Dexamethasone in Patients with Spontaneous Intracerebral Hemorrhage: An Updated Meta-Analysis

2020 ◽  
Vol 49 (5) ◽  
pp. 495-502
Author(s):  
Stephanie Wintzer ◽  
Josef Georg Heckmann ◽  
Hagen B. Huttner ◽  
Stefan Schwab

<b><i>Background:</i></b> Spontaneous intracerebral hemorrhage (ICH) is a frequent cerebrovascular disorder and still associated with high mortality and poor clinical outcomes. The purpose of this review was to update a 15-year-old former meta-analysis on randomized clinical trials (RCTs) addressing the question of whether ICH patients treated with dexamethasone have better outcomes than controls. <b><i>Methods:</i></b> The electronic databases PubMed, SCOPUS, and Cochrane as well as web platforms on current clinical trials were searched for the years 1970–2020 without constriction on language. Data were extracted and outcomes were pooled for conventional and cumulative meta-analysis using a commercial software program (www.Meta-Analysis.com). <b><i>Results:</i></b> Finally, 7 RCTs were identified and analyzed including 248 participants in the dexamethasone groups and 242 in the control groups. Five studies showed a high risk of bias. The overall relative risk (RR) for death was 1.32 (95% confidence interval [CI] 0.99–1.76; <i>p</i> = 0.06) and did not differ significantly between the 2 groups. After exclusion of studies with high risk of bias, the RR for death was 1.37 (95% CI 0.54–3.42; <i>p</i> = 0.51). The RR for poor outcome did not differ significantly between the 2 groups analyzed for all included studies (RR = 0.69; 95% CI 0.47–1; <i>p</i> = 0.05) and after exclusion of studies with high risk of bias (RR = 0.7; 95% CI 0.45–1.08; <i>p</i> = 0.11). The RR for complications did not differ significantly including all studies (RR = 1.29; 95% CI 0.77–2.17; <i>p</i> = 0.34) and after exclusion of studies with high risk of bias (RR = 1.27; 95% CI 0.18–8.89; <i>p</i> = 0.81). The cumulative statistics delivered no other results; however, it pointed out fewer complications over time in the dexamethasone group. <b><i>Conclusion:</i></b> Clear evidence of a beneficial or negative effect of dexamethasone is still lacking. Modern RCTs or observational studies with propensity design are necessary to evaluate the efficacy and safety of treatment with dexamethasone in patients with ICH.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pooya Ebrahimi ◽  
Mahdi Hadilou ◽  
Ferdos Naserneysari ◽  
Amirmohammad Dolatabadi ◽  
Rana Tarzemany ◽  
...  

Abstract Background Photobiomodulation is widely being used to improve the wound healing process in dentistry and a vast majority of studies have proven its benefits. But there are plenty of knowledge gaps according to the optimal laser characteristics which should be used to maximize the healing effects of lasers. The goal of this systematic review and meta-analysis was to determine the effect of photobiomodulation (PBM) as an adjunctive treatment to periodontal therapies to evaluate secondary intention gingival wound healing and post-operative pain. Methods Five databases (PubMed, Embase, Scopus, ProQuest, and Web of Sciences) were searched up to November 30, 2020, for clinical trials that reported the result of the application of PBM on secondary gingival healing wounds and post-operative pain and discomfort after periodontal surgeries. Two independent reviewers selected the eligible studies and the outcomes of interest were extracted. The quality of eligible studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions. Results Ultimately, twelve studies were included in this review. The application of PBM as an adjunct to periodontal surgeries resulted in a significant improvement in wound healing indices. The Landry wound healing index at the 7th post-operative day was significantly improved (SMD = 1.044 [95% CI 0.62–1.46]; p < 0.01) in PBM + surgery groups compared to the control groups. There was also a statistically significant increase in the complete wound epithelialization (RR = 3.23 [95% CI 1.66–6.31]; p < 0.01) at the 14th post-operative day compared to the control groups. The methods used to assess the post-operative pain were heterogeneous, and therefore the results were limited which made the meta-analysis for post-operative pain assessment not possible. Conclusion Based on the results of this review, PBM can be effectively used as a method to improve secondary intention wound healing. High-quality randomized clinical trials, however, are needed in the future to identify the optimal PBM irradiation parameters and the effect of PBM on post-operative pain.


