WorldWideScience

Sample records for medicinal product systematic

  1. 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    We have systematically identified medicinal products withdrawn worldwide because of adverse drug reactions, assessed the level of evidence used for making the withdrawal decisions, and explored the patterns of withdrawals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 We searched PubMed, the WHO database of withdrawn products, and selected texts. We included products that were withdrawn after launch from 1950 onwards, excluding non-human and over-the-counter medicines.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 Of 353 medicinal products withdrawn from any country, only 40 were withdrawn worldwide.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 In conclusion, the time it takes for drugs to be withdrawn worldwide after reports of adverse drug reactions has shortened over time.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.

  2. 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.

  3. 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.

  4. Visualization of evidence-based medicine domain knowledge: production and citation of Cochrane systematic reviews.

    Science.gov (United States)

    Shen, Jiantong; Li, Youping; Clarke, Mike; Du, Liang; Wang, Li; Zhong, Dake

    2013-02-01

    To evaluate the production and utilization of Cochrane systematic reviews (CSRs) and to analyze its influential factors, so as to improve the capacity of translating CSRs into practice. All CSRs and protocols were retrieved from the Cochrane Library (Issue 2, 2011) and citation data were retrieved from SCI database. Citation analysis was used to analyze the situation of CSRs production and utilization. CSR publication had grown from an annual average of 32 to 718 documents. Only one developing country was among the ten countries with the largest amount of publications. High-income countries accounted for 83% of CSR publications and 90.8% of cited counts. A total 34.7% of CSRs had a cited count of 0, whereas only 0.9% had been cited more than 50 times. Highly cited CSRs were published in England, Australia, Canada, USA and other high-income countries. The countries with a Cochrane center or a Cochrane methodology group had a greater capability of CSRs production and citing than others. The CSRs addressing the topics of diseases were more than those targeted at public health issues. There was a big gap in citations of different interventions even on the same topic. The capability of CSR production and utilization grew rapidly, but varied among countries and institutions, which was affected by several factors such as the capability of research, resources and the applicability of evidence. It is important to improve evidence translation through educating, training and prioritizing the problems based on real demands of end users. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  5. 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 Systematic reviews and meta-analyses in orthopaedics sports medicine literature relied on evidence levels 4 and 5 in 53% of studies over the 5-year study period. Overall, PRISMA and

  6. Mentoring in academic medicine: a systematic review.

    Science.gov (United States)

    Sambunjak, Dario; Straus, Sharon E; Marusić, Ana

    2006-09-06

    Mentoring, as a partnership in personal and professional growth and development, is central to academic medicine, but it is challenged by increased clinical, administrative, research, and other educational demands on medical faculty. Therefore, evidence for the value of mentoring needs to be evaluated. To systematically review the evidence about the prevalence of mentorship and its relationship to career development. MEDLINE, Current Contents, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, PsycINFO, and Scopus databases from the earliest available date to May 2006. We identified all studies evaluating the effect of mentoring on career choices and academic advancement among medical students and physicians. Minimum inclusion criteria were a description of the study population and availability of extractable data. No restrictions were placed on study methods or language. The literature search identified 3640 citations. Review of abstracts led to retrieval of 142 full-text articles for assessment; 42 articles describing 39 studies were selected for review. Of these, 34 (87%) were cross-sectional self-report surveys with small sample size and response rates ranging from 5% to 99%. One case-control study nested in a survey used a comparison group that had not received mentoring, and 1 cohort study had a small sample size and a large loss to follow-up. Less than 50% of medical students and in some fields less than 20% of faculty members had a mentor. Women perceived that they had more difficulty finding mentors than their colleagues who are men. Mentorship was reported to have an important influence on personal development, career guidance, career choice, and research productivity, including publication and grant success. Mentoring is perceived as an important part of academic medicine, but the evidence to support this perception is not strong. Practical recommendations on mentoring in

  7. Complementary medicines (herbal and nutritional products) in the treatment of Attention Deficit Hyperactivity Disorder (ADHD): a systematic review of the evidence.

    Science.gov (United States)

    Sarris, Jerome; Kean, James; Schweitzer, Isaac; Lake, James

    2011-08-01

    Complementary and Alternative Medicines (CAMs) are frequently given to children and adolescents for reputed benefits in the treatment of hyperkinetic and concentration disorders such as Attention Deficit Hyperactivity Disorder (ADHD). In such vulnerable populations high quality evidence is required to support such claims. The aim of the paper is to assess the current evidence of herbal and nutritional interventions for ADHD using a systematic search of clinical trials meeting an acceptable standard of evidence. PubMed, PsycINFO, Cochrane Library and CINAHL were searched up to May 26th, 2011 for randomised, controlled clinical trials using CAM products as interventions to treat ADHD. A quality analysis using a purpose-designed scale, and an estimation of effect sizes (Cohen's d) where data were available, were also calculated. The review revealed that 16 studies met inclusion criteria, with predominant evidentiary support found for zinc, iron, Pinus marinus (French maritime pine bark), and a Chinese herbal formula (Ningdong); and mixed (mainly inconclusive) evidence for omega-3, and l-acetyl carnitine. Current data suggest that Ginkgo biloba (ginkgo), and Hypercium perforatum (St. John's wort) are ineffective in treating ADHD. The research suggests only some CAMs may be beneficial in ADHD, thus clinicians need to be aware of the current evidence. Promising candidates for future research include Bacopa monniera (brahmi) and Piper methysticum (kava), providing potential efficacy in improving attentional and hyperkinetic disorders via a combination of cognitive enhancing and sedative effects. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. Empirical methods for systematic reviews and evidence-based medicine

    NARCIS (Netherlands)

    van Enst, W.A.

    2014-01-01

    Evidence-Based Medicine is the integration of best research evidence with clinical expertise and patient values. Systematic reviews have become the cornerstone of evidence-based medicine, which is reflected in the position systematic reviews have in the pyramid of evidence-based medicine. Systematic

  9. Career choice in academic medicine: systematic review.

    Science.gov (United States)

    Straus, Sharon E; Straus, Christine; Tzanetos, Katina

    2006-12-01

    To review systematically the evidence about what factors influence the decision to choose or not choose a career in academic medicine. A systematic review of relevant literature from 1990 to May 2005. Searches of The Cochrane Library, Medline (using Ovid and PubMed) from 1990 to May 2005, and EMBASE from 1990 to May 2005 were completed to identify relevant studies that explored the influential factors. Additional articles were identified from searching the bibliographies of retrieved articles. We attempted to identify studies that included residents, fellows, or staff physicians. No restrictions were placed on the study methodologies identified and all articles presenting empirical evidence were retrieved. For cohort, case-control, and cross-sectional studies, minimum inclusion criteria were the presence of defined groups, and the ability to extract relevant data. For surveys that involved case series, minimum inclusion criteria were a description of the population, and the availability of extractable data. Minimum inclusion criteria for qualitative studies were descriptions of the sampling strategy and methods. The search identified 251 abstracts; 25 articles were included in this review. Completion of an MD with a graduate degree or fellowship program is associated with a career in academic medicine. Of the articles identified in this review, this finding is supported by the highest quality of evidence. Similarly, the completion of research and publication of this research in medical school and residency are associated with a career in academic medicine. The desire to teach, conduct research, and the intellectual stimulation and challenge provided in academia may also persuade people to choose this career path. The influence of a role model or a mentor was reported by physicians to impact their decision making. Trainees' interest in academic medicine wanes as they progress through their residency. In order to revitalize academic medicine, we must engage trainees

  10. 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

  11. 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.

  12. 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.

  13. 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...

  14. Systematic thinks of nuclear medicine diagnosis

    International Nuclear Information System (INIS)

    Wang Jing

    2002-01-01

    For proper diagnosis using nuclear medicine techniques, an integrated man-machine system should be the starting point; the best choice should be the essential purpose and modeling is the necessary method

  15. 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.

  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 results.

  17. [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.

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

    OpenAIRE

    azadeh Khonsari; kourosh Gorji; arman Mousavi; foad Abdollahpur

    2010-01-01

    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 repor...

  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. traditional medicinal uses of small mammal products

    African Journals Online (AJOL)

    Dr. Nelson Boniface

    hunted small mammals mainly by dogs for cultural and ornamental reasons. Products of African ... (WHO) defines traditional medicine as ''health practices ... particularly in Asian countries. ..... Ntiamoa- Baidu Y 1992 Local Perceptions and.

  1. 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

  2. Ayurvedic medicine for rheumatoid arthritis: a systematic review.

    Science.gov (United States)

    Park, Jongbae; Ernst, Edzard

    2005-04-01

    To systematically review all randomized controlled trials (RCTs) on the effectiveness of Ayurvedic medicine for rheumatoid arthritis (RA). Computerized literature searches for all RCTs of Ayurvedic medicine for RA in the following databases: Medline (March 1969 to March 2003), Embase (February 1985 to February 2003), AMED (March 1980 to March 2003), Cochrane Controlled Trial Register (October 1997 to March 2003), and the abstract service of Central Council for Research in Ayurveda and Siddha (CCRAS; 1976 to March 2003). Hand searches were performed in 1 Sri Lankan and 3 Indian journals and the authors' personal files. Key data of included studies were extracted and reviewed. The methodological quality of all studies was evaluated with the Jadad scale. Seven studies met our inclusion criteria. Trials tested either Ayurvedic medicine against placebo or other Ayurvedic medicines. In general, patient and physician global assessments on the severity of pain, and morning stiffness were used as endpoints. Of 3 placebo-controlled RCTs, 1 high-quality trial did not show benefit of the active treatment against placebo, while another incompletely reported study indicated beneficial effects of an Ayurvedic medicine. A further incompletely reported study showed no significant difference. The remaining 4 trials were difficult to interpret because they tested an Ayurvedic medicine against other Ayurvedic medicines whose effects were not proven. There is a paucity of RCTs of Ayurvedic medicines for RA. The existing RCTs fail to show convincingly that such treatments are effective therapeutic options for RA.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

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

    Science.gov (United States)

    Tansaz, Mojgan; Nazemiyeh, Hossein; Fazljou, Seyed Mohammad Bagher

    2018-01-01

    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 treatment of menstrual

  9. 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

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

    Science.gov (United States)

    Moini Jazani, Arezoo; Hamdi, Kobra; Tansaz, Mojgan; Nazemiyeh, Hossein; Sadeghi Bazargani, Homayoun; Fazljou, Seyed Mohammad Bagher; Nasimi Doost Azgomi, Ramin

    2018-01-01

    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. 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. 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 treatment of menstrual irregularities, the results and

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. [Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products].

    Science.gov (United States)

    Qu, Li-Ping; Zhang, Xiao-Qun; Xiong, Yan; Wang, Yi-Tao; Zou, Wen-Jun

    2017-10-01

    Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU. Copyright© by the Chinese Pharmaceutical Association.

  17. 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

  18. Barriers to evidence-based medicine: a systematic review.

    Science.gov (United States)

    Sadeghi-Bazargani, Homayoun; Tabrizi, Jafar Sadegh; Azami-Aghdash, Saber

    2014-12-01

    Evidence-based medicine (EBM) has emerged as an effective strategy to improve health care quality. The aim of this study was to systematically review and carry out an analysis on the barriers to EBM. Different database searching methods and also manual search were employed in this study using the search words ('evidence-based' or 'evidence-based medicine' or 'evidence-based practice' or 'evidence-based guidelines' or 'research utilization') and (barrier* or challenge or hinder) in the following databases: PubMed, Scopus, Web of Knowledge, Cochrane library, Pro Quest, Magiran, SID. Out of 2592 articles, 106 articles were finally identified for study. Research barriers, lack of resources, lack of time, inadequate skills, and inadequate access, lack of knowledge and financial barriers were found to be the most common barriers to EBM. Examples of these barriers were found in primary care, hospital/specialist care, rehabilitation care, medical education, management and decision making. The most common barriers to research utilization were research barriers, cooperation barriers and changing barriers. Lack of resources was the most common barrier to implementation of guidelines. The result of this study shows that there are many barriers to the implementation and use of EBM. Identifying barriers is just the first step to removing barriers to the use of EBM. Extra resources will be needed if these barriers are to be tackled. © 2014 John Wiley & Sons, Ltd.

  19. Systematic Molecular Phenotyping: A Path Toward Precision Emergency Medicine?

    Science.gov (United States)

    Limkakeng, Alexander T; Monte, Andrew A; Kabrhel, Christopher; Puskarich, Michael; Heitsch, Laura; Tsalik, Ephraim L; Shapiro, Nathan I

    2016-10-01

    Precision medicine is an emerging approach to disease treatment and prevention that considers variability in patient genes, environment, and lifestyle. However, little has been written about how such research impacts emergency care. Recent advances in analytical techniques have made it possible to characterize patients in a more comprehensive and sophisticated fashion at the molecular level, promising highly individualized diagnosis and treatment. Among these techniques are various systematic molecular phenotyping analyses (e.g., genomics, transcriptomics, proteomics, and metabolomics). Although a number of emergency physicians use such techniques in their research, widespread discussion of these approaches has been lacking in the emergency care literature and many emergency physicians may be unfamiliar with them. In this article, we briefly review the underpinnings of such studies, note how they already impact acute care, discuss areas in which they might soon be applied, and identify challenges in translation to the emergency department (ED). While such techniques hold much promise, it is unclear whether the obstacles to translating their findings to the ED will be overcome in the near future. Such obstacles include validation, cost, turnaround time, user interface, decision support, standardization, and adoption by end-users. © 2016 by the Society for Academic Emergency Medicine.

  20. Statutory instruments: 1984 No. 1261 Medicines - The Medicines (Committee on Radiation from Radioactive Medicinal Products) (Revocation) Order 1984

    International Nuclear Information System (INIS)

    1984-01-01

    This Order, which came into force on 6 September 1984, revokes the Medicines (Committee on Radiation from Radioactive Medicinal Products) Order 1978 thereby abolishing the Committee, which was established for the purpose of giving advice on safety, quality and efficacy in relation to radiation involving any substance or article for human use to which the Medicins Act 1968 is applicable. (NEA) [fr

  1. Systematic Molecular Phenotyping: A Path Towards Precision Emergency Medicine?

    Science.gov (United States)

    Limkakeng, Alexander T.; Monte, Andrew; Kabrhel, Christopher; Puskarich, Michael; Heitsch, Laura; Tsalik, Ephraim L.; Shapiro, Nathan I.

    2016-01-01

    Precision medicine is an emerging approach to disease treatment and prevention that considers variability in patient genes, environment, and lifestyle. However, little has been written about how such research impacts emergency care. Recent advances in analytical techniques have made it possible to characterize patients in a more comprehensive and sophisticated fashion at the molecular level, promising highly individualized diagnosis and treatment. Among these techniques are various systematic molecular phenotyping analyses (e.g., genomics, transcriptomics, proteomics, and metabolomics). Although a number of emergency physicians use such techniques in their research, widespread discussion of these approaches has been lacking in the emergency care literature and many emergency physicians may be unfamiliar with them. In this article, we briefly review the underpinnings of such studies, note how they already impact acute care, discuss areas in which they might soon be applied, and identify challenges in translation to the emergency department. While such techniques hold much promise, it is unclear whether the obstacles to translating their findings to the emergency department will be overcome in the near future. Such obstacles include validation, cost, turnaround time, user interface, decision support, standardization, and adoption by end users. PMID:27288269

  2. [Review on community herbal monographs for traditional herbal medicinal products].

    Science.gov (United States)

    Zou, Wenjun; Qu, Liping; Ye, Zuguang; Ji, Jianxin; Li, Bogang

    2011-12-01

    This article discusses the characteristics of cmmunity herbal monographs for traditional herbal medicinal products and its establishment procedure. It also reviews the new development of cmmunity traditional herbal monographs. The purpose is to clarify the relationship between cmmunity herbal monographs and simplified registration for traditional herbal medicinal product in European Union and provide reference to the registration of taditional Chinese mdicinal products in Europe.

  3. 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

  4. Systematics of Fission-Product Yields

    International Nuclear Information System (INIS)

    Wahl, A.C.

    2002-01-01

    Empirical equations representing systematics of fission-product yields have been derived from experimental data. The systematics give some insight into nuclear-structure effects on yields, and the equations allow estimation of yields from fission of any nuclide with atomic number Z F = 90 thru 98, mass number A F = 230 thru 252, and precursor excitation energy (projectile kinetic plus binding energies) PE = 0 thru ∼200 MeV--the ranges of these quantities for the fissioning nuclei investigated. Calculations can be made with the computer program CYFP. Estimates of uncertainties in the yield estimates are given by equations, also in CYFP, and range from ∼ 15% for the highest yield values to several orders of magnitude for very small yield values. A summation method is used to calculate weighted average parameter values for fast-neutron (∼ fission spectrum) induced fission reactions

  5. Systematics of Fission-Product Yields

    Energy Technology Data Exchange (ETDEWEB)

    A.C. Wahl

    2002-05-01

    Empirical equations representing systematics of fission-product yields have been derived from experimental data. The systematics give some insight into nuclear-structure effects on yields, and the equations allow estimation of yields from fission of any nuclide with atomic number Z{sub F} = 90 thru 98, mass number A{sub F} = 230 thru 252, and precursor excitation energy (projectile kinetic plus binding energies) PE = 0 thru {approx}200 MeV--the ranges of these quantities for the fissioning nuclei investigated. Calculations can be made with the computer program CYFP. Estimates of uncertainties in the yield estimates are given by equations, also in CYFP, and range from {approx} 15% for the highest yield values to several orders of magnitude for very small yield values. A summation method is used to calculate weighted average parameter values for fast-neutron ({approx} fission spectrum) induced fission reactions.

  6. [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.

  7. 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.

  8. Is individualized medicine more cost-effective? A systematic review.

    Science.gov (United States)

    Hatz, Maximilian H M; Schremser, Katharina; Rogowski, Wolf H

    2014-05-01

    Individualized medicine (IM) is a rapidly evolving field that is associated with both visions of more effective care at lower costs and fears of highly priced, low-value interventions. It is unclear which view is supported by the current evidence. Our objective was to systematically review the health economic evidence related to IM and to derive general statements on its cost-effectiveness. A literature search of MEDLINE database for English- and German-language studies was conducted. Cost-effectiveness and cost-utility studies for technologies meeting the MEDLINE medical subject headings (MeSH) definition of IM (genetically targeted interventions) were reviewed. This was followed by a standardized extraction of general study characteristics and cost-effectiveness results. Most of the 84 studies included in the synthesis were from the USA (n = 43, 51 %), cost-utility studies (n = 66, 79 %), and published since 2005 (n = 60, 71 %). The results ranged from dominant to dominated. The median value (cost-utility studies) was calculated to be rounded $US22,000 per quality-adjusted life year (QALY) gained (adjusted to $US, year 2008 values), which is equal to the rounded median cost-effectiveness in the peer-reviewed English-language literature according to a recent review. Many studies reported more than one strategy of IM with highly varying cost-effectiveness ratios. Generally, results differed according to test type, and tests for disease prognosis or screening appeared to be more favorable than tests to stratify patients by response or by risk of adverse effects. However, these results were not significant. Different definitions of IM could have been used. Quality assessment of the studies was restricted to analyzing transparency. IM neither seems to display superior cost-effectiveness than other types of medical interventions nor to be economically inferior. Instead, rather than 'whether' healthcare was individualized, the question of 'how' it was individualized was

  9. Complementary and alternative medicine for lowering blood lipid levels: A systematic review of systematic reviews.

    Science.gov (United States)

    Posadzki, Paul; AlBedah, Abdullah M N; Khalil, Mohamed M K; AlQaed, Meshari S

    2016-12-01

    The aim of this article is to summarize and critically evaluate the evidence from systematic reviews (SRs) of complementary and alternative medicine (CAM) for lowering blood lipid levels (BLL). Eight electronic databases were searched until March 2016. Additionally, all the retrieved references were inspected manually for further relevant papers. Systematic reviews were considered eligible, if they included patients of any age and/or gender with elevated blood lipid levels using any type of CAM. We used the Oxman and AMSTAR criteria to critically appraise the methodological quality of the included SRs. Twenty-seven SRs were included in the analyses. The majority of the SRs were of high methodological quality (mean Oxman score=4.81, SD=4.88; and the mean AMSTAR score=7.22, SD=3.38). The majority of SRs (56%) arrived at equivocal conclusions (of these 8 were of high quality); 7 SRs (37%) arrived at positive conclusions (of these 6 were of high quality), and 2 (7%) arrived at negative conclusions (both were of high quality). There was conflicting evidence regarding the effectiveness of garlic; and promising evidence for yoga. To conclude, the evidence from SRs evaluating the effectiveness of CAM in lowering BLL is predominantly equivocal and confusing. Several limitations exist, such as variety of doses and preparations, confounding effects of diets and lifestyle factors, or heterogeneity of the primary trials among others. Copyright © 2016. Published by Elsevier Ltd.

  10. Productivity in services: a systematic review

    Directory of Open Access Journals (Sweden)

    Noel Torres Júnior

    2013-03-01

    Full Text Available Through the method of Systematic Review of Literature (SRL, this study conducted an analysis of productivity in services. For this purpose, fourteen journals of Operations Management and Scielo database were consulted. The studies were analyzed with respect to six criteria for classification: i type of study, ii investigated business sector, iii affiliation of authors, iv prevailing methodological approach, v themes, e vi methods used in comparative analyzes of performance. It was found that the greatest amount of work used the modeling approach to assess the productivity, particularly by linear programming methodology - Data Analysis Envelopment (DEA. It was observed that the vast majority of authors are academic, there are few publications of researchers from companies or that have both types of researchers. The study identified four recurring themes in the articles. Then, some studies have focused on the establishment of productivity indicators and their analysis over time, comparing the performance of different firms or industries. Other studies have identified the characteristics and difficulties of measuring productivity in services in relation to manufacturing companies. Different studies have proposed indicators to measure productivity in services. Finally, in light of the main textbooks on operation's management and service literature, this study identified key strategies and methods for improving productivity in services. It was found that the theme productivity in services is a promising research topic.

  11. Mind-Body Medicine and Immune System Outcomes: A Systematic Review

    OpenAIRE

    Wahbeh, Helané; Haywood, Ashley; Kaufman, Karen; Zwickey, Heather

    2009-01-01

    This study is a systematic review of mind-body interventions that used immune outcomes in order to: 1) characterize mind-body medicine studies that assessed immune outcomes, 2) evaluate the quality of mind-body medicine studies measuring immune system effects, and 3) systematically evaluate the evidence for mind-body interventions effect on immune system outcomes using existing formal tools. 111 studies with 4,777 subjects were reviewed. The three largest intervention type categories were Rel...

  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. 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.

  14. Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

    Science.gov (United States)

    Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

    2015-01-01

    Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

  15. World Workshop on Oral Medicine VI : a systematic review of medication-induced salivary gland dysfunction

    NARCIS (Netherlands)

    Villa, Alessandro; Wolff, A.; Narayana, N.; Dawes, C.; Aframian, D. J.; Pedersen, A. M. Lynge; Vissink, A.; Aliko, A.; Sia, Y. W.; Joshi, R. K.; McGowan, R.; Jensen, S. B.; Kerr, A. R.; Ekstrom, J.; Proctor, G.

    The aim of this paper was to perform a systematic review of the pathogenesis of medication-induced salivary gland dysfunction (MISGD). Review of the identified papers was based on the standards regarding the methodology for systematic reviews set forth by the World Workshop on Oral Medicine IV and

  16. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

    Science.gov (United States)

    Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

    2015-07-01

    Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  17. The Prohibition of Medicinal Claims: Food in Fact But Medicinal Product in Law?

    NARCIS (Netherlands)

    Bremmers, H.J.; Meulen, van der B.M.J.; Waarts, Y.R.

    2015-01-01

    Under EU medicinal law, any substance or combination of substances presented as having properties for treating or preventing disease in human beings is a medicinal product by virtue of its presentation. Under EU food law it is prohibited to attribute to any food the property of preventing, treating

  18. Evaluation of systematic I-131 thyroid measurements for nuclear medicine workers

    International Nuclear Information System (INIS)

    Puscalau, M.A.

    2002-01-01

    In Nuclear Medicine, I-131 is used intensively for the diagnosis and for the treatment of the different severities maladies of the thyroid. This radionuclide generates an important internal contamination to the patients, because of its oral administration, and, also, through inhalation, to the workers involved in the radiopharmaceuticals production , to the nursing staff and to the physicians that care and treat the patients in the hospitals. The paper presents the data obtained by systematically thyroid monitoring of the physicians and nurses from the Endocrinology Hospital, that are contaminated by I-131 inhalation because of their permanent relation with the patients treated with 3.7 MBq I-131 for investigation and with activities in the range 1100 MBq - 4000 MBq for therapy. The measurements were carried out with our Body Counter equipped with a NaI(Tl) scintillation detector, 50 mm thickness and 40mm diameter. Values of the estimated committed equivalent doses are, also, reported

  19. 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.

