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Frontiers in Immunology 2022Nemolizumab is deemed as a promising drug for atopic dermatitis (AD) patients with pruritus. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Nemolizumab is deemed as a promising drug for atopic dermatitis (AD) patients with pruritus.
OBJECTIVE
This study aimed to evaluate the efficacy of nemolizumab in treating patients with AD and the association between the dosage or regimen of nemolizumab with the improvement in clinical indices.
METHODS AND MATERIALS
PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials (RCTs) published from inception to August 2021.
RESULTS
A total of 14 cohorts of participants from six randomized controlled studies were included in the meta-analysis. Nemolizumab significantly reduced the pruritus VAS (WMD = -18.86, 95% CI: -27.57 to -10.15, < 0.001; = 56.2%, = 0.005) and EASI (WMD = -11.76, 95% CI: -20.55 to -2.96, = 0.009; = 0%, = 0.978) scores compared with placebo. No significant difference was observed in the occurrence of any AEs (RR = 1.03, 95% CI: 0.93 to 1.13, = 0.593; = 0%, = 0.980) between the two groups. The univariate meta-regression showed that both the dosage and study duration had no association with the change of pruritus VAS score.
CONCLUSION
Nemolizumab presented a promising effect based on the difference in the average change in pruritus VAS and EASI scores compared with placebo. The results indicated its efficacy in relieving pruritus and the severity of AD and improving patients' quality of life.
Topics: Antibodies, Monoclonal, Humanized; Dermatitis, Atopic; Double-Blind Method; Humans; Pruritus; Randomized Controlled Trials as Topic; Regression Analysis
PubMed: 35558086
DOI: 10.3389/fimmu.2022.825312 -
Neurocritical Care Aug 2022Vinpocetine as a neuroprotective agent is effective in acute ischemic stroke in some randomized controlled trials (RCTs). Since the last systematic review has been... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vinpocetine as a neuroprotective agent is effective in acute ischemic stroke in some randomized controlled trials (RCTs). Since the last systematic review has been published in 2008, which didn't find conclusive evidence favoring its use, two more RCTs have also been completed.
METHODS
Relevant electronic databases were searched with a suitable combination of Medical Subject Headings terms to detect publications describing RCTs exploring the safety and efficacy of vinpocetine in patients with acute ischemic stroke. The risk of bias was determined by using the Cochrane Collaboration's tool for assessing the risk of bias in RCTs after full-text review and relevant data extraction. Higgins and Thompson's I method was used to assess heterogeneity in studies. The presence of publication bias was assessed by Egger's test. We used a random effect model when I was more than 50% and a fixed-effect model for other parameters.
RESULTS
Four placebo-controlled RCTs enrolling a total of 601 and 236 patients in vinpocetine and placebo groups, respectively, were included. The number of patients with death or significant disability was lower in the vinpocetine group than that in the placebo group at both 1 and 3 months (relative risk 0.80, 95% confidence interval [CI] 0.65-0.99 and relative risk 0.67, CI 0.48-0.92, p = 0.04 and 0.02, respectively). The degree of disability in participants at 1 month and 3 months was also lower in vinpocetine group than that in the placebo group (standardized mean difference (SMD) 0.49, 95% CI 0.03-0.95 and SMD 1.22, CI 0.23-2.24, p = 0.001 and 0.04, respectively). Change in mini-mental state examination score compared with baseline at trial enrolment was also better in the vinpocetine group than in the placebo group (pooled weighted mean difference 0.92, 95% CI 0.02-1.82, p = 0.04).
CONCLUSIONS
Vinpocetine has some promising efficacy in patients with ischemic stroke when used in the acute stage in reducing the disability, but presently there is not enough evidence to suggest that it also reduces case fatality. More double-blind, placebo-controlled RCTs of adequate sample size are needed before making recommendations for the routine administration of vinpocetine for all patients with acute ischemic stroke.
