. Disagreements were resolved through consensus or consulting a third reviewer. Two independent reviewers extracted data using a predesigned data collection form. Main outcome measure was the impact of the selected NCDs on productivity, measured in DALYs, productivity costs, and labor market participation, including unemployment, return to work and sick leave. From 4542 references, 126 studies met the inclusion criteria, many of which focused on the impact of more than one NCD on productivity. Breast cancer was the most common (n = 45), followed by stroke (n = 31), COPD (n = 24), colon cancer (n = 24), DM (n = 22), lung cancer (n = 16), CVD (n = 15), cervical cancer (n = 7) and CKD (n = 2). Four studies were from the WHO African Region, 52 from the European Region, 53 from the Region of the Americas and 16 from the Western Pacific Region, one from the Eastern Mediterranean Region and none from South East Asia. We found large regional differences in DALYs attributable to NCDs but especially for cervical and lung cancer. Productivity losses in the USA ranged from 88 million

  19. In search of standards to support circularity in product policies: A systematic approach.

    Science.gov (United States)

    Tecchio, Paolo; McAlister, Catriona; Mathieux, Fabrice; Ardente, Fulvio

    2017-12-01

    The aspiration of a circular economy is to shift material flows toward a zero waste and pollution production system. The process of shifting to a circular economy has been initiated by the European Commission in their action plan for the circular economy. The EU Ecodesign Directive is a key policy in this transition. However, to date the focus of access to market requirements on products has primarily been upon energy efficiency. The absence of adequate metrics and standards has been a key barrier to the inclusion of resource efficiency requirements. This paper proposes a framework to boost sustainable engineering and resource use by systematically identifying standardization needs and features. Standards can then support the setting of appropriate material efficiency requirements in EU product policy. Three high-level policy goals concerning material efficiency of products were identified: embodied impact reduction, lifetime extension and residual waste reduction. Through a lifecycle perspective, a matrix of interactions among material efficiency topics (recycled content, re-used content, relevant material content, durability, upgradability, reparability, re-manufacturability, reusability, recyclability, recoverability, relevant material separability) and policy goals was created. The framework was tested on case studies for electronic displays and washing machines. For potential material efficiency requirements, specific standardization needs were identified, such as adequate metrics for performance measurements, reliable and repeatable tests, and calculation procedures. The proposed novel framework aims to provide a method by which to identify key material efficiency considerations within the policy context, and to map out the generic and product-specific standardisation needs to support ecodesign. Via such an approach, many different stakeholders (industry, academics, policy makers, non-governmental organizations etc.) can be involved in material efficiency

  20. Systematic Review of Health Communication for Non-Cigarette Tobacco Products.

    Science.gov (United States)

    Cornacchione Ross, Jennifer; Noar, Seth M; Sutfin, Erin L

    2017-12-13

    The Food and Drug Administration, which now has regulatory authority over all tobacco products meeting the statutory definition, is tasked with communicating the risks of these products to the public through health warnings and public education. However, there have been no attempts to summarize what is known about non-cigarette tobacco product (NCTP) health messaging. We conducted a systematic review to examine the existing literature on health communication for NCTPs and identify key research gaps. A total of 45 unique studies were retrieved and coded, with the majority focused on messaging for smokeless tobacco (SLT, k = 32, 71.1%), followed by waterpipe tobacco (WT, k = 9, 20%), electronic nicotine delivery systems (ENDS, k = 2, 4.4%), cigars (k = 2, 4.4%), and a potentially reduced exposure product (k = 1, 2.2%). Studies most commonly examined tobacco product warnings (k = 26, 57.8%) and public education (k = 19, 42.2%), which included mass media campaigns. Most studies examined knowledge, attitudes, and beliefs as outcomes (k = 27, 60%), while behavior was an outcome in the minority of studies (k = 8, 17.8%). Pictorial warnings and public education about NCTPs demonstrated positive impact in some studies, although the literature is nascent. Given the increasing use of NCTPs such as ENDS, WT, and cigars, particularly among adolescents and young adults, more research is needed on effective ways to communicate product risk to those audiences most at risk.

  1. EURO-MED-STAT: monitoring expenditure and utilization of medicinal products in the European Union countries: a public health approach.