  20. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Science.gov (United States)

    2010-10-22

    ...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

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

    Science.gov (United States)

    Soosaraei, Masoud; Fakhar, Mahdi; Hosseini Teshnizi, Saeed; Ziaei Hezarjaribi, Hajar; Banimostafavi, Elham Sadat

    2017-09-01

    Leishmaniasis is a major public health problem worldwide. The aim of the present study was to investigate medicinal plants with anti- Leishmania activity which used in Iran. Data were systematically gathered from five English databases including Ebsco, Science Direct, PubMed, Google Scholar and Scopus, four Persian databases including Magiran, Iran doc, Iran medex and the Scientific Information Database (SID) from 1999 to April 2015. Information obtained included plant family, extraction method, concentrations of extracts, animal models and parasite strains. A total of 68 articles including 188 experiments (140 in vitro and 48 in vivo) between 1999 and 2015, met our eligibility criteria. Thoroughly, 98 types of plants were examined against three genera of Leishmania spp. For the heterogeneity study conducted, it was showed that there was a great deal of variation among studies. Based on random effect, meta-analysis pooled mean of IC50 was obtained 456.64 (95% CI: 396.15, 517.12). 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.

  3. 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.

  4. PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

    Science.gov (United States)

    Krause, Stephan O

    2015-01-01

    This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

  5. A systematic review of qualitative research on the meaning and characteristics of mentoring in academic medicine.

    Science.gov (United States)

    Sambunjak, Dario; Straus, Sharon E; Marusic, Ana

    2010-01-01

    Mentorship is perceived to play a significant role in the career development and productivity of academic clinicians, but little is known about the characteristics of mentorship. This knowledge would be useful for those developing mentorship programs. To complete a systematic review of the qualitative literature to explore and summarize the development, perceptions and experiences of the mentoring relationship in academic medicine. Medline, PsycINFO, ERIC, Scopus and Current Contents databases from the earliest available date to December 2008. We included studies that used qualitative research methodology to explore the meaning and characteristics of mentoring in academic medicine. Two investigators independently assessed articles for relevance and study quality, and extracted data using standardized forms. No restrictions were placed on the language of articles. A total of 8,487 citations were identified, 114 full text articles were assessed, and 9 articles were selected for review. All studies were conducted in North America, and most focused on the initiation and cultivation phases of the mentoring relationship. Mentoring was described as a complex relationship based on mutual interests, both professional and personal. Mentees should take an active role in the formation and development of mentoring relationships. Good mentors should be sincere in their dealings with mentees, be able to listen actively and understand mentees' needs, and have a well-established position within the academic community. Some of the mentoring functions aim at the mentees' academic growth and others at personal growth. Barriers to mentoring and dysfunctional mentoring can be related to personal factors, relational difficulties and structural/institutional barriers. Successful mentoring requires commitment and interpersonal skills of the mentor and mentee, but also a facilitating environment at academic medicine's institutions.

  6. [Research strategies for feed additives and veterinary medicines from side products of Chinese medicine resources industrialization].

    Science.gov (United States)

    Zhao, Ming; Duan, Jin-Ao; Zhang, Sen; Guo, Sheng; Su, Shu-Lan; Wu, Qi-Nan; Tang, Yu-Ping; Zeng, Jian-Guo

    2017-09-01

    The global antimicrobial resistance has been a big challenge to the human health for years. It has to make balance between the safety of animal products and the use of antimicrobials in animal husbandry. Any methods that can minimize or even phase out the use of antimicrobials in animal husbandry should be encouraged. We herein describe the research strategies for feed additives and veterinary medicines from the side products of Chinese medicine resources industrialization. Killing two birds with one stone-besides the major purposes, the rational utilization of non-medicinal parts and wastes of industrialization of Chinese herbal medicines is also achieved under the proposed strategies. Copyright© by the Chinese Pharmaceutical Association.

  7. 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.

  8. Conditional approval: Japan lowers the bar for regenerative medicine products.

    Science.gov (United States)

    Sipp, Douglas

    2015-04-02

    A new system for conditional approval of regenerative medicine products will allow products of undetermined efficacy to enter the Japanese market. The potential scientific, economic, and ethical implications of this program highlight the need for further discussion and refinement. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. 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

  10. 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.

  11. Modern radioisotope production technologies for medicine

    International Nuclear Information System (INIS)

    Bechtold, V.; Schweickert, H.

    1989-01-01

    The advantages of the accelerator production of radioisotopes for medical purposes, are, above all, the high specific activity attainable as well as the possibility of the generation of nuclei with only a few neutrons which disintegrate due to β + emission or electron capture. It is, for example, possible to diagnostically utilize the developing long-range γ quanta by means of computerized tomography. The production of I-123 at the cyclotron of Karlsruhe (nuclear reaction, target, irradiation arrangement) as well as of ultra-pure I-123 with the help of compact cyclotrons, and the plant developed for this are described in brief. As another radioisotope which can be produced with the help of the compact cyclotron, Rb-81 is mentioned, the disintegration product Kr-81m of which is used in pulmonary diagnostics. (RB) [de

  12. 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

  13. Defining and Measuring the Affordability of New Medicines: A Systematic Review.

    Science.gov (United States)

    Antoñanzas, Fernando; Terkola, Robert; Overton, Paul M; Shalet, Natalie; Postma, Maarten

    2017-08-01

    In many healthcare systems, affordability concerns can lead to restrictions on the use of expensive efficacious therapies. However, there does not appear to be any consensus as to the terminology used to describe affordability, or the thresholds used to determine whether new drugs are affordable. The aim of this systematic review was to investigate how affordability is defined and measured in healthcare. MEDLINE, EMBASE and EconLit databases (2005-July 2016) were searched using terms covering affordability and budget impact, combined with definitions, thresholds and restrictions, to identify articles describing a definition of affordability with respect to new medicines. Additional definitions were identified through citation searching, and through manual searches of European health technology assessment body websites. In total, 27 definitions were included in the review. Of these, five definitions described affordability in terms of the value of a product; seven considered affordability within the context of healthcare system budgets; and 15 addressed whether products are affordable in a given country based on economic factors. However, there was little in the literature to indicate that the price of medicines is considered alongside both their value to individual patients and their budget impact at a population level. Current methods of assessing affordability in healthcare may be limited by their focus on budget impact. A more effective approach may involve a broader perspective than is currently described in the literature, to consider the long-term benefits of a therapy and cost savings elsewhere in the healthcare system, as well as cooperation between healthcare payers and the pharmaceutical industry to develop financing models that support sustainability as well as innovation.

  14. Should Anthroposophic Medicinal Products Be Regulated in Europe?

    Science.gov (United States)

    Michaux, Geneviève

    2017-03-01

    European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

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

    Directory of Open Access Journals (Sweden)

    Schünemann Holger J

    2010-04-01

    Full Text Available Abstract Objective 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. Methods 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. Results 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. Conclusion 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.

  16. 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…

  17. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative

    DEFF Research Database (Denmark)

    Myles, P S; Boney, O; Botti, M

    2018-01-01

    Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus...

  18. 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.

  19. Comparison of Authorization/Registration/Notification Processes among Biocidal Products, Cosmetics, Plant Protection Products and Human Medicinal Products

    OpenAIRE

    Söyleriz, Yüksel

    2015-01-01

    In this study, comparison of the authorization/registration/notification processes of biocidal products, cosmetics, plant protection products and medicinal products are made and in this respect, the situation in EU is assessed.

  20. 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.

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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

  8. Complementary and alternative medicine for rheumatic diseases: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Phang, Jie Kie; Kwan, Yu Heng; Goh, Hendra; Tan, Victoria Ie Ching; Thumboo, Julian; Østbye, Truls; Fong, Warren

    2018-04-01

    To summarize all good quality randomized controlled trials (RCTs) using complementary and alternative medicine (CAM) interventions in patients with rheumatic diseases. A systematic literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) was performed. We excluded non-English language articles and abstract-only publications. Due to the large number of RCTs identified, we only include "good quality" RCTs with Jadad score of five. We identified 60 good quality RCTs using CAM as intervention for patients with rheumatic diseases: acupuncture (9), Ayurvedic treatment (3), homeopathic treatment (3), electricity (2), natural products (31), megavitamin therapies (8), chiropractic or osteopathic manipulation (3), and energy healing therapy (1). The studies do not seem to suggest a particular type of CAM is effective for all types for rheumatic diseases. However, some CAM interventions appear to be more effective for certain types of rheumatic diseases. Acupuncture appears to be beneficial for osteoarthritis but not rheumatoid arthritis. For the other therapeutic modalities, the evidence base either contains too few trials or contains trials with contradictory findings which preclude any definitive summary. There were only minor adverse reactions observed for CAM interventions presented. We identified 60 good quality RCTs which were heterogenous in terms of interventions, disease, measures used to assess outcomes, and efficacy of CAM interventions. Evidence indicates that some CAM therapies may be useful for rheumatic diseases, such as acupuncture for osteoarthritis. Further research with larger sample size is required for more conclusive evidence regarding efficacy of CAM interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

  9. 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, ...

  10. 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...

  11. Clinical characteristics and outcomes of traditional Chinese medicine-induced liver injury: a systematic review.

    Science.gov (United States)

    Wang, Ran; Qi, Xingshun; Yoshida, Eric M; Méndez-Sánchez, Nahum; Teschke, Rolf; Sun, Mingyu; Liu, Xu; Su, Chunping; Deng, Jiao; Deng, Han; Hou, Feifei; Guo, Xiaozhong

    2018-04-01

    Traditional Chinese medicine (TCM) is becoming increasingly popular and related adverse events are often ignored or underestimated. This systematic review aimed to evaluate the clinical characteristics and outcomes of TCM-induced liver injury (TCM-ILI) and to estimate the proportion of TCM-ILI in all drug-induced liver injuries (DILI). China National Knowledge Infrastructure, Wanfang, VIP, PubMed, and Embase databases were searched. Demographic, clinical, and survival data were extracted and pooled. Factors associated with worse outcomes were calculated. For the proportion meta-analyses, the data were pooled by using a random-effects model. Overall, 21,027 articles were retrieved, of which 625 were finally included. There was a predominance of female and older patients. The proportion of liver transplantation was 2.18% (7/321). The mortality was 4.67% (15/321). Male, higher aspartate aminotransferase and direct bilirubin, and lower albumin were significantly associated with an increased risk of death/liver transplantation in TCM-ILI patients. The proportion of TCM-ILI in all DILI was 25.71%. The proportion was gradually increased with year. Our work summarises current knowledge regarding clinical presentation, disease course, and prognosis of TCM-ILI. TCM can result in hepatotoxicity, even death or necessitate life-saving liver transplantation. Governmental regulation of TCM products should be strictly established.

  12. Identifying Complementary and Alternative Medicine Usage Information from Internet Resources. A Systematic Review.

    Science.gov (United States)

    Sharma, Vivekanand; Holmes, John H; Sarkar, Indra N

    2016-08-05

    Identify and highlight research issues and methods used in studying Complementary and Alternative Medicine (CAM) information needs, access, and exchange over the Internet. A literature search was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines from PubMed to identify articles that have studied Internet use in the CAM context. Additional searches were conducted at Nature.com and Google Scholar. The Internet provides a major medium for attaining CAM information and can also serve as an avenue for conducting CAM related surveys. Based on the literature analyzed in this review, there seems to be significant interest in developing methodologies for identifying CAM treatments, including the analysis of search query data and social media platform discussions. Several studies have also underscored the challenges in developing approaches for identifying the reliability of CAM-related information on the Internet, which may not be supported with reliable sources. The overall findings of this review suggest that there are opportunities for developing approaches for making available accurate information and developing ways to restrict the spread and sale of potentially harmful CAM products and information. Advances in Internet research are yet to be used in context of understanding CAM prevalence and perspectives. Such approaches may provide valuable insights into the current trends and needs in context of CAM use and spread.

  13. IDENTIFYING COMPLEMENTARY AND ALTERNATIVE MEDICINE USAGE INFORMATION FROM INTERNET RESOURCES: A SYSTEMATIC REVIEW

    Science.gov (United States)

    Sharma, V.; Holmes, J.H.; Sarkar, I.N.

    2016-01-01

    SUMMARY Objective Identify and highlight research issues and methods used in studying Complementary and Alternative Medicine (CAM) information needs, access, and exchange over the Internet. Methods A literature search was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines from PubMed to identify articles that have studied Internet use in the CAM context. Additional searches were conducted at Nature.com and Google Scholar. Results The Internet provides a major medium for attaining CAM information and can also serve as an avenue for conducting CAM related surveys. Based on the literature analyzed in this review, there seems to be significant interest in developing methodologies for identifying CAM treatments, including the analysis of search query data and social media platform discussions. Several studies have also underscored the challenges in developing approaches for identifying the reliability of CAM-related information on the Internet, which may not be supported with reliable sources. The overall findings of this review suggest that there are opportunities for developing approaches for making available accurate information and developing ways to restrict the spread and sale of potentially harmful CAM products and information. Conclusions Advances in Internet research are yet to be used in context of understanding CAM prevalence and perspectives. Such approaches may provide valuable insights into the current trends and needs in context of CAM use and spread. PMID:27352304

  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 effects were not consistently assessed but where reported were generally mild. There is preliminary evidence for the effectiveness of acupuncture, Chinese herbal medicine, Ayurvedic herbal medicine, and topical severance secret cream in improving IELT and other outcomes. However, results are based on clinically

  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. A systematic review and thematic synthesis of patients' experience of medicines adherence.

    Science.gov (United States)

    Rathbone, A P; Todd, A; Jamie, K; Bonam, M; Banks, L; Husband, A K

    Medicines non-adherence continues to be problematic in health care practice. After decades of research, few interventions have a robust evidence-based demonstrating their applicability to improve adherence. Phenomenology has a place within the health care research environment. To explore patients' lived experiences of medicines adherence reported in the phenomenonologic literature. A systematic literature search was conducted to identify peer-reviewed and published phenomenological investigations in adults that aimed to investigate patients' lived experiences of medicines adherence. Studies were appraised using the Critical Appraisal Skills Programme (CASP) Qualitative Research Tool. Thematic synthesis was conducted using a combination of manual coding and NVivo10 [QSR International, Melbourne] coding to aid data management. Descriptive themes identified included i) dislike for medicines, ii) survival, iii) perceived need, including a) symptoms and side-effects and b) cost, and iv) routine. Analytic themes identified were i) identity and ii) interaction. This work describes adherence as a social interaction between the identity of patients and medicines, mediated by interaction with family, friends, health care professionals, the media and the medicine, itself. Health care professionals and policy makers should seek to re-locate adherence as a social phenomenon, directing the development of interventions to exploit patient interaction with wider society, such that patients 'get to know' their medicines, and how they can be taken, throughout the life of the patient and the prescription. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Mind-Body Medicine and Immune System Outcomes: A Systematic Review.

    Science.gov (United States)

    Wahbeh, Helané; Haywood, Ashley; Kaufman, Karen; Zwickey, Heather

    2009-01-01

    This study is a systematic review of mind-body interventions that used immune outcomes in order to: 1) characterize mind-body medicine studies that assessed immune outcomes, 2) evaluate the quality of mind-body medicine studies measuring immune system effects, and 3) systematically evaluate the evidence for mind-body interventions effect on immune system outcomes using existing formal tools. 111 studies with 4,777 subjects were reviewed. The three largest intervention type categories were Relaxation Training (n=25), Cognitive Based Stress Management (n=22), and Hypnosis (n=21). Half the studies were conducted with healthy subjects (n=51). HIV (n=18), cancer (n=13) and allergies (n=7) were the most prominent conditions examined in the studies comprising of non-healthy subjects. Natural killer cell and CD4 T lymphocyte measures were the most commonly studied outcomes. Most outcome and modality categories had limited or inconclusive evidence. Relaxation training had the strongest scientific evidence of a mind-body medicine affecting immune outcomes. Immunoglobulin A had the strongest scientific evidence for positive effects from mind-body medicine. Issues for mind-body medicine studies with immune outcomes are discussed and recommendations are made to help improve future clinical trials.

  18. [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.

  19. 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

  20. 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

    Background 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. Methods 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. Findings 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. Conclusion 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

  1. Readability assessment of package inserts of biological medicinal products from the European medicines agency website.

    Science.gov (United States)

    Piñero-López, Ma Ángeles; Modamio, Pilar; Lastra, Cecilia F; Mariño, Eduardo L

    2014-07-01

    Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability. Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same package inserts in 2010. A total of 33 package inserts were selected and classified into five groups according to the type of medicine: monoclonal antibody-based products, cytokines, therapeutic enzymes, recombinant blood factors and other blood-related products, and recombinant hormones. The package inserts were downloaded from the European Medicines Agency website in 2007 and 2010. Readability was evaluated for the entire text of five of the six sections of the package inserts and for the 'Annex' when there was one. Three readability formulas were used: SMOG (Simple Measure of Gobbledygook) grade, Flesh-Kincaid grade level, and Szigriszt's perspicuity index. No significant differences were found between the readability results for the 2007 package inserts and those from 2010 according to any of the three readability indices studied (p>0.05). However, there were significant differences (preadability scores of the sections of the package inserts in both 2007 and 2010. The readability of the package inserts was above the recommended sixth grade reading level (ages 11-12) and may lead to difficulties of understanding for people with limited literacy. All the sections should be easy to read and, therefore, the readability of the medicine package inserts studied should be improved.

  2. 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.

  3. 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.

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

    OpenAIRE

    Masoud Soosaraei; Mahdi Fakhar; Saeed Hosseini Teshnizi; Hajar Ziaei Hezarjaribi; Elham Sadat Banimostafavi

    2017-01-01

    Background: Leishmaniasis is a major public health problem worldwide. The aim of the present study was to investigate medicinal plants with anti-Leishmania activity which used in Iran. Methods: Data were systematically gathered from five English databases including Ebsco, Science Direct, PubMed, Google Scholar and Scopus, four Persian databases including Magiran, Iran doc, Iran medex and the Scientific Information Database (SID) from 1999 to April 2015. Information obtained included plant ...

  5. Date fruit: chemical composition, nutritional and medicinal values, products.

    Science.gov (United States)

    Tang, Zhen-Xing; Shi, Lu-E; Aleid, Salah M

    2013-08-15

    Date fruit has served as a staple food in the Arab world for centuries. Worldwide production of date fruit has increased almost threefold over the last 40 years, reaching 7.68 million tons in 2010. Date fruit can provide many essential nutrients and potential health benefits to the consumer. Date fruit goes through four ripening stages named kimri, khalal, rutab and tamer. The main chemical components of date fruit include carbohydrates, dietary fibre, enzymes, protein, fat, minerals, vitamins, phenolic acids and carotenoids. The chemical composition of date fruit varies according to ripening stage, cultivar, growing environment, postharvest conditions, etc. The nutritional and medicinal activities of date fruit are related to its chemical composition. Many studies have shown that date fruit has antioxidant, antimutagenic, anti-inflammatory, gastroprotective, hepatoprotective, nephroprotective, anticancer and immunostimulant activities. Various date fruit-based products such as date syrup, date paste, date juice and their derived products are available. Date by-products can be used as raw materials for the production of value-added products such as organic acids, exopolysaccharides, antibiotics, date-flavoured probiotic-fermented dairy produce, bakery yeasts, etc. In this paper the chemical composition and nutritional and medicinal values of date fruit as well as date fruit-based products are reviewed. © 2013 Society of Chemical Industry.

  6. 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.

  7. 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.

  8. 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.

  9. Search for bioactive natural products from medicinal plants of Bangladesh.

    Science.gov (United States)

    Ahmed, Firoj; Sadhu, Samir Kumar; Ishibashi, Masami

    2010-10-01

    In our continuous search for bioactive natural products from natural resources, we explored medicinal plants of Bangladesh, targeting cancer-related tumor necrosis factor-related apoptosis-inducing ligand-signaling pathway, along with some other biological activities such as prostaglandin inhibitory activity, 1,1-diphenyl-2-picrylhydrazyl free-radical-scavenging activity, and cell growth inhibitory activity. Along with this, we describe a short field study on Sundarbans mangrove forests, Bangladesh, in the review.

  10. 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...

  11. 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.

  12. Complementary and alternative medicine for cancer pain: an overview of systematic reviews.

    Science.gov (United States)

    Bao, Yanju; Kong, Xiangying; Yang, Liping; Liu, Rui; Shi, Zhan; Li, Weidong; Hua, Baojin; Hou, Wei

    2014-01-01

    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.

  13. 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)

  14. 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.

  15. [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.

  16. 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

  17. 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 ...

  18. [Establishment of design space for production process of traditional Chinese medicine preparation].

    Science.gov (United States)

    Xu, Bing; Shi, Xin-Yuan; Qiao, Yan-Jiang; Wu, Zhi-Sheng; Lin, Zhao-Zhou

    2013-03-01

    The philosophy of quality by design (QbD) is now leading the changes in the drug manufacturing mode from the conventional test-based approach to the science and risk based approach focusing on the detailed research and understanding of the production process. Along with the constant deepening of the understanding of the manufacturing process, the design space will be determined, and the emphasis of quality control will be shifted from the quality standards to the design space. Therefore, the establishment of the design space is core step in the implementation of QbD, and it is of great importance to study the methods for building the design space. This essay proposes the concept of design space for the production process of traditional Chinese medicine (TCM) preparations, gives a systematic introduction of the concept of the design space, analyzes the feasibility and significance to build the design space in the production process of traditional Chinese medicine preparations, and proposes study approaches on the basis of examples that comply with the characteristics of traditional Chinese medicine preparations, as well as future study orientations.

  19. Systematic Product Development of Control and Diagnosis Functionalities

    Science.gov (United States)

    Stetter, R.; Simundsson, A.

    2017-01-01

    In the scientific field of systematic product development a wide range of helpful methods, guidelines and tools were generated and published in recent years. Until now little special attention was given to design guidelines aiming at supporting product development engineers to design products that allow and support control or diagnosis functions. The general trend to ubiquitous computing and the first development steps towards cognitive systems as well as a general trend toward higher product safety, reliability and reduced total cost of ownership (TCO) in many engineering fields lead to a higher importance of control and diagnosis. In this paper a first attempt is made to formulate general valid guidelines how products can be developed in order to allow and to achieve effective and efficient control and diagnosis. The guidelines are elucidated on the example of an automated guided vehicle. One main concern of this paper is the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of systematic product development have attracted significant attention during the last decades. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The paper starts with a background describing Systematic Product Development. The second section deals with the product development of the sample product. The third part clarifies the notions monitoring, control and diagnosis. The following parts summarize some insights and formulate first hypotheses concerning control and diagnosis in Systematic Product Development.

  20. Design of formulated products: a systematic methodology

    DEFF Research Database (Denmark)

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

    2011-01-01

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

    Science.gov (United States)

    Cevik, Erdem; Karakus Yilmaz, Banu; Acar, Yahya Ayhan; Dokur, Mehmet

    2015-03-01

    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. 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. 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. It was concluded that very few theses in the field of emergency medicine were published in journals that were indexed in SCI/SCI-E.

  2. The healing properties of medicinal plants used in the Brazilian public health system: a systematic review.

    Science.gov (United States)

    Marmitt, Diorge Jônatas; Bitencourt, Shanna; Silva, Amanda do Couto E; Rempel, Claudete; Goettert, Márcia Inês

    2018-06-01

    The aim of this study was to conduct a systematic review of the healing potential of medicinal plants belonging to the Brazilian National List of Medicinal Plants of Interest to the Unified Health System (RENISUS). PubMed and ScienceDirect databases were searched for relevant articles, regardless of the language, from 2010 to June 2016. Two reviewers independently assessed study eligibility. Articles were included if they presented evidence of healing potential of medicinal plants. Only those available as full and open access texts were considered. A total of 1381 articles met the inclusion criteria. Of these, 156 studies were considered eligible and were reviewed as full text. Following full analysis, 64 studies were included in this review. The studies covered 27 of the 71 plants belonging to RENISUS, nine of which are native to Brazil. In addition, two species are currently available in the Brazilian public health system as herbal medicine. This review may encourage and contribute to the appropriate use of medicinal plants in the public health system in Brazil.

  3. 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

    2018-06-01

    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.

  4. Efficacy of Chinese herbal medicine for stroke modifiable risk factors: a systematic review.

    Science.gov (United States)

    Peng, Wenbo; Lauche, Romy; Ferguson, Caleb; Frawley, Jane; Adams, Jon; Sibbritt, David

    2017-01-01

    The vast majority of stroke burden is attributable to its modifiable risk factors. This paper aimed to systematically summarise the evidence of Chinese herbal medicine (CHM) interventions on stroke modifiable risk factors for stroke prevention. A literature search was conducted via the MEDLINE, CINAHL/EBSCO, SCOPUS, and Cochrane Database from 1996 to 2016. Randomised controlled trials or cross-over studies were included. Risk of bias was assessed according to the Cochrane Risk of Bias tool. A total of 46 trials (6895 participants) were identified regarding the use of CHM interventions in the management of stroke risk factors, including 12 trials for hypertension, 10 trials for diabetes, eight trials for hyperlipidemia, seven trials for impaired glucose tolerance, three trials for obesity, and six trials for combined risk factors. Amongst the included trials with diverse study design, an intervention of CHM as a supplement to biomedicine and/or a lifestyle intervention was found to be more effective in lowering blood pressure, decreasing blood glucose level, helping impaired glucose tolerance reverse to normal, and/or reducing body weight compared to CHM monotherapy. While no trial reported deaths amongst the CHM groups, some papers do report moderate adverse effects associated with CHM use. However, the findings of such beneficial effects of CHM should be interpreted with caution due to the heterogeneous set of complex CHM studied, the various control interventions employed, the use of different participants' inclusion criteria, and low methodological quality across the published studies. The risk of bias of trials identified was largely unclear in the domains of selection bias and detection bias across the included studies. This study showed substantial evidence of varied CHM interventions improving the stroke modifiable risk factors. More rigorous research examining the use of CHM products for sole or multiple major stroke risk factors are warranted.