Topics: Humans; Ischemic Stroke; Neuroprotective Agents; Randomized Controlled Trials as Topic; Stroke; Vinca Alkaloids
PubMed: 35488169
DOI: 10.1007/s12028-022-01499-y -
The Cochrane Database of Systematic... Mar 2022This is an updated version of the Cochrane Review previously published in 2019. Epilepsy is one of the most common neurological disorders. It is estimated that up to 30%... (Review)
Review
BACKGROUND
This is an updated version of the Cochrane Review previously published in 2019. Epilepsy is one of the most common neurological disorders. It is estimated that up to 30% of individuals with epilepsy continue to have epileptic seizures despite treatment with an antiepileptic drug. These patients are classified as drug-resistant and require treatment with a combination of multiple antiepileptic drugs. Brivaracetam is a third-generation antiepileptic drug that is a high-affinity ligand for synaptic vesicle protein 2A. In this review we investigated the use of brivaracetam as add-on therapy for epilepsy.
OBJECTIVES
To evaluate the efficacy and tolerability of brivaracetam when used as add-on treatment for people with drug-resistant epilepsy.
SEARCH METHODS
For the latest update we searched the following databases on 7 September 2021: the Cochrane Register of Studies (CRS Web); MEDLINE (Ovid) 1946 to 3 September 2021. CRS Web includes randomised controlled trials (RCTs) and quasi-RCTs from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including Cochrane Epilepsy.
SELECTION CRITERIA
We searched for parallel-group RCTs that recruited people of any age with drug-resistant epilepsy. We accepted studies with any level of blinding (double-blind, single-blind, or unblinded).
DATA COLLECTION AND ANALYSIS
In accordance with standard Cochrane methodological procedures, two review authors independently assessed trials for inclusion before evaluating trial quality and extracting relevant data. The primary outcome to be assessed was 50% or greater reduction in seizure frequency. Secondary outcomes were: seizure freedom, treatment withdrawal for any reason, treatment withdrawal due to adverse events, the proportion of participants who experienced any adverse events, and drug interactions. We used an intention-to-treat population for all primary analyses, and presented results as risk ratios (RRs) with 95% confidence intervals (CIs).
MAIN RESULTS
We did not identify any new studies for this update, therefore the results and conclusions of the review are unchanged. The previous review included six studies involving a total of 2411 participants. Only one study included participants with both focal and generalised onset seizures; the other five trials included participants with focal onset seizures only. Study participants were aged 16 to 80 years. Treatment periods ranged from 7 to 16 weeks. We judged two studies to have low risk of bias and four to have unclear risk of bias. Details on the method used for allocation concealment and how blinding was maintained were insufficient in one study each. One study did not report all outcomes prespecified in the trial protocol, and there were discrepancies in reporting in a further study. Participants receiving brivaracetam add-on were more likely to experience a 50% or greater reduction in seizure frequency than those receiving placebo (RR 1.81, 95% CI 1.53 to 2.14; 6 studies; moderate-certainty evidence). Participants receiving brivaracetam were more likely to attain seizure freedom; however, the evidence is of low certainty (RR 5.89, 95% CI 2.30 to 15.13; 6 studies). The incidence of treatment withdrawal for any reason was slightly greater for participants receiving brivaracetam compared to those receiving placebo (RR 1.27, 95% CI 0.94 to 1.74; 6 studies; low-certainty evidence). The risk of participants experiencing one or more adverse events did not differ significantly following treatment with brivaracetam compared to placebo (RR 1.08, 95% CI 1.00 to 1.17; 5 studies; moderate-certainty evidence). However, participants receiving brivaracetam did appear to be more likely to withdraw from treatment due to adverse events compared with those receiving placebo (RR 1.54, 95% CI 1.02 to 2.33; 6 studies; low-certainty evidence).
