scholarly journals Methodological Aspects of Randomized Controlled Trials for Tinnitus: A Systematic Review and How a Decision Support System Could Overcome Barriers

2021 ◽  
Vol 10 (8) ◽  
pp. 1737
Author(s):  
Dimitrios Kikidis ◽  
Evgenia Vassou ◽  
Winfried Schlee ◽  
Eleftheria Iliadou ◽  
Nikolaos Markatos ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Current Knowledge ◽  
Therapeutic Interventions ◽  
Future Studies ◽  
Randomized Controlled ◽  
Management Interventions ◽  
Wide Range ◽  
Tinnitus Treatment ◽  
Methodological Aspects

Although a wide range of tinnitus management interventions is currently under research and a variety of therapeutic interventions have already been applied in clinical practice, no optimal and universal tinnitus treatment has been reached yet. This fact is to some extent a consequence of the high heterogeneity of the methodologies used in tinnitus related clinical studies. In this manuscript, we have identified, summarized, and critically appraised tinnitus-related randomized clinical trials since 2010, aiming at systematically mapping the research conducted in this area. The results of our analysis of the 73 included randomized clinical trials provide important insight on the identification of limitations of previous works, methodological pitfalls or gaps in current knowledge, a prerequisite for the adequate interpretation of current literature and execution of future studies.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

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 Herbal Formula Modified Buzhong-Yiqi-Tang for Functional Constipation in Adults: A Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Hanlin Gong ◽  
Feng Qin ◽  
Hongbo He
Keyword(s):  
Clinical Trials ◽  
Therapeutic Effect ◽  
Randomized Clinical Trials ◽  
Functional Constipation ◽  
Adult Patients ◽  
Controlled Trials ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Prokinetic Agents

Background. Herbal formula Modified Buzhong-Yiqi-Tang (MBYT) has been widely used for the treatment of functional constipation in East Asia, but its efficacy and safety are unclear. Methods. The study was to evaluate the efficacy and safety of MBYT for adult patients with functional constipation. Randomized clinical trials were selected according to predefined inclusion and exclusion criteria. Results. In total, twenty-five randomized controlled clinical trials were included with 2089 patients. There was evidence that MBYT treatment significantly improved the symptoms of functional constipation compared with stimulant laxatives, osmotic laxatives, and prokinetic agents. Our results also demonstrated that, when used as an adjuvant therapy, MBYT significantly improved the symptoms of functional constipation, when compared with osmotic laxatives alone, prokinetic agents alone, and biofeedback alone. Moreover, patients taking MBYT experienced fewer adverse events compared to the control groups. Conclusion. This review suggests that MBYT appears to have excellent therapeutic effect on adult patients with functional constipation and no serious side effects were identified. However, due to overall limited quality, the therapeutic benefit of MBYT may be substantiated to a limited degree. Better methodological quality and large controlled trials are expected to further quantify the therapeutic effect of MBYT.

scholarly journals Systematic Review of Randomized Clinical Trials of Acupressure Therapy for Primary Dysmenorrhea

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Hui-ru Jiang ◽  
Shuang Ni ◽  
Jin-long Li ◽  
Miao-miao Liu ◽  
Ji Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled ◽  
Central Register

The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs), we searched MEDLINE, the Chinese Biomedical Database (CBM), and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. Eight RCTs were identified from the retrieved 224 relevant records. Acupressure improved pain measured with VAS (−1.41 cm 95% CI [−1.61, −1.21]), SF-MPQ at the 3-month followup (WMD −2.33, 95% CI [−4.11, −0.54]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]), and MDQ at the 3-month followup (WMD −2.31, 95% CI [−3.74, −0.87]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]). All trials did not report adverse events. These results were limited by the methodological flaws of trials.

Randomized Controlled Trials in the Evaluation of Antenatal Care

1992 ◽  
Vol 8 (S1) ◽  
pp. 40-45 ◽  
Author(s):  
Murray W. Enkin
Keyword(s):  
Clinical Trials ◽  
Antenatal Care ◽  
Randomized Controlled Trials ◽  
Perinatal Outcome ◽  
Randomized Clinical Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Adverse Perinatal Outcome ◽  
Randomized Controlled

AbstractMany of the practices carried out during antenatal care improve the well-being of mother or baby and reduce the burden of adverse perinatal outcome. Other practices have either not been evaluated or have been shown to be ineffective. Evidence from randomized clinical trials provides the best evidence about the effectiveness of these practices.

scholarly journals The risk of bleeding minimization with direct oral anticoagulants

2021 ◽  
pp. 106-126
Author(s):  
Т. N. Novikova
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Anticoagulant Therapy ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Blood Analysis ◽  
Systemic Embolism ◽  
Risk Of Bleeding ◽  
Wide Range