  5. 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.

  6. 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

  7. Systematic approach to modernizing the production company

    Directory of Open Access Journals (Sweden)

    Irina Valeryevna Makarova

    2011-06-01

    Full Text Available This paper discusses development of modernization processes in the Russian industrial enterprises. The object of the current study is the JSC "Perm Company of petroleum machinery-producing industry". It has been manufacturing oilfield service products of various kinds. It is shown that the impact of modernization on the enterprise depends not only on the local effectiveness of selected solutions, but also on the overall strategy of sustainable development. Modernization is a strategic planning tool. Taking into account the need for a comprehensive approach to strategic development and modernization, the top five stages of the development strategy of the company were mentioned: 1 analysis of internal and external environment; 2 definition of the mission and goals; 3 choice of strategy and baseline scenarios; 4 development of basic strategy; 5 implementation of the strategy. At each stage, methods and tools for strategic planning, as well as the tools of modernization are defined. The relationship between modernization and development strategy of the company is shown. It was revealed that an integrated approach to the modernization and incremental implementation are the basics for the use of a hierarchical system of optimization models to describe the process of manufacturing company modernization. As the target model of the upper level, financial performance of the company is defined. This approach has the following advantages over the point upgrading - reducing the probability of omission of important limitations and ineffective use of resources during the transition to modernization of the company. Basing on the main strategic goals, main directions and tasks of modernization, which are integrated into the tree ends were formed. A thesis was substantiated that he essence of modernization lies in the continuity of mutually complex processes of improving all its directions. For the JSC "Perm Company of petroleum machinery-producing industry

  8. Delivery of genomic medicine for common chronic adult diseases: a systematic review.

    Science.gov (United States)

    Scheuner, Maren T; Sieverding, Pauline; Shekelle, Paul G

    2008-03-19

    The greatest public health benefit of advances in understanding the human genome may be realized for common chronic diseases such as cardiovascular disease, diabetes mellitus, and cancer. Attempts to integrate such knowledge into clinical practice are still in the early stages, and as a result, many questions surround the current state of this translation. To synthesize current information on genetic health services for common adult-onset conditions by examining studies that have addressed the outcomes, consumer information needs, delivery, and challenges in integrating these services. MEDLINE articles published between January 2000 and February 2008. Original research articles and systematic reviews dealing with common chronic adult-onset conditions were reviewed. A total of 3371 citations were reviewed, 170 articles retrieved, and 68 articles included in the analysis. Data were independently extracted by one reviewer and checked by another with disagreement resolved by consensus. Variables assessed included study design and 4 key areas: outcomes of genomic medicine, consumer information needs, delivery of genomic medicine, and challenges and barriers to integration of genomic medicine. Sixty-eight articles contributed data to the synthesis: 5 systematic reviews, 8 experimental studies, 35 surveys, 7 pre/post studies, 3 observational studies, and 10 qualitative reports. Three systematic reviews, 4 experimental studies, and 9 additional studies reported on outcomes of genetic services. Generally there were modest positive effects on psychological outcomes such as worry and anxiety, behavioral outcomes have shown mixed results, and clinical outcomes were less well studied. One systematic review, 1 randomized controlled trial, and 14 other studies assessed consumer information needs and found in general that genetics knowledge was reported to be low but that attitudes were generally positive. Three randomized controlled trials and 13 other studies assessed how

  9. 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.

  10. Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices

    Science.gov (United States)

    Tomić, Siniša; Filipović Sučić, Anita; Plazonić, Ana; Truban Žulj, Rajka; Macolić Šarinić, Viola; Čudina, Branka; Ilić Martinac, Adrijana

    2010-01-01

    Aim To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges. Methods Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency’s database and analyzed by descriptive statistics. Results The number of issued medicine authorizations rose from 240 in 2004 to 580 in 2008. The greatest number of new chemical and biological entities was approved in 2005. The greatest number of regular quality controls (n = 5833) and special quality controls was performed in 2008 (n = 589), while the greatest number of off-shelf quality controls (n = 132) was performed in 2007. The greatest number of medicine labeling irregularities was found in 2007 (n = 19) and of quality irregularities in 2004 (n = 9). The greatest number of adverse reactions was reported in 2008 (n = 1393). The number of registered medical devices rose from 213 in 2004 to 565 in 2008. Conclusion Over its 5 years of existence, the Agency has successfully coped with the constant increase in workload. In the future, as Croatia enters the European Union, the Agency will have to face the challenge of joining the integrated European regulatory framework. PMID:20401952

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

    Directory of Open Access Journals (Sweden)

    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.

  12. 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

  13. 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

  14. 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

  15. 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.

  16. Oral Chinese proprietary medicine for angina pectoris: an overview of systematic reviews/meta-analyses.

    Science.gov (United States)

    Luo, Jing; Xu, Hao; Yang, Guoyan; Qiu, Yu; Liu, Jianping; Chen, Keji

    2014-08-01

    Oral Chinese proprietary medicine (CPM) is commonly used to treat angina pectoris, and many relevant systematic reviews/meta-analyses are available. However, these reviews have not been systematically summarized and evaluated. We conducted an overview of these reviews, and explored their methodological and reporting quality to inform both practice and further research. We included systematic reviews/meta-analyses on oral CPM in treating angina until March 2013 by searching PubMed, Embase, the Cochrane Library and four Chinese databases. We extracted data according to a pre-designed form, and assessed the methodological and reporting characteristics of the reviews in terms of AMSTAR and PRISMA respectively. Most of the data analyses were descriptive. 36 systematic reviews/meta-analyses involving over 82,105 participants with angina reviewing 13 kinds of oral CPM were included. The main outcomes assessed in the reviews were surrogate outcomes (34/36, 94.4%), adverse events (31/36, 86.1%), and symptoms (30/36, 83.3%). Six reviews (6/36, 16.7%) drew definitely positive conclusions, while the others suggested potential benefits in the symptoms, electrocardiogram, and adverse events. The overall methodological and reporting quality of the reviews was limited, with many serious flaws such as the lack of review protocol and incomprehensive literature searches. Though many systematic reviews/meta-analyses on oral CPM for angina suggested potential benefits or definitely positive effects, stakeholders should interpret the findings of these reviews with caution, considering the overall limited methodological and reporting quality. We recommend further studies should be appropriately conducted and systematic reviews reported according to PRISMA standard. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. 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.

  18. 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.

  19. 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.

  20. Good manufacturing practices for medicinal products for human use.

    Science.gov (United States)

    Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.

  1. Good manufacturing practices for medicinal products for human use

    Science.gov (United States)

    Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

  2. 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

  3. Systematic Reviews Published in Emergency Medicine Journals Do Not Routinely Search Clinical Trials Registries: A Cross-Sectional Analysis.

    Science.gov (United States)

    Keil, Lukas G; Platts-Mills, Timothy F; Jones, Christopher W

    2015-10-01

    Publication bias compromises the validity of systematic reviews. This problem can be addressed in part through searching clinical trials registries to identify unpublished studies. This study aims to determine how often systematic reviews published in emergency medicine journals include clinical trials registry searches. We identified all systematic reviews published in the 6 highest-impact emergency medicine journals between January 1 and December 31, 2013. Systematic reviews that assessed the effects of an intervention were further examined to determine whether the authors described searching a clinical trials registry and whether this search identified relevant unpublished studies. Of 191 articles identified through PubMed search, 80 were confirmed to be systematic reviews. Our sample consisted of 41 systematic reviews that assessed a specific intervention. Eight of these 41 (20%) searched a clinical trials registry. For 4 of these 8 reviews, the registry search identified at least 1 relevant unpublished study. Systematic reviews published in emergency medicine journals do not routinely include searches of clinical trials registries. By helping authors identify unpublished trial data, the addition of registry searches may improve the validity of systematic reviews. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  4. 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...

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. Medicines

    Science.gov (United States)

    Medicines can treat diseases and improve your health. If you are like most people, you need to take medicine at some point in your life. You may need to take medicine every day, or you may only need to ...

  12. [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.

  13. Production of 111In for diagnosis in nuclear medicine

    International Nuclear Information System (INIS)

    Osso Junior, J.A.

    1982-01-01

    111 In (t sub(1/2 = 2.82d)) due to its favorable physical decay characteristics, can substitute sup(113m) In (t sub(1/2 = 1.66hr)), whose application is limited to rapid physiological studies, advantageously. A routine production method has been developed by 28 MeV alpha particle bombardment of natural silver at the CV-28 Cyclotron of the Instituto de Engenharia Nuclear. The target is dissolved in conc. nitric acid, and silver is precipitated with hydrochloric acid. Carrier-free 111 In which remains in solution is separated from 109 Cd, the decay product of 109 In, which is produced simultaneously during the irradiation, by an anion exchange resin. All the production and separation steps are made remotely, with the use of manipulators, tongs and electric and pneumatic systems. The thick target yield is 0.18 mCi/μAh and in each run 16 mCi of 111 In are produced, which can be used in nuclear medicine centers. Methods of labelling 111 In-EDTA and 111 In-DTPA have been developed. 111 In offers a favorable half-life for the study of rather slow biological processes, in which observation periods of 24-72 hrs after administration are required, e.g., cisternography, visualization of the lymphatic system, tumor localization and others. (Author) [pt

  14. Synthetic and bioengineered products in nuclear medicine and drug delivery

    International Nuclear Information System (INIS)

    Frier, M.

    1997-01-01

    Full text. The supply of radio pharmaceuticals based on pooled human blood products, for example human serum albumin (H S A) and fibrinogen, has previously met with some problems due to the possibility of donor infection A common feature of all biologicals of animal or human origin is the potential risk of viral contamination from the source material. Recombinant DNA technology provides an alternative source of biological materials that have applications throughout medicine. Micro capsules prepared from recombinant human serum albumin (r H S A) are currently under development as ultrasound contrast agents. Similar products would serve as an alternative source of material to serum albumin pooled from human donors and would offer great potential in the production of radio pharmaceuticals. There is a growing interest in the use of macromolecular carriers for therapeutic agents. When labelled with and appropriate gamma-emitter, their biodistribution can be be followed by scintigraphy. The biodistribution of a synthetic branched polypeptide, based on a poly-L-lysine backbone (average molecular mass 45 kDa) is described. The polymer was conjugated to diethylene triamine penta-acetic acid and labelled by chelation with Indium-111. Mice were injected i.v. with labelled material and imaged with a gamma camera with a pin hole collimator. Images showed the majority of tracer remaining in the blood poll, but about 35% appeared in the urinary bladder within 1.5 h

  15. 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

  16. 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.

  17. 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.

  18. Gallate Contact Dermatitis: Product Update and Systematic Review.

    Science.gov (United States)

    Holcomb, Zachary E; Van Noord, Megan G; Atwater, Amber Reck

    Allergic contact dermatitis related to cosmetic use can result from allergens not routinely evaluated by standard patch test protocols. Propyl, octyl, and dodecyl gallates are commonly used antioxidant preservatives with reports of associated allergic contact dermatitis in the literature. The objectives of this review were to investigate the role of gallates in allergic contact dermatitis and to explore products containing these preservatives. A systematic review of the literature through April 2016 was performed to explore cases of reported gallate allergy. Food and cosmetic product databases were searched for products containing gallates. Seventy-four cases of gallate contact allergy have been reported. In addition, a variety of commercially available cosmetic products and foods contain gallate chemicals. Propyl gallate is the most commonly reported gallate contact allergen and often causes facial and/or hand dermatitis.

  19. 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.

  20. Evaluation of the physicians‘ of n hospital opinion on clinical trials of medicinal products

    OpenAIRE

    Videikaitė, Lina

    2014-01-01

    Aim of the research. To evaluate the physicians‘ of N Hospital opinion on clinical trials of medicinal products. Objectives. To evaluate the factors affecting physicians' motivation to perform clinical trials of medicinal products as well as those that prevent the physicians getting involved in the trials. To assess physicians' attitude towards clinical trials of medicinal products. To compare the opinions of physicians who have and have’nt participated in clinical trials. Methods of...

  1. Systematic review of complementary and alternative medicine treatments in inflammatory bowel diseases.

    Science.gov (United States)

    Langhorst, J; Wulfert, H; Lauche, R; Klose, P; Cramer, H; Dobos, G J; Korzenik, J

    2015-01-01

    We performed a systematic review for Complementary and Alternative Medicine [CAM] as defined by the National Institute of Health in Inflammatory Bowel Disease [IBD], ie Crohn's disease [CD] and ulcerative colitis [UC], with the exception of dietary and nutritional supplements, and manipulative therapies. A computerized search of databases [Cochrane Library, Pubmed/Medline, PsychINFO, and Scopus] through March 2014 was performed. We screened the reference sections of original studies and systematic reviews in English language for CAM in IBD, CD and UC. Randomized controlled trials [RCT] and controlled trials [CT] were referred and assessed using the Cochrane risk of bias tool. A total of: 26 RCT and 3 CT for herbal medicine, eg aloe-vera gel, andrographis paniculata, artemisia absinthium, barley foodstuff, boswellia serrata, cannabis, curcumin, evening primrose oil, Myrrhinil intest®, plantago ovata, silymarin, sophora, tormentil, wheatgrass-juice and wormwood; 1 RCT for trichuris suis ovata; 7 RCT for mind/body interventions such as lifestyle modification, hypnotherapy, relaxation training and mindfulness; and 2 RCT in acupuncture; were found. Risk of bias was quite heterogeneous. Best evidence was found for herbal therapy, ie plantago ovata and curcumin in UC maintenance therapy, wormwood in CD, mind/body therapy and self-intervention in UC, and acupuncture in UC and CD. Complementary and alternative therapies might be effective for the treatment of inflammatory bowel diseases; however, given the low number of trials and the heterogeneous methodological quality of trials, further in-depth research is necessary. Copyright © 2014 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  2. Technology-enhanced simulation in emergency medicine: a systematic review and meta-analysis.

    Science.gov (United States)

    Ilgen, Jonathan S; Sherbino, Jonathan; Cook, David A

    2013-02-01

    Technology-enhanced simulation is used frequently in emergency medicine (EM) training programs. Evidence for its effectiveness, however, remains unclear. The objective of this study was to evaluate the effectiveness of technology-enhanced simulation for training in EM and identify instructional design features associated with improved outcomes by conducting a systematic review. The authors systematically searched MEDLINE, EMBASE, CINAHL, ERIC, PsychINFO, Scopus, key journals, and previous review bibliographies through May 2011. Original research articles in any language were selected if they compared simulation to no intervention or another educational activity for the purposes of training EM health professionals (including student and practicing physicians, midlevel providers, nurses, and prehospital providers). Reviewers evaluated study quality and abstracted information on learners, instructional design (curricular integration, feedback, repetitive practice, mastery learning), and outcomes. From a collection of 10,903 articles, 85 eligible studies enrolling 6,099 EM learners were identified. Of these, 56 studies compared simulation to no intervention, 12 compared simulation with another form of instruction, and 19 compared two forms of simulation. Effect sizes were pooled using a random-effects model. Heterogeneity among these studies was large (I(2) ≥ 50%). Among studies comparing simulation to no intervention, pooled effect sizes were large (range = 1.13 to 1.48) for knowledge, time, and skills and small to moderate for behaviors with patients (0.62) and patient effects (0.43; all p 0.1). Qualitative comparisons of different simulation curricula are limited, although feedback, mastery learning, and higher fidelity were associated with improved learning outcomes. Technology-enhanced simulation for EM learners is associated with moderate or large favorable effects in comparison with no intervention and generally small and nonsignificant benefits in comparison

  3. Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

    Science.gov (United States)

    Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

    2018-02-01

    The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

  4. 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

  5. Usage of Intramammary Antimicrobial Veterinary Medicinal Products in The Republic of Serbia from 2011 to 2014

    Directory of Open Access Journals (Sweden)

    Andjelkovic Jelena

    2017-03-01

    Full Text Available Prudent use of antimicrobial medicine is an imperative in both human and veterinary medicine today. Antibiotic usage in humans and animals has increased over the years, consequently giving rise to antimicrobial resistance in pathogenic microorganisms. Mastitis is one of the most common conditions in bovine species, and intramammary antibacterial medicinal products are used in animal husbandry for mastitis treatment and prophylaxis.

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

    Energy Technology Data Exchange (ETDEWEB)

    Michallek, Florian; Dewey, Marc [Humboldt-Universitaet zu Berlin, Freie Universitaet Berlin, Charite - Universitaetsmedizin Berlin, Medical School, Department of Radiology, Berlin (Germany)

    2014-01-15

    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. (orig.)

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

    International Nuclear Information System (INIS)

    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. (orig.)

  8. 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.

  9. Measurement Properties of Questionnaires Assessing Complementary and Alternative Medicine Use in Pediatrics: A Systematic Review

    Science.gov (United States)

    Toupin April, Karine; Moher, David; Stinson, Jennifer; Byrne, Ani; White, Meghan; Boon, Heather; Duffy, Ciarán M.; Rader, Tamara; Vohra, Sunita; Tugwell, Peter

    2012-01-01

    Objective Complementary and alternative medicine (CAM) is commonly used by children, but estimates of that use vary widely partly due to the range of questionnaires used to assess CAM use. However, no studies have attempted to appraise measurement properties of these questionnaires. The aim of this systematic review was to critically appraise and summarize measurement properties of questionnaires of CAM use in pediatrics. Study design A search strategy was implemented in major electronic databases in March 2011 and conference websites, scientific journals and experts were consulted. Studies were included if they mentioned a questionnaire assessing the prevalence of CAM use in pediatrics. Members of the team independently rated the methodological quality of the studies (using the COSMIN checklist) and measurement properties of the questionnaires (using the Terwee and Cohen criteria). Results A total of 96 CAM questionnaires were found in 104 publications. The COSMIN checklist showed that no studies reported adequate methodological quality. The Terwee criteria showed that all included CAM questionnaires had indeterminate measurement properties. According to the Cohen score, none were considered to be a well-established assessment, two approached the level of a well-established assessment, seven were promising assessments and the remainder (n = 87) did not reach the score’s minimum standards. Conclusion None of the identified CAM questionnaires have been thoroughly validated. This systematic review highlights the need for proper validation of CAM questionnaires in pediatrics, which may in turn lead to improved research and knowledge translation about CAM in clinical practice. PMID:22768098

  10. 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

  11. 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.

  12. 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

  13. [Interpretation of the concept of 'medicinal product' in relation to herb- and cannabinoid-based products].

    Science.gov (United States)

    Zsigmond, Ferge

    2014-11-30

    On 10th of July 2014 the European Court of Justice made in his decisions in relation to the cases D. (C-358/13) and G. (C-181/14) an interpretation, that the concept of 'medicinal product' according to the law of the European Union does not include the materials, which are - as not covering substances, such as those at issue in the main proceedings, which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health. The Court made his interpretation after the request for preliminary ruling from the Bundesgerichtshof (the High Court of Justice in Germany). The Court had to decide in two criminal procedures, whether for the retail of mixtures including syntetic canabinoids, such as complements of marihuana, due the fact that they are "unsafe medicinal products", a criminal proceeding can be initiated or not. The Ordinary Courts had two persons (D. and G.) for selling the unsafe medicinal products sentenced to one year and nine months imprisonment, and suspension (D.), and sentenced (G.) to four years and six months imprisonment and fined with a charge of two hundred thousand Euro. The retail of herb mixtures containing, inter alia, synthetic cannabinoids, did not fall under the German law on narcotic drugs at the material time, resulting that the German Authorities could not initiate a criminal procedure.

  14. 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

  15. How does burnout affect physician productivity? A systematic literature review

    Science.gov (United States)

    2014-01-01

    Background Interest in the well-being of physicians has increased because of their contributions to the healthcare system quality. There is growing recognition that physicians are exposed to workplace factors that increase the risk of work stress. Long-term exposure to high work stress can result in burnout. Reports from around the world suggest that about one-third to one-half of physicians experience burnout. Understanding the outcomes associated with burnout is critical to understanding its affects on the healthcare system. Productivity outcomes are among those that could have the most immediate effects on the healthcare system. This systematic literature review is one of the first to explore the evidence for the types of physician productivity outcomes associated with physician burnout. It answers the question, “How does burnout affect physician productivity?” Methods A systematic search was performed of: Medline Current, Medline in process, PsycInfo, Embase and Web of Science. The search period covered 2002 to 2012. The searches identified articles about practicing physicians working in civilian settings. Articles that primarily looked only at residents or medical students were excluded. Productivity was captured by hours worked, patients seen, sick leave, leaving the profession, retirement, workload and presenteeism. Studies also were excluded if: (1) the study sample was not comprised of at least 50% physicians, (2) the study did not examine the relationship between burnout and productivity or (3) a validated measure of burnout was not used. Results The search identified 870 unique citations; 5 met the inclusion/exclusion criteria. This review indicates that globally there is recognition of the potential impact of physician burnout on productivity. Productivity was examined using: number of sick leave days, work ability, intent to either continue practicing or change jobs. The majority of the studies indicate there is a negative relationship between

  16. How does burnout affect physician productivity? A systematic literature review.

    Science.gov (United States)

    Dewa, Carolyn S; Loong, Desmond; Bonato, Sarah; Thanh, Nguyen Xuan; Jacobs, Philip

    2014-07-28

    Interest in the well-being of physicians has increased because of their contributions to the healthcare system quality. There is growing recognition that physicians are exposed to workplace factors that increase the risk of work stress. Long-term exposure to high work stress can result in burnout. Reports from around the world suggest that about one-third to one-half of physicians experience burnout. Understanding the outcomes associated with burnout is critical to understanding its affects on the healthcare system. Productivity outcomes are among those that could have the most immediate effects on the healthcare system. This systematic literature review is one of the first to explore the evidence for the types of physician productivity outcomes associated with physician burnout. It answers the question, "How does burnout affect physician productivity?" A systematic search was performed of: Medline Current, Medline in process, PsycInfo, Embase and Web of Science. The search period covered 2002 to 2012. The searches identified articles about practicing physicians working in civilian settings. Articles that primarily looked only at residents or medical students were excluded. Productivity was captured by hours worked, patients seen, sick leave, leaving the profession, retirement, workload and presenteeism. Studies also were excluded if: (1) the study sample was not comprised of at least 50% physicians, (2) the study did not examine the relationship between burnout and productivity or (3) a validated measure of burnout was not used. The search identified 870 unique citations; 5 met the inclusion/exclusion criteria. This review indicates that globally there is recognition of the potential impact of physician burnout on productivity. Productivity was examined using: number of sick leave days, work ability, intent to either continue practicing or change jobs. The majority of the studies indicate there is a negative relationship between burnout and productivity. However

  17. 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

  18. 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

  19. 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...... for lifting analyses and Galois connections. We prove that for analyses developed using our method, the soundness of lifting follows by construction. Finally, we discuss approximating variability in an analysis and we derive variational data-flow equations for an example analysis, a constant propagation...

  20. Complementary and alternative medicine for the treatment of bronchiolitis in infants: A systematic review.

    Science.gov (United States)

    Kua, Kok Pim; Lee, Shaun Wen Huey

    2017-01-01

    Bronchiolitis is a common cause of hospitalization among infants. The limited effectiveness of conventional medication has prompted the use of complementary and alternative medicine (CAM) as alternative or adjunctive therapy for the management of bronchiolitis. To determine the effectiveness and safety of CAM for the treatment of bronchiolitis in infants aged less than 2 years. A systematic electronic search was performed in Medline, Embase, CINAHL, AMED, and Cochrane Central Register of Controlled Trials (CENTRAL) from their respective inception to June 30, 2016 for studies evaluating CAM as an intervention to treat bronchiolitis in infants (1 month to 2 years of age). The CAM could be any form of treatment defined by the National Center for Complementary and Integrative Health (NCCIH) and was utilized either as a single agent or adjunctive therapy. The predefined primary outcome was length of hospital stay. Secondary outcomes were time to resolution of bronchiolitis symptoms, adverse events, and all other clinical outcomes reported by the included studies. The review identified 11 studies (8 randomized controlled trials and 3 cohort studies) examining four herbal preparations and four supplements used either as adjunctive or alternative therapy for bronchiolitis in 904 infants. Most studies were of moderate quality. Among six studies reporting on length of stay, a significant benefit was found for Chinese herbal medicine compared to ribavirin in one cohort study (n = 66) and vitamin D compared to placebo in one randomized controlled trial (n = 89). Studies of Chinese herbal medicine (4 studies, n = 365), vitamin D (1 study, n = 89), N-acetylcysteine (1 study, n = 100), and magnesium (2 studies, n = 176) showed some benefits with respect to clinical severity scores, oxygen saturation, and other symptoms, although data were sparse for any single intervention and the outcomes assessed and reported varied across studies. Only five studies reported on adverse events

  1. Medicinal and aromatic crops: Production, Phytochemistry, and Utilization

    Science.gov (United States)

    In the later part of the 20th century the United States experienced a remarkable surge in public interest towards medicinal and aromatic crops and this trend continues. This consumer interest helped create a significant demand for plants with culinary and medicinal applications as the public discove...