AUTHORS' CONCLUSIONS
When used as add-on therapy for individuals with drug-resistant epilepsy, brivaracetam may be effective in reducing seizure frequency and may aid patients in achieving seizure freedom. However, add-on brivaracetam is probably associated with a greater proportion of treatment withdrawals due to adverse events compared with placebo. It is important to note that only one of the eligible studies included participants with generalised epilepsy. None of the included studies involved participants under the age of 16, and all studies were of short duration. Consequently, the findings of this review are mainly applicable to adult patients with drug-resistant focal epilepsy. Future research should focus on investigating the tolerability and efficacy of brivaracetam during longer-term follow-up, as well as assess the efficacy and tolerability of add-on brivaracetam in managing other types of seizures and in other age groups.
Topics: Adult; Anticonvulsants; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsy, Generalized; Humans; Pyrrolidinones; Randomized Controlled Trials as Topic; Seizures
PubMed: 35285519
DOI: 10.1002/14651858.CD011501.pub3 -
Iranian Journal of Nursing and... 2022Blinding is one of the critical criteria of clinical trials that prevents probable bias. Judgment regarding results of an intervention significantly depends on the... (Review)
Review
BACKGROUND
Blinding is one of the critical criteria of clinical trials that prevents probable bias. Judgment regarding results of an intervention significantly depends on the quality of such studies, one of which is blinding. This study aimed to investigate blinding and its quality in clinical trials in patients with breast cancer.
MATERIALS AND METHODS
A systematic review was conducted on the online databases of PubMed, ScienceDirect and ProQuest using keywords, MeSH terms and grey literature. Articles were screened by predefined inclusion and exclusion criteria. They were evaluated based on the checklists introduced by Cochrane database.
RESULTS
From 22519 articles obtained at the initial stage, 20 articles remained after screening for the inclusion and exclusion criteria. Fifteen articles had used single, five: double and none had used triple or quadruple blinding. Seventeen studies had described the details of blinding. Of the 15 single blind articles, the blinded subjects were patients in five, patients and research assistants in three, research assistants in five studies, and two had not given any details.
CONCLUSIONS
The majority of researchers had used the single blind method, though using double, triple or quadruple blinding increases the trustworthiness of results and increases the quality of clinical trials. The details of blinding should be explained to other researchers and for a better understanding of the method if it is to be repeated. Thereafter, nurses can apply new interventions and earn their patients' trust and help those with breast cancer by relieving them of their disease symptoms and its treatment complications.
PubMed: 35280192
DOI: 10.4103/ijnmr.IJNMR_49_20 -
F1000Research 2022Novel Corona Virus Disease 2019 (COVID-19) can affect multiple organs, including the lungs, resulting in pneumonia. Apart from steroids, other anti-COVID drugs that...
Novel Corona Virus Disease 2019 (COVID-19) can affect multiple organs, including the lungs, resulting in pneumonia. Apart from steroids, other anti-COVID drugs that have been studied appear to have little or no effect on COVID-19 pneumonia. There is a well-known history of inflammatory disease, including pneumonia, treated with low-dose radiation therapy (LDRT). It reduces the production of proinflammatory cytokines, Interleukin-1a (IL-1a), and leukocyte recruitment. A comprehensive literature search was conducted using PubMed, Scopus, Embase, CINAHL, and Google Scholar, with keywords such as "radiotherapy," "low-dose radiation therapy," "low-dose irradiation," "covid-19 pneumonia," "SARS-CoV-2 pneumonia," and "covid pneumonia." with additional filters for human studies and customized articles in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We reviewed randomized controlled trials, quasi-experimental studies, cohort, case-control, and cross-sectional studies with a clearly defined intervention, including low-dose radiotherapy alone or in combination with any therapy to treat COVID-19 pneumonia from December 2019 to May 2021. Patients receiving standard or high-dose radiotherapy, including for other diseases, were excluded. Zotero software was used to collect and organize research from various databases, remove duplicates, extract relevant data, and record decisions. Participants' demographics and baseline status were obtained from the full-text articles along with the intervention's outcome/effect on patient status. Four studies with 61 participants that met the inclusion criteria were included. One was a double-blind randomized controlled trial, one a non-randomized trial, while the other two were single-arm clinical trials. Low-dose radiation therapy did not show any significant improvement in COVID-19 patients. Only two studies included in this review demonstrated an improvement in inflammatory markers; however, patients were also given steroids or other drugs. Therefore, the confounding effects must be considered before drawing conclusions. This systematic review does not support mortality benefit, clinical course improvement, or imaging changes with LDRT.
