scholarly journals Safety and Seroconversion of Immunotherapies against SARS-CoV-2 Infection: A Systematic Review and Meta-Analysis of Clinical Trials

Pathogens ◽  
2021 ◽  
Vol 10 (12) ◽  
pp. 1537
Author(s):  
Kevin Sheng-Kai Ma ◽  
Chien-Chang Lee ◽  
Ko-Jiunn Liu ◽  
James Cheng-Chung Wei ◽  
Yuan-Ti Lee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Viral Vector ◽  
Meta Analysis ◽  
Control Treatment ◽  
Placebo Control ◽  
Cochrane Central Register ◽  
Active Immunity ◽  
Central Register ◽  
Meta Analyses

Clinical trials evaluating the safety and antibody response of strategies to manipulate prophylactic and therapeutic immunity have been launched. We aim to evaluate strategies for augmentation of host immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. We searched clinical trials registered at the National Institutes of Health by 25 May 2021 and conducted analyses on inoculated populations, involved immunological processes, source of injected components, and trial phases. We then searched PubMed, Embase, Scopus, and the Cochrane Central Register of Controlled Trials for their corresponding reports published by 25 May 2021. A bivariate, random-effects meta-analysis was used to derive the pooled estimate of seroconversion and adverse events (AEs). A total of 929,359 participants were enrolled in 389 identified trials. The working mechanisms included heterologous immunity, active immunity, passive immunity, and immunotherapy, with 62.4% of the trials on vaccines. A total of 9072 healthy adults from 27 publications for 22 clinical trials on active immunity implementing vaccination were included for meta-analyses. The pooled odds ratios (ORs) of seroconversion were 13.94, 84.86, 106.03, and 451.04 (all p < 0.01) for vaccines based on protein, RNA, viral vector, and inactivated virus, compared with that of respective placebo/control treatment or pre-vaccination sera. The pooled ORs for safety, as defined by the inverse of systemic adverse events (AEs) were 0.53 (95% CI = 0.27–1.05; p = 0.07), 0.35 (95% CI = 0.16–0.75; p = 0.007), 0.32 (95% CI = 0.19–0.55; p < 0.0001), and 1.00 (95% CI = 0.73–1.36; p = 0.98) for vaccines based on protein, RNA, viral vector, and inactivated virus, compared with that of placebo/control treatment. A paradigm shift from all four immune-augmentative interventions to active immunity implementing vaccination was observed through clinical trials. The efficacy of immune responses to neutralize SARS-CoV-2 for these vaccines was promising, although systemic AEs were still evident for RNA-based and viral vector-based vaccines.

scholarly journals Ciclosporin or Infliximab as Rescue Therapy in Acute Glucorticosteroid-Refractory Ulcerative Colitis: Systematic Review and Network Meta-Analysis

2020 ◽  
Author(s):  
Brigida Barberio ◽  
Christopher J Black ◽  
Edoardo V Savarino ◽  
Alexander C Ford
Keyword(s):  
Ulcerative Colitis ◽  
Rescue Therapy ◽  
Meta Analysis ◽  
Previous Treatment ◽  
Response To Therapy ◽  
Cochrane Central Register ◽  
Serious Adverse Events ◽  
Central Register ◽  
Meta Analyses

Abstract Background Despite randomized controlled trials [RCTs] and trial-based meta-analyses, the optimal rescue therapy for patients with acute glucorticosteroid-refractory ulcerative colitis [UC], to avoid colectomy and improve long-term outcomes, remains unclear. We conducted a network meta-analysis examining this issue. Methods We searched MEDLINE, EMBASE, EMBASE Classic and the Cochrane central register up to June 2020. We included RCTs comparing ciclosporin and infliximab, either with each other or with placebo, in patients with glucorticosteroid-refractory UC. Results We identified seven RCTs containing 534 patients [415 in head-to-head trials of ciclosporin vs infliximab]. Risk of colectomy at ≤ 1 month was reduced significantly with both treatments, compared with placebo (relative risk [RR] of colectomy with infliximab vs placebo = 0.37; 95% confidence interval [CI] 0.21–0.65, RR with ciclosporin vs placebo = 0.40; 95% CI 0.21–0.77). In terms of colectomy between &gt; 1 month and &lt; 1 year, both drugs ranked equally [P-score 0.75]. Neither treatment was more effective than placebo in reducing the risk of colectomy at ≥ 1 year. Both ciclosporin and infliximab were significantly more efficacious than placebo in achieving a response. Neither treatment was more effective than placebo in inducing remission, nor more likely to cause serious adverse events than placebo. Conclusions Both ciclosporin and infliximab were superior to placebo in terms of response to therapy and avoiding colectomy up to 1 year, with no significant differences in efficacy or safety between the two. Ciclosporin remains a valid option to treat refractory UC patients, especially those who do not respond to previous treatment with infliximab, or as a bridge to other biological therapies.