  2. 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

  3. 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

  4. 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

    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...... 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...... across different time, cost, quality and flexibility measures while product complexity lacks evidence of strong relationships with MOP measures....

  5. 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

  6. 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.

  7. Traditional Chinese medicine injection for angina pectoris: an overview of systematic reviews.

    Science.gov (United States)

    Luo, Jing; Shang, Qinghua; Han, Mei; Chen, Keji; Xu, Hao

    2014-01-01

    Traditional Chinese medicine (TCM) injection is widely used to treat angina pectoris in China. This overview aims to systematically summarize the general characteristics of systematic reviews (SRs) on TCM injection in treating angina, and assess the methodological and reporting quality of these reviews. We searched PubMed, Embase, the Cochrane Library and four Chinese databases from inception until March 2013. Data were extracted according to a preset form. The AMSTAR and PRISMA checklists were used to explore the methodological quality and reporting characteristics of included reviews, respectively. All data analyses were descriptive. 46 SRs involving over 57,463 participants with angina reviewing 23 kinds of TCM injections were included. The main outcomes evaluated in the reviews were symptoms (43/46, 93.5%), surrogate outcomes (42/46, 91.3%) and adverse events (41/46, 87.0%). Few reviews evaluated endpoints (7/46, 15.2%) and quality of life (1/46, 2.2%). One third of the reviews (16/46, 34.8%) drew definitely positive conclusions while the others (30/46, 65.2%) suggested potential benefits mainly in symptoms, electrocardiogram and adverse events. With many serious flaws such as lack of a protocol and inappropriate data synthesis, the overall methodological and reporting quality of the reviews was limited. While many SRs of TCM injection on the treatment of angina suggested potential benefits or definitely positive effects, stakeholders should not accept the findings of these reviews uncritically due to the limited methodological and reporting quality. Future SRs should be appropriately conducted and reported according to international standards such as AMSTAR and PRISMA, rather than published in large numbers.

  8. 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

    2018-05-01

    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

  9. 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

  10. [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.

  11. 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

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

    Science.gov (United States)

    Weißkircher, Janosch; Koch, Cora; Dreimüller, Nadine; Lieb, Klaus

    2017-01-01

    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 described improved knowledge

  13. 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.

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

    DEFF Research Database (Denmark)

    Kohli, Vishv Priya

    and falsification of medicinal products meets the social objectives of public health (Articles 9 and 168) and consumer protection (Articles 12 and 169), as envisaged by the Treaty on the Function of the European Union. The thesis establishes that the problem of counterfeiting and falsification of medicinal products...... lies at the intersection of three spheres of law - IP law, Medicine law, and Criminal law. This insight provides the foundation for the understanding of the weaknesses in the legal regime that contains tools for combatting counterfeiting and falsification of medicines in the EU....

  15. Knowledge translation studies in paediatric emergency medicine: A systematic review of the literature.

    Science.gov (United States)

    Wilson, Catherine L; Johnson, David; Oakley, Ed

    2016-02-01

    Systematic review of knowledge translation studies focused on paediatric emergency care to describe and assess the interventions used in emergency department settings. Electronic databases were searched for knowledge translation studies conducted in the emergency department that included the care of children. Two researchers independently reviewed the studies. From 1305 publications identified, 15 studies of varied design were included. Four were cluster-controlled trials, two patient-level randomised controlled trials, two interrupted time series, one descriptive study and six before and after intervention studies. Knowledge translation interventions were predominantly aimed at the treating clinician, with some targeting the organisation. Studies assessed effectiveness of interventions over 6-12 months in before and after studies, and 3-28 months in cluster or patient level controlled trials. Changes in clinical practice were variable, with studies on single disease and single treatments in a single site showing greater improvement. Evidence for effective methods to translate knowledge into practice in paediatric emergency medicine is fairly limited. More optimal study designs with more explicit descriptions of interventions are needed to facilitate other groups to effectively apply these procedures in their own setting. © 2016 The Authors Journal of Paediatrics and Child Health © 2016 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  16. Chinese Medicine Shenfu Injection for Heart Failure: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Song Wen-Ting

    2012-01-01

    Full Text Available Objective. Heart failure (HF is a global public health problem. Early literature studies manifested that Shenfu injection (SFI is one of the most commonly used traditional Chinese patent medicine for HF in China. This article intended to systematically evaluate the efficacy and safety of SFI for HF. Methods. An extensive search was performed within 6 English and Chinese electronic database up to November 2011. Ninety-nine randomized controlled trails (RCTs were collected, irrespective of languages. Two authors extracted data and assessed the trial quality independently. RevMan 5.0.2 was used for data analysis. Results. Compared with routine treatment and/or device support, SFI combined with routine treatment and/or device support showed better effect on clinical effect rate, mortality, heart rate, NT-proBNP and 6-minute walk distance. Results in ultrasonic cardiography also showed that SFI combined with routine treatment improved heart function of HF patients. There were no significant difference in blood pressure between SFI and routine treatment groups. Adverse events were reported in thirteen trails with thirteen specific symptoms, while no serious adverse effect was reported. Conclusion. SFI appear to be effective for treating HF. However, further rigorously designed RCTs are warranted because of insufficient methodological rigor in the majority of included trials.

  17. Chinese medicine shenfu injection for heart failure: a systematic review and meta-analysis.

    Science.gov (United States)

    Wen-Ting, Song; Fa-Feng, Cheng; Li, Xu; Cheng-Ren, Lin; Jian-Xun, Liu

    2012-01-01

    Objective. Heart failure (HF) is a global public health problem. Early literature studies manifested that Shenfu injection (SFI) is one of the most commonly used traditional Chinese patent medicine for HF in China. This article intended to systematically evaluate the efficacy and safety of SFI for HF. Methods. An extensive search was performed within 6 English and Chinese electronic database up to November 2011. Ninety-nine randomized controlled trails (RCTs) were collected, irrespective of languages. Two authors extracted data and assessed the trial quality independently. RevMan 5.0.2 was used for data analysis. Results. Compared with routine treatment and/or device support, SFI combined with routine treatment and/or device support showed better effect on clinical effect rate, mortality, heart rate, NT-proBNP and 6-minute walk distance. Results in ultrasonic cardiography also showed that SFI combined with routine treatment improved heart function of HF patients. There were no significant difference in blood pressure between SFI and routine treatment groups. Adverse events were reported in thirteen trails with thirteen specific symptoms, while no serious adverse effect was reported. Conclusion. SFI appear to be effective for treating HF. However, further rigorously designed RCTs are warranted because of insufficient methodological rigor in the majority of included trials.

  18. 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.

  19. 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.

  20. Traditional Chinese medicine for knee osteoarthritis: An overview of systematic review.

    Directory of Open Access Journals (Sweden)

    Min Yang

    Full Text Available Traditional Chinese medicine (TCM has been accepted as a complementary therapy for knee osteoarthritis. However, the efficacy and safety of the intervention were still conflicting and uncertain. Meanwhile, the quality of methodology and evidence in the field was unknown.To summarize the characteristics and critically evaluate the quality of methodology, as well as the evidence of systematic reviews (SRs on TCM for knee osteoarthritis.Five electronic databases were searched from inception to April 2016. The methodological quality of the included studies was assessed by AMSTAR and ROBIS. The quality of the evidence was determined using the GRADE approach.Ten SRs were included. The conclusions suggest that TCM provides potential benefits for patients with knee osteoarthritis. These benefits include pain relief, functional improvement, and presence of few adverse events. Limitations of the methodological quality mainly included the lack of a-priori protocol or protocol registration and incomprehensive literature search. A list of excluded studies was also not provided. The overall quality of evidence in the SRs was poor, ranging from "very low" to "low," mainly because of the serious risk of bias of original trials, inconsistencies, and imprecision in the outcomes.TCM generally appears to be effective for knee osteoarthritis treatment. However, the evidence is not robust enough because of the methodological flaws in SRs. Hence, these conclusions on available SRs should be treated with caution for clinical practice.

  1. [Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

    2014-09-01

    Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

  2. 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....

  3. 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

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

    Science.gov (United States)

    Fu, Shufei; Zhang, Junhua; Menniti-Ippolito, Francesca; Gao, Xiumei; Galeotti, Francesca; Massari, Marco; Hu, Limin; Zhang, Boli; Ferrelli, Rita; Fauci, Alice; Firenzuoli, Fabio; Shang, Hongcai; Guerra, Ranieri; Raschetti, Roberto

    2011-05-06

    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 possibly some

  5. 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

  6. [Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

    Science.gov (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin

    2015-11-01

    At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

  7. Production and citation of cochrane systematic reviews: a bibliometrics analysis.

    Science.gov (United States)

    Shen, Jiantong; Li, Youping; Clarke, Mike; Du, Liang; Wang, Li; Zhong, Dake

    2014-05-06

    To evaluate the production and utilization of Cochrane systematic reviews(CSRs) and to analyze its influential factors, so as to improve the capacity of translating CSRs into practice. All CSRs and protocols were retrieved from the Cochrane Library ISSUE 2, 2011 and citation data were retrieved from SCI database. Citation analysis was used to analyze the situation of CSRs production and utilization. CSR publication had grown from an annual average of 32 to 718 documents. Only one developing country was among the ten countries with the largest amount of publications. High income countries accounted for 83% of CSR publications and 90.8% of cited counts. 34.7% of CSRs had a cited count of 0, while only 0.9% had been cited more than 50 times. Highly cited CSRs were published in England, Australia, Canada, USA and other high income countries. The countries with a Cochrane center or a Cochrane methodology group had a greater capability of CSRs production and citing than others. The CSRs addressing the topics of diseases were more than those targeted at public health issues. There was a big gap in citations of different interventions even for the same topic. The capability of CSR production and translation grew rapidly, but varied among countries and institutions, which was affected by several factors such as the capability of research, the resourcesand the applicability of the evidence. It is important to improve evidence translation through educating, training and prioritizing the problems based on real demands of end user. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  8. Systematic review on the evaluation criteria of orphan medicines in Central and Eastern European countries.

    Science.gov (United States)

    Zelei, Tamás; Molnár, Mária J; Szegedi, Márta; Kaló, Zoltán

    2016-06-04

    In case of orphan drugs applicability of the standard health technology assessment (HTA) process is limited due to scarcity of good clinical and health economic evidence. Financing these premium priced drugs is more controversial in the Central and Eastern European (CEE) region where the public funding resources are more restricted, and health economic justification should be an even more important aspect of policy decisions than in higher income European countries. To explore and summarize the recent scientific evidence on value drivers related to the health technology assessment of ODs with a special focus on the perspective of third party payers in CEE countries. The review aims to list all potentially relevant value drivers in the reimbursement process of orphan drugs. A systematic literature review was performed; PubMed and Scopus databases were systematically searched for relevant publications until April 2015. Extracted data were summarized along key HTA elements. From the 2664 identified publications, 87 contained relevant information on the evaluation criteria of orphan drugs, but only 5 had direct information from the CEE region. The presentation of good clinical evidence seems to play a key role especially since this should be the basis of cost-effectiveness analyses, which have more importance in resource-constrained economies. Due to external price referencing of pharmaceuticals, the relative budget impact of orphan drugs is expected to be higher in CEE than in Western European (WE) countries unless accessibility of patients remains more limited in poorer European regions. Equity principles based on disease prevalence and non-availability of alternative treatment options may increase the price premium, however, societies must have some control on prices and a rationale based on multiple criteria in reimbursement decisions. The evaluation of orphan medicines should include multiple criteria to appropriately measure the clinical added value of orphan

  9. 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.

  10. Clinical evidence for orphan medicinal products-a cause for concern?

    NARCIS (Netherlands)

    Picavet, Eline; Cassiman, David; Hollak, Carla E.; Maertens, Johan A.; Simoens, Steven

    2013-01-01

    The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at

  11. 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

  12. 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.

  13. 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.

  14. Comparison between herbal medicine and fluoxetine for depression: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Ren, Yi; Zhu, Chenjun; Wu, Jianjun; Zheng, Ruwen; Cao, Huijaun

    2015-10-01

    To evaluate the effectiveness and safety of Chinese herbal medicine (CHM) versus fluoxetine on depression. A systematic review of randomized controlled trials (RCTs). RCT with two parallel groups that compared CHM and fluoxetine on treatment of depression with reported decreased Hamilton Depression Scale (HAMD) and adverse events during treatment were included after searching through six electric-databases. The methodological quality of RCTs was assessed according to the Cochrane risk of bias tool. Meta-analysis was conducted using RevMan 5.3 software with pooled mean difference (MD) or risk ratio (RR) and their 95% confidence interval (CI) if no significant heterogeneity was detected. A SOF table was generated using GRADEPro software to evaluate the overall quality of the evidence. Twenty-six trials with 3294 participants were included in the review. Most of them had high risk of bias during conducting and reporting. The results achieved weak evidence which showed CHM had similar effect to fluoxetine (20mg/day) on relieving depression according to HAMD assessment (for primary depression: MD=-0.08, 95%CI -0.98-0.82; for secondary depression: MD=-0.36, 95%CI -1.55-0.83), but fewer incidences of adverse events than the drug (for primary depression: RR=0.31, 95%CI 0.17-0.59; for post-stroke depression: RR=0.04, 95%CI 0.00-0.25). No serious adverse event was found in neither CHM nor fluoxetine group. Due to the poor quality of included trials and the potential publication bias of this review, no confirmed conclusion could be draw to evaluate the effectiveness and safety of CHM for depression compared with fluoxetine. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. 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.

  16. A systematic review of the Ayurvedic medicinal herb Bacopa monnieri in child and adolescent populations.

    Science.gov (United States)

    Kean, James D; Downey, Luke A; Stough, Con

    2016-12-01

    Clinicians utilise critical research to advance their knowledge when prescribing standard and alternative therapies for developmental disorders. Recent research has reported that the traditional Ayurvedic medicine Bacopa monnieri may improve cognitive outcomes in adult populations; however, few studies have investigated its benefits in younger cohorts. The aim of the current review is to systematically assess and critically summarize clinical trial outcomes and safety of Bacopa and its effects on the cognition and behaviour in children and adolescents. PubMed, Scopus, Cochrane Library, Google and CINAHL were searched up to August 2015 for trials investigating Bacopa monnieri in child and adolescent populations. There were no restrictions in study design. Cognitive and behavioural outcomes were grouped into validated constructs and effect sizes were calculated for all significant data to allow for direct comparisons. Five studies met inclusion criteria for this review. The results demonstrated significant consistent improvements in the language behaviour cognitive domain and in a number of the memory sub-domains. Significant improvements were also seen in hyperactivity and attention-deficit domains. Overall outcome data demonstrated small to medium effect sizes (mean d=0.42). Safety and tolerability data was well reported for 80% of studies with only 2.3% of all participants reporting mild side-effects. This review highlights the safe use of Bacopa monnieri in child and adolescent populations for improving elements of cognition as well as behaviour and attention-deficit domains. However, there is a significant need for replicated study designs and stringent statistical analysis to validate these outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. 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.

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

    Science.gov (United States)

    Jang, Su Hee; Kim, Dong Il; Choi, Min-Sun

    2014-01-10

    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. 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. 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. 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 better reduction of symptoms compared to

  19. 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

  20. 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

  1. 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 ...

  2. 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...

  3. 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.

  4. 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...... market. There is a difference in the balance between confidence and control, as well as availability and safety when it comes to NPMs in non-pharmacy settings that needs to be further discussed....

  5. Medicinal and dietary supplements: specialty forest products with a long tradition

    Science.gov (United States)

    James L. Chamberlain; A.L. Hammett

    1999-01-01

    Over the last five years forest products other than timber-based products have received a great deal of attention. The markets for medicinal plants that are collected from the forests are growing rapidly. Some reports suggest this segment of the non-timber forest products industry is expanding faster than the timber-based industry. Plants used for their therapeutic...

  6. 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.

  7. Exploring Mechanisms for Effective Technology-Enhanced Simulation-based Education in Wilderness Medicine: A Systematic Review.

    Science.gov (United States)

    MacKinnon, Ralph; Aitken, Deborah; Humphries, Christopher

    2015-12-17

     Technology-enhanced simulation is well-established in healthcare teaching curricula, including those regarding wilderness medicine. Compellingly, the evidence base for the value of this educational modality to improve learner competencies and patient outcomes are increasing.  The aim was to systematically review the characteristics of technology-enhanced simulation presented in the wilderness medicine literature to date. Then, the secondary aim was to explore how this technology has been used and if the use of this technology has been associated with improved learner or patient outcomes.  EMBASE and MEDLINE were systematically searched from 1946 to 2014, for articles on the provision of technology-enhanced simulation to teach wilderness medicine. Working independently, the team evaluated the information on the criteria of learners, setting, instructional design, content, and outcomes.  From a pool of 37 articles, 11 publications were eligible for systematic review. The majority of learners in the included publications were medical students, settings included both indoors and outdoors, and the main focus clinical content was initial trauma management with some including leadership skills. The most prevalent instructional design components were clinical variation and cognitive interactivity, with learner satisfaction as the main outcome.  The results confirm that the current provision of wilderness medicine utilizing technology-enhanced simulation is aligned with instructional design characteristics that have been used to achieve effective learning. Future research should aim to demonstrate the translation of learning into the clinical field to produce improved learner outcomes and create improved patient outcomes.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. Environmental risk assessment for veterinary medicinal products. Part 1. Other than GMO-containing and immunological products. First update

    NARCIS (Netherlands)

    Montforts MHMM; CSR

    1999-01-01

    The EC has issued directives (1981, 1992) requesting for registration of veterinary medicinal product information to enable an assessment of the product's safety for the environment. As a whole, the risk assessment is structured around the hazard quotient approach used in USES (1994). Predicted

  14. 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.

  15. Conventional and Nuclear Medicine Imaging in Ectopic Cushing's Syndrome: A Systematic Review

    Science.gov (United States)

    Isidori, Andrea M.; Sbardella, Emilia; Zatelli, Maria Chiara; Boschetti, Mara; Vitale, Giovanni; Colao, Annamaria

    2015-01-01

    Context: Ectopic Cushing's Syndrome (ECS) can be a diagnostic challenge with the hormonal source difficult to find. This study analyzes the accuracy of imaging studies in ECS localization. Evidence Acquisition: Systematic review of medical literature for ECS case series providing individual patient data on at least one conventional imaging technique (computed tomography [CT]/magnetic resonance imaging) and one of the following: 111In-pentetreotide (OCT), 131I/123I-metaiodobenzylguanidine, 18F-fluoro-2-deoxyglucose-positron emission tomography (FDG-PET), 18F-fluorodopa-PET (F-DOPA-PET), 68Ga-DOTATATE-PET/CT or 68Ga-DOTATOC-PET/CT scan (68Gallium-SSTR-PET/CT). Evidence Summary: The analysis comprised 231 patients (females, 50.2%; age, 42.6 ± 17 y). Overall, 52.4% (121/231) had “overt” ECS, 18.6% had “occult” ECS, and 29% had “covert” ECS. Tumors were located in the lung (55.3%), mediastinum-thymus (7.9%), pancreas (8.5%), adrenal glands (6.4%), gastrointestinal tract (5.4%), thyroid (3.7%), and other sites (12.8%), and primary tumors were mostly bronchial neuroendocrine tumors (NETs) (54.8%), pancreatic NETs (8%), mediastinum-thymus NETs (6.9%), gastrointestinal NETs (5.3%), pheochromocytoma (6.4%), neuroblastoma (3.2%), and medullary thyroid carcinoma (3.2%). Tumors were localized by CT in 66.2% (137/207), magnetic resonance imaging in 51.5% (53/103), OCT in 48.9% (84/172), FDG-PET in 51.7% (46/89), F-DOPA-PET in 57.1% (12/21), 131/123I-metaiodobenzylguanidine in 30.8% (4/13), and 68Gallium-SSTR-PET/CT in 81.8% (18/22) of cases. Molecular imaging discovered 79.1% (53/67) of tumors unidentified by conventional radiology, with OCT the most commonly used, revealing the tumor in 64%, followed by FDG-PET in 59.4%. F-DOPA-PET was used in only seven covert cases (sensitivity, 85.7%). Notably, 68Gallium-SSTR-PET/CT had 100% sensitivity among covert cases. Conclusions: Nuclear medicine improves the sensitivity of conventional radiology when tumor site

  16. 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.

  17. Study of Scientific Production of Community Medicines' Department Indexed in ISI Citation Databases.

    Science.gov (United States)

    Khademloo, Mohammad; Khaseh, Ali Akbar; Siamian, Hasan; Aligolbandi, Kobra; Latifi, Mahsoomeh; Yaminfirooz, Mousa

    2016-10-01

    In the scientometric, the main criterion in determining the scientific position and ranking of the scientific centers, particularly the universities, is the rate of scientific production and innovation, and in all participations in the global scientific development. One of the subjects more involved in repeatedly dealt with science and technology and effective on the improvement of health is medical science fields. In this research using scientometric and citation analysis, we studied the rate of scientific productions in the field of community medicine, which is the numbers of articles published and indexed in ISI database from 2000 to 2010. This study is scientometric using the survey and analytical citation. The study samples included all of the articles in the ISI database from 2000 to 2010. For the data collection, the advance method of searching was used at the ISI database. The ISI analyses software and descriptive statistics were used for data analysis. Results showed that among the five top universities in producing documents, Tehran University of Medical Sciences with 88 (22.22%) documents are allocated to the first rank of scientific products. M. Askarian with 36 (90/9%) published documents; most of the scientific outputs in Community medicine, in the international arena is the most active author in this field. In collaboration with other writers, Iranian departments of Community Medicine with 27 published articles have the greatest participation with scholars of English authors. In the process of scientific outputs, the results showed that the scientific process was in its lowest in the years 2000 to 2004, and while the department of Community medicine in 2009 allocated most of the production process to itself. Iranian Journal of Public Health and Saudi Medical Journal each of them had 16 articles which had most participation rate in the publishing of community medicine's department. On the type of carrier, community medicine's department by

  18. 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.

  19. The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus

    Science.gov (United States)

    Zhan, Jinliang; Lu, Pei

    2006-11-01

    Since the quality of traditional Chinese medicine products are affected by raw material, machining and many other factors, it is difficult for traditional Chinese medicine production process especially the extracting process to ensure the steady and homogeneous quality. At the same time, there exist some quality control blind spots due to lacking on-line quality detection means. But if infrared spectrum analysis technology was used in traditional Chinese medicine production process on the basis of off-line analysis to real-time detect the quality of semi-manufactured goods and to be assisted by advanced automatic control technique, the steady and homogeneous quality can be obtained. It can be seen that the on-line detection of extracting process plays an important role in the development of Chinese patent medicines industry. In this paper, the design and implement of a traditional Chinese medicine extracting process monitoring experiment system which is based on PROFIBUS-DP field bus, OPC, and Internet technology is introduced. The system integrates intelligence node which gathering data, superior sub-system which achieving figure configuration and remote supervisory, during the process of traditional Chinese medicine production, monitors the temperature parameter, pressure parameter, quality parameter etc. And it can be controlled by the remote nodes in the VPN (Visual Private Network). Experiment and application do have proved that the system can reach the anticipation effect fully, and with the merits of operational stability, real-time, reliable, convenient and simple manipulation and so on.

  20. Recent Advances in Developing Insect Natural Products as Potential Modern Day Medicines

    Directory of Open Access Journals (Sweden)

    Norman Ratcliffe

    2014-01-01

    Full Text Available Except for honey as food, and silk for clothing and pollination of plants, people give little thought to the benefits of insects in their lives. This overview briefly describes significant recent advances in developing insect natural products as potential new medicinal drugs. This is an exciting and rapidly expanding new field since insects are hugely variable and have utilised an enormous range of natural products to survive environmental perturbations for 100s of millions of years. There is thus a treasure chest of untapped resources waiting to be discovered. Insects products, such as silk and honey, have already been utilised for thousands of years, and extracts of insects have been produced for use in Folk Medicine around the world, but only with the development of modern molecular and biochemical techniques has it become feasible to manipulate and bioengineer insect natural products into modern medicines. Utilising knowledge gleaned from Insect Folk Medicines, this review describes modern research into bioengineering honey and venom from bees, silk, cantharidin, antimicrobial peptides, and maggot secretions and anticoagulants from blood-sucking insects into medicines. Problems and solutions encountered in these endeavours are described and indicate that the future is bright for new insect derived pharmaceuticals treatments and medicines.

