scholarly journals The Clinical Efficacy and Adverse Effects of Entecavir plus Thymosin alpha-1 Combination Therapy versus Entecavir Monotherapy in HBV-related Cirrhosis: A Systematic Review and Meta-analysis

2020 ◽  
Author(s):  
Dan Peng ◽  
Hai-Yan Xing ◽  
Chen Li ◽  
Xian-Feng Wang ◽  
Min Hou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Combination Therapy ◽  
Loss Rate ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Significant Heterogeneity ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Thymosin Alpha 1

Abstract Background Previous studies have demonstrated the benefits of thymosin alpha-1 (Tα1) in anti-virus, immunological enhancement and anti-inflammation. However, it is controversial about the efficacy and safety of entecavir (ETV) plus T α1 combination therapy versus ETV monotherapy in cirrhotic patients with hepatitis B virus (HBV) infection. Methods The systematic review and meta-analysis of randomized clinical trials (RCTs) were performed to evaluate the efficacy and safety of ETV plus Tα1 combination therapy versus ETV monotherapy in HBV -related patients with cirrhosis. We performed a systematic literature search on seven databases. Relative risk (RR) and standardized mean difference (SMD) with a fixed- or random- effect model were calculated. Heterogeneity was assessed through a Cochrane Q-test and I 2 values. Results Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis. Compared with ETV monotherapy, ETV plus Tα1 combination therapy led to a higher complete response. In post treatment for 24 weeks, the HBV DNA undetectable rate and HBeAg loss rate were higher in ETV plus Tα1 group than in ETV alone group. However, after 48 and 52 weeks of treatment, there was no significant difference between the combination therapy and ETV monotherapy. At week 52 of treatment, the HBsAg loss rate of ETV plus Tα1 group was no significance with that of ETV alone group. In comparison with ETV alone, the some biochemical parameters and liver fibrosis were obviously improved by ETV plus Tα1 , and there was significant heterogeneity. In addition, the number of adverse events was significantly reduced by ETV plus Tα1, compared to ETV alone. Conclusions ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone. However, the whole patients included in this meta-analysis were from Chinese mainland, so that more worldwide RCTs with a larger sample size are needed to verify the current findings.

scholarly journals The clinical efficacy and adverse effects of Entecavir plus Thymosin alpha-1 combination therapy versus Entecavir Monotherapy in HBV-related cirrhosis: a systematic review and meta-analysis

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Dan Peng ◽  
Hai-Yan Xing ◽  
Chen Li ◽  
Xian-Feng Wang ◽  
Min Hou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Combination Therapy ◽  
Loss Rate ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Significant Heterogeneity ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Thymosin Alpha 1

Abstract Background Previous studies have demonstrated the benefits of thymosin alpha-1 (Tα1) in anti-virus, immunological enhancement and anti-inflammation. However, it is controversial about the efficacy and safety of entecavir (ETV) plus Tα1 combination therapy versus ETV monotherapy in cirrhotic patients with hepatitis B virus (HBV) infection. Methods The systematic review and meta-analysis of randomized clinical trials (RCTs) were performed to evaluate the efficacy and safety of ETV plus Tα1 combination therapy versus ETV monotherapy in HBV-related patients with cirrhosis. We performed a systematic literature search via PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Journals Database (VIP), and Chinese Biological Medicine database (CBM). Relative risk (RR) and standardized mean difference (SMD) with a fixed- or random- effect model were calculated. Heterogeneity was assessed through a Cochrane Q-test and I2 values. Results Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis. Compared with ETV monotherapy, ETV plus Tα1 combination therapy led to a higher complete response (RR = 1.18; 95% CI, 1.07–1.30). In post treatment for 24 weeks, the HBV DNA undetectable rate and HBeAg loss rate were higher in ETV plus Tα1 group than in ETV alone group (RR = 1.91; 95% CI, 1.56–2.35; RR = 2.05; 95% CI, 1.62–2.60). However, after 48 and 52 weeks of treatment, there was no significant difference between the combination therapy and ETV monotherapy (RR = 1.07; 95% CI, 0.96–1.18; RR = 1.17; 95% CI, 0.89–1.55). At week 52 of treatment, the HBsAg loss rate of ETV plus Tα1 group was no significance with that of ETV alone group (RR = 1.03; 95% CI, 0.15–7.26). In comparison with ETV alone, the some biochemical parameters and liver fibrosis were obviously improved by ETV plus Tα1, and there was significant heterogeneity. In addition, the number of adverse events was significantly reduced by ETV plus Tα1, compared to ETV alone (RR = 0.48; 95% CI, 0.24–0.95). Conclusions ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone. However, the whole patients included in this meta-analysis were from Chinese mainland, so that more worldwide RCTs with a larger sample size are needed to verify the current findings.

