Statin wars: have we been misled about the evidence? A narrative review

2018 ◽  
Vol 52 (14) ◽  
pp. 905-909 ◽  
Author(s):  
Maryanne Demasi
Keyword(s):  
Clinical Trials ◽  
Heart Disease ◽  
Low Risk ◽  
Healthy People ◽  
Public Confidence ◽  
Efficacy And Safety ◽  
Cholesterol Lowering ◽  
Raw Data ◽  
The World ◽  
Total Sales

Statins are the most widely prescribed, cholesterol-lowering drugs in the world. Despite the expiration of their patents, revenue for statins is expected to rise, with total sales on track to reach an estimated US$1 trillion by 2020. A bitter dispute has erupted among doctors over suggestions that statins should be prescribed to millions of healthy people at low risk of heart disease. There are concerns that the benefits have been exaggerated and the risks have been underplayed. Also, the raw data on the efficacy and safety of statins are being kept secret and have not been subjected to scrutiny by other scientists. This lack of transparency has led to an erosion of public confidence. Doctors and patients are being misled about the true benefits and harms of statins, and it is now a matter of urgency that the raw data from the clinical trials are released.

scholarly journals The efficacy and safety of interferons for the treatment of patients with COVID-19: protocol for systematic review and meta-analysis of controlled trials

2021 ◽  
Author(s):  
Afsaneh Noormandi ◽  
Mohammad Fathalipour ◽  
Reza Daryabeygi-Khotbehsara ◽  
Soheil Hassanipour
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Global Pandemic ◽  
The World ◽  
Health Organization ◽  
Time Of Administration

Background and objective: COVID-19 has since been declared a global pandemic by the World Health Organization (WHO), infecting millions worldwide. The use of Interferon (INF) subtypes previously examined in the treatment of SARS and MERS is also being initiated in some clinical trials. Although different clinical trials were evaluated IFNs in the treatment of COVID-19, their efficacy and safety remain unknown. Therefore, this study aims to systematically assess IFNs efficacy and safety in treating patients with COVID-19. Methods: The protocol has been registered in the PROSPERO International Prospective Register (CRD42020200643) on 24 July 2020. This protocol has been arranged according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015 checklist. Discussion: Due to lack of approved medication for the covid-19 treatment and also various mutations of this virus, evaluated the efficacy and safety of medications by various studies could help for finding treatments with high effectiveness. IFNs are one of the medications that have been administered in covid-19 infection.  Moreover, the best time of administration and dose of this medication was unknown. Although meta-analysis is a potent source for assessing the accuracy of subjects, heterogeneity of articles is a potent limitation of our work.

Clinical trials of COVID 19 vaccines and vaccination campaign: ethical issues

2021 ◽  
Author(s):  
VE Goncharova
Keyword(s):  
Clinical Trials ◽  
Preventive Measures ◽  
Ethical Issues ◽  
Vaccine Development ◽  
Vaccination Campaign ◽  
Public Confidence ◽  
Basic Principles ◽  
Literary Sources ◽  
The World ◽  
Decisive Action

For many centuries, infectious diseases have posed a serious threat: epidemics and pandemics claim lives and multiply the burden on health systems and countries' economies. Humanity managed to defeat a number of infections only thanks to specific preventive measures, i.e., vaccination. In 2020, society faced the new COVID-19 virus that has swept the whole world. The situation required swift and decisive action, including in what concerned vaccine development. It has also raised a number of ethical issues. The article analyzes ethical issues related to clinical trials and vaccination against COVID-19 by studying the regulations, literary sources and bioethical incidents. The key problems identified are: human participation in clinical trials during a pandemic, availability and, simultaneously, voluntariness of vaccination, public confidence in the SARS-Cov-2 vaccines approved for clinical practice. The study showed that the basic principles of clinical trials, voluntariness and awareness, are violated. It was revealed that despite all the efforts of public organizations and WHO initiatives in the world, there is a pronounced imbalance in the availability of the developed vaccines, while the vaccination voluntariness principle is violated by application of various mechanisms to put pressure on people, and public confidence in the developed vaccines can be called insufficient. In general, the problem of vaccination against COVID-19 remains relevant and requires comprehensive discussion.

The Potential of Medicinal Plants as Galactagogue in Indonesia: A Review from Medical Perspective

2021 ◽  
Vol 14 (3) ◽  
pp. 1595-1612
Author(s):  
Astrid Feinisa Khairani ◽  
Teuku Muhammad Adzdzikri ◽  
Shafa Tasya Menggala ◽  
Muhammad Hasan Bashari ◽  
Enny Rohmawaty ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Breast Milk ◽  
Medicinal Plants ◽  
Literature Review ◽  
Common Factor ◽  
World Health ◽  
Efficacy And Safety ◽  
Positive Effects ◽  
The World ◽  
Medical Perspective

The World Health Assembly's target in exclusive breastfeeding has not been achieved. The most common factor contributing to this problem is the perceived insufficient production of breast milk, leading to the inability to give breastmilk to her child. Milk production can be increased using some ways, such as herbal galactagogue. This article aimed to review the effectiveness of some medicinal plants as galactagogues. This study uses a literature review approach by using several sources selected based on the criteria that have been set by researchers. Based on thirteen literature, herbs reviewed in this article showed positive effects as a galactagogue. Evidence regarding its efficacy and safety is scarce. Additionally, few clinical trials exist to justify its effectiveness. Further clinical trials are needed to support these findings.

