scholarly journals New approved drugs for psoriatic arthritis

Reumatismo ◽  
2016 ◽  
Vol 68 (2) ◽  
pp. 57 ◽  
Author(s):  
F.M. Perrotta ◽  
E. Lubrano
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Structural Damage ◽  
Randomized Clinical Trials ◽  
Poor Quality ◽  
Chronic Inflammatory Disease ◽  
New Drugs ◽  
Approved Drugs ◽  
Symptoms And Signs

Psoriatic arthritis (PsA) is a chronic inflammatory disease that possibly leads to structural damage and to a reduction of joint function and poor quality of life. Treatment of PsA has changed since its introduction of anti- TNF drugs, which have shown to reduce the symptoms and signs of the disease and slow the radiographic progression. However, recently, the discovery of new pathogenic mechanisms have made possible the development of new molecules that target pro-inflammatory cytokines involved in skin, joint and entheseal inflammation. New drugs like ustekinumab, secukinumab and apremilast inhibit interleukin axis and intracellular pathways and showed their efficacy and safety in randomized clinical trials. These drugs have been recently approved for the treatment of PsA and included in the new EULAR and GRAPPA treatment recommendations. The aim of this paper is to briefly review the clinical trials that led to their approval for PsA.

scholarly journals Acupuncture for the Treatment of Opiate Addiction

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Jaung-Geng Lin ◽  
Yuan-Yu Chan ◽  
Yi-Hung Chen
Keyword(s):  
Clinical Trials ◽  
Study Design ◽  
Randomized Clinical Trials ◽  
Poor Quality ◽  
The Body ◽  
Present Review ◽  
Opiate Addiction ◽  
Clinical Conditions ◽  
Chinese And English

Acupuncture is an accepted treatment worldwide for various clinical conditions, and the effects of acupuncture on opiate addiction have been investigated in many clinical trials. The present review systematically analyzed data from randomized clinical trials published in Chinese and English since 1970. We found that the majority agreed on the efficacy of acupuncture as a strategy for the treatment of opiate addiction. However, some of the methods in several included trials have been criticized for their poor quality. This review summarizes the quality of the study design, the types of acupuncture applied, the commonly selected acupoints or sites of the body, the effectiveness of the treatment, and the possible mechanism underlying the effectiveness of acupuncture in these trials.

scholarly journals Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?

2021 ◽  
Vol 10 (4) ◽  
pp. 746
Author(s):  
Adela Rodriguez ◽  
Francis Esposito ◽  
Helena Oliveres ◽  
Ferran Torres ◽  
Joan Maurel
Keyword(s):  
Clinical Trials ◽  
Clinical Benefit ◽  
Randomized Clinical Trials ◽  
Progression Free Survival ◽  
Drug Approval ◽  
New Drugs ◽  
Phase Iii ◽  
European Medicines Agency ◽  
Clinical Benefits

The approval of a new drug for cancer treatment by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is based on positive, well-designed randomized phase III clinical trials (RCTs). However, not all of them are analyzed to support the recommendations. For this reason, there are different scales to quantify and evaluate the quality of RCTs and the magnitude of the clinical benefits of new drugs for treating solid tumors. In this review, we discuss the value of the progression-free survival (PFS) as an endpoint in RCTs and the concordance between it and the overall survival (OS) as a measure of the quality of clinical trial designs. We summarize and analyze the different scales to evaluate the clinical benefits of new drugs such as the The American Society of Clinical Oncology value framework (ASCO-VF-NHB16) and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) and the concordance between them, focusing on metastatic colorectal cancer (mCRC). We propose several definitions that would help to evaluate the quality of RCT, the magnitude of clinical benefit and the appropriate approval of new drugs in oncology.

scholarly journals Blockade of the angiotensin system improves mental health domain of quality of life: A meta-analysis of randomized clinical trials

2017 ◽  
Vol 52 (1) ◽  
pp. 24-38 ◽  
Author(s):  
Daniel J Brownstein ◽  
Estela Salagre ◽  
Cristiano Köhler ◽  
Brendon Stubbs ◽  
João Vian ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Angiotensin System ◽  
Health Domain

scholarly journals Brain Metastases Research 1990–2010: Pattern of Citation and Systematic Review of Highly Cited Articles

