scholarly journals 720. Efficacy of Nifurtimox + Eflornithine in the Treatment of African Trypanosomiasis. Systematic Review

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S459-S459
Author(s):  
Jessica Hidalgo ◽  
Raghavendra Tirupathi ◽  
Juan Fernando Ortiz ◽  
Stephanie P Fabara ◽  
Dinesh Reddy ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Trypanosoma Brucei ◽  
Observational Studies ◽  
Case Fatality ◽  
Patient Discharge ◽  
Tsetse Fly ◽  
Open Label ◽  
Second Stage ◽  
Additional Clinical Trial

Abstract Background Sleeping sickness is an infectious disease transmitted mainly by the Trypanosoma Brucei, with the tsetse fly as a vector. The condition has two stages: The hemolymphatic and the meningo-encephalitic stage. The second stage is caused mainly by the Trypanosoma Brucei Gambiense. The treatment of the second stage has changed from melarsoprol, eflornithine, to now nifurtimox-eflornithine (NECT). This systematic review will focus on the efficacy and the toxicity of the medication. Methods We use PRISMA and MOOSE protocol for this review. On figure 1, we detail the methodology used for the extraction of information from the systematic review. To assess the study's bias, we used Cochrane Collaboration’s tool for risk assessment of the clinical trials and the Robins I tool for the observational studies. Results We collected four clinical trials and two observational studies after an extensive search. Three clinical trials showed that NECT was non-inferior to eflornithine with the following cure rates (NECT VS eflornithine): 1) 96.3% vs. 94.1% ; 2) 90.9% vs. 88.9%; 3) 91.6% vs. 96.5%. An additional clinical trial revealed that the proportion of patient discharge from the hospital was 98.4% (619/629); 95% CI [97.1%; 99.1%]). The two observational studies discussed the pharmacovigilance of the drug and toxicity related to NECT. In one study, patients treated with NECT, 589 (86%) experienced at least one adverse effect (AE) during treatment, and 70 (10.2%) experience serious AE. On average, children experienced fewer AEs than adults. In the other study at least one AE was described in 1043 patients (60.1%), and Serious AE was reported in 19 patients (1.1% of treated), leading to nine deaths (case fatality rate of 0.5%). The major limitations of the studies were the lack of blinding because most of them were open-label. Also, there was heterogenicity in the definition of the outcomes in the observational studies. PRISMA Flow Chart Conclusion NECT is not inferior to eflornithine, and the proportion of patients discharged from the hospital alive showed favorable results. The observational studies revealed a high frequency of AE. However, NECT is more convenient and safe than Eflornithine and Melarsoprol. Disclosures All Authors: No reported disclosures

scholarly journals Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Melina von Wernsdorff ◽  
Martin Loef ◽  
Brunna Tuschen-Caffier ◽  
Stefan Schmidt
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Condition ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Open Label ◽  
Cancer Related Fatigue ◽  
Promising Treatment ◽  
Irritable Bowel

AbstractOpen-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

scholarly journals Post-Exposure Effects of Vaccines on Infectious Diseases

2019 ◽  
Author(s):  
Tara Gallagher ◽  
Marc Lipsitch
Keyword(s):  
Clinical Trials ◽  
Observational Studies ◽  
Case Fatality ◽  
Hepatitis E ◽  
Vaccine Preventable Diseases ◽  
Post Exposure ◽  
Vaccine Trials ◽  
Tick Borne Encephalitis ◽  
Pubmed Database ◽  
Definition Of