scholarly journals Diacerein in the treatment of osteoarthritis in patients with comorbidity

2018 ◽  
Vol 12 (4) ◽  
pp. 54-58
Author(s):  
E. P. Sharapova ◽  
L. I. Alekseeva ◽  
A. M. Lila
Keyword(s):  
Diabetes Mellitus ◽  
Coronary Heart Disease ◽  
Clinical Trials ◽  
Heart Disease ◽  
Cardiovascular Diseases ◽  
Efficacy And Safety ◽  
Delayed Release ◽  
Obesity And Diabetes ◽  
Inflammatory Drugs ◽  
High Comorbidity

Osteoarthritis (OA) belongs to diseases with high comorbidity and is most frequently concurrent with hypertension and other cardiovascular diseases (coronary heart disease, atherosclerosis), obesity, and diabetes mellitus. The paper deals with the use of delayed-release symptomatic medications in the treatment of patients with OA and comorbidity. It reviews clinical trials of the efficacy and safety of diacerein in OA patients and its effect on comorbidity. The paper discusses the possibility of using diacerein as an alternative to traditional nonsteroidal anti-inflammatory drugs in patients with contraindications to the latter.

The clinical trials of the Organisation for Oncology and Translational Research (OOTR)

2012 ◽  
Vol 27 (4) ◽  
pp. 353-356
Author(s):  
Louis Wc Chow ◽  
Masakazu Toi
Keyword(s):  
Clinical Trials ◽  
Translational Research ◽  
Predictive Models ◽  
Effective Interaction ◽  
Medical Professionals ◽  
Efficacy And Safety ◽  
Tumor Resistance ◽  
The Past ◽  
The World ◽  
Clinical Trial Designs

The Organisation for Oncology and Translational Research (OOTR) was established in 2002 by Dr Louis WC Chow and Dr Masakazu Toi to gather medical professionals from different countries to work together in translational research as one of the missions of the organisation. Therefore, we seek to create networking among oncologists and develop effective interaction among the most advanced academic institutions throughout the world in order to conduct clinical trials and translational research together. Several clinical trials evaluating the use of neoadjuvant therapy for breast cancer have been designed and conducted for the past 10 years in the OOTR. The design of these studies has shifted from evaluating the efficacy and safety of new anticancer therapies and exploring new predictive and prognostic biomarkers to overcoming and unveiling the mechanism of tumor resistance as well as compiling predictive models for treatment response. This article briefly summarizes the concept and development of the OOTR clinical trial designs.

scholarly journals The International Neuroblastoma Risk Group (INRG) Classification System: An INRG Task Force Report

2009 ◽  
Vol 27 (2) ◽  
pp. 289-297 ◽  
Author(s):  
Susan L. Cohn ◽  
Andrew D.J. Pearson ◽  
Wendy B. London ◽  
Tom Monclair ◽  
Peter F. Ambros ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pediatric Oncology ◽  
Classification System ◽  
Risk Group ◽  
Prognostic Significance ◽  
Staging System ◽  
Low Risk ◽  
Task Force Report ◽  
Clinical Criteria ◽  
The World

Purpose Because current approaches to risk classification and treatment stratification for children with neuroblastoma (NB) vary greatly throughout the world, it is difficult to directly compare risk-based clinical trials. The International Neuroblastoma Risk Group (INRG) classification system was developed to establish a consensus approach for pretreatment risk stratification. Patients and Methods The statistical and clinical significance of 13 potential prognostic factors were analyzed in a cohort of 8,800 children diagnosed with NB between 1990 and 2002 from North America and Australia (Children's Oncology Group), Europe (International Society of Pediatric Oncology Europe Neuroblastoma Group and German Pediatric Oncology and Hematology Group), and Japan. Survival tree regression analyses using event-free survival (EFS) as the primary end point were performed to test the prognostic significance of the 13 factors. Results Stage, age, histologic category, grade of tumor differentiation, the status of the MYCN oncogene, chromosome 11q status, and DNA ploidy were the most highly statistically significant and clinically relevant factors. A new staging system (INRG Staging System) based on clinical criteria and tumor imaging was developed for the INRG Classification System. The optimal age cutoff was determined to be between 15 and 19 months, and 18 months was selected for the classification system. Sixteen pretreatment groups were defined on the basis of clinical criteria and statistically significantly different EFS of the cohort stratified by the INRG criteria. Patients with 5-year EFS more than 85%, more than 75% to ≤ 85%, ≥ 50% to ≤ 75%, or less than 50% were classified as very low risk, low risk, intermediate risk, or high risk, respectively. Conclusion By defining homogenous pretreatment patient cohorts, the INRG classification system will greatly facilitate the comparison of risk-based clinical trials conducted in different regions of the world and the development of international collaborative studies.

Using a Low-Risk Population to Estimate the Specificity of the World Heart Federation Criteria for the Diagnosis of Rheumatic Heart Disease

2016 ◽  
Vol 29 (3) ◽  
pp. 253-258 ◽  
Author(s):  
Bradley C. Clark ◽  
Anita Krishnan ◽  
Robert McCarter ◽  
Janet Scheel ◽  
Craig Sable ◽  
...  
Keyword(s):  
Heart Disease ◽  
Rheumatic Heart Disease ◽  
Low Risk ◽  
Risk Population ◽  
The World ◽  
Rheumatic Heart
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