2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492


2019 ◽  
Vol 52 (01) ◽  
pp. 25-31 ◽  
Author(s):  
Marina Tsoli ◽  
Krystallenia I. Alexandraki ◽  
Maria-Eleni Spei ◽  
Gregory A. Kaltsas ◽  
Kosmas Daskalakis

AbstractMany trials have demonstrated prime antitumor activity of novel, small molecule multikinase inhibitors (MKIs) in advanced and/or metastatic thyroid cancer (TC). In this work, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, SCOPUS, and clinicaltrials.gov databases were searched. Quality/risk of bias were assessed using GRADE criteria. Randomized clinical trials (RCTs) comparing two or more systemic therapies in patients with advanced and/or metastatic thyroid cancer were assessed. A total of 1347 articles and 548 clinical trials in clinicaltrials.gov were screened. We included seven relevant RCTs comprising 1934 unique patients assigned to different MKIs. Two separate network meta-analyses included four RCTs in radioiodine refractory well-differentiated thyroid cancer (RR-WDTC) and three RCTs in medullary thyroid cancer (MTC), respectively; all with a low risk of bias. We identified three therapies for RR-WDTC: sorafenib [disease control rate (DCR) odds ratio (OR): 0.11 (95% CI: 0.03–0.40); progression-free survival (PFS) hazard ratio (HR): 1.99 (95% CI: 1.62–2.46)], vandetanib [DCR_OR:0.26 (95% CI: 0.06–1.24); PFS_HR: 0.99 (95% CI: 0.82–1.20)] and lenvatinib [DCR_OR: 0.26 (95% CI: 0.05–1.33); PFS_HR: 0.99 (95% CI: 0.81–1.22)]; and the following therapies for MTC: vandetanib 300 mg [objective response rate (ORR)_OR: 3.31 (95% CI: 0.68–16.22); vandetanib 150 mg ORR_OR: 0.60 (95% CI: 0.16–2.33)]; and cabozantinib [ORR_OR: 85.32 (95% CI: 5.22–1395.15)]. Serious side effect (SE) analysis per organ/system demonstrated a varying MKI SE profile across both RR-WDTC and MTC diagnoses, more commonly involving metabolic/nutritional disorders [OR: 2.07 [95% CI: 0.82–5.18)] and gastrointestinal SE [OR: 1.63 (95% CI: 1.0–2.66)]. This network meta-analysis on advanced and/or metastatic TC points towards a higher efficacy of lenvatinib in RR-WDTC. The included MKIs exhibit a varying SE profile across different organs/systems favoring a patient-tailored approach with the anticipated toxicities guiding clinicians’ decisions.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ana Carolina de Figueiredo Costa ◽  
Thays Allane Cordeiro Maia ◽  
Paulo Goberlânio de Barros Silva ◽  
Lucas Guimarães Abreu ◽  
Delane Viana Gondim ◽  
...  

Abstract Objectives The aim of this systematic review and meta-analysis was to assess the effects of low-level laser therapy (LLLT) on the orthodontic mini-implants (OMI) stability. Materials and methods An unrestricted electronic database search in PubMed, Science Direct, Embase, Scopus, Web of Science, Cochrane Library, LILACS, Google Scholar, and ClinicalTrials.gov and a hand search were performed up to December 2020. Randomized clinical trials (RCTs) or non-randomized clinical trials (Non-RCTs) that assessed the effects of LLLT on the OMI stability were included. Data regarding the general information, LLLT characteristics, and outcomes were extracted. The authors performed risk of bias assessment with Cochrane Collaboration’s or ROBINS-I tool. Meta-analysis was also conducted. Results Five RCTs and one Non-RCT were included and 108 patients were evaluated. The LLLT characteristics presented different wavelength, power, energy density, irradiation time, and protocol duration. Five RCTs had a low risk of selection bias. Two RCTs had a low risk of performance and detection bias. All RCTs had a low risk of attrition bias, reporting bias and other bias. The Non-RCT presented a low risk of bias for all criteria, except for the bias in selection of participants. The meta-analysis revealed that LLLT significantly increased the OMI stability (p < 0.001, Cohen’s d = 0.67) and the highest clinical benefit was showed after 1 (p < 0.001, Cohen’s d = 0.75), 2 (p < 0.001, Cohen’s d = 1.21), and 3 (p < 0.001, Cohen’s d = 1.51) months of OMI placement. Conclusions LLLT shows positive effects on the OMI stability.