  1. Honey: an effective regenerative medicine product in wound management.

    Science.gov (United States)

    Martinotti, Simona; Bucekova, Marcela; Majtan, Juraj; Ranzato, Elia

    2018-05-10

    Honey has successfully been used in treatment of a broad spectrum of injuries including burns and non-healing wounds. It acts as antibacterial and anti-biofilm agent with anti/pro-inflammatory properties. However, besides these traditional properties, recent evidence suggests that honey is also an immunomodulator in wound healing and contains several bee and plant-derived components that may speed up the wound healing and tissue regeneration process. Identifying their exact mechanism of action allows better understanding of honey healing properties and promotes its wider translation into clinical practice. This review will discuss the physiological basis for the use of honey in wound management, its current clinical uses, as well as the potential role of honey bioactive compounds in dermal regenerative medicine and tissue re-modelling. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  2. 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.

  3. 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....... We hereby present a number of examples where the traditional medicinal use of the plant matches with the medicinal use of the drug that is structurally similar to a plant component. With this approach, we have brought to light a number of obscure compounds of natural origin (e.g. kanugin......, we compared their structures with those of drugs from DrugBank and we constructed a structural similarity network. Information on the traditional therapeutic use of the plants was integrated in the network in order to provide further evidence for the predicted biologically active natural compounds...

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. Communication in production animal medicine: modelling a complex interaction with the example of dairy herd health medicine

    Directory of Open Access Journals (Sweden)

    Kleen Joachim L

    2011-07-01

    Full Text Available Abstract Background The importance of communication skills in veterinary medicine is increasingly recognised. Appropriate communication skills towards the client are of utmost importance in both companion animal practice and production animal field and consultancy work. The need for building a relationship with the client, alongside developing a structure for the consultation is widely recognised and applies to both types of veterinary practice. Results Veterinary advisory practice in production animal medicine is, however, characterised by a more complex communication on different levels. While the person-orientated communication is a permanent process between veterinarian and client with a rather personal perspective and defines the roles of interaction, the problem-orientated communication deals with emerging difficulties; the objective is to solve an acute health problem. The solution - orientated communication is a form of communication in which both veterinarian and client address longstanding situations or problems with the objective to improve herd health and subsequently productivity performance. All three forms of communication overlap. Conclusions Based on this model, it appears useful for a veterinary practice to offer both a curative and an advisory service, but to keep these two separated when deemed appropriate. In veterinary education, the strategies and techniques necessary for solution orientated communication should be included in the teaching of communication skills.

  10. Communication in production animal medicine: modelling a complex interaction with the example of dairy herd health medicine.

    Science.gov (United States)

    Kleen, Joachim L; Atkinson, Owen; Noordhuizen, Jos Ptm

    2011-07-20

    The importance of communication skills in veterinary medicine is increasingly recognised. Appropriate communication skills towards the client are of utmost importance in both companion animal practice and production animal field and consultancy work. The need for building a relationship with the client, alongside developing a structure for the consultation is widely recognised and applies to both types of veterinary practice. Veterinary advisory practice in production animal medicine is, however, characterised by a more complex communication on different levels. While the person-orientated communication is a permanent process between veterinarian and client with a rather personal perspective and defines the roles of interaction, the problem-orientated communication deals with emerging difficulties; the objective is to solve an acute health problem. The solution - orientated communication is a form of communication in which both veterinarian and client address longstanding situations or problems with the objective to improve herd health and subsequently productivity performance. All three forms of communication overlap. Based on this model, it appears useful for a veterinary practice to offer both a curative and an advisory service, but to keep these two separated when deemed appropriate. In veterinary education, the strategies and techniques necessary for solution orientated communication should be included in the teaching of communication skills.

  11. Innovation, productivity, and pricing: Capturing value from precision medicine technology in Canada.

    Science.gov (United States)

    Emery, J C Herbert; Zwicker, Jennifer D

    2017-07-01

    For new technology and innovation such as precision medicine to become part of the solution for the fiscal sustainability of Canadian Medicare, decision-makers need to change how services are priced rather than trying to restrain emerging technologies like precision medicine for short-term cost savings. If provincial public payers shift their thinking to be public purchasers, value considerations would direct reform of the reimbursement system to have prices that adjust with technologically driven productivity gains. This strategic shift in thinking is necessary if Canadians are to benefit from the promised benefits of innovations like precision medicine.

  12. [Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

    Science.gov (United States)

    Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

    2012-04-01

    For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

  13. 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.

  14. 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.

  15. 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 ...

  16. 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...

  17. Methodology Used to Assess Acceptability of Oral Pediatric Medicines: A Systematic Literature Search and Narrative Review.

    Science.gov (United States)

    Mistry, Punam; Batchelor, Hannah

    2017-06-01

    Regulatory guidelines require that any new medicine designed for a pediatric population must be demonstrated as being acceptable to that population. There is currently no guidance on how to conduct or report on acceptability testing. Our objective was to undertake a review of the methods used to assess the acceptability of medicines within a pediatric population and use this review to propose the most appropriate methodology. We used a defined search strategy to identify literature reports of acceptability assessments of medicines conducted within pediatric populations and extracted information about the tools used in these studies for comparison across studies. In total, 61 articles were included in the analysis. Palatability was the most common (54/61) attribute measured when evaluating acceptability. Simple scale methods were most commonly used, with visual analog scales (VAS) and hedonic scales used both separately and in combination in 34 of the 61 studies. Hedonic scales alone were used in 14 studies and VAS alone in just five studies. Other tools included Likert scales; forced choice or preference; surveys or questionnaires; observations of facial expressions during administration, ease of swallowing, or ability to swallow the dosage; prevalence of complaints or refusal to take the medicine; and time taken for a nurse to administer the medicine. The best scale in terms of validity, reliability, feasibility, and preference to use when assessing acceptability remains unclear. Further work is required to select the most appropriate method to justify whether a medicine is acceptable to a pediatric population.

  18. 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.

  19. Alternative Blood Products and Clinical Needs in Transfusion Medicine

    OpenAIRE

    Whitsett, Carolyn; Vaglio, Stefania; Grazzini, Giuliano

    2012-01-01

    The primary focus of national blood programs is the provision of a safe and adequate blood supply. This goal is dependent on regular voluntary donations and a regulatory infrastructure that establishes and enforces standards for blood safety. Progress in ex vivo expansion of blood cells from cell sources including peripheral blood, cord blood, induced pluripotent stem cells, and human embryonic stem cell lines will likely make alternative transfusion products available for clinical use in the...

  20. 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.

  1. [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.

  2. 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.

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

    Science.gov (United States)

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

    2018-05-15

    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.

  4. 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.

  5. 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

  6. 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.

  7. Studies on saponin production in tropical medicinal plants Maesa argentea and Maesa lanceolata

    Science.gov (United States)

    Faizal, Ahmad; Geelen, Danny

    2015-09-01

    The continuous need for new compounds with important medicinal activities has lead to the identification and characterization of various plant-derived natural products. As a part of this program, we studied the saponin production from two tropical medicinal plants Maesa argentea and M. lanceolata and evaluated several treatments to enhance their saponin production. In this experiment, we present the analyses of saponin production from greenhouse grown plants by means of TLC and HPLC-MS. We observed that the content of saponin from these plants varied depending on organ and physiological age of the plants. In addition, the impact of elicitors on saponin accumulation on in vitro grown plants was analyzed using TLC. The production of saponin was very stable and not affected by treatment with methyl jasmonate, and salicylic acid. In conclusion, Maesa saponins are constitutively produced in plants and the level of these compounds in plants is mainly affected by the developmental or physiological stage.

  8. 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.

  9. Chinese Patent Medicine Tongxinluo Capsule for Hypertension: A Systematic Review of Randomised Controlled Trials

    Directory of Open Access Journals (Sweden)

    Jie Wang

    2014-01-01

    Full Text Available Background. This study was intended to evaluate the efficacy and safety of Tongxinluo capsule for hypertension. Search Strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL in the Cochrane Library, The PubMed, EMBASE, Chinese Bio-Medical Literature Database (CBM, Chinese National Knowledge Infrastructure (CNKI, Chinese Scientific Journal Database, and Wan-fang Data started from the first of database to October 28, 2013. No language restriction was applied. We included randomized clinical trials testing Tongxinluo capsule against western medicine, Tongxinluo capsule versus placebo, and Tongxinluo capsule combined with western medicine versus western medicine. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results. 25 trials with 1958 participants were included. The methodological quality of the included trials was evaluated as generally low. The blood pressure (BP lowering effect of Tongxinluo capsule plus western medicine was significantly higher than that of western medicine (systolic blood pressure (SBP: −3.87, −5.32 to −2.41, P<0.00001; and diastolic blood pressure (DBP: −2.72, −4.19 to −1.24, P=0.0003. The BP also decreased significantly from baseline with Tongxinluo capsule than placebo (SBP: −9.40, −10.90 to −7.90, P<0.00001; and DBP: −11.80, −12.40 to −11.20, P<0.00001 or western medicine (SBP: −3.90, −4.93 to −2.87, P<0.00001; and DBP: −3.70, −3.83 to −3.57, P<0.00001. 12 trials reported adverse events without details. Conclusions. There is some but weak evidence about the effectiveness of TXL in treating patients with hypertension.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. Herbal medicinal products in the treatment of pain as a symptom of osteoarthritis

    Directory of Open Access Journals (Sweden)

    Maksimović Zoran

    2016-01-01

    Full Text Available Herbal medicinal products which are used perorally in the treatment of minor articular pain include those obtained from willow bark, Salicis cortex, devil's claw root, Harpagophyti radix, nettle leaf and herb, Urticae folium/herba, meadowsweet flower and herb, Filipendulae ulmariae flos/herba, ash leaf, Fraxini folium, and blackcurrant leaf, Ribis nigri folium. They can be in the form of a herbal tea or solid and liquid dosage forms. Anti-inflammatory and/or analgetic action form/s basis for their therapeutic usage. Among mentioned herbal drugs, only willow bark, Salicis cortex, is employed for producing herbal medicinal products with well-established use (dry standardised hydroethanolic extract in the solid dosage form intended for oral application. Furthermore, traditional herbal medicines prepared from arnica flower, Arnicae flos, which are intended for dermal application (liquid and semi-solid dosage forms are used for symptomatic relief of rheumatic complaints, also because of their anti-inflammatory and analgetic effects. Owing to rubefacient activity, herbal medicinal products with well-established use based on the soft extracts of capsicum, Capsici frustus, (medicated plasters and semi-solid dosage forms for cutaneous use, as well as traditional herbal medicines based on rosemary leaf and oil, Rosmarini folium/aetheroleum, juniper oil, Juniperi aetheroleum, and eucalyptus oil, Eucalypti aetheroleum (bath additives and/or liquid and semi-solid dosage forms for dermal application, are used to decrease pain.

  15. 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.

  16. Systematic Methodology for Design of Tailor-Made Blended Products: Fuels and Other Blended Products

    DEFF Research Database (Denmark)

    Yunus, Nor Alafiza Binti

    property values are verified by means of rigorous models for the properties and the mixtures. Besides the methodology, as the main contribution, specific supporting tools that were developed to perform each task are also important contributions of this research work. The applicability of the developed...... important in daily life, since they not only keep people moving around, but also guarantee that machines and equipment work smoothly. The objective of this work is to tackle the blending problems using computer-aided tools for the initial stage of the product design. A systematic methodology for design...... 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....

  17. The impact of medicinal drugs on traffic safety: a systematic review of epidemiological studies.

    Science.gov (United States)

    Orriols, Ludivine; Salmi, Louis-Rachid; Philip, Pierre; Moore, Nicholas; Delorme, Bernard; Castot, Anne; Lagarde, Emmanuel

    2009-08-01

    To evaluate the quality of epidemiological research into effects of medicinal drugs on traffic safety and the current knowledge in this area. The bibliographic search was done in Medline electronic database using the keywords: ((accident* or crash*) and traffic and drug*) leading to 1141 references. Additional references were retrieved from the Safetylit website and the reference lists of selected studies. Original articles published in English or French, between 1 April 1979 and 31 July 2008, were considered for inclusion. We excluded descriptive studies, studies limited to alcohol or illicit drug involvement and investigations of injuries other than from traffic crashes. Studies based on laboratory tests, driving simulators or on-the-road driving tests were also excluded. Eligible studies had to evaluate the causal relationship between the use of medicinal drugs and the risk of traffic crashes. Study quality was assessed by two independent experts, according to a grid adapted from the strengthening the reporting of observational studies in epidemiology (STROBE) statement. Twenty two studies of variable methodological quality were included. Definition of drug exposure varied across studies and depended on the data sources. Potential confounding due to the interaction between the effects of the medicinal drug and disease-related symptoms was often not controlled. The risk of motor-vehicle crashes related to benzodiazepines has been amply studied and demonstrated. Results for other medicinal drugs remain controversial. There is a need for large studies, investigating the role of individual substances in the risk of road traffic crashes. Copyright 2009 John Wiley & Sons, Ltd.

  18. 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 (psupernatural cause of hypertension (RR 2.11), and family history 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.

  19. A Systematic Approach to Quality Oriented Product Sequencing for Multistage Manufacturing Systems

    OpenAIRE

    Zhang, Faping; Butt, Shahid Ikramullah

    2016-01-01

    Product sequencing is one way to reduce cost and improve product quality for multistage manufacturing systems (MMS). However, systematically evaluating the influence of product sequence on quality performance for MMS is still a challenge. By considering the rate of incoming conforming product, manufacturing system quality transition between batch to batch, and quality propagation along stages, this paper investigates the appropriate batch policies and product sequencing for MMS so that satisf...

  20. 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.

  1. 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.

  2. 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…

  3. [Assessing research productivity in Department of Internal Medicine, University of Zagreb, School of Medicine and University Hospital Centre Zagreb].

    Science.gov (United States)

    Petrak, Jelka; Sember, Marijan; Granić, Davorka

    2012-01-01

    Bibliometric analysis may give an objective information about publishing activity, citation rate and collaboration patterns of individuals, groups and institutions. The publication productivity of the present medical staff (79 with specialist degree and 22 residents) in Department of Internal Medicine, University of Zagreb School of Medicine in University Hospital Centre Zagreb was measured by the number of papers indexed by Medline, their impact was measured by the number of times these papers had subsequently been cited in the medical literature, while the collaboration pattern was estimated by the authors' addresses listed in the papers. PubMed database was a source for verifying the bibliographic data, and the citation data were searched via Thomson Web of Scence (WoS) platform. There were a total of 1182 papers, published from 1974 to date. The number of papers per author ranged from 0 to 252. Sixty of papers were published in English, and 39% in Croatian language. The roughly equal share was published in local and foreign journals. The RCT studies and practice guidelines were among the most cited papers and were at the same time published by the highly ranked journals. The collaboration analysis confirmed the extensive involment in the international multicentric clinical trials as well as in the development of international/local practice guidelines.

  4. 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.

  5. 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.

  6. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

    Science.gov (United States)

    Sato, Yoji

    2014-01-01

    In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.

  7. Material science as basis for nuclear medicine: Holmium irradiation for radioisotopes production

    Science.gov (United States)

    Usman, Ahmed Rufai; Khandaker, Mayeen Uddin; Haba, Hiromitsu; Otuka, Naohiko

    2018-05-01

    Material Science, being an interdisciplinary field, plays important roles in nuclear science. These applications are seen in weaponry, armoured vehicles, accelerator structure and development, semiconductor detectors, nuclear medicine and many more. Present study presents the applications of some metals in nuclear medicine (radioisotope production). The charged-particle-induced nuclear reactions by using cyclotrons or accelerators have become a very vital feature of the modern nuclear medicine. Realising the importance of excitation functions for the efficient production of medical radionuclides, some very high purity holmium metals are generally prepared or purchased for bombardment in nuclear accelerators. In the present work, various methods to obtain pure holmium for radioisotope production have been discussed while also presenting details of our present studies. From the experimental work of the present studies, some very high purity holmium foils have been used in the work for a comprehensive study of residual radionuclides production cross-sections. The study was performed using a stacked-foil activation technique combined with γ-ray spectrometry. The stack was bombarded with 50.4 MeV alpha particle beam from AVF cyclotron of RI Beam Factory, Nishina Centre for Accelerator-Based Science, RIKEN, Japan. The work produced thulium radionuclides useful in nuclear medicine.

  8. PRICING, REIMBURSEMENT, AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICINAL PRODUCTS IN BULGARIA.

    Science.gov (United States)

    Benisheva-Dimitrova, Tatyana; Sidjimova, Dobriana; Cherneva, Daniela; Kralimarkov, Nikolay

    2017-01-01

    The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

  9. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Science.gov (United States)

    2010-08-17

    ...] (formerly Docket No. 1999D-4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary...) entitled ``Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients... 2001 final guidance), has been developed for veterinary use by the International Cooperation on...

  10. 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.

  11. Effect of Herbal Medicine on Vaginal Epithelial Cells: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Rahmani, Yousef; Chaleh, Khadijeh Chaleh; Shahmohammadi, Afshar; Safari, Shahla

    2018-04-01

    The present meta-analysis aimed to assess the effect of the herbal medicine on the vaginal epithelial cells (VECs) among the menopausal subjects. The literature related to VECs exposed to various herbal medicines in menopausal women were searched on three databases, MEDLINE (1966-August 2017), Scopus (1990-August 2017) and Cochrane Library (Cochrane Central Register of Controlled Trials; 2014). Totally, the meta-analysis was conducted on 11 randomised controlled trials. Based on the findings, the standardized mean difference (SMD) of maturation value (MV) was observed to be elevated by 0.48% (95% interval confidence [CI], 0.108-0.871; P = 0.012), as well as the heterogeneity was high (I 2 = 84%; P < 0.001). The MV revealed a significant increase in soy group (SMD, 0.358; 95% CI, 0.073-0.871; P = 0.014) compared to the control group. The herbal medicines exhibited a statistically significant effect on the VECs. A significant effect on the VECs was also found in the subgroup analysis of the patients, who received soy. However, further and extensive studies are required to achieve reliable outcomes.

  12. 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

  13. The quantity and quality of complementary and alternative medicine clinical practice guidelines on herbal medicines, acupuncture and spinal manipulation: systematic review and assessment using AGREE II.

    Science.gov (United States)

    Ng, Jeremy Y; Liang, Laurel; Gagliardi, Anna R

    2016-10-29

    Complementary and alternative medicine (CAM) use is often not disclosed by patients, and can be unfamiliar to health care professionals. This may lead to underuse of beneficial CAM therapies, and overuse of other CAM therapies with little proven benefit or known contraindications. No prior research has thoroughly evaluated the credibility of knowledge-based resources. The purpose of this research was to assess the quantity and quality of CAM guidelines. A systematic review was conducted to identify CAM guidelines. MEDLINE, EMBASE and CINAHL were searched in January 2016 from 2003 to 2015. The National Guideline Clearinghouse, National Center for Complementary and Integrative Health web site, and two CAM journals were also searched. Eligible guidelines published in English language by non-profit agencies on herbal medicine, acupuncture, or spinal manipulation for adults with any condition were assessed with the Appraisal of Guidelines, Research and Evaluation II (AGREE II) instrument. From 3,126 unique search results, 17 guidelines (two herbal medicine, three acupuncture, four spinal manipulation, eight mixed CAM therapies) published in 2003 or later and relevant to several clinical conditions were eligible. Scaled domain percentages from highest to lowest were clarity of presentation (85.3 %), scope and purpose (83.3 %), rigour of development (61.2 %), editorial independence (60.1 %), stakeholder involvement (52.0 %) and applicability (20.7 %). Quality varied within and across guidelines. None of the 17 guidelines were recommended by both appraisers; 14 were recommended as Yes or Yes with modifications. Guidelines that scored well could be used by patients and health care professionals as the basis for discussion about the use of these CAM therapies. In future updates, guidelines that achieved variable or lower scores could be improved according to specifications in the AGREE II instrument, and with insight from a large number of resources that are available

  14. 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

  15. 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

  16. Underestimating the Toxicological Challenges Associated with the Use of Herbal Medicinal Products in Developing Countries

    Directory of Open Access Journals (Sweden)

    Vidushi S. Neergheen-Bhujun

    2013-01-01

    Full Text Available Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

  17. Underestimating the toxicological challenges associated with the use of herbal medicinal products in developing countries.

    Science.gov (United States)

    Neergheen-Bhujun, Vidushi S

    2013-01-01

    Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

  18. 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.

  19. 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.

  20. 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.

  1. A single European pharmaceutical market: Does maximum harmonization enhance medicinal product innovation?

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata

    2013-01-01

    the orphan medicinal products scheme. The latter is subject to uniform Union rules specifically introduced to stimulate research and development and has led to the development of a number of new products. The article shows that the most radical positive integration depends to a large extent on the prospect...... – 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...... of it yielding revenue for the innovator. Hence, fuller harmonization can benefit innovation, but it is just as important, if not more important, to address other factors such as pricing, reimbursement and patent protection....

  2. Restrictions on the reimbursement policy with regard to retail marketing of medicinal products in Poland.

    Science.gov (United States)

    Zimmermann, Agnieszka

    2013-01-01

    On January 1, 2012, the law of 12 May 2011 on the reimbursement of medicines, food products of special nutritional purpose and medicinal products, intended to tighten up the reimbursement system, came into force in Poland. The new legislative act has significantly altered the previous principles of retail marketing of products subject to publicly financed reimbursement. First of all, the prices of reimbursed products have been unified through the introduction of fixed margins and prices and a ban--completely unknown until now--on using free market sales practices. These regulations are intended to lead to the abolition of price competition and its replacement with competition as to the quality of services provided by pharmacies. At the same time, entities engaged in retail marketing of medicinal products have been imposed a number of new obligations and highly repressive penalties for failure to fulfill them. The paper analyzes the legislative changes and points out the consequences, both those which can already be seen and the predictable ones. The assumed priority and criterion of evaluation of the reimbursement policy in question is its impact on the functioning of pharmacies which, according to the premises of Polish pharmaceutical law, should play the role of public health protection institutions.

  3. 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.

  4. 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

  5. Use of lipid-lowering medicinal herbs during pregnancy: A systematic review on safety and dosage

    Directory of Open Access Journals (Sweden)

    Hojjat Rouhi-Boroujeni

    2017-06-01

    Full Text Available BACKGROUND: Hyperlipidemia is one of the important diseases in pregnancy that causes fetal abnormalities during pregnancy and after the birth. Unfortunately, the usual anti-fat drugs are associated with high morbidity in fetus and due to people's inclination towards taking herbs, it is required to identify side effects of medicinal herbs in pregnancy. The aim of this study was to present hypolipidemic herbs that would not any complications for mother and fetus. METHODS: In this review article, the major electronic databases such as EBSCO, Central Register of Controlled Trials (CENTRAL, China Network Knowledge Infrastructure (CNKI, Cochrane, Google scholar, MEDLINE, SciVerse, Scopus, and Web of Science were searched using the key words “herbal” and “hyperlipidemia”, “herbal” and “pregnancy” matched by MeSH from their respective inceptions till September, 2016. Total of 1723 publications (145 review articles, 855 original research articles, and 723 abstracts about the effect of herbals on hyperlipidemia and 682 publications (200 abstracts, 423 original research articles, and 59 review articles about the effect of herbals in pregnancy were retrieved. At the end, a list of medicinal plants effective on hyperlipidemia alongside their effects on pregnancy was developed. Finally, the plants effective on hyperlipidemia and safe during pregnancy were determined and their dosage, complications, mechanism of action, and side effects were reported. RESULTS: A total of 110 effective herbs on hyperlipidemia were identified and complications of 95 plants in pregnancy were studied. At last, among the 55 selected plants effective on hyperlipidemia and examined for pregnancy, we reported 12 herbs with their dosage and special considerations that can be used to treat hyperlipidemia during pregnancy. CONCLUSION: Some medicinal plants can be used to treat hyperlipidemia during pregnancy without any significant side effects both on mother or fetus. 

  6. Chinese Herbal Medicine for Acute Mountain Sickness: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Jie Wang

    2013-01-01

    Full Text Available Objectives. We aimed to assess the current clinical evidence of Chinese herbal medicine for AMS. Methods. Seven electronic databases were searched until January 2013. We included randomized clinical trials testing Chinese herbal medicine against placebo, no drugs, Western drugs, or a combination of routine treatment drugs against routine treatment drugs. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Results. Nine randomized trials were included. The methodological quality of the included trials was evaluated as low. Two trials compared prescriptions of Chinese formula used alone with Western drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −2.23 [−3.98, −0.49], P=0.01. Only one trial compared prescriptions of Chinese formula used alone with no drugs. A meta-analysis showed a significant beneficial effect in decreasing the score of AMS (MD: −6.00 [−6.45, −5.55], P<0.00001. Four trials compared Chinese formula used alone with placebo. A meta-analysis also showed a significant beneficial effect in decreasing the score of AMS (MD: −1.10 [−1.64, −0.55], P<0.0001. Two trials compared the combination of Chinese formula plus routine treatment drugs with routine treatment drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −5.99 [−11.11, −0.86], P=0.02. Conclusions. No firm conclusion on the effectiveness and safety of Chinese herbal medicine for AMS can be made. More rigorous high-quality trials are required to generate a high level of evidence and to confirm the results.