Topics: Humans; Case-Control Studies; COVID-19; Cross-Sectional Studies; Double-Blind Method; Randomized Controlled Trials as Topic; SARS-CoV-2; Radiotherapy Dosage
PubMed: 35186275
DOI: 10.12688/f1000research.74558.1 -
Drugs Feb 2022Brivaracetam (BRV), cenobamate (CNB), eslicarbazepine acetate (ESL), lacosamide (LCM) and perampanel (PER) are antiseizure medications (ASMs) approved for adjunctive... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Brivaracetam (BRV), cenobamate (CNB), eslicarbazepine acetate (ESL), lacosamide (LCM) and perampanel (PER) are antiseizure medications (ASMs) approved for adjunctive treatment of focal-onset seizures. So far, no randomised controlled trial directly compared the efficacy and safety of these drugs.
OBJECTIVE
We estimated the comparative efficacy and safety of these ASMs for the treatment of focal-onset seizures in adults with epilepsy using a network meta-analysis (NMA).
METHODS
We systematically searched (June week 4, 2021) MEDLINE (accessed by PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL), and the US National Institutes of Health Clinical Trials Registry ( http://www.clinicaltrials.gov ). There were no date limitations or language restrictions. Randomised, double-blinded, controlled, parallel-group, add-on studies that compared oral BRV, CNB, ESL, LCM, and PER versus any comparator over maintenance periods of at least 12 weeks and included adult patients with focal seizures uncontrolled by concomitant ASMs were identified. The efficacy outcomes were the proportions of patients with ≥ 50% and 100% reduction in baseline seizure frequency during the maintenance period. The tolerability outcomes were the proportions of participants who experienced at least one treatment-emergent adverse event (TEAE) and experienced at least one TEAE leading to discontinuation. Effect sizes were estimated by network meta-analyses within a frequentist framework. The hierarchy of competing interventions was established using the surface under the cumulative ranking curve (SUCRA).
RESULTS
Sixteen trials (BRV: n = 3, CNB: n = 1, ESL: n = 4, LCM: n = 4, PER: n = 4) were included, overall enrolling 4507 patients randomised to add-on active treatments (BRV = 803, CNB = 221, ESL =9 90, LCM = 1104, and PER = 1389) and 2246 to add-on placebo. Cenobamate was associated with a higher rate of ≥ 50% seizure frequency reduction than BRV [odds ratio (OR) 2.02, 95% confidence interval (CI) 1.11-3.66], ESL (OR 1.93, 95% CI 1.07-3.48), LCM (OR 1.86, 95% CI 1.04-3.32), and PER (OR 2.07, 95% CI 1.16-3.70). There was a not statistically significant trend favouring CNB over ESL, LCM and PER for the seizure freedom outcome. Brivaracetam (OR 0.61, 95% CI 0.44-0.86) and LCM (OR 0.60, 95% CI 0.40-0.88) were associated with a lower proportion of participants experiencing TEAEs compared to ESL, and patients treated with PER were associated with a higher risk to experience at least one TEAE (OR 1.42, 95% CI 1.02-1.96) than BRV. According to SUCRA, CNB had the greatest likelihood of being the best option for the ≥ 50% and 100% seizure frequency reduction, and BRV and LCM had the highest probabilities of being the best-tolerated treatments.