This review is devoted to the safety issues of anticoagulant therapy prescribed for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Direct oral anticoagulants are considered worldwide in accordance with the guidelines for the diagnosis and treatment of atrial fibrillation as the preferred anticoagulant choice for the prevention of stroke and systemic embolism. Direct oral anticoagulants in comparison with vitamin K antagonists generally have similar efficacy, but different safety profiles, primarily, this concerns the risk of large extracranial and, primarily, gastrointestinal hemorrhages. To minimize the risk of bleeding during therapy with direct oral anticoagulants, an individual approach to the choice of the drug for each individual patient is required after assessing the risk of bleeding, searching for a potential bleeding substrate, correcting existing risk factors and eliminating, if possible, the substrate. When choosing an anticoagulant therapy, special attention should be paid to the most vulnerable categories of patients, such as patients of older age groups and patients with concomitant chronic kidney disease. Among the direct oral anticoagulants registered in the Russian Federation, according to meta-analyzes of key randomized clinical trials and real clinical trials, apixaban has the most optimal benefit: risk ratio in a wide range of patients, including vulnerable populations. Dynamic observation, including regular assessment of renal function, control of clinical blood analysis, erythrocyte and platelet levels, after prescribing an individually selected anticoagulant to the patient, ensures the maximum safety of therapy. Small, so-called, annoying bleeding is not a reason for canceling the anticoagulant, but requires a careful search for the causes of bleeding and their correction.

scholarly journals Comparing The Efficacy of Anti-Infectious Drugs For The Treatment of Mild To Severe COVID-19 Patients: A Protocol For A Systematic Review And Network Meta-Analysis of Randomized Clinical Trials.

2021 ◽  
Author(s):  
Dejene Tolossa Debela ◽  
Kidist Digamo Heraro ◽  
Abebaw Fekadu ◽  
Merga Belina ◽  
Tsegahun Manyazewal
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
English Language ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Antiviral Drug ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Primary Endpoints ◽  
Independent Review

Abstract Background: COVID-19 is a viral infection spreading at a great speed and has quickly caused an extensive burden to individuals, families, countries, and the world. No intervention has yet been proven highly effective for the treatment of COVID-19. Different drugs were being evaluated and reported through randomized clinical trials, and more are currently under trial. This review aimed to compare the efficacy of anti-infectious drugs with a comparator of the standard of care or placebo in patients with COVID-19.Methods: Two independent review authors will extract data and assess a risk of bias using RoB2. Randomized controlled trials (RCT) that evaluate single and/or combined antiviral drugs recommended by WHO latest guideline for the treatment of COVID-19 will be included. We will search for Pub Med, the Cochrane Center for Clinical Trial database (CENTRAL), clinicaltrials.gov, etc. databases for articles published in the English language between December 2019 to April 2021. We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) involving Network Meta-analysis guidelines to design and report of the results. The primary endpoints will be time to clinical recovery and time to RNA negativity. The certainty of evidence will be evaluated using the GRADE extension of NMA. Data analysis will be performed using the frequentist NMA approach with the netmeta package implemented in R.Discussion: This review will reveal the best antiviral drug treatment for covid-19 and show the hierarchy of those drugs.Systematic review registration: The protocol was registered on PROSPERO with ID number CRD42021230919

scholarly journals Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

2020 ◽  
Author(s):  
Joseph A. Ladapo ◽  
John E. McKinnon ◽  
Peter A. McCullough ◽  
Harvey Risch
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Exposure Prophylaxis

Objective--To determine if hydroxychloroquine (HCQ) reduces the incidence of new illness, hospitalization or death among outpatients at risk for or infected with SARS-CoV-2 (COVID-19). Design--Systematic review and meta-analysis of randomized clinical trials. Data sources--Search of MEDLINE, EMBASE, PubMed, medRxiv, PROSPERO, and the Cochrane Central Register of Controlled Trials. Also review of reference lists from recent meta-analyses. Study selection--Randomized clinical trials in which participants were treated with HCQ or placebo/standard-of-care for pre-exposure prophylaxis, post-exposure prophylaxis, or outpatient therapy for COVID-19. Methods--Two investigators independently extracted data on trial design and outcomes. Medication side effects and adverse reactions were also assessed. The primary outcome was COVID-19 hospitalization or death. When unavailable, new COVID-19 infection was used. We calculated random effects meta-analysis according to the method of DerSimonian and Laird. Heterogeneity between the studies was evaluated by calculation of Cochran Q and I2 parameters. An Egger funnel plot was drawn to investigate publication bias. We also calculated the fixed effects meta-analysis summary of the five studies. All calculations were done in Excel, and results were considered to be statistically significant at a two-sided threshold of P=.05. Results--Five randomized controlled clinical trials enrolling 5,577 patients were included. HCQ was associated with a 24% reduction in COVID-19 infection, hospitalization or death, P=.025 (RR, 0.76 [95% CI, 0.59 to 0.97]). No serious adverse cardiac events were reported. The most common side effects were gastrointestinal. Conclusion--Hydroxychloroquine use in outpatients reduces the incidence of the composite outcome of COVID-19 infection, hospitalization, and death. Serious adverse events were not reported and cardiac arrhythmia was rare. Systematic review registration--This review was not registered.

Sign in / Sign up

Export Citation Format

Share Document