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Carsten Nieder ◽  
Anca L. Grosu ◽  
Minesh P. Mehta
Keyword(s):  
Clinical Trials ◽  
Brain Metastases ◽  
Randomized Clinical Trials ◽  
Citation Rate ◽  
Prognostic Score ◽  
Median Number ◽  
Research Activity ◽  
Secondary Endpoints ◽  
Number Of Citations

Background. High and continuously increasing research activity related to different aspects of prevention, prediction, diagnosis and treatment of brain metastases has been performed between 1990 and 2010. One of the major databases contains 2695 scientific articles that were published during this time period. Different measures of impact, visibility, and quality of published research are available, each with its own pros and cons. For this overview, article citation rate was chosen.Results. Among the 10 most cited articles, 7 reported on randomized clinical trials. Nine covered surgical or radiosurgical approaches and the remaining one a widely adopted prognostic score. Overall, 30 randomized clinical trials were published between 1990 and 2010, including those with phase II design and excluding duplicate publications, for example, after longer followup or with focus on secondary endpoints. Twenty of these randomized clinical trials were published before 2008. Their median number of citations was 110, range 13–1013, compared to 5-6 citations for all types of publications. Annual citation rate appeared to gradually increase during the first 2-3 years after publication before reaching high levels.Conclusions. A large variety of preclinical and clinical topics achieved high numbers of citations. However, areas such as quality of life, side effects, and end-of-life care were underrepresented. Efforts to increase their visibility might be warranted.

scholarly journals Effects of Neural Mobilization Techniques on Painand Disabilityin PatientsWith Neurodynamic Dysfunction: A Systematic Review of Randomized Controlled Trials

2021 ◽  
Author(s):  
Hasan Shamsi ◽  
Khosro Khademi-Kalantari ◽  
Farshad Okhovatian
Keyword(s):  
Clinical Trials ◽  
Nervous System ◽  
Randomized Clinical Trials ◽  
Tension Type Headache ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Level 3 ◽  
Tunnel Syndrome ◽  
Type Headache

Introduction: Neural mobilization is the most important  technique  used for the treatment  of nervous system dysfunction. This study aimed to systematically review and evaluate the therapeutic efficacy of neural mobilization techniques in nervous system dysfunctions by assessing Randomized Controlled Clinical Trials (RCTs). Materials and Methods: We used all English papers published in five electronic databases from 2000 to 2020 using the following keywords: “neural mobilization”, “nerve mobilization”, “physical therapy”, “nerve glide exercises”, “neural stretching”, “neurodynamics”, and “neural physiotherapy”. The full text of the articles identified was reviewed to select papers specifically discussing neural mobilization as a treatment modality. The PEDro scale was used to assess the quality of these trials. The randomized clinical trials were selected that examined the therapeutic effect of neural mobilization. Results: Twelve RCTs were identified. Five RCTs used the same median nerve tensioning technique in patients  with Carpal Tunnel  Syndrome  (CTS).  In some studies, the methods  of neural mobilization were different. Fourteen papers examined different neurodynamic dysfunctions such as lateral epicondylalgia, radicular neck pain, postoperative spinal surgery, radicular low back pain, and chronic tension-type headache. There is moderate evidence (Level 2) to support distal nerve tensioning and tendon gliding techniques in CTS Also, there was limited (Level 3) and insufficient (Level 4) evidence about using cervical lateral gliding away from their involved side and upper limb tension test mobilization and the use of slump stretches and combinations techniques in the treatment of neurodynamic dysfunction, respectively. Besides, all studies reported a positive effect compared to neutral effects. Conclusion: Although clinicians frequently use neuromobilization techniques for both diagnosis and treatment of nervous system dysfunctions, the quality assessment of 20 RCTs has shown insufficient evidence to support the efficacy of these techniques in the treatment of nervous system dysfunctions.

scholarly journals Impact of Adalimumab on Symptoms of Psoriatic Arthritis in Patients with Moderate to Severe Psoriasis: A Pooled Analysis of Randomized Clinical Trials

Dermatology ◽  
2010 ◽  
Vol 220 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Philip J. Mease ◽  
James Signorovitch ◽  
Andrew P. Yu ◽  
Eric Q. Wu ◽  
Shiraz R. Gupta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Randomized Clinical Trials ◽  
Pooled Analysis ◽  
Severe Psoriasis
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