  7. Librarian co-authors correlated with higher quality reported search strategies in general internal medicine systematic reviews.

    Science.gov (United States)

    Rethlefsen, Melissa L; Farrell, Ann M; Osterhaus Trzasko, Leah C; Brigham, Tara J

    2015-06-01

    To determine whether librarian and information specialist authorship was associated with better reported systematic review (SR) search quality. SRs from high-impact general internal medicine journals were reviewed for search quality characteristics and reporting quality by independent reviewers using three instruments, including a checklist of Institute of Medicine Recommended Standards for the Search Process and a scored modification of the Peer Review of Electronic Search Strategies instrument. The level of librarian and information specialist participation was significantly associated with search reproducibility from reported search strategies (Χ(2) = 23.5; P Librarian co-authored SRs had significantly higher odds of meeting 8 of 13 analyzed search standards than those with no librarian participation and six more than those with mentioned librarian participation. One-way ANOVA showed that differences in total search quality scores between all three groups were statistically significant (F2,267 = 10.1233; P librarian or information specialist co-authors are correlated with significantly higher quality reported search strategies. To minimize bias in SRs, authors and editors could encourage librarian engagement in SRs including authorship as a potential way to help improve documentation of the search strategy. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. 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.

  9. 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

  10. Systematic review of efficacy for manual lymphatic drainage techniques in sports medicine and rehabilitation: an evidence-based practice approach.

    Science.gov (United States)

    Vairo, Giampietro L; Miller, Sayers John; McBrier, Nicole M; Buckley, William E

    2009-01-01

    Manual therapists question integrating manual lymphatic drainage techniques (MLDTs) into conventional treatments for athletic injuries due to the scarcity of literature concerning musculoskeletal applications and established orthopaedic clinical practice guidelines. The purpose of this systematic review is to provide manual therapy clinicians with pertinent information regarding progression of MLDTs as well as to critique the evidence for efficacy of this method in sports medicine. We surveyed English-language publications from 1998 to 2008 by searching PubMed, PEDro, CINAHL, the Cochrane Library, and SPORTDiscus databases using the terms lymphatic system, lymph drainage, lymphatic therapy, manual lymph drainage, and lymphatic pump techniques. We selected articles investigating the effects of MLDTs on orthopaedic and athletic injury outcomes. Nine articles met inclusion criteria, of which 3 were randomized controlled trials (RCTs). We evaluated the 3 RCTs using a validity score (PEDro scale). Due to differences in experimental design, data could not be collapsed for meta-analysis. Animal model experiments reinforce theoretical principles for application of MLDTs. When combined with concomitant musculoskeletal therapy, pilot and case studies demonstrate MLDT effectiveness. The best evidence suggests that efficacy of MLDT in sports medicine and rehabilitation is specific to resolution of enzyme serum levels associated with acute skeletal muscle cell damage as well as reduction of edema following acute ankle joint sprain and radial wrist fracture. Currently, there is limited high-ranking evidence available. Well-designed RCTs assessing outcome variables following implementation of MLDTs in treating athletic injuries may provide conclusive evidence for establishing applicable clinical practice guidelines in sports medicine and rehabilitation.

  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. Application of plant metabonomics in quality assessment for large-scale production of traditional Chinese medicine.

    Science.gov (United States)

    Ning, Zhangchi; Lu, Cheng; Zhang, Yuxin; Zhao, Siyu; Liu, Baoqin; Xu, Xuegong; Liu, Yuanyan

    2013-07-01

    The curative effects of traditional Chinese medicines are principally based on the synergic effect of their multi-targeting, multi-ingredient preparations, in contrast to modern pharmacology and drug development that often focus on a single chemical entity. Therefore, the method employing a few markers or pharmacologically active constituents to assess the quality and authenticity of the complex preparations has a number of severe challenges. Metabonomics can provide an effective platform for complex sample analysis. It is also reported to be applied to the quality analysis of the traditional Chinese medicine. Metabonomics enables comprehensive assessment of complex traditional Chinese medicines or herbal remedies and sample classification of diverse biological statuses, origins, or qualities in samples, by means of chemometrics. Identification, processing, and pharmaceutical preparation are the main procedures in the large-scale production of Chinese medicinal preparations. Through complete scans, plants metabonomics addresses some of the shortfalls of single analyses and presents a considerable potential to become a sharp tool for traditional Chinese medicine quality assessment. Georg Thieme Verlag KG Stuttgart · New York.

  13. 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.

  14. Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.

    Science.gov (United States)

    Pai, Sarayu A; Kshirsagar, Nilima A

    2016-11-01

    With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR). Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries. Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

  15. 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

    Ecodesign is a proactive environmental management approach employed in the product development process (PDP) which aims to minimize the environmental impacts caused during products’ life-cycle, improving its environmental performance. The establishment of measurable environmental performance...

  16. 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...... operations. This integration of manufacturing and service business holds a number of potential advantages, such as optimised operational performance and improved insights into use phase processes. To realise these potential advantages, products and service operations must fit to and support each other, which...... calls for an integrated approach to their development. The integrated development of solution concepts spanning products, service delivery systems and matching delivery business models is the theme of this thesis. A design based approach - service oriented product development - is proposed...

  17. Complementary medicine, self-help, and lifestyle interventions for obsessive compulsive disorder (OCD) and the OCD spectrum: a systematic review.

    Science.gov (United States)

    Sarris, Jerome; Camfield, David; Berk, Michael

    2012-05-01

    In Obsessive Compulsive Disorder (OCD) current standard pharmacotherapies may be of limited efficacy. Non-conventional interventions such as Complementary and Alternative Medicine (CAM), self-help techniques, and lifestyle interventions are commonly used by sufferers of OCD, however to date no systematic review of this specific area exists. We conducted a systematic review of studies using CAM, self-help, and lifestyle interventions for treatment of OCD and trichotillomania (TTM). PubMed, PsycINFO, China Academic Journals Full-text Database, The Cochrane Library and CINAHL were searched (up to Jan 11th 2011), for controlled clinical trials using non-conventional interventions for OCD. A quality analysis using a purpose-designed scale and an estimation of effect sizes (Cohen's d) where data was available, were also calculated. The literature search revealed 14 studies that met inclusion criteria. Methodological quality of nutraceutical studies (nutrients and herbal medicines) were rated as high (mean 8.6/10), whereas mind-body or self-help studies were poorer (mean 6.1/10). In OCD, tentative evidentiary support from methodologically weak studies was found for mindfulness meditation (d=0.63), electroacupuncture (d=1.16), and kundalini yoga (d=1.61). Better designed studies using the nutrient glycine (d=1.10), and traditional herbal medicines milk thistle (insufficient data for calculating d) and borage (d=1.67) also revealed positive results. A rigorous study showed that N-acetylcysteine (d=1.31) was effective in TTM, while self-help technique "movement decoupling" also demonstrated efficacy (d=0.94). Mixed evidence was found for myo-inositol (mean d=0.98). Controlled studies suggest that St John's wort, EPA, and meridian-tapping are ineffective in treating OCD. While several studies were positive, these were un-replicated and commonly used small samples. This precludes firm confidence in the strength of clinical effect. Preliminary evidence however is encouraging

  18. Does the scientific evidence support the advertising claims made for products containing Lactobacillus casei and Bifidobacterium lactis? A systematic review.

    Science.gov (United States)

    Meléndez-Illanes, Lorena; González-Díaz, Cristina; Chilet-Rosell, Elisa; Álvarez-Dardet, Carlos

    2016-09-01

    To analyse the scientific evidence that exists for the advertising claims made for two products containing Lactobacillus casei and Bifidobacterium lactis and to conduct a comparison between the published literature and what is presented in the corporate website. Systematic review, using Medline through Pubmed and Embase. We included human clinical trials that exclusively measured the effect of Lactobacillus casei or Bifidobacterium lactis on a healthy population, and where the objective was related to the health claims made for certain products in advertising. We assessed the levels of evidence and the strength of the recommendation according to the classification criteria established by the Oxford Centre for Evidence Based Medicine (CEBM). We also assessed the outcomes of the studies published on the website that did not appear in the search. Of the 440 articles identified, 16 met the inclusion criteria. Only four (25%) of these presented a level of evidence of 1b and a recommendation grade of A, all corresponding to studies on product containing Bifidobacterium lactis, and only 12 of the 16 studies were published on the corporate website (47). There is insufficient scientific evidence to support the health claims made for these products, especially in the case of product containing Lactobacillus casei. © The Author 2015. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  19. 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.

  20. 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

  1. 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.

    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,

  2. 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

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

    DEFF Research Database (Denmark)

    Cignitti, Stefano; Zhang, Lei; Kalakul, Sawitree

    -physical property needs and the process/application needs. Process/application and property needs are connected through an analysis of the property influence on the process/application models and thermodynamic relations. The sustainability is considered through product and process/application performance, economics......-designing demand increased sustainability and minimal trade-off with system performance. In the CAPD formulation, the product properties are related to the needs of heat pump cycle and its components through sensitivity analysis of the thermodynamic models and energy balances of the system. Furthermore, simple...... models are included for efficient assessment of the sustainability and design criteria of both the cycle and its components. It will be demonstrated that the working fluid product designed is optimal with respect to the sustainability and the heat pump cycle performance....

  4. 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.

  5. 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

  6. Systematics of new isotopic production cross sections from neon projectiles

    International Nuclear Information System (INIS)

    Chen, C.X.; Guzik, T.G.; McMahon, M.; Wefel, J.P.; Flores, I.; Lindstrom, P.J.; Tull, C.E.; Mitchell, J.W.; Cronqvist, M.; Crawford, H.J.

    1996-02-01

    New isotopic production cross sections from 22 Ne projectiles at 377,581 and 891 MeV/nucleon in a liquid hydrogen target have been measured. These data allow to investigate the projectile energy and nuclear composition dependence of the cross sections. The comparisons between data and predictions can have important consequences in source abundance investigations. (K.A.)

  7. Systematics of new isotopic production cross sections from neon projectiles

    Energy Technology Data Exchange (ETDEWEB)

    Chen, C X; Guzik, T G; McMahon, M; Wefel, J P [Louisiana State Univ., Baton Rouge, LA (United States); Flores, I; Lindstrom, P J; Tull, C E [Lawrence Berkeley Lab., CA (United States); Mitchell, J W [National Aeronautics and Space Administration, Greenbelt, MD (United States). Goddard Space Flight Center; Cronqvist, M; Crawford, H J [California Univ., Berkeley, CA (United States). Space Sciences Lab.; and others

    1996-02-01

    New isotopic production cross sections from {sup 22}Ne projectiles at 377,581 and 891 MeV/nucleon in a liquid hydrogen target have been measured. These data allow to investigate the projectile energy and nuclear composition dependence of the cross sections. The comparisons between data and predictions can have important consequences in source abundance investigations. (K.A.). 9 refs.

  8. 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.

  9. The Opportunities Map at Cornell University: finding direction in dairy production medicine.

    Science.gov (United States)

    Mitchell, Hilda M; Nydam, Daryl V; Reyher, Kristen; Gilbert, Robert O

    2004-01-01

    Discussion between faculty and interested students revealed the existence of a multitude of opportunities in dairy production medicine at the College of Veterinary Medicine at Cornell University. Many of these were not well known to students, or even to some of the faculty, and the means of accessing specific learning experiences were sometimes obscure. Together, an informal group of faculty, students, and alumni set about cataloging available educational opportunities, resulting in a 31-page publication referred to as the "Opportunities Map." Essentially a student handbook for production medicine students, the Opportunities Map at Cornell helps guide the travel of food animal-interested students through the curriculum without missing the important highlights along the way. The map was originally developed to chronicle the opportunities and resources available to students, but it has also been used to foster face-to-face communications between students and faculty, to welcome incoming students with production animal interests, and to provide a baseline description for further discussion about the curriculum.

  10. 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.

  11. 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

  12. 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

  13. Correlation between Traditional Chinese Medicine Constitution and Dyslipidemia: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Ye-lin Ma

    2017-01-01

    Full Text Available Objective. To study the correlation between Traditional Chinese Medicine (TCM constitution and dyslipidemia. Methods. CNKI, VIP, Wanfang database, CBMdisc, PubMed, and Embase were searched, and meta-analysis was performed by Review Manager 5.2 software. Results. Altogether 11 studies were included with 12890 individuals. The results showed that balanced constitution was a protective factor of dyslipidemia (OR = 0.62, 95% CI 0.47~0.82 while phlegm-dampness constitution was a risk factor of it (OR = 2.50, 95% CI 2.22~2.80, and the effect of phlegm-dampness constitution in South China (OR = 3.31, 95% CI 1.71~6.43 was more obvious than that in East (OR = 2.40, 95% CI 2.06~2.80 and North China (OR = 2.24, 95% CI 1.81~2.78. Conclusion. This study provides evidence for the prevention and treatment of dyslipidemia in TCM. However, most of the studies included are of moderate quality; more high quality, multicenter, large-sample studies are expected to provide higher level evidence.

  14. The production and recovery of 77Br at Los Alamos for nuclear medicine studies

    International Nuclear Information System (INIS)

    Grant, P.M.; Whipple, R.E.; Barnes, J.W.; Bentley, G.E.; Wanek, P.M.; O'Brien, H.A. Jr.

    1981-01-01

    A procedure for the synthesis and isolation of 77 Br for nuclear medicine research has been developed at LASL. Metallic Mo targets are irradiated at LAMPF with medium-energy protons at high beam current. Following dissolution, volatilization, precipitation, and ion exchange techniques, 77 Br is recovered with a (91 +- 7)% chemical yield and is completely free of all other radioactive species with the exception of small levels of 76 Br and 82 Br. Ci-quantity production capabilities have been demonstrated, and the product is proving successful for the labelling of diverse radiopharmaceuticals. Future improvements in the process are also discussed. (author)

  15. 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.

  16. 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.

  17. Systematic Review on the Efficacy and Safety of Herbal Medicines for Vascular Dementia

    Directory of Open Access Journals (Sweden)

    Sui Cheung Man

    2012-01-01

    Full Text Available We present a systematic review of existing research that aims to assess the efficacy and safety of herbal medications (HM, as either monotherapy or adjunct to orthodox medications (OM, mainly comprised of cholinesterase inhibitors, for vascular dementia (VaD. We included 47 studies conducted in mainland China, each testing different HM. Of 43 HM monotherapy studies, 37 reported HM to be significantly better than OM or placebo; six reported similar efficacy between HM and OM. All four HM adjuvant studies reported significant efficacy. No major adverse events for HM were reported. Heterogeneity in diagnostic criteria, interventions and outcome measures hindered comprehensive data analysis. Studies suggested that HM can be a safe and effective treatment for VaD, either alone or in conjunction with OM. However, methodological flaws in the design of the studies limited the extent to which the results could be interpreted. Thirty most commonly used herbal constituents, including Rhizoma Chuanxiong (Chuanxiong in Chinese, Radix Polygoni Multiflori (Heshouwu in Chinese and Radix Astragali (Huangqi in Chinese. were ranked. Further multi-center trials with large sample sizes, high methodological quality and standardized HM ingredients are necessary for clinical recommendations to be made.

  18. 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.

  19. 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.

  20. Use and Acceptance of Complementary and Alternative Medicine Among the General Population and Medical Personnel: A Systematic Review

    Science.gov (United States)

    Frass, Michael; Strassl, Robert Paul; Friehs, Helmut; Müllner, Michael; Kundi, Michael; Kaye, Alan D.

    2012-01-01

    Background The interest in complementary and alternative medicine (CAM) has increased during the past decade and the attitude of the general public is mainly positive, but the debate about the clinical effectiveness of these therapies remains controversial among many medical professionals. Methods We conducted a systematic search of the existing literature utilizing different databases, including PubMed/Medline, PSYNDEX, and PsycLit, to research the use and acceptance of CAM among the general population and medical personnel. A special focus on CAM-referring literature was set by limiting the PubMed search to “Complementary Medicine” and adding two other search engines: CAMbase (www.cambase.de) and CAMRESEARCH (www.camresearch.net). These engines were used to reveal publications that at the time of the review were not indexed in PubMed. Results A total of 16 papers met the scope criteria. Prevalence rates of CAM in each of the included studies were between 5% and 74.8%. We found a higher utilization of homeopathy and acupuncture in German-speaking countries. Excluding any form of spiritual prayer, the data demonstrate that chiropractic manipulation, herbal medicine, massage, and homeopathy were the therapies most commonly used by the general population. We identified sex, age, and education as predictors of CAM utilization: More users were women, middle aged, and more educated. The ailments most often associated with CAM utilization included back pain or pathology, depression, insomnia, severe headache or migraine, and stomach or intestinal illnesses. Medical students were the most critical toward CAM. Compared to students of other professions (ie, nursing students: 44.7%, pharmacy students: 18.2%), medical students reported the least consultation with a CAM practitioner (10%). Conclusions The present data demonstrate an increase of CAM usage from 1990 through 2006 in all countries investigated. We found geographical differences, as well as differences between

  1. External Application of Traditional Chinese Medicine for Venous Ulcers: A Systematic Review and Meta-Analysis

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    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.

  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. 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

  4. 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.

  5. [The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

    Science.gov (United States)

    Berger, A; Schüle, S; Flory, E

    2011-07-01

    Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

  6. 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

  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. 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.

  9. Condensed tannins in extracts from European medicinal plants and herbal products.

    Science.gov (United States)

    Ropiak, Honorata M; Ramsay, Aina; Mueller-Harvey, Irene

    2016-03-20

    Medicinal plant materials are not usually analysed for condensed tannins (CT). Thirty commercially available European medicinal plants and herbal products were screened for CT and fourteen CT samples were analysed in detail. This is also the first comprehensive CT analysis of pine buds, walnut leaves, heather flowers and great water dock roots. Acetone/water extracts contained between 3.2 and 25.9 g CT/100g of extract, had CT with mean degrees of polymerisation of 2.9 to 13.3, procyanidin/prodelphinidin ratios of 1.6/98.4 to 100/0 and cis/trans flavan-3-ol ratios of 17.7/82.3 to 97.3/2.7. The majority of samples contained procyanidins, four contained A-type linkages (blackthorn flowers, heather flowers, bilberry leaves and cowberry leaves) and one sample also had galloylated procyanidins (great water dock roots). Copyright © 2015 Elsevier B.V. All rights reserved.

  10. The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.

    Science.gov (United States)

    Rafiq, Qasim A; Ortega, Ilida; Jenkins, Stuart I; Wilson, Samantha L; Patel, Asha K; Barnes, Amanda L; Adams, Christopher F; Delcassian, Derfogail; Smith, David

    2015-11-01

    Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.

  11. 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…

  12. 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.

  13. Does the development of new medicinal products in the European Union address global and regional health concerns?

    Directory of Open Access Journals (Sweden)

    Álvarez-Martín Elena

    2010-12-01

    Full Text Available Abstract Background Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective. Methods We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs in the European Union and worldwide. Results We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005 in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030 and worldwide (ρ = 0.490, p = 0.033. The most neglected conditions at the European level (based on their attributable health losses were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases. Conclusions We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this

  14. 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

    2018-08-01

    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.

  15. Shengmai Injection, a Traditional Chinese Patent Medicine, for Intradialytic Hypotension: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Chao-yang Chen

    2013-01-01

    Full Text Available Intradialytic hypotension (IDH is a global public health problem. A rising number of IDH sufferers resort to Chinese patent medicine, Shengmai Injection (SMI in China. The objectives of present study are to assess the effectiveness and safety of SMI as an adjunct therapy for IDH. A systematic search of 6 medical databases was performed up to December 2011. Randomized trials involving SMI adjuvant therapy versus conventional therapy were identified. RevMan 5.0 was used for data analysis. Ten randomized clinical trials with 437 participants were identified. Methodological quality was considered inadequate in all trials. Compared with conventional therapy, SMI adjunct therapy showed significant effects in improving the clinic effective rate (P<0.01, decreasing the incidence of IDH episode (P<0.01, decreasing the frequency of nursing interventions (P<0.01, and increasing diastolic blood pressure (P<0.01. There was no statistical significance in the improvement of mean arterial pressure (P=0.22 and systolic blood pressure (P=0.08 between two groups. Four studies had mentioned adverse events, but no serious adverse effects were reported in any of the included trials. In conclusion, SMI adjunct therapy appears to be potentially effective in treatment of IDH and is generally safe. However, further rigorous designed trials are needed.

  16. Shengmai injection, a traditional chinese patent medicine, for intradialytic hypotension: a systematic review and meta-analysis.

    Science.gov (United States)

    Chen, Chao-Yang; Lu, Ling-Yan; Chen, Peng; Ji, Kang-Ting; Lin, Jia-Feng; Yang, Peng-Lin; Tang, Ji-Fei; Wang, Yan

    2013-01-01

    Intradialytic hypotension (IDH) is a global public health problem. A rising number of IDH sufferers resort to Chinese patent medicine, Shengmai Injection (SMI) in China. The objectives of present study are to assess the effectiveness and safety of SMI as an adjunct therapy for IDH. A systematic search of 6 medical databases was performed up to December 2011. Randomized trials involving SMI adjuvant therapy versus conventional therapy were identified. RevMan 5.0 was used for data analysis. Ten randomized clinical trials with 437 participants were identified. Methodological quality was considered inadequate in all trials. Compared with conventional therapy, SMI adjunct therapy showed significant effects in improving the clinic effective rate (P < 0.01), decreasing the incidence of IDH episode (P < 0.01), decreasing the frequency of nursing interventions (P < 0.01), and increasing diastolic blood pressure (P < 0.01). There was no statistical significance in the improvement of mean arterial pressure (P = 0.22) and systolic blood pressure (P = 0.08) between two groups. Four studies had mentioned adverse events, but no serious adverse effects were reported in any of the included trials. In conclusion, SMI adjunct therapy appears to be potentially effective in treatment of IDH and is generally safe. However, further rigorous designed trials are needed.

  17. 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

  18. 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

  19. [The use of medicinal products "off-label use" in the pediatric population--the border risk, or reasonable diligence?].

    Science.gov (United States)

    Zajdel, Justyna

    2011-01-01

    Any medicinal product marketed in the country has its registration, under which are strictly defined indications and the extent to which a product can be used. It is of significance that the use of the product which is registered in the given range produces an effect similar to or identical to that effect, which is obtained after applying the product having a registration in a given indication. Relied on to justify the use of a medicinal product or medical product "off-label use" in Poland, there is also the fact that the same product has a registration in a particular indication in another EU member state or outside the Community. It is worth noting that the medicinal product may be used in therapeutic management of omitting or reducing the principles resulting from the SPC. However, this applies only to cases where the use of the medicinal product "off-label use" dictated by the necessity of saving life or health of the patient, and the previous ways and methods of treatment with the use of registered medicines have proved ineffective or insufficient to achieve the desired therapeutic effect.

  20. 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....

  1. 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.

  2. 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)

  3. Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders

    Science.gov (United States)

    Ianiro, Gianluca; Pecere, Silvia; Bibbò, Stefano; Cammarota, Giovanni

    2016-01-01

    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. Linked Articles 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

  4. Reactor production and processing of radioisotopes for therapeutic applications in nuclear medicine

    International Nuclear Information System (INIS)

    Knapp, F.F. Jr.; Mirzadeh, S.; Beets, A.L.

    1995-01-01

    Nuclear reactors continue to play an important role in providing radioisotopes for nuclear medicine. Many reactor-produced radioisotopes are ''neutron rich'' and decay by beta-emission and are thus of interest for therapeutic applications. This talk discusses the production and processing of a variety of reactor-produced radioisotopes of current interest, including those produced by the single neutron capture process, double neutron capture and those available from beta-decay of reactorproduced radioisotopes. Generators prepared from reactorproduced radioisotopes are of particular interest since repeated elution inexpensively provides many patient doses. The development of the alumina-based W-188/Re-188 generator system is discussed in detail

  5. 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

  6. 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.

  7. Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children.

    Science.gov (United States)

    Hawke, Kate; van Driel, Mieke L; Buffington, Benjamin J; McGuire, Treasure M; King, David

    2018-04-09

    Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs each year. Although these infections are self limiting, the symptoms can be distressing. Many treatments are used to control symptoms and shorten the duration of illness. They often have minimal benefit and may lead to adverse effects. Oral homeopathic medicinal products could play a role in the treatment of ARTIs for children if evidence for effectiveness is established. To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections in children. We searched CENTRAL (2017, Issue 11), which contains the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 27 November 2017), Embase (2010 to 27 November 2017), CINAHL (1981 to 27 November 2017), AMED (1985 to December 2014), CAMbase (searched 29 March 2018), British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov trials registers (29 March 2018), checked references, and contacted study authors to identify additional studies. Double-blind, randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years. We used standard methodological procedures expected by Cochrane. We included eight RCTs of 1562 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for upper respiratory tract infections (URTIs). Four treatment studies examined the effect on recovery from URTIs, and four studies investigated the effect on preventing URTIs after one to three months of treatment and followed up for the remainder of the year. Two treatment and two prevention studies

  8. Hospital structure and technical efficiency in the production of nuclear medicine. Doctoral thesis

    International Nuclear Information System (INIS)

    Wilson, G.W.