    Science.gov (United States)

    2003-09-01

    There is uncertainty about the level of utilization and expenditure for medicines in the European Union (EU), making assessment of their impact on public health difficult. Our aim is to develop indicators to monitor price, expenditure and utilization of medicinal products in the EU, so as to facilitate comparisons. There are four major tasks. Task 1: To catalogue data sources and available data in each EU Member State. Task 2: To assess the reliability and comparability of data among the EU Member States by ATC/DDD on country coverage, reimbursement, prescriptions, price category (e.g. wholesale, hospital, retail) and private versus public spending. Task 3: To develop Standard Operating Procedures for data management and to define clearly the proposed indicators in terms of objective, definition, description, rationale, and data collection. Task 4: To pool, compare and report the validated data according to the established indicators, using cardiovascular medicines as an example. Preliminary results from Tasks 1 and 2 are available and demonstrate the methodological difficulties in comparing data from different countries. Multiple data sources must be used. These cover different populations, and refer to different prices or costs. Nevertheless, useful data can be derived, illustrated by the example of lipid lowering medicines. The data shows that only five products are commonly available in all countries. Even when a medicine is available in all countries, there may be substantial differences in packages, which can hinder comparison. Data on utilization of statins shows high usage in Scandinavian countries and least in Italy. The preliminary results of EURO-MED-STAT show wide differences in availability, and use of medicines across Europe that may have substantial implications for public health.

  2. Herbal medicine for hand-foot syndrome induced by fluoropyrimidines: A systematic review and meta-analysis.

    Science.gov (United States)

    Deng, Bo; Sun, Wei

    2018-04-16

    The aims of this study were to evaluate the efficacy of herbal medicine for the prevention and management of hand-foot syndrome (HFS) induced by fluoropyrimidines and to identify herbs associated with HFS alleviation for further research. The PubMed, Cochrane, Springer, China National Knowledge Infrastructure, and Wanfang databases were searched up to May 2017 for randomized controlled trials (RCTs) that evaluated herbal medicine for relieving HFS in patients undergoing fluoropyrimidine-based chemotherapy. Study evaluation and synthesis methods were in accordance with the Cochrane Handbook, and data were analyzed using RevMan 5.3. In total, 35 RCTs (2,668 participants) were included. Meta-analysis showed that the addition of herbal medicine significantly reduced the incidences of all-grade and high-grade HFS. The total effective rate and complete remission rate of HFS patients increased significantly with herbal medicine arm. Further sensitivity analysis identified Paeoniae Radix Alba, Carthami Flos, Cinnamomi Ramulus, and Glycyrrhizae Radix et Rhizoma as being consistently associated with significant reductions in HFS incidence without important heterogeneity. However, the lack of blinding in most studies may have led to overestimation of these effects. More high-quality RCTs and experimental research are needed to confirm and investigate the efficacy of the herbs identified in this study. Copyright © 2018 John Wiley & Sons, Ltd.

  3. Doctors' perceptions and use of evidence-based medicine: a systematic review and thematic synthesis of qualitative studies.

    NARCIS (Netherlands)

    Swennen, M.H.J.; Heijden, G.J.M.G. van der; Boeije, H.R.; Rheenen, N. van; Verheul, F.J.M.; Graaf, Y. van der; Kalkman, C.J.

    2013-01-01

    Purpose: Many primary qualitative studies of barriers and facilitators for doctors’ use of evidence-based medicine (EBM) are available, but knowledge remains fragmented. This study sought to synthesize the results of these qualitative studies, taking the variability across context (i.e., medical

  4. Nurse prescribing of medicines in Western European and Anglo-Saxon countries: a systematic review of the literature.

    NARCIS (Netherlands)

    Kroezen, M.; Dijk, L. van; Groenewegen, P.P.; Francke, A.L.

    2011-01-01

    Background: A growing number of countries are introducing some form of nurse prescribing. However, international reviews concerning nurse prescribing are scarce and lack a systematic and theoretical approach. The aim of this review was twofold: firstly, to gain insight into the scientific and

  5. Nurse prescribing of medicines in Western European and Anglo-Saxon countries: a systematic review of the literature.

    NARCIS (Netherlands)

    Kroezen, M.; Dijk, L. van; Groenewegen, P.P.; Francke, A.L.

