scholarly journals Efficacy and safety of systematic corticosteroids among severe COVID-19 patients: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Shaolei Ma ◽  
Changsheng Xu ◽  
Shijiang Liu ◽  
Xiaodi Sun ◽  
Renqi Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Disease Progression ◽  
Sequential Analysis ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
All Cause Mortality

AbstractThe benefits and harms of corticosteroids for patients with severe coronavirus disease 2019 (COVID-19) remain unclear. We systematically searched PubMed, Embase, and Cochrane Central Register of Controlled Trials from December 31, 2019 to October 1, 2020 to identify randomized controlled trials (RCTs) that evaluated corticosteroids in severe COVID-19 patients. The primary outcome was all-cause mortality at the longest follow-up. Secondary outcomes included a composite disease progression (progression to intubation, ventilation, extracorporeal membrane oxygenation, ICU transfer, or death among those not ventilated at enrollment) and incidence of serious adverse events. A random-effects model was applied to calculate risk ratio (RR) with 95% confidence intervals (CIs). We used the Grading of Recommendations Assessment, Development, and Evaluation approach to evaluate the certainty of the evidence. Seven RCTs involving 6250 patients were included, of which the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial comprised nearly 78% of all included subjects. Results showed that corticosteroids were associated with a decreased all-cause mortality (27.3 vs. 31.1%; RR: 0.85; 95% CI: 0.73–0.99; P = 0.04; low-certainty evidence). Trial sequential analysis suggested that more trials were still required to confirm the results. However, such survival benefit was absent if RECOVERY trial was excluded (RR: 0.83; 95% CI: 0.65–1.06; P = 0.13). Furthermore, corticosteroids decreased the occurrence of composite disease progression (30.6 vs. 33.3%; RR: 0.77; 95% CI: 0.64–0.92; P = 0.005), but not increased the incidence of serious adverse events (3.5 vs. 3.4%; RR: 1.16; 95% CI: 0.39–3.43; P = 0.79).

scholarly journals Ganglioside-monosialic acid (GM1) for prevention of chemotherapy-induced peripheral neuropathy: a meta-analysis with trial sequential analysis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shaoyong Wu ◽  
Xiaohui Bai ◽  
Caixia Guo ◽  
Zhimei Huang ◽  
Handong Ouyang ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Clinical Issue ◽  
Randomized Controlled

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting side effect that largely remains an unresolved clinical issue, leading to long-term morbidity. This meta-analysis aimed to evaluate the efficacy and safety of Ganglioside-monosialic acid (GM1) in preventing CIPN. Methods Systematic literature searches of PubMed, Web of Science, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were performed to identify randomized controlled trials and cohort studies that evaluated the efficacy of GM1 for preventing CIPN. Conventional meta-analysis with a random-effects model and trial sequential analysis (TSA) were performed. Results A total of five studies involving 868 participants were included. The results showed that GM1 did not reduce the overall incidence of grade ≥ 2 CIPN when the common terminology criteria for adverse events (CTCAE) was used (OR 0.34, 95% CI 0.34–1.11). Subgroup analyses showed that GM1 could not reduce the risk of CTCAE grade ≥ 2 CIPN (OR 0.63, 95% CI 0.35–1.13) and neurotoxicity criteria of Debiopharm (DEB-NTC) grade ≥ 2 CIPN (OR 0.25, 95% CI 0.01–7.10) in oxaliplatin-treated patients, despite that GM1 was associated with a reduced risk of CTCAE grade ≥ 2 CIPN in the taxane subgroup of one study (OR 0.003, 95% CI 0.00–0.05). These results were confirmed by the sub-analysis of randomized controlled trials (RCTs). In TSA, the z-curve for the taxane subgroup crossed the upper trial sequential monitoring boundary (TSMB) but do not reach the required information size (RIS). The z-curves for the oxaliplatin subgroup remained in the nonsignificant area and did not reach the RIS. Further, GM1 did not influence the rate of response to chemotherapy and CTCAE grade ≥ 2 adverse events such as fatigue, nausea, diarrhea, and rash. Conclusions GM1 seemed to be well-tolerated and did not influence the anti-cancer effects of chemotherapeutic agents. Although the data did not confirm the effectiveness of GM1 in preventing oxaliplatin-induced peripheral neuropathy, GM1 might be able to prevent taxane-induced peripheral neuropathy. More studies are required in different ethnic populations receiving taxane-based chemotherapy to confirm these findings.