AbstractMany available vaccines have demonstrated post-exposure effectiveness, but no published systematic reviews have synthesized these findings. We searched the PubMed database for clinical trials and observational human studies concerning the post-exposure vaccination effects, targeting infections with an FDA-licensed vaccine plus dengue, hepatitis E, malaria, and tick borne encephalitis, which have licensed vaccines outside of the U.S. Studies concerning animal models, serologic testing, and pipeline vaccines were excluded. Eligible studies were evaluated by definition of exposure, and their attempt at distinguishing pre- and post-exposure effects was rated on a scale of 1-4. We screened 4518 articles and ultimately identified 14 clinical trials and 31 observational studies for this review, amounting to 45 eligible articles spanning 7 of the 28 vaccine-preventable diseases. For secondary attack rate, this body of evidence found the following medians for post-exposure vaccination effectiveness: hepatitis A: 85% (IQR: 28; 5 sources), hepatitis B: 85% (IQR: 22; 5 sources), measles: 83% (IQR: 21; 8 sources), varicella: 67% (IQR: 48; 9 sources), smallpox: 45% (IQR: 39; 4 sources), and mumps: 38% (IQR: 7; 2 sources). For case fatality proportions resulting from rabies and smallpox, the vaccine efficacies had medians of 100% (IQR: 0; 6 sources) and 63% (IQR: 50; 8 sources) post-exposure. Although mainly used for preventive measures, many available vaccines can modify or preclude disease if administered after exposure. This post-exposure effectiveness could be important to consider during vaccine trials and while developing new vaccines.

scholarly journals Associations of Plant-Based Foods and Diets with Gestational Diabetes: A Systematic Review of Observational Studies and Clinical Trials

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 948-948
Author(s):  
Tristesse Burton ◽  
James Alexander ◽  
Petar Planinic ◽  
Arpita Basu
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gestational Diabetes ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Chinese Herb ◽  
Nutrition Therapy ◽  
Cross Sectional ◽  
Evening Primrose ◽  
Funding Sources

Abstract Objectives Gestational diabetes mellitus (GDM) is one of the most common health complications during pregnancy. Medical nutrition therapy is the mainstay of treatment for GDM, however, there is no current consensus on the optimal dietary approaches for prevention and management of hyperglycemia during pregnancy. Our objective is to assess the relationship of plant-based diets, foods, and dietary supplements with GDM and maternal glycemic biomarkers in observational and clinical studies. Methods A systematic review was performed using PubMed to identify original articles from 1999–2019 following the PRISMA checklist statement. Articles were excluded if they were review articles, conference abstracts, not in English or did not meet the pre-defined PICOS (Population, Intervention/exposure, Comparison, Outcome, Study design) criteria. Articles were screened for relevance, extracted and summarized, and assessed for risk of bias and quality. Results A total of 431 articles were screened, 33 observational studies (prospective cohort: n = 26, case-control: n = 3, cross-sectional: n = 4) involving 147,576 women and 11 randomized clinical trials involving 3940 women were included. Among the observational studies, Mediterranean diet (MedDiet), fiber, and vegetable rich diets were associated with a significant decrease in GDM risk. Among the clinical trials, Dietary Approaches to Stop Hypertension (DASH) diet, MedDiet, soy, phytosterol spread, evening primrose, chili powder and a traditional Chinese herb, Artemisia scoparia Waldst. & Kit. (Asteraceae) (n = 1) exhibited improved maternal hyperglycemia, insulin resistance or sensitivity, and hypoadiponectinemia. Conclusions These findings suggest that plant-based diets may be effective in preventing and managing hyperglycemia during pregnancy. Particularly, adherence to a MedDiet may improve maternal glycemic biomarker and decrease risk of GDM. Funding Sources UNLV Faculty research start up award.

Low Glycemic Load or Index Diet in Association with Acne Vulgaris: A Systematic Review and Meta-analysis

2020 ◽  
Author(s):  
Roya Sakhaei ◽  
Mohammad Ali Mohsenpour
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Social Life ◽  
Observational Studies ◽  
Meta Analysis ◽  
Acne Vulgaris ◽  
Glycemic Load ◽  
Dietary Factors ◽  
Dietary Habit ◽  
The Mean