scholarly journals Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Individual Patient Data ◽  
Viral Vector ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Serious Adverse Events ◽  
Meta Analyses ◽  
Harmful Effects

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

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.

scholarly journals Acupuncture in oncological pain relief: A systematic review of randomized clinical trials

2021 ◽  
Vol 34 ◽  
Author(s):  
Michel Marcos Dalmedico ◽  
Caroline Machado de Toledo ◽  
Paula Karina Hembecker ◽  
Juliana Londero Silva Ávila ◽  
Chayane Karla Lucena de Carvalho ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cancer Pain ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Central Register ◽  
Opioid Use ◽  
Central Register ◽  
Considerable Impact ◽  
Analgesic Use

Abstract Introduction: Cancer pain has a considerable impact on patients’ health and quality of life, and its treatment is essentially based on opioid use. Objective: To report the effectiveness of acupuncture in relieving cancer pain (secondary to the disease or to the corresponding therapy) or in decreasing opioid use compared to other interventions. Methods: A systematic review of randomized clinical trials was conducted following the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. The trials were selected from the PubMed, Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Results: The search strategy resulted in the inclusion of eight trials, of which five compared acupuncture and drug therapy and three compared acupuncture and placebo. Seven trials reported decreased pain and analgesic use. The trials showed clinical heterogeneity, making a meta-analysis unfeasible. Conclusion: The findings herein provided no robust evidence to support the routine use of acupuncture as an adjuvant therapy in the treatment of cancer pain. However, its use is promising since the results showed a trend toward decreased pain and analgesic use, thus justifying further studies in the future.

scholarly journals Meta-analysis of drug efficacy in adult vs pediatric trials of patients with PGTC seizures

Neurology ◽  
2020 ◽  
Vol 94 (17) ◽  
pp. e1845-e1852
Author(s):  
Douglas R. Nordli ◽  
Emilia Bagiella ◽  
Alexis Arzimanoglou ◽  
Jinping Wang ◽  
Dinesh Kumar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Seizure Frequency ◽  
Pediatric Population ◽  
Meta Analysis ◽  
Evaluation Criteria ◽  
Drug Efficacy ◽  
Cochrane Central Register ◽  
Central Register ◽  
Adults And Children ◽  
Clonic Seizures

ObjectiveA meta-analysis of published studies was performed to determine whether the efficacy of antiseizure drugs in adults with primary generalized tonic-clonic seizures (PGTCS) is comparable with that in the pediatric population (2–12 years of age).MethodsElectronic searches were conducted in EMBASE, Medline, and the Cochrane Central Register of Controlled Trials for clinical trials of PGTCS in adults and children 2–12 years of age. Neurologists used standardized search and study evaluations to select eligible trials. Median percent reduction in seizure frequency from baseline and ≥50% responder rates were used to compare drug efficacy in adults and children.ResultsAmong 7 adjunctive-therapy PGTCS trials in adults and children (2–12 years of age) that met evaluation criteria, effect sizes were consistent between adults and children for lamotrigine and topiramate. The baseline-subtracted median percent seizure reduction in seizure frequency ranged from 50.0% to 79.7% in children and 57.0% to 64.0% in adults. The ≥50% responder rate was similar between children and adults in a topiramate study (50% in children compared with 58% in adults).ConclusionsThis meta-analysis supports the use of drug response from antiseizure drug clinical trials for PGTCS in adults to predict comparable treatment response in children 2–12 years of age with PGTCS.

scholarly journals Efficacy of Adjunctive Treatments Added to Olanzapine or Clozapine for Weight Control in Patients with Schizophrenia: A Systematic Review and Meta-Analysis

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Yun-Jung Choi
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Weight Reduction ◽  
Weight Control ◽  
Randomized Clinical Trials ◽  
Psychiatric Symptoms ◽  
Meta Analysis ◽  
Cochrane Central Register ◽  
Meta Analyses