    1976-01-01

    The relationship of hospital structure to production efficiency is explored. The hospital subindustry on which this research centers is nuclear medicine. The hypotheses generated were that technical efficiency is reduced by increased competitive intensity, by a lack of profit incentive, by a broader service range, and by in-house training of technical personnel. Most data employed in the study were gathered from the American College of Radiology and the Energy Research and Development Administration Census of Nuclear Medicine. More specific information came from questionnaires sent to 2,050 short-term general hospitals known to have a nuclear medicine facility. Of the responses 1,362 were usable for the study. A major study finding was that over half of the variations observed in technical efficiency were attributable to the structural elements being studied. The research indicated that competition for staff physicians has a role in reducing technical efficiency; that the output effect of in-house manpower training was relatively unimportant; and that profit incentives do have a significant impact. It is suggested that increased technical efficiency could be achieved through reduced competitive intensity, stronger profit orientation, and reduced service range. A bibliography is included

  9. 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.

  10. 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.

  11. In vitro propagation and withaferin A production in Withania ashwagandha, a rare medicinal plant of India.

    Science.gov (United States)

    Mir, Bilal Ahmad; Mir, Shabir Ahmad; Koul, Sushma

    2014-07-01

    Withania ashwagandha, belonging to the family Solanaceae, is an important medicinal herb of India with restricted geographic distribution. It is a rich source of withaferin A (WA) and other bioactive withanolides. In the present study a rapid in vitro mass propagation protocol of W. ashwagandha was developed from nodal explants. Nodal explants were cultured on MS medium supplemented with various concentrations and combinations of plant growth regulators (PGRs). The highest number of regenerated shoots per ex-plant (33 ± 2.7) and highest WA (13.4 ± 1.15 mg/g of DW) production was obtained on MS medium supplemented with 5.0 μM 6-benzyladenine (BA) and 1.0 μM Kinetin (Kn). In vitro raised shoots were further rooted on half-strength MS medium containing 2.0 μM Indole-3-butyric acid (IBA) and analyzed for WA production. The rooted plantlets when transferred to poly bags in the greenhouse showed 90 % survival frequency. Levels of WA were higher in the in vitro and ex vitro derived shoot and root tissues as compared to field grown mother plants. In an attempt to further maximize WA production, shoot cultures were further grown in liquid MS medium supplemented with 5.0 μM 6-benzyladenine (BA) and 1.0 μM Kinetin (Kn). Root cultures were grown on half strength MS liquid medium fortified with 2.0 μM of IBA. WA production in the liquid cultures was significantly higher compared to the static composition of the same media. This protocol, first of its kind in this plant, can be successfully employed for conservation, proliferation and large-scale production of WA. The regenerated plants can also be used in traditional medicine as an alternative to naturally collected plants.

  12. 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

  13. Efficacy and safety of traditional Chinese medicine for the treatment of acquired immunodeficiency syndrome: a systematic review.

    Science.gov (United States)

    Deng, Xin; Jiang, Manjun; Zhao, Xiaofang; Liang, Jian

    2014-02-01

    To systematically review the efficacy and safety of Traditional Chinese Medicine (TCM) interventions, compared with control interventions (placebo or conventional Western medical therapy), in the treatment of acquired immunodeficiency syndrome (AIDS). Electronic databases including PubMed, the Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang Data were searched to identify relevant randomized controlled trials (RCTs) published as of May 2012. Studies were selected according to the specified inclusion and exclusion criteria and then subjected to methodological quality assessment, data extraction, and meta-analysis according to the Cochrane Handbook for Systematic Reviews of Interventions. Twelve RCTs involving 881 patients with AIDS were included. Methodological quality assessment showed that two were high-quality, two were moderate-quality, and eight were low-quality. Meta-analysis showed that TCM interventions were associated with significantly reduced plasma viral load compared with placebo [odds ratio OR = 2.46, 95% confidence interval CI (1.02, 5.94); P = 0.04]. However, the reductions in plasma viral load significantly favored conventional Western medical therapy alone over integrated traditional Chinese and Western medical therapy [OR = 0.16, 95% CI (0.05, 0.55); P = 0.004]. Patients receiving TCM interventions had significantly higher CD4+ T lymphocyte counts compared with those on placebo [OR = 2.54, 95% CI (1.40, 4.60); P = 0.002]. In addition, TCM interventions were significantly more likely to have improved clinical symptoms [OR = 2.82, 95% CI (1.85, 4.31); P risk of adverse events (AEs) compared with control interventions [OR = 1.87, 95% CI (0.58, 6.01); P = 0.29]. Current evidence suggests that TCM interventions are significantly more effective than placebo in reducing plasma viral load and increasing CD4+ T lymphocyte count in patients with AIDS. When compared with conventional Western medical therapy, TCM interventions

  14. 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

  15. Chinese patent medicines for the treatment of the common cold: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Chen, Wei; Liu, Bo; Wang, Li-qiong; Ren, Jun; Liu, Jian-ping

    2014-07-30

    Many Chinese patent medicines (CPMs) have been authorized by the Chinese State of Food and Drug Administration for the treatment of the common cold. A number of clinical trials have been conducted and published. However, there is no systematic review or meta-analysis on their efficacy and safety for the common cold to justify their clinical use. We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites for published and unpublished randomized clinical trials (RCTs) of CPMs for the common cold till 31 March 2013. Revman 5.2 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). A total of five RCTs were identified. All of the RCTs were of high risk of bias with flawed study design and poor methodological quality. All RCTs included children aged between 6 months to 14 years. Results of individual trials showed that Shuanghuanglian oral liquid (RR 4.00; 95% CI: 2.26 to 7.08), and Xiaoer Resuqing oral liquid (RR 1.43; 95% CI: 1.15 to 1.77) had higher cure rates compared with antivirus drugs. Most of the trials did not report adverse events, and the safety of CPMs was still uncertain. Some CPMs showed a potential positive effect for the common cold on cure rate. However, due to the poor methodology quality and the defects in the clinical design of the included RCTs, such as the lack of placebo controlled trials, the inappropriate comparison intervention and outcome measurement, the confirmative conclusions on the beneficial effect of CPMs for the common cold could not be drawn.

  16. Wenjing decoction (herbal medicine) for the treatment of primary dysmenorrhea: a systematic review and meta-analysis.

    Science.gov (United States)

    Gao, Li; Jia, Chunhua; Zhang, Heng; Ma, Cuilan

    2017-10-01

    Wenjing decoction is a well-accepted traditional Chinese medicine for the treatment of primary dysmenorrhea in East Asia, but its clinical effectiveness and risk have not been adequately assessed. In this paper, we conducted a systematic review and meta-analysis to evaluate the efficacy of Wenjing decoction for the treatment of primary dysmenorrhea. Eight databases were used in our research: the Cochrane Library, the Web of Science, PubMed, EMBASE, the Chinese Biomedical Literature Database (CBM), the Chinese National Knowledge Infrastructure (CNKI), the Chinese Scientific Journal Database, and the Wan-fang Database. The following search terms were used: (Wenjing decoction OR Wenjing formula OR Wenjing tang) AND (primary dysmenorrhea OR dysmenorrhea OR painful menstruation) AND (randomized controlled trial). No language limitation was used. A total of 18 studies, including 1736 patients, were included in the meta-analysis. Wenjing decoction was shown to be significantly better than nonsteroidal anti-inflammatory drugs for the improvement of primary dysmenorrhea according to the clinical effective rate (RR 1.41, 95% CI 1.24-1.61), the visual analogue scale (MD -1.77, 95% CI -2.69 to -0.84), and the pain scale for dysmenorrhea (MD -1.81, 95% CI -2.41 to -1.22). The results supported the clinical use of Wenjing decoction for the treatment of primary dysmenorrhea. However, the quality of the evidence for this finding was low due to a high risk of bias in the included studies. Therefore, well-designed randomized controlled trials are still needed to further evaluate the efficacy of Wenjing decoction for the treatment of primary dysmenorrhea.

  17. Effectiveness of traditional Chinese medicine as an adjunct therapy for Parkinson's disease: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Guoxin Zhang

    Full Text Available Idiopathic Parkinson disease (PD is a common neurodegenerative disease that seriously hinders limb activities and affects patients' lives. We performed a meta-analysis aiming to systematically review and quantitatively synthesize the efficacy and safety of traditional Chinese medicine (TCM as an adjunct therapy for clinical PD patients.An electronic search was conducted in PubMed, Cochrane Controlled Trials Register, China National Knowledge Infrastructure, Chinese Scientific Journals Database and Wanfang data to identify randomized trials evaluating TCM adjuvant therapy versus conventional treatment. The change from baseline of the Unified Parkinson's Disease Rating Scale score (UPDRS was used to estimate the effectiveness of the therapies.Twenty-seven articles involving 2314 patients from 1999 to 2013 were included. Potentially marked improvements were shown in UPDRS I (SMD 0.68, 95%CI 0.38, 0.98, II (WMD 2.41, 95%CI 1.66, 2.62, III (WMD 2.45, 95%CI 2.03, 2.86, IV (WMD 0.32, 95%CI 0.15, 049 and I-IV total scores (WMD 6.18, 95%CI 5.06, 7.31 in patients with TCM plus dopamine replacement therapy (DRT compared to DRT alone. Acupuncture add-on therapy was markedly beneficial for improving the UPDRS I-IV total score of PD patients (WMD 10.96, 95%CI 5.85, 16.07. However, TCM monotherapy did not improve the score. The effectiveness seemed to be more obvious in PD patients with longer adjunct durations. TCM adjuvant therapy was generally safe and well tolerated.Although the data were limited by methodological flaws in many studies, the evidence indicates the potential superiority of TCM as an alternative therapeutic for PD treatment and justifies further high-quality studies.

  18. 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.

  19. 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.

  20. 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.

  1. Three-Dimensional Printing of Medicinal Products and the Challenge of Personalized Therapy.

    Science.gov (United States)

    Zema, Lucia; Melocchi, Alice; Maroni, Alessandra; Gazzaniga, Andrea

    2017-07-01

    By 3-dimensional (3D) printing, solid objects of any shape are fabricated through layer-by-layer addition of materials based on a digital model. At present, such a technique is broadly exploited in many industrial fields because of major advantages in terms of reduced times and costs of development and production. In the biomedical and pharmaceutical domains, the interest in 3D printing is growing in step with the needs of personalized medicine. Printed scaffolds and prostheses have partly replaced medical devices produced by more established techniques, and more recently, 3D printing has been proposed for the manufacturing of drug products. Notably, the availability of patient-tailored pharmaceuticals would be of utmost importance for children, elderly subjects, poor and high metabolizers, and individuals undergoing multiple drug treatments. 3D printing encompasses a range of differing techniques, each involving advantages and open issues. Particularly, solidification of powder, extrusion, and stereolithography have been applied to the manufacturing of drug products. The main challenge to their exploitation for personalized pharmacologic therapy is likely to be related to the regulatory issues involved and to implementation of production models that may allow to efficiently turn the therapeutic needs of individual patients into small batches of appropriate drug products meeting preset quality requirements. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  2. Medicinal Plants Based Products Tested on Pathogens Isolated from Mastitis Milk

    Directory of Open Access Journals (Sweden)

    Claudia Pașca

    2017-09-01

    Full Text Available Bovine mastitis a major disease that is commonly associated with bacterial infection. The common treatment is with antibiotics administered intramammary into infected quarters of the udder. The excessive use of antibiotics leads to multidrug resistance and associated risks for human health. In this context, the search for alternative drugs based on plants has become a priority in livestock medicine. These products have a low manufacturing cost and no reports of antimicrobial resistance to these have been documented. In this context, the main objective of this study was to determine the antimicrobial effect of extracts and products of several indigenous, or acclimatized plants on pathogens isolated from bovine mastitis. A total of eleven plant alcoholic extracts and eight plant-derived products were tested against 32 microorganisms isolated from milk. The obtained results have shown an inhibition of bacterial growth for all tested plants, with better results for Evernia prunastri, Artemisia absinthium, and Lavandula angustifolia. Moreover, E. prunastri, Populus nigra, and L. angustifolia presented small averages of minimum inhibitory and bactericidal concentrations. Among the plant-derived products, three out of eight have shown a strong anti-microbial effect comparable with the effect of florfenicol and enrofloxacin, and better than individual plant extracts possibly due to synergism. These results suggest an important anti-microbial effect of these products on pathogens isolated from bovine mastitis with a possible applicability in this disease.

  3. Xanthine oxidase inhibitors from Archidendron clypearia (Jack.) I.C. Nielsen: Results from systematic screening of Vietnamese medicinal plants.

    Science.gov (United States)

    Duong, Nguyen Thuy; Vinh, Pham Duc; Thuong, Phuong Thien; Hoai, Nguyen Thi; Thanh, Le Nguyen; Bach, Tran The; Nam, Nguyen Hai; Anh, Nguyen Hoang

    2017-06-01

    To screen Vietnamese medicinal plants for xanthine oxidase (XO) inhibitory activity and to isolate XO inhibitor(s) from the most active plant. The plants materials were extracted by methanol. The active plant materials were fractionated using different organic solvents, including n-hexane, ethyl acetate, and n-butanol. Bioassay-guided fractionation and column chromatography were used to isolate compounds. The compounds structures were elucidated by analysis of spectroscopic data, including IR, MS, and NMR. Three hundreds and eleven methanol extracts (CME) belonging to 301 Vietnamese herbs were screened for XO inhibitory activity. Among these plants, 57 extracts displayed XO inhibitory activity at 100 μg/mL with inhibition rates of over 50%. The extracts of Archidendron clypearia (A. clypearia), Smilax poilanei, Linociera ramiflora and Passiflora foetida exhibited the greatest potency with IC 50 values below 30 μg/mL. Chemical study performed on the extract of A. clypearia resulted in the isolation of six compounds, including 1-octacosanol, docosenoic acid, daucosterol, methyl gallate, quercitrin and (-)-7-O-galloyltricetiflavan. The compound (-)-7-O-galloyltricetiflavan showed the most potent XO inhibitory activity with an IC 50 value of 25.5 μmol/L. From this investigation, four Vietnamese medicinal plants were identified to have XO inhibitory effects with IC 50 values of the methanol extracts below 30 μg/mL. Compound (-)-7-O- galloyltricetiflavan was identified as an XO inhibitor from A. clypearia with IC 50 value of 25.5 μmol/L. Copyright © 2017 Hainan Medical University. Production and hosting by Elsevier B.V. All rights reserved.

  4. 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.

  5. Structure, control and regulation of the formal market for medicinal plants' products in Nigeria.

    Science.gov (United States)

    Oguntade, Adegboyega E; Oluwalana, Isaac B

    2011-01-01

    There are informal and formal markets for medicinal plants' products in Nigeria. The formal market is subject to the national regulatory framework for Food and Drug Administration and Control. It is relatively new and underdeveloped. This study was designed to appraise this market with special emphasis on the market participants, market structure, marketing functions performed, conduct of sellers in the market and; standards and regulations to which the market is subject. Information used for this study was collected through personal interviews and interactions with key participants in the market; especially the officials of regulatory agency. The market structure was analysed in terms of the share of market controlled by participants and product types. Concentration Ratios (CR2 and CR4) were used to assess the market share. Marketing functions being performed were described in terms of the exchange, physical and facilitating functions while the conduct was described in terms of pricing and promotional strategies. The regulatory framework under which the market operates was appraised. The market was highly concentrated with a CR2 and CR4 of 58.5% and 80.8 %; respectively. Imported products accounted for only 12.3% of the market. The predominant modes of presentation of the product were capsule (41.6%) and liquid (36.2%). About 20.77% of the products were classified as multivitamins, 13.85% were antibiotics while 10.77% addressed sexual dysfunctional problems. These products were regulated under the Food and Drug Administration and Control (NAFDAC) decrees, 1993-1999. Only 2.3% of the products have received full registration status while the others were only listed.

  6. 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

  7. Giving information on medicinal products to the general public--in search of a definition to safeguard the patient.

    Science.gov (United States)

    Faeh, Andrea

    2014-04-01

    Information on medicinal products is vital for enabling patients to give informed consent to the use of a specific product. Within the European Union (EU) the debate about how much information about prescription-only medicinal products should be made available to patients has gone on for the past five years with no definite conclusion yet. This contribution assesses the current legislation and the ongoing debate in order to identify the challenges and the prospect of new legislation, and consider its potential implications for the scope for advertising and for patient safety.

  8. 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.

  9. Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal product manufacturing.

    Science.gov (United States)

    Grazzini, Giuliano; Ceccarelli, Anna; Calteri, Deanna; Catalano, Liviana; Calizzani, Gabriele; Cicchetti, Americo

    2013-09-01

    In Italy, the financial reimbursement for labile blood components exchanged between Regions is regulated by national tariffs defined in 1991 and updated in 1993-2003. Over the last five years, the need for establishing standard costs of healthcare services has arisen critically. In this perspective, the present study is aimed at defining both the costs of production of blood components and the related prices, as well as the prices of plasma-derived medicinal products obtained by national plasma, to be used for interregional financial reimbursement. In order to analyse the costs of production of blood components, 12 out 318 blood establishments were selected in 8 Italian Regions. For each step of the production process, driving costs were identified and production costs were. To define the costs of plasma-derived medicinal products obtained by national plasma, industrial costs currently sustained by National Health Service for contract fractionation were taken into account. The production costs of plasma-derived medicinal products obtained from national plasma showed a huge variability among blood establishments, which was much lower after standardization. The new suggested plasma tariffs were quite similar to those currently in force. Comparing the overall costs theoretically sustained by the National Health Service for plasma-derived medicinal products obtained from national plasma to current commercial costs, demonstrates that the national blood system could gain a 10% cost saving if it were able to produce plasma for fractionation within the standard costs defined in this study. Achieving national self-sufficiency through the production of plasma-derived medicinal products from national plasma, is a strategic goal of the National Health Service which must comply not only with quality, safety and availability requirements but also with the increasingly pressing need for economic sustainability.

  10. 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

    Background: India is the world's third largest consumer of tobacco. There are twice as many users of smokeless tobacco products (STPs) as cigarette smokers. The Government of Tamil Nadu has banned the sale of gutkha and pan masala in 2013. Our aim was to identify the varieties of illegal STP...... 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...

  11. 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....

  12. Food effects in paediatric medicines development for products Co-administered with food.

    Science.gov (United States)

    Batchelor, Hannah; Kaukonen, Ann Marie; Klein, Sandra; Davit, Barbara; Ju, Rob; Ternik, Robert; Heimbach, Tycho; Lin, Wen; Wang, Jian; Storey, David

    2018-02-05

    A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability. However the impact of this co-administered food on the absorption and subsequent pharmacokinetic profile of the drug is unknown. Existing information on food effects is limited to standard protocols used to evaluate the impact of a high fat meal in an adult population using the adult medication. In the absence of a substantial body of data, there are no specific guidelines available during development of paediatric products relating to low volumes of potentially low calorie food. This paper brings together expertise to consider how the impact of co-administered food can be risk assessed during the development of a paediatric medicine. Two case studies were used to facilitate discussions and seek out commonalities in risk assessing paediatric products; these case studies used model drugs that differed in their solubility, a poorly soluble drug that demonstrated a positive food effect in adults and a highly soluble drug where a negative food effect was observed. For poorly soluble drugs risk assessments are centred upon understanding the impact of food on the in vivo solubility of the drug which requires knowledge of the composition of the food and the volumes present within the paediatric gastrointestinal tract. Further work is required to develop age appropriate in vitro and in silico models that are representative of paediatric populations. For soluble drugs it is more important to understand the mechanisms that may lead to a food effect, this may include interactions with transporters or the impact of the food composition on gastro-intestinal transit or even altered gastric motility. In silico models have the most promise for highly soluble drug products although it is essential that these models reflect the relevant mechanisms involved in potential food effects. The development of appropriate in vitro and in silico tools is

  13. 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.

  14. 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...

  15. 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%.

  16. The Impact of Active Workstations on Workplace Productivity and Performance: A Systematic Review.

    Science.gov (United States)

    Ojo, Samson O; Bailey, Daniel P; Chater, Angel M; Hewson, David J

    2018-02-27

    Active workstations have been recommended for reducing sedentary behavior in the workplace. It is important to understand if the use of these workstations has an impact on worker productivity. The aim of this systematic review was to examine the effect of active workstations on workplace productivity and performance. A total of 3303 articles were initially identified by a systematic search and seven articles met eligibility criteria for inclusion. A quality appraisal was conducted to assess risk of bias, confounding, internal and external validity, and reporting. Most of the studies reported cognitive performance as opposed to productivity. Five studies assessed cognitive performance during use of an active workstation, usually in a single session. Sit-stand desks had no detrimental effect on performance, however, some studies with treadmill and cycling workstations identified potential decreases in performance. Many of the studies lacked the power required to achieve statistical significance. Three studies assessed workplace productivity after prolonged use of an active workstation for between 12 and 52 weeks. These studies reported no significant effect on productivity. Active workstations do not appear to decrease workplace performance.

  17. The Impact of Active Workstations on Workplace Productivity and Performance: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Samson O. Ojo

    2018-02-01

    Full Text Available Active workstations have been recommended for reducing sedentary behavior in the workplace. It is important to understand if the use of these workstations has an impact on worker productivity. The aim of this systematic review was to examine the effect of active workstations on workplace productivity and performance. A total of 3303 articles were initially identified by a systematic search and seven articles met eligibility criteria for inclusion. A quality appraisal was conducted to assess risk of bias, confounding, internal and external validity, and reporting. Most of the studies reported cognitive performance as opposed to productivity. Five studies assessed cognitive performance during use of an active workstation, usually in a single session. Sit-stand desks had no detrimental effect on performance, however, some studies with treadmill and cycling workstations identified potential decreases in performance. Many of the studies lacked the power required to achieve statistical significance. Three studies assessed workplace productivity after prolonged use of an active workstation for between 12 and 52 weeks. These studies reported no significant effect on productivity. Active workstations do not appear to decrease workplace performance.

  18. The cultural production of Bioterapia: psychic healing and the natural medicine movement in Slovakia.

    Science.gov (United States)

    Rubens, D; Gyurkovics, D; Hornacek, K

    1995-11-01

    Despite powerful opposition, natural medicine (NM) has achieved a toe-hold in the state-run biomedical system in the Slovak Republic. The physician-leader of the NM movement hopes to leverage his ministerial post as NM 'supreme expert' and his interlocking NM clinical and research facilities to achieve a complex, unified health care system under control of medical doctors. This health care model simultaneously reinforces biomedical hegemony and decenters classical medicine by substituting a bioenergetical paradigm. NM includes, among other diagnostic and healing modalities, acupuncture, herbal therapies, bee therapy, reflexology, iridology. However, its paradigmatic form is bioterapia, the focus of this paper. Bioterapia is a form of psychic healing or therapeutic touch. According to its practitioners, it is based on bioenergetic and information-processing principles. Conceptually, bioterapia unifies psyche, soma and energy dimensions of the human body and situates the human organism in an extended transpersonal social, physical and cosmological environment. Bioterapia is a scientized and medicalized reconstruction of a folk healing tradition whose appropriation simultaneously secularized and re-sacralized this tradition by re-locating its practice from lay healers to medical doctors, from the religious domain to the venerated scientific domain, from deviant science to normal science. The reconfiguration into bioterapia as part of the creation of an academic secular parapsychology in the former Soviet Bloc in the late 1960s, illustrates the use of the privileged discourse of science for a cultural production that seems to have both supported and subverted the regime.

  19. Risks in production and utilisation of labelled compounds for nuclear medicine. 2. Benefits and risks of utilization of 99mTc generator in nuclear medicine

    International Nuclear Information System (INIS)

    Olteanu-Chiper, D.; Barna, C.; Gard, E.; Negoita, N.