scholarly journals The Clinical Efficacy and Adverse Effects of Entecavir plus Thymosin alpha-1 Combination Therapy versus Entecavir Monotherapy in HBV-related Cirrhosis: A Systematic Review and Meta-analysis

2020 ◽  
Author(s):  
Dan Peng ◽  
Hai-Yan Xing ◽  
Chen Li ◽  
Xian-Feng Wang ◽  
Min Hou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Combination Therapy ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Large Sample Size ◽  
Significant Heterogeneity ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Thymosin Alpha 1

Abstract Background Previous studies have demonstrated the benefits of thymosin alpha-1 (Tα1) in anti-virus, immunological enhancement and anti-inflammation. However, it is controversial about the efficacy and safety of entecavir (ETV) plus Tα1 combination therapy versus ETV monotherapy in cirrhosis patients with hepatitis B virus (HBV) infection. Objective The systematic review and meta-analysis of randomized clincal trials (RCTs) were performed to evaluate the efficacy and safety of ETV plus Tα1 compared with ETV monotherapy in HBV-related cirrhosis. Methods A systematic search was performed via PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Journals Database (VIP), and Chinese Biological Medicine database (CBM). Relative risk (RR) and standardized mean difference (SMD) with a fixed- or random- effect model were calculated. Heterogeneity were assessed with the Cochrane Q-test and I 2 values. Results Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis. Compared with ETV monotherapy, ETV plus Tα1 combination therapy led to a higher complete response (RR = 1.18; 95% CI, 1.07 - 1.30). The HBV DNA undetectable rate and HBeAg loss rate of ETV plus Tα1 therapy for 24 weeks was higher than the ETV alone (RR = 1.91; 95% CI, 1.56 - 2.35; RR = 2.05; 95% CI, 1.62 - 2.60). However, after treatment for 48 and 52 weeks, there was no significantly different between the combination therapy and ETV monotherapy (RR = 1.07; 95% CI, 0.96 - 1.18; RR = 1.17; 95% CI, 0.89 - 1.55). In comparison with ETV alone, ETV plus Tα1 improved part of biochemical parameters and liver fibrosis. There was significant heterogeneity. In addition, The ETV plus Tα1 significantly reduced adverse events compared to ETV monotherapy (RR = 0.48; 95% CI, 0.24 - 0.95). Conclusions ETV plus Tα1 combination therapy might have a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related cirrhosis patients compared with ETV monotherapy. Meanwhile, the whole patients included in this meta-analysis were from chinese mainland, so that more worldwide RCTs with a large sample size are needed to verify the current findings.

How much is reasonable to expect about overall survival (OS) benefit when designing studies with new drugs for patients affected by castration resistant prostate cancer (CRPC)? Meta-analysis of 23 randomized clinical trials (RCT) including 17,640 patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16053-e16053
Author(s):  
Francesco Massari ◽  
Francesca Maines ◽  
Sara Pilotto ◽  
Camillo Porta ◽  
Paolo Carlini ◽  
...  
Keyword(s):  
Treatment Strategy ◽  
Significant Interaction ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Phase Iii ◽  
Sensitivity Analyses ◽  
Significant Heterogeneity ◽  
Significant Difference

