scholarly journals Gender bias in clinical trials of biological agents for severe asthma: A systematic review

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257765
Author(s):  
Pablo Ciudad-Gutiérrez ◽  
Beatriz Fernández-Rubio ◽  
Ana Belén Guisado-Gil
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gender Bias ◽  
Severe Asthma ◽  
Biological Agents ◽  
Separate Analysis ◽  
Randomized Controlled ◽  
Main Variable ◽  
Sex Disparities ◽  
The Mean

Asthma is one of the most common chronic diseases characterized by sex disparities. Gender bias is a well-documented issue detected in the design of published clinical trials (CTs). International guidelines encourage researchers to analyze clinical data by sex, gender, or both where appropriate. The objective of this work was to evaluate gender bias in the published CTs of biological agents for the treatment of severe asthma. A systematic review of randomized controlled CTs of the biological agents (omalizumab, benralizumab, reslizumab, mepolizumab or dupilumab) for the treatment of severe asthma was conducted. The literature search was performed using PubMed and EMBASE without language restrictions. This study followed the corresponding international recommendations. We identified a total of 426 articles, of which 37 were finally included. Women represented 60.4% of patients included. The mean percentage of women in these trials was 59.9%, ranged from 40.8% to 76.7%. The separate analysis by sex of the main variable was only performed in 5 of the 37 publications included, and none of the trials analyzed secondary variables by sex. Only 1 of the articles discussed the results separately by sex. No study included the concept of gender in the text or analyzed the results separately by gender. The proportion of women included in CTs was higher compared to publications of other disciplines, where women were under-represented. The analysis of the main and secondary variables by sex or gender, even the discussion separately by sex, was insufficient. This gives rise to potential gender bias in these CTs.

The Efficacy and Safety Of Therapeutic Aheresis In Sepsis and Septic Shock: A Systematic Review and Meta-Analysis

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1119-1119
Author(s):  
Emily K. Rimmer ◽  
Brett L. Houston ◽  
Anand Kumar ◽  
Ahmed Abou-Setta ◽  
Carol Friesen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Septic Shock ◽  
Clinical Trials ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
The Mean ◽  
Sepsis And Septic Shock

Abstract Introduction Sepsis and septic shock are leading causes of ICU mortality. They are characterized by excessive host inflammation, upregulation of procoagulant proteins and depletion of natural anticoagulants. Therapeutic apheresis has the potential to improve survival in sepsis by removing injurious elements and inflammatory cytokines and restoring deficient plasma proteins. The objective of our systematic review was to evaluate the efficacy and safety of apheresis in patients with sepsis or septic shock. Methods We searched PubMed, EMBASE, and CENTRAL (from inception to February 2013), the International Clinical Trials Registry Platform, relevant conference proceedings and bibliographies of pertinent reviews and included clinical trials. Two reviewers independently identified randomized controlled trials of patients diagnosed with sepsis, severe sepsis, septic shock or disseminated intravascular coagulation due to infection who received plasmapheresis, plasma exchange, or plasma filtration compared to placebo or usual care. Two reviewers independently extracted trial-level data including population characteristics, interventions, outcomes, and funding sources. We assessed risk of bias using the Cochrane risk of bias tool. Our primary outcome was all-cause mortality reported at the longest follow-up. Secondary outcomes were hospital and ICU lengths of stay, and reported adverse events. We expressed summary effect measures as odds ratios (OR) with 95% confidence intervals (CI). Random effect models using the Mantel-Haenszel method were used for pooled analyses. Results We identified 1771 potential citations of which 3 trials (144 patients) met inclusion criteria. The mean age of patients ranged from 38 to 53 years in the two adult trials and 1 to 18 years in the single pediatric trial. The mean APACHE score was 25.2 (APACHE II) in one study and 54.9 (APACHE III) in the other study reporting illness severity scores. All 3 studies were adjudicated to be unclear or high risk of bias. We observed that the use of apheresis was not associated with a significant reduction in all cause mortality (OR 0.42, 95% CI 0.16 - 1.12, I2=30%) (see Figure). In a subgroup analysis of studies including children exclusively, we observed that apheresis was associated with a significant reduction in mortality (OR 0.03, 95% CI 0.00 – 0.94). None of the included studies reported ICU or hospital length of stay. Only one study reported adverse events associated with apheresis including 6 episodes of hypotension and one allergic reaction to fresh frozen plasma. Central-venous catheter related complications were not reported. Conclusions In patients with sepsis or septic shock, apheresis is not associated a significant reduction in all cause mortality. There is currently insufficient evidence to recommend apheresis as an adjunctive therapy in patients with sepsis or septic shock. Rigorous randomized controlled trials powered to detect differences in patient-centered, clinically relevant outcomes are required to evaluate the impact of apheresis in this patient population. Disclosures: No relevant conflicts of interest to declare.