CONCLUSIONS
Cenobamate ranked best for efficacy, and BRV and LCM were best tolerated over the other comparators. Although NMAs cannot replace direct comparisons, they may support physicians in clinical decision making.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Dibenzazepines; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Lacosamide; Male; Middle Aged; Network Meta-Analysis; Nitriles; Pyridones; Pyrrolidinones; Randomized Controlled Trials as Topic; Seizures; Tetrazoles
PubMed: 35061214
DOI: 10.1007/s40265-021-01661-4 -
International Journal of Environmental... Jan 2022Dietary nitrate supplementation is evidenced to induce physiological effects on skeletal muscle function in fast-twitch muscle fibers and may enhance high-intensity... (Review)
Review
Dietary nitrate supplementation is evidenced to induce physiological effects on skeletal muscle function in fast-twitch muscle fibers and may enhance high-intensity exercise performance. An important component of sport-specific skills is the ability to perform explosive movements; however, it is unclear if nitrate supplementation can impact explosive efforts. We examined the existing evidence to determine whether nitrate supplementation improves explosive efforts lasting ≤ 6 s. PubMed, Scopus and Directory of Open Access Journals (DOAJ) were searched for articles using the following search strategy: (nitrate OR nitrite OR beetroot) AND (supplement OR supplementation) AND (explosive OR power OR high intensity OR high-intensity OR sprint* OR "athletic performance"). Out of 810 studies, 18 were eligible according to inclusion criteria. Results showed that 4 of the 10 sprint-type studies observed improved sprint time, power output, and total work in cycling or running, whereas 4 of the 10 resistance-based exercise studies observed improvements to power and velocity of free-weight bench press as well as isokinetic knee extension and flexion at certain angular velocities. These results suggest that nitrate potentially improves explosive exercise performance, but further work is required to clarify the factors influencing the efficacy of nitrate in different exercise modalities.
Topics: Athletic Performance; Dietary Supplements; Double-Blind Method; Explosive Agents; Nitrates; Nitrites
PubMed: 35055584
DOI: 10.3390/ijerph19020762 -
Respirology (Carlton, Vic.) Mar 2022This study aimed to quantitatively compare the efficacy of fluticasone furoate (FF) and fluticasone propionate (FP) in adolescents and adults with asthma. We searched... (Meta-Analysis)
Meta-Analysis Review
Quantitative comparison of dose-effect and time-course of fluticasone furoate and fluticasone propionate in adult and adolescent patients with persistent asthma: A systematic review and meta-analysis.
This study aimed to quantitatively compare the efficacy of fluticasone furoate (FF) and fluticasone propionate (FP) in adolescents and adults with asthma. We searched the PubMed and EMBASE databases for placebo-controlled trials that met the inclusion criteria. Pharmacodynamic models were established to describe the time-course of the primary outcome (trough forced expiratory volume in the first second [FEV ]). Secondary outcomes (asthma symptoms, quality of life and exacerbations) were also compared via a meta-analysis. A total of 14 articles were included in the analysis, involving 6640 subjects. The efficacy plateau of the two drugs could be reached in 2 weeks. The changes from the baseline in trough FEV (95% CI) at week 2 of FF at 200 and 100 μg/day were 0.168 L (0.064-0.199) and 0.127 L (0.048-0.163), respectively. The changes from the baseline in trough FEV (95% CI) at week 2 of FP at 1000, 500, 250 and 100 μg/day were 0.133 L (0.049-0.171), 0.127 L (0.043-0.163), 0.117 L (0.039-0.150) and 0.093 L (0.032-0.129), respectively. The efficacy of FP had reached a plateau at the maximum evaluated dose (1000 μg/day), while a plateau effect was not seen at the maximum evaluated dose of FF (200 μg/day). In terms of secondary outcomes, the relative effects of the two drugs relative to the placebo were similar and did not show obvious dose-effect relationships. In this study, the time-course and dose-effect characteristics of FP, FF and placebo were quantitatively evaluated, providing necessary quantitative information for asthma-related guidelines.