Objectives. This study was conducted to review systematically adjunctive treatments for weight reduction in patients with schizophrenia and compare efficacies of clinical trials through meta-analysis, so as to provide effective clinical guideline regarding weight control for patients taking atypical antipsychotics.Methods. Candidate clinical trials were identified through searching the Cochrane Central Register of Controlled Trials, PubMed, and PsycINFO. Fourteen randomized clinical trials were included for systematic review and meta-analysis from 132 potential trials. The Comprehensive Meta-Analysis version 2 was used for meta-analysis.Results. Difference in means and significances from meta-analyses regarding weight control by adjunctive treatments showed that topiramate, aripiprazole, or sibutramine was more effective than metformin or reboxetine. Psychiatric evaluations did not show statistically significant changes between treatment groups and placebo groups except topiramate adjunctive treatments. Adverse effects regarding adjunctive therapies were tolerable and showed statistically no significances compared to control groups.Conclusion. Though having several reports related to exacerbation of psychiatric symptoms, topiramate and aripiprazole are more efficacious than other medications in regard to weight reduction and less burden of critical adverse effects as well as being beneficial for clinical improvement.

scholarly journals Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Shixue Chen ◽  
Zhibo Zhang ◽  
Xuan Zheng ◽  
Haitao Tao ◽  
Sujie Zhang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Subsequent Treatment ◽  
Drug Combinations ◽  
Cochrane Central Register ◽  
First Line ◽  
Response Efficacy ◽  
Central Register ◽  
Cancer Types

BackgroundImmune checkpoint inhibitors targeting the PD-1/PD-L1 pathway have demonstrated promise in treating a variety of advanced cancers; however, little is known regarding their efficacy under various clinical situations, including different cancer types, treatment lines, drug combinations, and therapeutic regimens.MethodsPublished articles and conference abstracts (in English) in PubMed, Embase, the Cochrane Central Register, and Web of Science were searched up to February 10, 2020. The data were analyzed by the meta-analysis program in Stata.ResultsA total of 16,400 patients from 91 clinical trials were included in this meta-analysis. PD-1/PD-L1 inhibitors had a mean ORR of 19.56% (95% CI: 15.09–24.03), a median TTR of 2.05 months (m) (95%CI: 1.85–2.26), and a median DOR of 10.65 m (95%CI: 7.78–13.52). First-line treatment had a higher ORR (36.57% vs. 13.18%) but a shorter DOR (9.00 m vs. 13.42 m) compared to the second-line or subsequent treatment. Immunotherapy combined with chemotherapy (I+C) (46.81% [95%CI: 36.02–57.60]) had a statistically significant higher ORR compared to immunotherapy (I) (17.75% [95%CI: 14.47–21.03]) or immunotherapy combined with immunotherapy (I+O) (12.25% [95%CI: 1.56–22.94]), while I+C (8.09 m [95%CI: 6.86–9.32]) appeared to reduce the DOR compared to I (12.39 m [95%CI: 7.60–17.18]). PD-1 inhibitors were associated with better ORR (21.65% vs. 17.60%) and DOR (11.26 m vs. 10.03 m) compared to PD-L1 inhibitors. There were no significant differences in TTR under different situations.ConclusionsPD-1/PD-L1 inhibitors were promising immunotherapeutic agents to achieve satisfactory response efficacies with different cancer types, treatment lines, drug combinations, and therapeutic regimens. This comprehensive summary of the response efficacy of PD-1/PD-L1 inhibitors serves as a reference for clinicians to make evidence-based decisions.

scholarly journals Intradermal versus Intramuscular Administration of Influenza Vaccination: Rapid Review and Meta-analysis

2020 ◽  
Author(s):  
Oluwaseun Egunsola ◽  
Fiona Clement ◽  
John Taplin ◽  
Liza Mastikhina ◽  
Joyce W. Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccination ◽  
Standard Dose ◽  
Meta Analysis ◽  
Vaccine Dose ◽  
Rapid Review ◽  
Cochrane Central Register ◽  
Intramuscular Dose ◽  
H1n1 Strain ◽  
Meta Analyses

AbstractBackgroundVaccinations are essential for prevention of influenza. We synthesized the published literature on the immunogenicity and safety of the influenza vaccine at reduced or full intradermal doses compared with full intramuscular doses.MethodsA rapid review of the literature was completed. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for studies published from 2010 until June 5th, 2020. All studies comparing intradermal and intramuscular influenza vaccinations were included. Random-effects meta-analyses of immunogenicity and safety outcomes were conducted.ResultsA total of 30 relevant studies were included. Seroconversion rates were equivalent between the 3 mcg, 6 mcg, 7.5 mcg, and 9 mcg intradermal vaccine doses and the 15 mcg intramuscular vaccine dose for each of the H1N1, H3N2, and B strains, but significantly higher with the 15 mcg intradermal compared with the 15 mcg intramuscular dose, for the H1N1 (RR 1.10, 95% CI: 1.01-1.20) and B strains (RR 1.40, 95% CI: 1.13-1.73). Seroprotection rates for the 9 mcg and 15 mcg intradermal doses were equivalent with the 15 mcg intramuscular dose for all the three strains, except for the 15 mcg intradermal dose for the H1N1 strain which was significantly higher (RR 1.05, 95% CI: 1.01-1.09). Local adverse events were significantly higher with intradermal doses. Fever and chills were significantly higher with the 9 mcg intradermal dose, while all other systemic adverse events were equivalent for all doses.ConclusionReduced dose intradermal influenza vaccination appears to be a reasonable alternative to standard dose intramuscular vaccination because of the similarity in immunogenicity.