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.

The effect of almond intake on lipid profile: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Omid Asbaghi ◽  
Vihan Moodi ◽  
Amir Hadi ◽  
Elham Eslampour ◽  
Mina Shirinbakhshmasoleh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Lipid Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.

Effects of cinnamon supplementation on systolic and diastolic blood pressure: a systematic review and meta-analysis of randomized controlled clinical trials

2021 ◽  
Author(s):  
Zeinab Yazdanpanah ◽  
Mandana Amiri ◽  
Azadeh Nadjarzadeh ◽  
Hadis Hooshmandi ◽  
Maryam Azadi-Yazdi
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Diastolic Blood Pressure ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Cochrane Collaboration ◽  
Controlled Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

Introduction: Hypertension is a chronic condition that might lead to renal and cardiovascular diseases. The previous trials examining the effect of cinnamon supplementation on blood pressure have led to conflicting results. The present systematic review aimed to summarize the effect of cinnamon supplementation on blood pressure using a meta-analysis of published randomized controlled clinical trials. Methods: To identify the eligible articles, MEDLINE, SCOPUS, ISI Web of Science, and Google Scholar were searched from inception until September 2019 for relevant articles. The risk of bias assessment was performed using the Cochrane collaboration tool. A Random-effects model was applied to calculate the summary effects. Results: Totally, 11 trials with 686 participants were included in this systematic review and meta-analysis. The dose of cinnamon supplement consumption varied from 500 to 10000 mg/d. The meta-analysis revealed that cinnamon supplementation significantly decreases systolic blood pressure (SBP) [WMD (weighted mean difference)= -5.72 mmHg, 95% confidence interval (CI): -8.63 to -2.80; P<0.001, I2= 81.1)] and diastolic blood pressure (DBP) (WMD= -4.06 mmHg, 95% CI: -6.68 to -1.44; P= 0.002, I2 = 88.6). Subgroup analysis suggested no significant reduction of DBP in subjects with diabetes (WMD= -2.015 mmHg, 95% CI: -4.55 to 0.52; P= 0.12, I2 = 72.3) and prediabetes or metabolic syndrome (WMD= -4.8 mmHg, 95% CI: -10.06 to 0.44; P= 0.073, I2= 92.5). Conclusions: Cinnamon supplementation could be beneficial in lowering SBP and DBP in adults. Further studies with different doses are recommended to confirm the present findings.

A systematic review of noninferiority margins in oncology clinical trials

2021 ◽  
Vol 10 (6) ◽  
pp. 443-455
Author(s):  
Mahmoud Hashim ◽  
Talitha Vincken ◽  
Florint Kroi ◽  
Samron Gebregergish ◽  
Mike Spencer ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Absolute Rate ◽  
Time To Event ◽  
End Points ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Noninferiority Trials ◽  
Oncology Clinical Trials ◽  
Noninferiority Margin

Aim: A systematic literature review was conducted to identify and characterize noninferiority margins for relevant end points in oncology clinical trials. Materials & methods: Randomized, controlled, noninferiority trials of patients with cancer were identified in PubMed and Embase. Results: Of 2284 publications identified, 285 oncology noninferiority clinical trials were analyzed. The median noninferiority margin was a hazard ratio of 1.29 (mean: 1.32; range: 1.05–2.05) for studies that reported time-to-event end points (n = 192). The median noninferiority margin was 13.0% (mean: 12.7%; range: 5.0–20.0%) for studies that reported response end points as absolute rate differences (n = 31). Conclusion: Although there was consistency in the noninferiority margins’ scale, variability was evident in noninferiority margins across trials. Increased transparency may improve consistency in noninferiority margin application in oncology clinical trials.

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