e16053 Background: Treatment decision making in patients affected by CRPC is difficult because the numerous available therapeutic opportunities can significantly affect OS. To demonstrate that comparing results in absence of head-to-head studies may lead to biased survival estimations, a literature-based meta-analysis was conducted. Methods: Hazard Ratios (HR) with 95% confidence intervals (CI) were extracted and cumulated according to a random-effect model from phase III trials. Sensitivity analyses were performed according to: 1) Treatment Strategy (TS, Chemotherapy versus Hormonal versus Immunotherapy versus Other), 2) Comparison (Chemotherapy versus Placebo versus Other), and 3) Disease setting with regard to treatment with Docetaxel (DOC),. Testing for heterogeneity was performed as well. Results: A significant heterogeneity for the 3 sensitivity analyses was found (p<0.0001). The cumulative HR in favor of (any) experimental arm was 0.91 (95% CI 0.84-0.99, p=0.028). We found a significant interaction according to the chosen TS (p<0.0001), in fact a significant difference in OS was more likely to be detected in RCT evaluating hormonal drugs (HR 0.76, 95% CI 0.64-0.92, p=0.005) versus studies testing immunotherapy (HR 1.16, 95% CI 0.86-1.56, p=0.31). With regard to Comparison, a significant interaction (p<0.0001) was found in favor of RCT having placebo as control (HR 0.86, 95% CI 0.76-0.97, p=0.015), versus studies evaluating chemotherapy (HR 1.00, 95% CI 0.84, 1.19, p=0.99). A significant interaction according to DOC-treatment was also detected (p<0.0001), being the Post-DOC the Setting where a significant OS benefit was more likely to be determined (HR 0.77, 95% CI 0.66-0.90, p=0.001). Conclusions: The cross-trials interpretation in absence of formal direct comparisons may drive biased conclusions with regard to OS estimation. When designing trials to evaluate drugs (or strategies) in CRPC, the expected OS benefit must take into account the comparator, the treatment strategy and the (eventual) pre-treatment with DOC.

scholarly journals The high risk of malarial recurrence in patients with Plasmodium-mixed infection after treatment with antimalarial drugs: a systematic review and meta-analysis

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Aongart Mahittikorn ◽  
Frederick Ramirez Masangkay ◽  
Kwuntida Uthaisar Kotepui ◽  
Giovanni De Jesus Milanez ◽  
Manas Kotepui
Keyword(s):  
Systematic Review ◽  
Mixed Infection ◽  
Subgroup Analysis ◽  
Initial Treatment ◽  
Meta Analysis ◽  
Antimalarial Drugs ◽  
Secondary Outcome ◽  
Significant Heterogeneity ◽  
Pooled Prevalence ◽  
Significant Difference

Abstract Background Malaria mixed infections are often unrecognized by microscopists in the hospitals, and a delay or failure to treat Plasmodium-mixed infection may lead to aggravated morbidity and increased mortality. The present study aimed to quantify the pooled proportion and risk of malarial recurrences after the treatment of Plasmodium-mixed infection. The results of the study may provide benefits in the management of Plasmodium-mixed infection in co-endemic regions. Methods This systematic review and meta-analysis searched the international Prospective Register of Systematic Reviews (PROSPERO; ID = CRD42020199709), MEDLINE, Web of Science, and Scopus for potentially relevant studies in any language published between January 1, 1936, and July 20, 2020, assessing drug efficacy in patients with Plasmodium-mixed infection. The primary outcome was the pooled prevalence of Plasmodium parasitemia after initiating antimalarial treatment for Plasmodium-mixed infection. The secondary outcome was the pooled risk ratio (RR) of malarial recurrence in Plasmodium-mixed infection compared with those in Plasmodium falciparum and Plasmodium vivax mono-infection. The pooled analyses were calculated by random-effects meta-analysis. After the initial treatment in different days of recurrences (≤ 28 days or > 28 days), the risk of Plasmodium parasitemia was compared in subgroup analysis. Results Out of 5217 screened studies, 11 were included in the meta-analysis, including 4390 patients from six countries. The pooled prevalence of all recurrences of Plasmodium-mixed parasitemia was 30% (95% confidence interval (CI) 16–43; I2: 99.2%; 11 studies). The RR of malarial recurrence within 28 days after the initial treatment (clinical treatment failure) of Plasmodium-mixed parasitemia compared with the treatment of P. falciparum was 1.22 (p: 0.029; 95% CI 1.02–1.47; Cochran Q: 0.93; I2: 0%; six studies), while there was no significant difference in the risk of recurrence 28 days after initial treatment compared with the treatment of P. falciparum (p: 0.696, RR: 1.14; 95% CI 0.59–2.18; Cochran Q < 0.05; I2: 98.2%; four studies). The subgroup analysis of antimalarial drugs showed that significant malarial recurrence within 28 days was observed in patients treated with artemisinin-based combination therapies (ACTs) with no significant heterogeneity (p: 0.028, RR: 1.31; 95% CI 1.03–1.66; Cochran Q: 0.834; I2: 0%). Conclusions The present findings showed a high prevalence of malarial recurrence after the initial treatment of Plasmodium-mixed infection. Moreover, significant malaria recurrence of mixed infection occurred within 28 days after treatment with ACTs. Graphic Abstract