scholarly journals Effect of Resin Infiltration on Enamel: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 (3) ◽  
pp. 48
Author(s):  
Madalena Soveral ◽  
Vanessa Machado ◽  
João Botelho ◽  
José João Mendes ◽  
Cristina Manso
Keyword(s):  
Bond Strength ◽  
Penetration Depth ◽  
Shear Bond Strength ◽  
Meta Analysis ◽  
Experimental Studies ◽  
Cochrane Central Register ◽  
Resin Infiltration ◽  
Central Register ◽  
Intact Surface ◽  
Meta Analyses

Subsurface enamel demineralization beneath an intact surface layer or white spots lesions (WSL) can and should be treated with non-invasive procedures to impede the development of a cavitated lesion. We aim to analyze if infiltrative resin improves enamel roughness, microhardness, shear bond strength, and penetration depth. MEDLINE [via Pubmed], Cochrane Central Register of Controlled Trials, Embase, Web of Science, Scholar, and LILACS were searched until May 2021. Methodological quality was assessed using the Joanna Briggs Institute Clinical Appraisal Checklist for Experimental Studies. Pairwise ratio of means (ROM) meta-analyses were carried out to compare the enamel properties after treatment with infiltrative resin on sound enamel and WSLs. From a total of 1604 articles, 48 studies were included. Enamel surface roughness decreased 35% in sound enamel (95%CI: 0.49–0.85, I2 = 98.2%) and 54% in WSLs (95%CI: 0.29–0.74, I2 = 98.5%). Microhardness reduced 24% in sound enamel (95%CI: 0.73–0.80, I2 = 99.1%) and increased by 68% in WSLs (95%CI: 1.51; 1.86, I2 = 99.8%). Shear bond strength reduced of 25% in sound enamel (95%CI: 0.60; 0.95, I2 = 96.9%) and increased by 89% in WSLs (95%CI: 1.28–2.79, I2 = 99.8%). Penetration depth was 65.39% of the WSLs (95%CI: 56.11–74.66, I2 = 100%). Infiltrative resins effectively promote evident changes in enamel properties in sound and WSLs. Future studies with long-term follow-ups are necessary to corroborate these results from experimental studies.

scholarly journals Efficacy and Safety of Specific Immunotherapy with Aeroallergens in the Management of Atopic Dermatitis: A Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Cita Rosita Sigit Prakoeswa ◽  
Sylvia Anggraeni ◽  
Damayanti Damayanti ◽  
Menul Ayu Umborowati ◽  
Cintya Dipta Riswanto ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Specific Immunotherapy ◽  
Meta Analysis ◽  
Placebo Control ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Central Register ◽  
And Gender

Abstract Background: Specific immunotherapy with standardized aeroallergens can reduce symptoms and increase the quality of life for related allergy patients. This therapy is still controversial for atopic dermatitis (AD). Hence, a meta-analysis to assess efficacy and safety of specific immunotherapy with aeroallergens on patients with AD could provide a clear oversight on advantages and limitations of such treatment.Methods: We systematically searched PubMed, DOAJ, and Cochrane Central Register of Controlled Trials databases for relevant studies published Randomized controlled trials (RCTs) up to October 2020. Studies involving all ages and gender with AD who treated with specific immunotherapy employing aeroallergens compared with placebo/control.Results: Seven studies RCTs were identified with 832 participants. Significantly decreased of SCORAD values favoring immunotherapy were observed (MD: -5.42; 95% CI - 10.31, -0.52; p=0.03). VAS score was significantly decrease (MD: -1.21; 95% CI -2.10, -0.31; p=0.008). However, immunotherapy showed no significant local and systemic adverse events ((RR 1.77; 95% CI 0.98, 3.19, p=0.06); (RR 0.69; 95% CI 0.16, 3.01, p=0.62)) and IgG4 Dermatophagoides farinae (MD: 92.36, 95% CI -89.14,273.87; p=0.32). Conclusion: Our five years meta-analysis included small number studies, indicated moderate-level evidence for immunotherapy with standardized extract of aeroallergens is effective and safe for AD patients.

Sign in / Sign up

Export Citation Format

Share Document