2018 ◽  
Vol 43 (3) ◽  
pp. E129-E151 ◽  
Author(s):  
A Reis ◽  
JL de Geus ◽  
L Wambier ◽  
M Schroeder ◽  
AD Loguercio

SUMMARY The literature was reviewed to evaluate the compliance of randomized clinical trials (RCTs) with the CONsolidated Standards of Reporting Trials (CONSORT ) and the risk of bias of these studies through the Cochrane Collaboration risk of bias tool (CCRT). RCTs were searched at Cochrane Library, PubMed, and other electronic databases to find studies about adhesive systems for cervical lesions. The compliance of the articles with CONSORT was evaluated using the following scale: 0 = no description, 1 = poor description, and 2 = adequate description. Descriptive analyses about the number of studies by journal, follow-up period, country, and quality assessments were performed with CCRT for assessing risk of bias in RCTs. One hundred thirty-eight RCTs were left for assessment. More than 30% of the studies received scores of 0 or 1. Flow chart, effect size, allocation concealment, and sample size were more critical items, with 80% receiving a score of 0. The overall CONSORT score for the included studies was 15.0 ± 4.8 points, which represents 46.9% of the maximum CONSORT score. A significant difference among countries was observed (p&lt;0.001), as well as range of year (p&lt;0.001). Only 4.3% of the studies were judged as at low risk; 36.2% were classified as having unclear risk and 59.4% as having high risk of bias. The adherence of RCTs evaluating adhesive systems to the CONSORT is low with unclear/high risk of bias.


2016 ◽  
Vol 16 (2) ◽  
pp. 135-146 ◽  
Author(s):  
Tae-Young Choi ◽  
Jong In Kim ◽  
Hyun-Ja Lim ◽  
Myeong Soo Lee

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.


2021 ◽  
Vol 39 ◽  
Author(s):  
Paola Janeiro Valenciano ◽  
Fabíola Unbehaun Cibinello ◽  
Jessica Caroliny de Jesus Neves ◽  
Dirce Shizuko Fujisawa

ABSTRACT Objective: To determine the effect of postural education on the learning and postural habits of elementary school children without physical intervention. Methods: We searched PubMed, Lilacs, SciELO, Cochrane, and Science Direct data bases and reference lists of studies in February 2020. The eligibility criteria were randomized clinical trials related to the effect of postural education in children aged between 6 and 12 years old. Two authors independently assessed trials for inclusion and risk of bias: randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result. Data were extracted in standardized tables including information on author, publication year, country, sample size, age, sex, intervention characteristics, outcome measurements and results. Results: We found seven clinical trials (involving 2,568 children) for the review. The studies were conducted between 2000 and 2018: four in Belgium, two in Spain, and one in Germany. All seven included trials underwent evaluation: only one had a clear process of randomization and allocation concealment. All included studies were judged as having high risk of bias in at least one domain or have concerns for multiple domains. Conclusions: The positive effects of acquired knowledge and postural habits found in the studies cannot be used to reliably support postural education in elementary school children due to a high risk of bias in the evaluated studies.


2020 ◽  
Author(s):  
Ahmad Sofi-Mahmudi ◽  
Pouria Iranparvar ◽  
Maryam Shakiba ◽  
Erfan Shamsoddin ◽  
Hossein Mohammad-Rahimi ◽  
...  

AbstractObjectivesThe Risk of Bias (RoB) and other characteristics of randomized clinical trials included in Cochrane oral health systematic reviews were assessed.Study Design and SettingsAll the trials included in Cochrane oral health systematic reviews were examined. The RoB was evaluated for all the included clinical trials according to the Cochrane review standards. The Overall Risk of Bias (ORoB) was defined in this study based on the criteria for determining the overall bias in Cochrane’s RoB tool-v2. Descriptive analyses were carried out to determine the frequency of each intended variable.ResultsA total of 2565 studies were included in our analysis. The majority of the studies (n=1600) had sample sizes of 50 or higher. As for blinding, 907 studies were labelled as double-blind. Performance bias showed the highest rate of high risk (31.4%). Almost half of the studies had a high ORoB compared to 11.1% with low ORoB. The studies that used placebos had higher low ORoB (14.8% vs. 10.7%). The double-blind studies had the highest low ORoB (23.6%). The studies with a cross-over design had the highest low ORoB (28.8%).ConclusionOverall, the RoB for the studies on dentistry and oral health in Cochrane reviews was deemed high.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
António H. S. Delgado ◽  
Hasan Jamal ◽  
Anne Young ◽  
Paul Ashley