The Incidence of Parkinson's Disease: A Systematic Review and Meta-Analysis

2016 ◽  
Vol 46 (4) ◽  
pp. 292-300 ◽  
Author(s):  
Lauren Hirsch ◽  
Nathalie Jette ◽  
Alexandra Frolkis ◽  
Thomas Steeves ◽  
Tamara Pringsheim
Keyword(s):  
Systematic Review ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Neurodegenerative Disorder ◽  
Meta Analysis ◽  
Age Groups ◽  
Significant Heterogeneity ◽  
International Studies ◽  
Significant Difference ◽  
And Gender

Background: Parkinson's disease (PD) is a common neurodegenerative disorder. Epidemiological studies on the incidence of PD are important to better understand the risk factors for PD and determine the condition's natural history. Objective: This systematic review and meta-analysis examine the incidence of PD and its variation by age and gender. Methods: We searched MEDLINE and EMBASE for epidemiologic studies of PD from 2001 to 2014, as a previously published systematic review included studies published until 2001. Data were analyzed separately for age group and gender, and meta-regression was used to determine whether a significant difference was present between groups. Results: Twenty-seven studies were included in the analysis. Meta-analysis of international studies showed rising incidence with age in both men and women. Significant heterogeneity was observed in the 80+ group, which may be explained by methodological differences between studies. While males had a higher incidence of PD in all age groups, this difference was only statistically significant for those in the age range 60-69 and 70-79 (p < 0.05). Conclusion: PD incidence generally increases with age, although it may stabilize in those who are 80+.

scholarly journals Gabapentin as an adjuvant therapy to splinting in carpal tunnel syndrome (CTS): a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 56 (1) ◽  
Author(s):  
Ahmed M. Ahmed ◽  
Osama G. Hassan ◽  
Ahmed A. Khalifa
Keyword(s):  
Systematic Review ◽  
Carpal Tunnel Syndrome ◽  
Carpal Tunnel ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Pinch Strength ◽  
Symptom Severity Scale ◽  
Significant Difference ◽  
Tunnel Syndrome

Abstract Background Carpal tunnel syndrome (CTS) is a common upper limb entrapment neuropathy; severe cases are treated surgically and mild to moderate can be managed conservatively. The purpose of this systematic review and meta-analysis was to define the efficacy of gabapentin as an adjuvant to splinting in the treatment of mild to moderate CTS. Methods A systematic search through 13 databases, randomized clinical trials (RCTs) reporting the use of gabapentin with splinting in CTS were included and analyzed. Results Three RCTs including 170 patients were eligible. There was no significant difference between gabapentin plus splinting and splinting alone in 5 measured parameters: (1) Symptom Severity Scale (SSS) [MD (95% CI) = − 0.76 (− 2.46–0.93), p = 0.378], (2) Functional Status Scale (FSS) [MD (95% CI) = − 0.23 (− 1.40–0.94), p = 0.701], (3) visual analogue scale (VAS) to assess pain [MD (95% CI) = − 0.6 (− 1.47–0.27), p = 0.174], (4) Grip strength [MD (95% CI) = − 0.11 (− 0.70–0.48), p = 0.718], and (5) pinch strength [MD (95% CI) = 0.72 (− 0.10–1.54), p = 0.083]. Conclusion This review provides low-quality evidence that gabapentin plus nocturnal splinting is not superior to splinting alone. More high-quality trials are needed to determine the role of this drug as an adjuvant in the management of CTS.