Topics: Administration, Inhalation; Adolescent; Adult; Androstadienes; Asthma; Double-Blind Method; Fluticasone; Forced Expiratory Volume; Humans; Quality of Life; Treatment Outcome
PubMed: 35043513
DOI: 10.1111/resp.14203 -
Europace : European Pacing,... Jul 2022Vasovagal syncope (VVS) is a common clinical condition that lacks effective medical therapies despite being associated with significant morbidity. Current guidelines... (Meta-Analysis)
Meta-Analysis
AIMS
Vasovagal syncope (VVS) is a common clinical condition that lacks effective medical therapies despite being associated with significant morbidity. Current guidelines suggest that midodrine, a prodrug for an α1-adrenergic receptor agonist, might suppress VVS but supporting studies have utilized heterogeneous methods and yielded inconsistent results. To evaluate the efficacy of midodrine to prevent syncope in patients with recurrent VVS by conducting a systematic review and meta-analysis of published studies.
METHODS AND RESULTS
Relevant randomized controlled trials were identified from the MEDLINE, Embase, CENTRAL, and CINAHL databases without language restriction from inception to June 2021. All studies were conducted in clinical syncope populations and compared the benefit of midodrine vs. placebo or non-pharmacological standard care. Weighted relative risks (RRs) were estimated using random effects meta-analysis techniques. Seven studies (n = 315) met inclusion criteria. Patients were 33 ± 17 years of age and 31% male. Midodrine was found to substantially reduce the likelihood of positive head-up-tilt (HUT) test outcomes [RR = 0.37 (0.23-0.59), P < 0.001]. In contrast, the pooled results of single- and double-blind clinical trials (I2 = 54%) suggested a more modest benefit from midodrine for the prevention of clinical syncope [RR = 0.51 (0.33-0.79), P = 0.003]. The two rigorous double-blind, randomized, placebo-controlled clinical trials included 179 VVS patients with minimal between-study heterogeneity (I2 = 0%) and reported a risk reduction with midodrine [RR = 0.71 (0.53-0.95), P = 0.02].
CONCLUSIONS
Midodrine is effective in preventing syncope induced by HUT testing and less, but still significant, RR reduction in randomized, double-blinded clinical trials.
Topics: Double-Blind Method; Female; Humans; Male; Midodrine; Randomized Controlled Trials as Topic; Syncope; Syncope, Vasovagal; Tilt-Table Test
PubMed: 35025999
DOI: 10.1093/europace/euab323 -
Brain and Behavior Feb 2022Anorexia nervosa (AN) is a severe psychiatric disorder characterized by starvation and malnutrition, a high incidence of coexisting psychiatric conditions, and treatment... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Anorexia nervosa (AN) is a severe psychiatric disorder characterized by starvation and malnutrition, a high incidence of coexisting psychiatric conditions, and treatment resistance. The effect of pharmacotherapy has been controversial.
METHOD
A systematic review was conducted for evidence of an effect of olanzapine versus placebo in adults or its effect as adjuvant treatment of AN in adolescents.
RESULTS
A total of seven articles (304 patients with AN) were identified. There were four double-blind, randomized studies examining the effect of olanzapine in the treatment of AN. The mean difference in body mass index (BMI) at the end of treatment between olanzapine and placebo was 0.67 kg/m (95% confidence interval (CI) 0.15-1.18 kg/m ; p = 0.01; I = 0%, p for heterogeneity < 0.79). The olanzapine groups showed a significant increase in BMI of 0.68 kg/m (95% CI 0.22-1.13 kg/m ; p < 0.001; I = 0%, p for heterogeneity = 0.74) compared to the placebo groups. Only two studies examined the effect of olanzapine as adjuvant treatment in adolescents and showed an increase in BMI of 0.66 kg/m (95% CI -0.36 to 1.67 kg/m ; p = 0.21; I = 11%, p for heterogeneity = 0.32).
DISCUSSION
Olanzapine showed efficacy in the treatment of AN with an increased BMI at the end of treatment in adults. The effect of olanzapine as adjuvant treatment in adolescents remains unclear.
Topics: Adolescent; Adult; Anorexia Nervosa; Benzodiazepines; Body Mass Index; Double-Blind Method; Humans; Olanzapine; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35020271
DOI: 10.1002/brb3.2498