    2011-01-01

    BACKGROUND: A growing number of countries are introducing some form of nurse prescribing. However, international reviews concerning nurse prescribing are scarce and lack a systematic and theoretical approach. The aim of this review was twofold: firstly, to gain insight into the scientific and

  6. Systematic high-yield production of human secreted proteins in Escherichia coli

    International Nuclear Information System (INIS)

    Dai Xueyu; Chen Qiang; Lian Min; Zhou Yanfeng; Zhou Mo; Lu Shanyun; Chen Yunjia; Luo Jingchu; Gu Xiaocheng; Jiang Ying; Luo Ming; Zheng Xiaofeng

    2005-01-01

    Human secreted proteins play a very important role in signal transduction. In order to study all potential secreted proteins identified from the human genome sequence, systematic production of large amounts of biologically active secreted proteins is a prerequisite. We selected 25 novel genes as a trial case for establishing a reliable expression system to produce active human secreted proteins in Escherichia coli. Expression of proteins with or without signal peptides was examined and compared in E. coli strains. The results indicated that deletion of signal peptides, to a certain extent, can improve the expression of these proteins and their solubilities. More importantly, under expression conditions such as induction temperature, N-terminus fusion peptides need to be optimized in order to express adequate amounts of soluble proteins. These recombinant proteins were characterized as well-folded proteins. This system enables us to rapidly obtain soluble and highly purified human secreted proteins for further functional studies

  7. Technical protocol for laboratory tests of transformation of veterinary medicinal products and biocides in liquid manures. Version 1.0

    Energy Technology Data Exchange (ETDEWEB)

    Kreuzig, Robert [Technische Univ. Braunschweig (Germany). Inst. fuer Oekologische Chemie und Abfallanalytik

    2010-07-15

    The technical protocol under consideration describes a laboratory test method to evaluate the transformation of chemicals in liquid bovine and pig manures under anaerobic conditions and primarily is designed for veterinary medicinal products and biocides. The environmentally relevant entry routes into liquid manures occur via urine and feces of cattle and pigs in stable housings after excretion of veterinary medicinal products as parent compounds or metabolites and after the application of biocides in animal housings. Further entry routes such as solid dung application and direct dung pat deposition by production animals on pasture are not considered by this technical protocol. Thus, this technical protocol focused on the sampling of excrements from cattles and pigs kept in stables and fed under standard nutrition conditions. This approach additionally ensures that excrement samples are operationally free of any contamination by veterinary medicinal products and biocides. After the matrix characterization, reference-manure samples are prepared from the excrement samples by adding tap water to adjust defined dry substance contents typical for bovine or pig manures. This technical protocol comprehends a tiered experimental design in two parts: (a) Sampling of excrements and preparation of reference bovine and pig manures; (b) Testing of anaerobic transformation of chemicals in reference manures.

  8. Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Huijuan Cao

    Full Text Available About 85.3% of hemolytic disease of the newborn (HDN is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended "best" therapy for ABO incompatibility during pregnancy.To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM for preventing HDN due to ABO incompatibility.The protocol of this review was registered on the PROSPERO website (No. CRD42016038637.Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available.Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30.After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14 and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups.This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition.

  9. [The diffusion and the reason for the use of complementary and alternative medicine among users of mental health services: a systematic review of literature].

    Science.gov (United States)

    Pellegrini, Nadia; Ruggeri, Mirella

    2007-01-01

    A systematic review of the studies on use of alternative and complementary medicine by mental health services' users to investigate the prevalence and motivations of CAM used to treat mental disorders. This paper shows a part of the results of a literature review, limited to studies between 1966 and 2005, was carried out using Ovid Medline, PsycINFO and EBM Reviews databases. This was supplemented by hand searching of reference lists. Ninety-one studies on CAM's use by psychiatric patients were analyzed. In this paper the twenty-five articles about the CAM's prevalence and use's motivations are described. The use of complementary and alternative medicine (CAM) varies across countries: data suggest that from 50% to 80% of people suffering of mental disorders use CAM. Heterogeneous methods, samples and results characterizing the studies make generalizations results difficult. Patients motivations of CAM's use were poorly investigated by research, however it seems that persons affected by mental disorders use MAC prevalently because they are dissatisfied with conventional medicine and/or because these alternatives approaches are congruent with their own values, beliefs and philosophical orientation toward health care. The review emphasize the importance of a best physicians' education and information about CAM to improve the management of non-conventional and orthodox medicine relationship. The motivations of CAM's use underline the relevance of patient's holistic conception and the therapeutic role of a patient-physician relationship based on emphaty. Besides it seems important to investigate furtherly patients' psychological and social aspects that influence their choise to use CAM.