scholarly journals Efficacy and Safety of Intranasal Ketamine for Acute Pain Management in the Emergency Setting: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 10 (17) ◽  
pp. 3978
Author(s):  
Yee Sin Seak ◽  
Junainah Nor ◽  
Tuan Hairulnizam Tuan Kamauzaman ◽  
Ariff Arithra ◽  
Md Asiful Islam
Keyword(s):  
Systematic Review ◽  
Pain Management ◽  
Acute Pain ◽  
Meta Analysis ◽  
Emergency Setting ◽  
Efficacy And Safety ◽  
Acute Pain Management ◽  
Significant Difference ◽  
Mean Differences ◽  
Randomised Controlled

Due to overcrowding, personnel shortages, or problematic intravenous (IV) cannulation, acute pain management is often sub-optimal in emergency departments (EDs). The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of intranasal (IN) ketamine for adult acute pain in the emergency setting. We searched and identified studies up to 21 May 2021 via PubMed, Scopus, Web of Science, Cochrane Database, and Google Scholar. The random-effects model with 95% confidence intervals (CIs) was used to estimate mean differences (MDs) and odds ratios (ORs). The I2 statistic and Cochran’s Q test were used to determine heterogeneity. The protocol was registered in PROSPERO (CRD42020213391). Seven randomised controlled trials were included with a total of 1760 patients. There was no significant difference in pain scores comparing IN ketamine with IV analgesics or placebo at 5 (MD 0.94, p = 0.26), 15 (MD 0.15, p = 0.74), 25 (MD 0.24, p = 0.62), 30 (MD −0.05, p = 0.87), and 60 (MD −0.42, p = 0.53) minutes. There was also no significant difference in the need for rescue analgesics between IN ketamine and IV analgesics (OR 1.66, 95% CI: 0.57−4.86, p = 0.35, I2 = 70%). Only mild adverse effects were observed in patients who received IN ketamine. Our results suggest that IN ketamine is non-inferior to IV analgesics and may have a role in acute pain management among adults in the ED.

scholarly journals The Seroprevalence of SARS-CoV-2 in Europe: A Systematic Review

2021 ◽  
Author(s):  
Natasha Marcella Vaselli ◽  
Daniel Hungerford ◽  
Ben Shenton ◽  
Arwa Khashkhusha ◽  
Nigel A. Cunliffe ◽  
...  
Keyword(s):  
Public Health ◽  
Systematic Review ◽  
Meta Analysis ◽  
Grey Literature ◽  
Age Groups ◽  
Significant Heterogeneity ◽  
Community Studies ◽  
Past Infection ◽  
Significant Difference ◽  
The Impact

AbstractBackgroundA year following the onset of the COVID-19 pandemic, new infections and deaths continue to increase in Europe. Serological studies, through providing evidence of past infection, can aid understanding of the population dynamics of SARS-CoV-2 infection.ObjectivesThis systematic review of SARS-CoV-2 seroprevalence studies in Europe was undertaken to inform public health strategies including vaccination, that aim to accelerate population immunity.MethodsWe searched the databases Web of Science, MEDLINE, EMBASE, SCOPUS, Cochrane Database of Systematic Reviews and grey literature sources for studies reporting seroprevalence of SARS-CoV-2 antibodies in Europe published between 01/12/2019 - 30/09/20. We provide a narrative synthesis of included studies. Studies were categorized into subgroups including healthcare workers (HCWs), community, outbreaks, pregnancy and children/school. Due to heterogeneity in other subgroups, we only performed a random effects meta-analysis of the seroprevalence amongst HCWs stratified by their country.Results109 studies were included spanning 17 European countries, that estimated the seroprevalence of SAR-CoV2 from samples obtained between November 2019 – August 2020. A total of 53/109 studies included HCWs with a reported seroprevalence among HCWs ranging from 0.7% to 45.3%, which did not differ significantly by country. In community studies significant heterogeneity was reported in the seroprevalence among different age groups and the majority of studies reported there was no significant difference by gender.ConclusionThis review demonstrates a wide heterogeneity in reported seroprevalence of SARS-CoV-2 antibodies between populations. Continued evaluation of seroprevalence is required to understand the impact of public health measures and inform interventions including vaccination programmes.

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