Abstract Background Adhesive restorations allow a conservative approach to caries management and are increasingly used as a restorative option in pediatric dentistry. Placement can be difficult in children because of the cooperation required for multiple bonding steps. Due to this, it is vital to assess if novel, simpler strategies have been featured in clinical trials and if clinical trials are researching the different existing adhesive strategies. Methods This review followed Preferred Reporting Items for Systematic Reviews and Meta-analysis adapted for Scoping Reviews (PRISMA-ScR) guidelines. PubMed/Medline, Cochrane Central, Scopus and EMBASE were used for systematic search, using free keywords and controlled search terms. Clinical trials of children requiring a restorative intervention which featured adhesive strategies were included. Only peer-reviewed trials of primary teeth restored with resin composites, published in the last 10-year period were eligible. Data charting was accomplished independently by two reviewers, and studies were summarized according to their date, type, intervention, sample size, observation period, outcomes and conclusions. Quality assessment was performed using Cochrane’s Risk of Bias 2.0 tool. Results 700 potentially relevant references were found, which after a rigorous inclusion scheme, resulted in a total of 8 eligible clinical trials. Out of these, 7 were randomized clinical trials. Most trials featured a split-mouth design and the observation period ranged from 12 to 36 months. The trials evaluated interventions of two self-adhesive composites, two bulk-fill composites, two novel composites, one compomer and eight adhesives from different strategies. Most studies (4/8) included were judged to raise some concerns regarding risk of bias, while two were classified as high risk and two as low. Conclusion Few studies comparing adhesive strategies were found, especially adhesives in sound substrates. The existing studies do not reflect all current approaches that could be used in pediatric dentistry. Further studies addressing bioactive composites and contemporary adhesives are necessary.


2021 ◽  
Author(s):  
Pooya Ebrahimi ◽  
Mahdi Hadilou ◽  
Ferdos Naserneysari ◽  
Amirmohammad Dolatabadi ◽  
Rana Tarzemany ◽  
...  

Abstract Background: Photobiomodulation is widely being used to improve the wound healing process in dentistry and a vast majority of studies have proven its benefits. But there are plenty of knowledge gaps according to the optimal laser characteristics which should be used to maximize the healing effects of lasers. The goal of this systematic review and meta-analysis was to determine the effect of photobiomodulation (PBM) as an adjunctive treatment to periodontal therapies to evaluate secondary intention gingival wound healing and post-operative pain.Methods: Five databases (PubMed, Embase, Scopus, ProQuest, and Web of Sciences) were searched up to November 30, 2020, for clinical trials that reported the result of the application of PBM on secondary gingival healing wounds and post-operative pain and discomfort after periodontal surgeries. Two independent reviewers selected the eligible studies and the outcomes of interest were extracted. The quality of eligible studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions.Results: Ultimately, twelve studies were included in this review. The application of PBM as an adjunct to periodontal surgeries resulted in a significant improvement in wound healing indices. The Landry wound healing index at the 7th post-operative day was significantly improved (SMD = 1.044 [95% CI: 0.62 to 1.46]; p<0.01) in PBM + surgery groups compared to the control groups. There was also a statistically significant increase in the complete wound epithelialization (RR = 3.23 [95% CI: 1.66 to 6.31]; p<0.01) at the 14th post-operative day compared to the control groups. The methods used to assess the post-operative pain were heterogeneous, and therefore the results were limited which made the meta-analysis for post-operative pain assessment not possible.Conclusion: Based on the results of this review, PBM can be effectively used as a method to improve secondary intention wound healing. High-quality randomized clinical trials, however, are needed in the future to identify the optimal PBM irradiation parameters and the effect of PBM on post-operative pain.


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