  10. Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen; Liu, Jian-Ping

    2017-01-01

    About 85.3% of hemolytic disease of the newborn (HDN) is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended "best" therapy for ABO incompatibility during pregnancy. To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. The protocol of this review was registered on the PROSPERO website (No. CRD42016038637).Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs) of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR) and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available. Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30).After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14) and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups. This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition.

  11. A systematic review of qualitative research on the contributory factors leading to medicine-related problems from the perspectives of adult patients with cardiovascular diseases and diabetes mellitus.

    Science.gov (United States)

    Al Hamid, A; Ghaleb, M; Aljadhey, H; Aslanpour, Z

    2014-09-19

    To synthesise contributing factors leading to medicine-related problems (MRPs) in adult patients with cardiovascular diseases and/or diabetes mellitus from their perspectives. A systematic literature review of qualitative studies regarding the contributory factors leading to MRPs, medication errors and non-adherence, followed by a thematic synthesis of the studies. We screened Pubmed, EMBASE, ISI Web of Knowledge, PsycInfo, International Pharmaceutical Abstract and PsycExtra for qualitative studies (interviews, focus groups and questionnaires of a qualitative nature). Thematic synthesis was achieved by coding and developing themes from the findings of qualitative studies. The synthesis yielded 21 studies that satisfied the inclusion and exclusion criteria. Three themes emerged that involved contributing factors to MRPs: patient-related factors including socioeconomic factors (beliefs, feeling victimised, history of the condition, lack of finance, lack of motivation and low self-esteem) and lifestyle factors (diet, lack of exercise/time to see the doctor, obesity, smoking and stress), medicine-related factors (belief in natural remedies, fear of medicine, lack of belief in medicines, lack of knowledge, non-adherence and polypharmacy) and condition-related factors (lack of knowledge/understanding, fear of condition and its complications, and lack of control). MRPs represent a major health threat, especially among adult patients with cardiovascular diseases and/or diabetes mellitus. The patients' perspectives uncovered hidden factors that could cause and/or contribute to MRPs in these groups of patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. Current advanced therapy cell-based medicinal products for type-1-diabetes treatment.

    Science.gov (United States)

    Cañibano-Hernández, Alberto; Del Burgo, Laura Sáenz; Espona-Noguera, Albert; Ciriza, Jesús; Pedraz, Jose Luis

    2018-03-27

    In the XXI century diabetes mellitus has become one of the main threats to human health with higher incidence in regions such as Europe and North America. Type 1 diabetes mellitus (T1DM) occurs as a consequence of the immune-mediated destruction of insulin producing β-cells located in the endocrine part of the pancreas, the islets of Langerhans. The administration of exogenous insulin through daily injections is the most prominent treatment for T1DM but its administration is frequently associated to failure in glucose metabolism control, finally leading to hyperglycemia episodes. Other approaches have been developed in the past decades, such as whole pancreas and islet allotransplantation, but they are restricted to patients who exhibit frequent episodes of hypoglycemia or renal failure because the lack of donors and islet survival. Moreover, patients transplanted with either whole pancreas or islets require of immune suppression to avoid the rejection of the transplant. Currently, advanced therapy medicinal products (ATMP), such as implantable devices, have been developed in order to reduce immune rejection response while increasing cell survival. To overcome these issues, ATMPs must promote vascularization, guaranteeing the nutritional contribution, while providing O 2 until vasculature can surround the device. Moreover, it should help in the immune-protection to avoid acute and chronic rejection. The transplanted cells or islets should be embedded within biomaterials with tunable properties like injectability, stiffness and porosity mimicking natural ECM structural characteristics. And finally, an infinitive cell source that solves the donor scarcity should be found such as insulin producing cells derived from mesenchymal stem cells (MSCs), embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). Several companies have registered their ATMPs and future studies envision new prototypes. In this review, we will discuss the mechanisms and etiology of

  13. High quality of evidence is uncommon in Cochrane systematic reviews in Anaesthesia, Critical Care and Emergency Medicine.