    1999-01-01

    The growth of radioisotope applications in nuclear medicine, imposed the reduction of the radiation effects and so, the reduction of associated risk of these applications. The utilization of radioactive isotopes for investigations in nuclear medicine is conditioned by the chemical behaviour and the means of detection of the emitted radiation on one hand, and by the radiation doses received by the patient, on the other hand. In these conditions, the nuclear medicine uses only the radioisotopes which are short half-time and low radiation energy, but high enough to be detected from the exterior of human body, 99m Tc being the most favourable for utilization in diagnostic purpose. This advantage is increased by the multiple possibilities to obtain different chemical forms with 99m Tc included, which permit the production of a large variety of radiopharmaceutical products, having a specific localization in the human body (organ-targets), thus allowing the diagnosis of numerous diseases. In the work the benefits and risks of the 99m Tc-Generator utilization in the nuclear medicine are shown and the utilization technique in these applications is presented . The 99m Tc-Generator is a compact chromatographic system, with lead shielding, which permits the elution of a sterile, pyrogen-free, injectable sodium pertechnetate solution, from an aluminium chromatographic column which keeps the 99 Mo. The 99m Tc-Generator system ensures the operator protection. The radioactive solution with 99m Tc is obtained in a closed vial, within lead shielding, the irradiation or contamination risks being mostly reduced. The utilization of 99m Tc in scintigraphic exam for diagnostic medicine implies a labelling operation with 99m Tc chemically bounded in forms appropriate to the target-organ and than the intravenously injection in doses dependent on the specific scintigraphic investigation or examination. (authors)

  20. Additional traditional Chinese medicine on gastrointestinal dysfunction in patients with sepsis: A systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, Yajing; Zhao, Zhiqiang; Tang, E; Hu, Yucai; Mao, Jingyuan

    2016-03-01

    To evaluate the clinical effect and safety of western medicine plus Traditional Chinese medicine for sepsis with gastrointestinal dysfunction. We searched CNKI (January 1979 to June 2014), VIP (January 1989 to June 2014), CBM (1978 to 2014), Wan Fang DATA (January 1990 to June 2014), PubMed (1978 to June 2014), The Cochrane Library (Issue 5, 2014), Embase (1974 to June 2014), and other relevant databases and journals to identify randomized controlled trials (RCTs) on western medicine plus Traditional Chinese medicine versus western medicine only for sepsis with gastrointestinal dysfunction. The methodological quality was assessed and the data was extracted according to the Cochrane Reviewer's Handbook and related methods. Meta-analyses were performed by RevMan 5.1.0 software. Five eligible studies included 278 patients. The results of meta-analyses showed that western medicine plus Traditional Chinese medicine therapy can improve the APACHEII score, the peristaltic sound score and SIRS score, improve abdominal distension, decreased white blood cell count, reduce DAO in sepsis patients with gastrointestinal dysfunction. 3 studies reported adverse reactions, there was no significant difference between two groups. Western medicine plus Traditional Chinese medicine can improve gastrointestinal dysfunction in sepsis.

  1. Regulation (EC No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

    Directory of Open Access Journals (Sweden)

    Lehmann Birka

    2008-12-01

    Full Text Available Abstract Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions. The Regulation (EC No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children. The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD, for the European Union (EU. The CTD establishes specific provisions regarding conduct of

  2. [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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. [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.

  10. Scientific Production of Research Fellows at the Zagreb University School of Medicine, Croatia

    Science.gov (United States)

    Polašek, Ozren; Kolčić, Ivana; Buneta, Zoran; Čikeš, Nada; Pećina, Marko

    2006-01-01

    Aim To evaluate scientific production among research fellows employed at the Zagreb University School of Medicine and identify factors associated with their scientific output. Method We conducted a survey among research fellows and their mentors during June 2005. The main outcome measure was publication success, defined for each fellow as publishing at least 0.5 articles per employment year in journals indexed in the Current Contents bibliographic database. Bivariate methods and binary logistic regression were used in data analysis. Results A total of 117 fellows (response rate 95%) and 83 mentors (100%) were surveyed. The highest scientific production was recorded among research fellows employed in public health departments (median 3.0 articles, interquartile range 4.0), compared with those from pre-clinical (median 0.0, interquartile range 2.0) and clinical departments (median 1.0, interquartile range 2.0) (Kruskal-Wallis, P = 0.003). A total of 36 (29%) research fellows published at least 0.5 articles per employment year and were considered successful. Three variables were associated with fellows’ publication success: mentor’s scientific production (odds ratio [OR], 3.14; 95% confidence interval [CI], 1.31-7.53), positive mentor’s assessment (OR, 3.15; 95% CI, 1.10-9.05), and fellows’ undergraduate publication in journals indexed in the Current Contents bibliographic database (OR, 4.05; 95% CI, 1.07-15.34). Conclusion Undergraduate publication could be used as one of the main criteria in selecting research fellows. One of the crucial factors in a fellow’s scientific production and career advancement is mentor’s input, which is why research fellows would benefit most from working with scientifically productive mentors. PMID:17042070

  11. Clinical evidence for orphan medicinal products-a cause for concern?

    Science.gov (United States)

    Picavet, Eline; Cassiman, David; Hollak, Carla E; Maertens, Johan A; Simoens, Steven

    2013-10-16

    The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is

  12. Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

    Science.gov (United States)

    Arguello, Blanca; Salgado, Teresa M; Fernandez-Llimos, Fernando

    2015-01-01

    Aims To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). Methods SmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing ‘conclusive’ or ‘ambiguous’ information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. Results Of the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. Conclusions Important information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. PMID:25224071

  13. A systematic review of co-creation and co-production: Embarking on the social innovation journey

    NARCIS (Netherlands)

    Voorberg, W.H.; Bekkers, V.J.J.M.; Tummers, L.G.|info:eu-repo/dai/nl/341028274

    2015-01-01

    This article presents a systematic review of 122 articles and books (1987-2013) of co-creation/ co-production with citizens in public innovation. It analyses a) the objectives of co-creation and co-production, b) its influential factors and c) the outcomes of co-creation and co-production processes.

  14. 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.

  15. 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.

  16. Factors influencing the implementation, adoption, use, sustainability and scalability of eLearning for family medicine specialty training: a systematic review protocol.

    Science.gov (United States)

    Cotič, Živa; Rees, Rebecca; Wark, Petra A; Car, Josip

    2016-10-19

    In 2013, there was a shortage of approximately 7.2 million health workers worldwide, which is larger among family physicians than among specialists. eLearning could provide a potential solution to some of these global workforce challenges. However, there is little evidence on factors facilitating or hindering implementation, adoption, use, scalability and sustainability of eLearning. This review aims to synthesise results from qualitative and mixed methods studies to provide insight on factors influencing implementation of eLearning for family medicine specialty education and training. Additionally, this review aims to identify the actions needed to increase effectiveness of eLearning and identify the strategies required to improve eLearning implementation, adoption, use, sustainability and scalability for family medicine speciality education and training. A systematic search will be conducted across a range of databases for qualitative studies focusing on experiences, barriers, facilitators, and other factors related to the implementation, adoption, use, sustainability and scalability of eLearning for family medicine specialty education and training. Studies will be synthesised by using the framework analysis approach. This study will contribute to the evaluation of eLearning implementation, adoption, use, sustainability and scalability for family medicine specialty training and education and the development of eLearning guidelines for postgraduate medical education. PROSPERO http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016036449.

  17. 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

  18. 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

    2012-08-07

    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. 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. 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. 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 and harms of such assessment strategies is

  19. 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.

  20. Dairy products and colorectal cancer in middle eastern and north African countries: a systematic review.

    Science.gov (United States)

    El Kinany, K; Deoula, M; Hatime, Z; Bennani, B; El Rhazi, K

    2018-03-01

    This systematic review was conducted to explain the association between dairy products and colorectal cancer (CRC) risk in Middle Eastern and North African countries (MENA). The database consulted were PubMed, Clinical Trials, and Cochrane to extract the relevant studies published till the 31stof December 2016, using inclusion and exclusion criteria according to Prisma Protocol. The characteristics of these studies comprised the consumption of all types of dairy products in relation to CRC risk. Seven studies were included in this review. For dairy products overall, no significant association was found. Regarding modern dairy products, included studies found controversial results with OR = 9.88 (95% CI: 3.80-24.65) and OR a  = 0.14 (95% CI: 0.02-0.71). A positive association was reported between traditional dairy products and CRC risk, to OR = 18.66 (95% CI: 3.06-113.86) to OR = 24 (95% CI: 1.74-330.82) to ORa = 1.42 (95% CI: 0.62-3.25), p trend  = 0.03. Calcium was inversely associated with the CRC risk with OR a  = 0.08 (95% CI: 0.04-0.17). This is the first systematic review which illustrated the association between dairy consumption and CRC risk in MENA region. The results were inconsistent and not always homogeneous. Further specified studies may be warranted to address the questions about the association between CRC and dairy products in a specific context of MENA region.

  1. A systematic literature review of Releasing Time to Care: The Productive Ward.

    Science.gov (United States)

    Wright, Stella; McSherry, Wilfred

    2013-05-01

    This systematic review provides an overview of the literature published on Releasing Time to Care: The Productive Ward between 2005 and June 2011. Releasing Time to Care: The Productive Ward programme was developed by the NHS Institute for Innovation and Improvement and launched in England in 2007. The programme comprises thirteen modules that aim to increase time for direct patient care, improve the patient and staff experience and make changes to the ward environment to improve efficiency. A systematic literature review. The terms 'Releasing Time to Care' and 'Productive Ward' were applied to key healthcare databases; CINAHL, Medline, Science Direct, ProQuest, Health Business Elite, British Nursing Index, Embase, Health Management Information Consortium and PsychInfo. All papers were read and subject to a quality assessment. The literature search identified 95 unique sources. A lack of research on The Productive Ward programme meant it was necessary to include non-empirical literature. In total, 18 articles met the inclusion criteria. Seven key themes were identified: the patient and staff experience, direct care time, patient safety, financial impact, embedding and sustainability, executive support and leadership, and common barriers and determinants of success. It also highlighted areas that require further exploration such as long-term sustainability of the programme and consistent data measurement between organisations. The review tentatively reports how The Productive Ward programme has been used to transform nursing practice for the benefit of patients and frontline staff, and how it resulted in cost savings. The literature review identified a potential positive results bias in the current literature whereby favourable outcomes were reported. This paper summarises the types of evidence and current literature on The Productive Ward providing a reference for frontline staff implementing the programme. © 2013 Blackwell Publishing Ltd.

  2. Optimization of ethanol production from garcinia cambogia residues and the effects of its medicinal component on production yield

    International Nuclear Information System (INIS)

    Ma, H.; Zhang, F.

    2017-01-01

    Garcinia cambogia, a Chinese herbal medicine, was popular due to its effect for weight loss. The main medical component inside was determined to be hydroxycitric acid (HCA). To realize the resource technology of garcinia cambogia residue, Optimum ethanol production from residues was investigated, and the effects of remaining HCA on the ethanol yield were investigated. A Plackett-Burman experimental design was used to screen the significance of several influencing factors, and cellulase, yeast extract, and KH2PO4 were observed to exert important effects. The optimum ethanol fermentation conditions were determined through an orthogonal design to include a cellulase concentration of 100 U/g, a yeast extract concentration of 15 g/L, and a KH2PO4 concentration of 1.0 g/L. The ethanol concentration obtained under optimal conditions was 4.0 g/L. The remained HCA in the residues showed minimal influences on ethanol fermentation and could even increase ethanol yield at low concentrations. (author)

  3. A systematic approach for introducing innovative product design in courses with engineering and nonengineering students.

    Science.gov (United States)

    Patterson, P E

    2007-01-01

    In our new global economy, biomedical product development teams need to be even more innovative in an environment constrained by fewer resources with less time from concept to market. Teams are often comprised of individuals spread around the world. To simulate this setting, we revised an existing course to incorporate teams of on-campus and distance students, with each team including both engineers and other specialties. Through interactive lectures and projects, we presented a systematic approach to innovation that should be useful to engineers and non-engineers alike. Students found the course challenging and exciting, displaying an improved ability to work in distributed teams and in developing innovative design solutions.

  4. 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...... methodology (SAM) for a series of substrates with similar molecular functionality has been developed. The objective is to achieve “flexible, fast and future” pharmaceutical production processes by adapting a generic modular process template. Application of the methodology is illustrated through a case study...

  5. 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

    2018-04-01

    CT-P10 (Truxima™) 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

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. The use of terrestrial and aquatic microcosms and mesocosms for the ecological risk assessment of veterinary medicinal products

    NARCIS (Netherlands)

    Brink, van den P.J.; Tarzona, J.V.; Solomon, K.R.; Knacker, T.; Brink, van den N.W.; Brock, T.C.M.; Hoogland, J.P.

    2005-01-01

    In this paper, we investigate the applicability of experimental model ecosystems (microcosms and mesocosms) for the ecological risk assessment of veterinary medicinal products (VMPs). VMPs are used in large quantities, but the assessment of associated risks to the environment is limited, although

  11. 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...

  12. Optimization, validation and application of UV-Vis spectrophotometric-colorimetric methods for determination of trimethoprim in different medicinal products

    Directory of Open Access Journals (Sweden)

    Goran Stojković

    2016-03-01

    Full Text Available Two simple, sensitive, selective, precise, and accurate methods for determination of trimethoprim in different sulfonamide formulations intended for use in human and veterinary medicine were optimized and validated. The methods are based on the trimethoprim reaction with bromcresol green (BCG and 2,4-dinitro-1-fluorobenzene (DNFB. As extraction solvents we used 10 % N,N-dimethylacetamide in methanol and acetone for both methods, respectively. The colored products are quantified applying visible spectrophotometry at their corresponding absorption maxima. The methods were validated for linearity, sensitivity, accuracy, and precision. We tested the method applicability on four different medicinal products in tablet and powder forms containing sulfametrole and sulfamethoxazole in combination with trimethoprim. The results revealed that both methods are equally accurate with recoveries within the range 95-105 %. The obtained between-day precision for both methods, when applied on four different medicinal products, was within in the range 1.08-3.20 %. By applying the F-statistical test (P<0.05, it was concluded that for three medicinal products tested both methods are applicable with statistically insignificant difference in precision. The optimized and validated BCG and DNFB methods could find application in routine quality control of trimethoprim in various formulation forms, at different concentration levels, and in combination with different sulfonamides.

  13. [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.

  14. 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

  15. 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.

  16. Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice.

    Science.gov (United States)

    Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

    2018-01-01

    Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided.

  17. 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.

  18. The Navigation Guide—Evidence-Based Medicine Meets Environmental Health: Systematic Review of Human Evidence for PFOA Effects on Fetal Growth

    Science.gov (United States)

    Sutton, Patrice; Atchley, Dylan S.; Koustas, Erica; Lam, Juleen; Sen, Saunak; Robinson, Karen A.; Axelrad, Daniel A.; Woodruff, Tracey J.

    2014-01-01

    Background: The Navigation Guide methodology was developed to meet the need for a robust method of systematic and transparent research synthesis in environmental health science. We conducted a case study systematic review to support proof of concept of the method. Objective: We applied the Navigation Guide systematic review methodology to determine whether developmental exposure to perfluorooctanoic acid (PFOA) affects fetal growth in humans. Methods: We applied the first 3 steps of the Navigation Guide methodology to human epidemiological data: 1) specify the study question, 2) select the evidence, and 3) rate the quality and strength of the evidence. We developed a protocol, conducted a comprehensive search of the literature, and identified relevant studies using prespecified criteria. We evaluated each study for risk of bias and conducted meta-analyses on a subset of studies. We rated quality and strength of the entire body of human evidence. Results: We identified 18 human studies that met our inclusion criteria, and 9 of these were combined through meta-analysis. Through meta-analysis, we estimated that a 1-ng/mL increase in serum or plasma PFOA was associated with a –18.9 g (95% CI: –29.8, –7.9) difference in birth weight. We concluded that the risk of bias across studies was low, and we assigned a “moderate” quality rating to the overall body of human evidence. Conclusion: On the basis of this first application of the Navigation Guide systematic review methodology, we concluded that there is “sufficient” human evidence that developmental exposure to PFOA reduces fetal growth. Citation: Johnson PI, Sutton P, Atchley DS, Koustas E, Lam J, Sen S, Robinson KA, Axelrad DA, Woodruff TJ. 2014. The Navigation Guide—evidence-based medicine meets environmental health: systematic review of human evidence for PFOA effects on fetal growth. Environ Health Perspect 122:1028–1039; http://dx.doi.org/10.1289/ehp.1307893 PMID:24968388

  19. Systematic Engineering of Escherichia coli for d-Lactate Production from Crude Glycerol.

    Science.gov (United States)

    Wang, Zei Wen; Saini, Mukesh; Lin, Li-Jen; Chiang, Chung-Jen; Chao, Yun-Peng

    2015-11-04

    Crude glycerol resulting from biodiesel production is an abundant and renewable resource. However, the impurities in crude glycerol usually make microbial fermentation problematic. This issue was addressed by systematic engineering of Escherichia coli for the production of d-lactate from crude glycerol. First, mgsA and the synthetic pathways of undesired products were eliminated in E. coli, rendering the strain capable of homofermentative production of optically pure d-lactate. To direct carbon flux toward d-lactate, the resulting strain was endowed with an enhanced expression of glpD-glpK in the glycerol catabolism and of a heterologous gene encoding d-lactate dehydrogenase. Moreover, the strain was evolved to improve its utilization of cruder glycerol and subsequently equipped with the FocA channel to export intracellular d-lactate. Finally, the fed-batch fermentation with two-phase culturing was carried out with a bioreactor. As a result, the engineered strain enabled production of 105 g/L d-lactate (99.9% optical purity) from 121 g/L crude glycerol at 40 h. The result indicates the feasibility of our approach to engineering E. coli for the crude glycerol-based fermentation.

  20. 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 (Pearson linear correlation coefficient (CC), fractional standard error (FSE), and root-mean-square error (RMSE) metrics during the summer. Compared with GSMaP_NRT and GSMaP_MVK, GSMaP_Gau possessed significantly improved metrics over mainland China and the eight subregions and performed better in terms of CC, RMSE, and FSE but underestimated precipitation to a greater degree than IMERG_Gau. As a quantitative assessment of the GPM-era GSMaP 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.

  1. 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.

  2. 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.

  3. 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.

  4. [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.

  5. 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.

  6. Food and medicines in the Mediterranean tradition. A systematic analysis of the earliest extant body of textual evidence.

    Science.gov (United States)

    Touwaide, Alain; Appetiti, Emanuela

    2015-06-05

    The relationship between food and medicines has long been investigated and is of crucial importance for the understanding of the development of ethnopharmacological knowledge through time. Hippocrates, considered the Father of Medicine, is credited with an aphorism equating food and medicine. No inquiry has been performed, however, into the collection of texts attributed to Hippocrates and, going beyond, into this statement, which is generally accepted without further examination. A clarification is much needed as the question of the relationship between food and medicines as potent substances are crucial to ethnopharmacology. To verify the validity (if not the authenticity) of the theory on the identity of food and medicine attributed to Hippocrates, we digitized the whole collection of texts ascribed to Hippocrates in the original Greek language (the so-called Hippocratic Collection), which date back from the age of Hippocrates (late 5th century and 4th century BCE) to a more recent time (2nd century CE). On this basis, we extracted and databased all the information related to remedial therapy, that is, their materia medica (vegetable, animal and mineral) and their use(s). We identified both the plant species according to modern up-to-date taxonomy and the medical conditions as precisely as possible. We then screened these plants to discover what their uses were and, going backward in time, we examined (when possible) their native distribution, domestication, possible introduction (in the case of non-native species) and cultivation to determine whether these species had been known for a long time and might have been the object of long-term observation as both foodstuffs and medicines. Tabulated data from the Hippocratic Collection revealed that 40% of the remedies in the Collection are made out of only 44 plants. Of this group, 33 species (=75% of the group) were also used for nutritional purposes in Antiquity. Domestication history of these species indicates

  7. A Systematic Review of Co-Creation and Co-Production: Embarking on the social innovation journey

    NARCIS (Netherlands)

    W.H. Voorberg (William); V.J.J.M. Bekkers (Victor); L.G. Tummers (Lars)

    2014-01-01

    textabstractThis article presents a systematic review of 122 articles and books (1987-2013) of co-creation/co-production with citizens in public innovation. It analyses (a) the objectives of co-creation and co-production, (b) its influential factors and (c) the outcomes of co-creation and

  8. A systematic review of co-creation and co-production: Embarking on the social innovation journey

    NARCIS (Netherlands)

    W.H. Voorberg (William); V.J.J.M. Bekkers (Victor); L.G. Tummers (Lars)

    2014-01-01

    markdownabstract__Abstract__ This article presents a systematic review of 122 articles and books (1987-2013) of co-creation/ co-production with citizens in public innovation. It analyses a) the objectives of co-creation and co-production, b) its influential factors and c) the outcomes of

  9. 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

  10. Effect of cocoa products and flavanols on platelet aggregation in humans: a systematic review.

    Science.gov (United States)

    Peluso, Ilaria; Palmery, Maura; Serafini, Mauro

    2015-07-01

    Previous evidence suggested an active role of cocoa products and flavanols in modulating platelet aggregation. However, cocoa flavanols are characterized by a low bioavailability that can deeply affect their presence in biological fluids and raise questions on their biological effect in humans. We performed a systematic search on Medline, Embase, Cochrane and ProQuest databases, until April 2015, on the effect of cocoa products on platelet aggregation in human intervention studies. We identified 13 interventions, of which only five involved repeated administration. Different effects were observed on the basis of the platelet aggregation test used, whereas neither a longer duration of treatment nor a higher dose was associated with a higher inhibition of platelet aggregation. In conclusion, the reviewed results suggest that consumption of cocoa products in bolus administration positively affects platelet aggregation in both healthy subjects and diseased patients. On the other hand, more evidence is required in order to assess the effect of long-term cocoa product ingestion and to identify the bioactive components involved.

  11. 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.

  12. A systematic investigation of production of synthetic prions from recombinant prion protein.

    Science.gov (United States)

    Schmidt, Christian; Fizet, Jeremie; Properzi, Francesca; Batchelor, Mark; Sandberg, Malin K; Edgeworth, Julie A; Afran, Louise; Ho, Sammy; Badhan, Anjna; Klier, Steffi; Linehan, Jacqueline M; Brandner, Sebastian; Hosszu, Laszlo L P; Tattum, M Howard; Jat, Parmjit; Clarke, Anthony R; Klöhn, Peter C; Wadsworth, Jonathan D F; Jackson, Graham S; Collinge, John

    2015-12-01

    According to the protein-only hypothesis, infectious mammalian prions, which exist as distinct strains with discrete biological properties, consist of multichain assemblies of misfolded cellular prion protein (PrP). A critical test would be to produce prion strains synthetically from defined components. Crucially, high-titre 'synthetic' prions could then be used to determine the structural basis of infectivity and strain diversity at the atomic level. While there have been multiple reports of production of prions from bacterially expressed recombinant PrP using various methods, systematic production of high-titre material in a form suitable for structural analysis remains a key goal. Here, we report a novel high-throughput strategy for exploring a matrix of conditions, additives and potential cofactors that might generate high-titre prions from recombinant mouse PrP, with screening for infectivity using a sensitive automated cell-based bioassay. Overall, approximately 20,000 unique conditions were examined. While some resulted in apparently infected cell cultures, this was transient and not reproducible. We also adapted published methods that reported production of synthetic prions from recombinant hamster PrP, but again did not find evidence of significant infectious titre when using recombinant mouse PrP as substrate. Collectively, our findings are consistent with the formation of prion infectivity from recombinant mouse PrP being a rare stochastic event and we conclude that systematic generation of prions from recombinant PrP may only become possible once the detailed structure of authentic ex vivo prions is solved. © 2015 The Authors.

  13. 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.

  14. Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.

    Science.gov (United States)

    Vlietinck, Arnold; Pieters, Luc; Apers, Sandra

    2009-06-01

    In the European Union (EU) herbal medicinal products have become increasingly important. This is, for instance, underlined by the recent introduction of a simplified procedure in the Member States of the EU allowing the registration of herbal medicinal products which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient evidence of its medicinal use throughout a period of at least 30 years for products in the EU and at least 15 years within the EU and 15 years elsewhere for products outside the EU. With regard to the manufacturing of these products and their quality, applications of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorization. The quality of herbal substances as well as herbal preparations will be determined by the availability of modern science-based public monographs in the European Pharmacopoeia and their equivalents developed by the pharmaceutical industry. The standards put forward in these monographs must allow us not only to define the quality of these products, but also to eliminate dangerous counterfeit, substandard, adulterated and contaminated (traditional) herbal medicinal products. The usefulness of these monographs to implement the criteria on quality and specifications put forward for these products in the different guidelines of the European Medicines Agency (EMEA) is discussed.

  15. Production of gel 99mTc generators for Nuclear Medicine at the Nuclear Power Institute of China, Chengdu

    International Nuclear Information System (INIS)

    Boyd, R.E.

    1996-07-01

    The development and testing of the gel-type 99m Tc generator technology has been going on for several years at the Nuclear Power Institute of China. This generator type has already been licensed by the Ministry of Health. With the co-operation of the IAEA, under Model Project CPR/2/006,it is intended to upgrade and optimise the existing facility for large scale production and continue to improve the generator performance in terms of quality and reliability of its use in nuclear medicine. The expert mission objective was to carry out final laboratory tests to assess the performance of the gel- type 99m Tc, locally produced, as well as to assess the suitability of the corresponding 99m Tc eluate for nuclear medicine studies. In particular, the expert tested the suitability of the 99m Tc for the labelling of sensitive biomolecules and its general performance in a nuclear medicine service

  16. 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

  17. 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

  18. 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