Background: Social life can be affected by skin condition. Acne Vulgaris (AV) is a multi-factorial skin disorder that affects many people. Several dietary factors are associated with AV. Objectives: Different findings on glycemic indices led us to investigate the effect of the dietary glycemic index (GI) and glycemic load (GL) on AV by a systematic review and meta-analysis. Methods: Observational studies and clinical trials were extracted from PubMed, EMBASE, Scopus, and Google Scholar. The mean ± Standard division (SD) for acne grading in clinical trials and the mean ± SD GI or GL of the diet for observational studies were used for meta-analysis. Results: We found that nine out of 15 studies were eligible for systematic review clinical trials (N = 3) and observational studies (N = 6) designs. The meta-analysis of three studies clinically assessed the effect of GI/GL on acne and showed that a diet with lower GI/GL reduced the acne severity (Hedges’g = -0.91, 95% CI: -1.57, -0.25, P = 0.007). The analysis of six observational studies showed that dietary habit with higher GI might not affect the acne severity in patients with AV (Hedges’g = 0.07, 95%CI: -0.23, 0.38, P = 0.636), but individuals with higher acne severity had a diet with higher GL (Hedges’g = 0.64, 95%CI: 0.01, 1.26, P = 0.045). Conclusions: Diet, as a part of life style, is associated with AV. Adherence to lower GL diet may reduce the severity of AV. Further well-designed clinical trials are required to confirm these results.

scholarly journals The efficacy of topical, oral and surgical interventions for the treatment of tungiasis: A systematic review of the literature

2021 ◽  
Vol 15 (8) ◽  
pp. e0009722
Author(s):  
Ana Carolina Tardin Martins ◽  
Amanda Ramos de Brito ◽  
Patrícia Shu Kurizky ◽  
Rodrigo Gurgel Gonçalves ◽  
Yago Ranniere Teixeira Santana ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Observational Studies ◽  
Treatment Options ◽  
Sufficient Evidence ◽  
Tissue Destruction ◽  
Adequate Treatment ◽  
Surgical Interventions ◽  
Surgical Extraction ◽  
Quantitative Descriptive

Background Tungiasis is a neglected disease caused by Tunga penetrans that can be complicated by secondary infections and local tissue destruction. Adequate treatment is important, especially in vulnerable populations; potential treatment options proposed range from surgical extraction to the use of oral and topical medications. We aimed to perform a systematic review to assess the efficacy of topical, oral and surgical interventions for the treatment of tungiasis. Methodology/Principal findings The present review is registered in PROSPERO (CRD42021234741). On September 1, 2020, we searched PubMed, EMBASE, Scopus, Web of Science, Science Direct, Scielo and LILACS BVS. We included clinical trials and longitudinal observational studies that evaluated any topical, systemic or mechanical treatment for tungiasis. We used the Revised Cochrane Risk of Bias (RoB) Tool for Randomized Trials for clinical trial analysis. Qualitative and quantitative descriptive syntheses were performed. Our search strategy resulted in 3376 references. Subsequently, 2568 titles/abstracts and 114 full texts were screened. We finally included 19 articles; 9 were classified as clinical trials. Two and 3 articles presented low and some RoB, respectively, according to the tool. Only two articles tested the efficacy of oral medications (niridazole, ivermectin), with discouraging results. Six clinical trials evaluated topical products for the treatment of tungiasis; 2 evaluated dimeticone-based compounds and reported positive results in lesion reduction and cure. None reported significant adverse reactions. Surgical extraction was evaluated only in observational studies. Conclusions/Significance We conclude that, although surgical extraction is the most commonly used treatment, there is sufficient evidence supporting the use of occlusive agents, especially manufactured dimeticone-based products.

Pharmacological interventions for COVID-19: a systematic review of observational studies and clinical trials

2021 ◽  
Author(s):  
Nida Bokharee ◽  
Yusra Habib Khan ◽  
Aisha Khokhar ◽  
Tauqeer Hussain Mallhi ◽  
Nasser Hadal Alotaibi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Observational Studies ◽  
Pharmacological Interventions
Sign in / Sign up

Export Citation Format

Share Document