    Science.gov (United States)

    Conway, Aaron; Conway, Zachary; Soalheira, Kathleen; Sutherland, Joanna

    2017-12-01

    The association between the quality of evidence in systematic reviews and authors' conclusions regarding the effectiveness of interventions relevant to anaesthesia has not been examined. The objectives of this study were: to determine the proportion of systematic reviews in which the authors made a conclusive statement about the effect of an intervention; to describe the quality of evidence derived from outcomes in reviews that used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group system for grading the quality of evidence; and to identify review characteristics associated with conclusiveness. Cross-sectional analysis of Cochrane systematic reviews from the Anaesthesia, Critical Care and Emergency Review Group was undertaken. The Cochrane webpage was used to identify reviews for inclusion (http://.ace.cochrane.org/). New and updated versions of systematic reviews published up to 17 September 2015 were eligible. Protocols for systematic reviews were excluded. A total of 159 reviews were included. GRADE was used in 103 reviews (65%). Of these, high-level evidence for the primary outcome was identified in 11 reviews (10%). The main reasons that quality of evidence for the primary outcome was downgraded were risk of bias (n = 44; 43%) and imprecision (n = 36; 35%). Authors of 47% (n = 75) of the total number of reviews made conclusive statements about the effects of interventions. Independent predictors of conclusiveness in the subgroup of reviews with GRADE assessments were quality of evidence for the primary outcome (odds ratio 2.03; 95% confidence interval: [1.18 to 3.52] and an increasing number of studies included in reviews (OR 1.05; 95% CI: [1.01 to 1.09]). It was common for conclusive statements to be made about the effects of interventions despite evidence for the primary outcome being rated less than high quality. Improving methodological quality of trials would have the greatest impact on improving the

  14. Enhancing isoprenoid production through systematically assembling and modulating efflux pumps in Escherichia coli.

    Science.gov (United States)

    Wang, Jian-Feng; Xiong, Zhi-Qiang; Li, Shi-Yuan; Wang, Yong

    2013-09-01

    Enhancement of the cellular exportation of heterologous compounds is an important aspect to improve the product yield in microbial cell factory. Efflux pumps can expel various intra- or extra-cellular substances out of microbial hosts and increase the cellular tolerance. Thus in this study, by using the hydrophobic sesquiterpene (amorphadiene) and diterpene (kaurene) as two model compounds, we attempted to improve isoprenoid production through systematically engineering the efflux pumps in Escherichia coli BL21(DE3). The pleiotropic resistant pumps, AcrAB-TolC, MdtEF-TolC from E. coli and heterologous MexAB-OprM pump from Pseudomonas aeruginosa, were overexpressed, assembled, and finely modulated. We found that overexpression of AcrB and TolC components can effectively enhance the specific yield of amorphadiene and kaurene, e.g., 31 and 37 % improvement for amorphadiene compared with control, respectively. The heterologous MexB component can enhance kaurene production with 70 % improvement which is more effective than TolC and AcrB. The results suggest that the three components of tripartite efflux pumps play varied effect to enhance isoprenoid production. Considering the highly organized structure of efflux pumps and importance of components interaction, various component combinations were constructed and the copy number of key components AcrB and TolC was finely modulated as well. The results exhibit that the combination TolC and TolC and AcrB improved the specific yield of amorphadiene with 118 %, and AcrA and TolC and AcrB improved that of kaurene with 104 %. This study indicates that assembling and finely modulating efflux pumps is an effective strategy to improve the production of heterologous compounds in E. coli.

  15. Ethnoveterinary Medicine: The prospects of integrating medicinal ...

    African Journals Online (AJOL)

    Medicinal plants products are part of the natural products that have been in use in traditional medicine and also a source of novel drugs. Therefore, the use of medicinal plant products would be a rational alternative to synthetic drugs. Ethnobotanical surveys carried out in many parts of Kenya have revealed a lot of plants ...

  16. [Report from the Committee for Advanced Therapies (CAT). Pitfalls on the way from concept to medical treatment with advanced therapy medicinal products].

    Science.gov (United States)

    Reiss, M; Büttel, I C; Schneider, C K

    2011-07-01

    Advanced therapy medicinal products (ATMP) are highly innovative and complex medicines. They comprise gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products (TEP). With the European Regulation on ATMP that came into force in 2008, a consolidated regulatory framework was created, where the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) plays a central role. This article discusses pitfalls and challenges that the CAT has experienced in its discussions of various procedures. Often ATMPs are developed by small and medium-sized enterprises (SME) which also face nonscientific challenges. The CAT wishes to meet these challenges on a scientific and regulatory level during its 2010-2015 work program.