scholarly journals Total extraperitoneal (TEP) versus laparoscopic transabdominal preperitoneal (TAPP) hernioplasty: systematic review and trial sequential analysis of randomized controlled trials

Hernia ◽  
2021 ◽  
Author(s):  
Alberto Aiolfi ◽  
Marta Cavalli ◽  
Simona Del Ferraro ◽  
Livia Manfredini ◽  
Francesca Lombardo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Randomized Controlled Trials ◽  
Sequential Analysis ◽  
Hernia Recurrence ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Transabdominal Preperitoneal ◽  
Tapp Repair

Abstract Purpose To examine the updated evidence on safety, effectiveness, and outcomes of the totally extraperitoneal (TEP) versus the laparoscopic transabdominal preperitoneal (TAPP) repair and to explore the timely tendency variations favoring one treatment over another. Methods Systematic review and trial sequential analysis (TSA) of randomized controlled trials (RCTs). MEDLINE, Scopus, Web of Science, Cochrane Central Library, and ClinicalTrials.gov were consulted. Risk Ratio (RR), weighted mean difference (WMD), and 95% confidence intervals (CI) were used as pooled effect size measures. Results Fifteen RCTs were included (1359 patients). Of these, 702 (51.6%) underwent TAPP and 657 (48.4%) TEP repair. The age of the patients ranged from 18 to 92 years and 87.9% were males. The estimated pooled RR for hernia recurrence (RR = 0.83; 95% CI 0.35–1.96) and chronic pain (RR = 1.51; 95% CI 0.54–4.22) were similar for TEP vs. TAPP. The TSA shows a cumulative z-curve without crossing the monitoring boundaries line (Z = 1.96), thus supporting true negative results while the information size was calculated as adequate for both outcomes. No significant differences were found in term of early postoperative pain, operative time, wound-related complications, hospital length of stay, return to work/daily activities, and costs. Conclusions TEP and TAPP repair seems comparable in terms of postoperative hernia recurrence and chronic pain. The cumulative evidence and information size are sufficient to provide a conclusive evidence on recurrence and chronic pain. Similar trials or meta-analyses seem unlikely to show diverse results and should be discouraged.

Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Controlled Trials ◽  
Technical Success ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

scholarly journals The efficacy and safety of intrathecal bupivacaine alone versus bupivacaine combined with magnesium sulfate in adults using spinal anesthesia: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Mi-Zhou Wang ◽  
Rui Dong ◽  
Li-Na Jia ◽  
Deng-Bin Ai ◽  
Jian-Hua Zhang
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Magnesium Sulfate ◽  
Motor Block ◽  
Meta Analysis ◽  
Sensory Block ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Rescue Analgesia ◽  
Randomized Controlled

Abstract Background: Several studies have investigated the effects of intrathecal magnesium sulfate as an adjuvant for bupivacaine; however, their conclusions are inconsistent. Therefore, it is necessary to conduct a meta-analysis on this topic.Methods We searched Pubmed, EMBASE (OvidSP) and Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials (RCTs) comparing the effect of intrathecal bupivacaine combined with magnesium sulfate versus bupivacaine alone in adults using spinal anesthesia.Results Eighteen studies that met our inclusion criteria were included in our analysis. We found that the addition of intrathecal magnesium sulfate to bupivacaine provided a longer duration of analgesia (SMD 0.99; 95% CI [0.45, 1.52], P = 0.0003, I2 = 93%), prolonged the duration of sensory block (MD=106.69; 95% CI, 60.93-152.45; P<0.00001), delayed the onset of sensory block (SMD 1.20; 95% CI [0.65, 1.75], P =<0.0001, I2 = 91%) and motor block (SMD 1.46; 95% CI [0.23, 2.69], P =0.02, I2 = 96%), decreased the requirement for rescue analgesia (SMD -0.81; 95% CI [-1.06, -0.56], P < 0.00001, I2 = 11%). For duration of motor block, and incidence of postoperative adverse events (such as nausea and vomiting, hypotension, bradycardia, pruritus, shivering and neurological deficit), no statistically differences were observed between the 2 groups.Conclusions Our meta-analysis demonstrated that intrathecal magnesium sulfate combined with bupivacaine prolongs the dusration of analgesia, without an impact on the adverse events. However, the quality of evidence was very low when using GRADE to assess it. Given adverse effects before use, more high-quality trials with large samples are required before magnesium sulfate is routinely used as a intrathecal adjunct.

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