  17. Prevalence of complementary and alternative medicine use in a community-based population in South Korea: a systematic review.

    Science.gov (United States)

    Seo, Hyun-Ju; Baek, Seung-Min; Kim, Sul Gi; Kim, Tae-Hun; Choi, Sun Mi

    2013-06-01

    To examine the prevalence of the use of complementary and alternative medicine (CAM) in the Republic of Korea and identify the factors responsible for variations in the reported prevalence, the socio-demographic factors associated with CAM use, and the relationship between CAM use and study methodological quality. Two international and 6 representative Korean medical databases were searched to identify cross-sectional studies that had surveyed the general Korean population in community settings to determine prevalence of CAM use. Data collection and assessment of the methodological quality of the studies were conducted by 3 independent reviewers. The prevalence of CAM use reported by the 11 studies that met the selection criteria ranged from 29% to 83%. Inclusion of Korean medicine within the definition of CAM was not found to be a significant factor in the heterogeneity, but several factors that may have contributed to it, namely, inconsistency in CAM taxonomies, recall bias, use of unrepresentative sampling strategies, and lack of pilot testing, were identified. Higher CAM use was found to be associated with female sex, high level of education, and advanced age. The inclusion of Korean medicine within the definition of CAM does not explain the heterogeneity in the reported prevalence of CAM use among the South Korean population. A standard questionnaire appropriate for the Korean context should be developed to define and classify the common CAM modalities and control for confounding factors. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  18. Social marketing of water and sanitation products: a systematic review of peer-reviewed literature.

    Science.gov (United States)

    Evans, W D; Pattanayak, S K; Young, S; Buszin, J; Rai, S; Bihm, Jasmine Wallace

    2014-06-01

    Like commercial marketing, social marketing uses the 4 "Ps" and seeks exchange of value between the marketer and consumer. Behaviors such as handwashing, and products such as those for oral rehydration treatment (ORT), can be marketed like commercial products in developing countries. Although social marketing in these areas is growing, there has been no systematic review of the current state of practice, research and evaluation. We searched the literature for published peer-reviewed studies available through major online publication databases. We identified manuscripts in the health, social science, and business literature on social marketing that used at least one of the 4 Ps of marketing and had a behavioral objective targeting the behaviors or products related to improving water and sanitation. We developed formalized decision rules and applied them in identifying articles for review. We initially identified 117 articles and reviewed a final set of 32 that met our criteria. Social marketing is a widespread strategy. Marketing efforts have created high levels of awareness of health threats and solutions, including behavior change and socially marketed products. There is widespread use of the 4 Ps of marketing, with price interventions being the least common. Evaluations show consistent improvements in behavioral mediators but mixed results in behavior change. Interventions have successfully used social marketing following widely recommended strategies. Future evaluations need to focus on mediators that explain successful behavior change in order to identify best practices and improve future programs. More rigorous evaluations including quasi-experimental designs and randomized trials are needed. More consistent reporting of evaluation results that permits meta-analysis of effects is needed. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Burden of reduced work productivity among people with chronic knee pain: a systematic review.

    Science.gov (United States)

    Agaliotis, Maria; Mackey, Martin G; Jan, Stephen; Fransen, Marlene

    2014-09-01

    The aims of this systematic review were to determine the prevalence of reduced work productivity among people with chronic knee pain as well as specifically categorise determinants of work productivity losses into individual, disease and work-related factors, conduct an evaluation of study methodological quality and present a best-evidence synthesis. We searched the literature using combinations of key words such as knee pain, knee osteoarthritis, absenteeism (days taken off work) and presenteeism (reduced productivity while at work) for observational studies published in English. Methodological quality appraisal and a best-evidence synthesis were used to pool the study findings. The studies were conducted exclusively in high income countries of North America, Western Europe and Hong Kong. 17 studies were included in the review, 10 measuring absenteeism and six measuring presenteeism. Of the 10 studies reporting absenteeism, seven found a 12-month absenteeism prevalence ranging from 5% to 22%. Only two studies evaluated presenteeism prevalence and reported a range from 66% to 71%. Using best-evidence synthesis: three high quality cohort studies and three cross-sectional studies provided strong evidence that knee pain or knee osteoarthritis was associated with absenteeism; two high quality cross-sectional studies and one cohort study provided limited evidence for an association with presenteeism; one cross-sectional study provided limited evidence for an association among age, hig