scholarly journals T28. BENEFITS AND HARMS OF ANTIPSYCHOTICS IN THE TREATMENT OF CHILDREN AND ADOLESCENTS WITH SCHIZOPHRENIA: A SYSTEMATIC REVIEW AND META-ANALYSIS

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S242-S242
Author(s):  
Katsuhiko Hagi ◽  
Tadashi Nosaka ◽  
Andrei Pikalov
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Two Dimensional ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Electronic Search ◽  
Clinical Benefits ◽  
Dimensional Graph

Abstract Background Childhood and adolescent schizophrenia is a severe and debilitating disorder associated with long-term impairments in functioning, poor physical health, and reduced life expectancy. Compared with adult-onset schizophrenia, childhood and adolescent schizophrenia may be a more severe disorder, negatively influencing social, cognitive and psychological development, educational achievements and life-long occupational functioning. Therefore, treatment of childhood and adolescent schizophrenia is highly important and presents a major therapeutic challenge. The aim of this systematic review and meta-analysis was to assess whether antipsychotics (APs) have different clinical benefits and harms profiles in acute treatment of childhood and adolescent schizophrenia. Methods We conducted systematic review and meta-analysis of randomized placebo-controlled trials (RCTs) assessing efficacy and adverse effects of APs in acute childhood and adolescent schizophrenia to compare clinical benefits and harms. An electronic search was conducted without language restrictions using Embase, Scopus, MEDLINE/PubMed, the Cochrane library, and the US National Institutes of Health clinical trials registry (http://www.clinicaltrials.gov). The electronic search was supplemented by a hand search of reference lists of relevant studies and reviews. The primary efficacy outcome examined was treatment response. The primary safety/tolerability was assessed based on discontinuation due to adverse event. In order to visualize the risk and benefit tradeoff of each AP, risk ratios (RRs) were plotted on two-dimensional graph for the primary efficacy and safety/tolerability outcomes. Results Ten studies were selected, comprising of 2,271 patients across eight active interventions (aripiprazole, asenapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone) and placebo. The mean intervention duration was 6.4 weeks (range 6–8 weeks). Lurasidone, asenapine and risperidone had significantly higher response rate (RR = 1.54, 95% CI = 1.21 to 1.95, p<0.001; RR = 1.38, 95% CI = 1.02 to 1.85, p=0.035; and RR = 1.71, 95% CI = 1.39 to 2.11, p<0.001, respectively) compared with placebo. These three antipsychotics also had significant single digit numbers needed to treat (NNT = 5, 4, and 8, respectively). All APs did not significantly separate from placebo in discontinuation rate due to adverse event compared with placebo (RR = 0.47 to 5.42). Aripiprazole had the significant number needed to harm (NNH = 25). On a two-dimensional graph plot of efficacy and safety/tolerability, lurasidone showed the most desirable profile for the risk / benefit tradeoff balance among all antipsychotics. Discussion Results from this meta-analysis illustrate that there are significant differences in benefits and harms among APs in the treatment of childhood and adolescent schizophrenia. Medications choice needs to be carefully evaluated to achieve optimal clinical benefit while minimizing burden of side effects for the patients.

Efficacy and Safety of Rivaroxaban Therapy for Patients With Peripheral Artery Disease: A Systematic Review and Meta-Analysis

2021 ◽  
pp. 153857442110129
Author(s):  
Yujun Hao ◽  
Weitao Han ◽  
Detang Mou ◽  
Jintao Wang
Keyword(s):  
Systematic Review ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Cochrane Library ◽  
Acute Limb Ischemia ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Artery Disease

Objective: We performed a systematic review and meta-analysis to evaluate the efficacy and safety of rivaroxaban in patients with PAD for the first time. Methods: We searched MEDLINE, EMBASE and the Cochrane Library database for randomized controlled trials (RCTs) conducted for PAD. Results: Three trials which contained 14873 patients were included for final meta-analysis. The results showed patients with rivaroxaban was associated with reduction in primary efficacy outcome (RR 0.83; 95% CI 0.76 to 0.90; p < 0.001). The RR was 0.85 (0.71 to 1.01) for patients with rivaroxaban alone and 0.81 (0.74 to 0.89) for those with rivaroxaban plus aspirin (p for heterogeneity between groups = 0.65). Patients with rivaroxaban showed a lower rate of acute limb ischemia (0.56; 0.47 to 0.66; p < 0.001). There was a trend toward a reduction in the rate of major amputation for vascular causes in the rivaroxaban arm (0.81; 0.63 to 1.03; p = 0.08). Compared with control, rivaroxaban therapy did not reduce the risks of myocardial infarction (0.87, 0.73 to 1.04, p = 0.12), ischemic stroke (0.85, CI 0.68 to 1.06, p = 0.15), death from cardiovascular causes (0.99, 0.85 to 1.15, p = 0.91) or death from any cause (1.00, 0.90 to 1.12, p = 0.98). Rivaroxaban therapy was associated with a 1.57-fold higher major bleeding rate as compared with those with aspirin or warfarin alone. Conclusions: Overall, the risks of the primary efficacy outcomes or adverse limb events were significantly lower with rivaroxaban than with aspirin or warfarin alone in patients with PAD. It also points out the significant major bleeding that occur because of such therapies.

scholarly journals Efficacy and safety of anti-epidermal growth factor receptor agents for the treatment of oesophageal cancer: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046352
Author(s):  
Lijuan Zhang ◽  
Yanli Song ◽  
Nan Jiang ◽  
Yaqi Huang ◽  
Bo Dong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Growth Factor ◽  
Outcome Measures ◽  
Oesophageal Cancer ◽  
Meta Analysis ◽  
Growth Factor Receptor ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Positive Effects

ObjectivesDespite remarkable advances in the treatment of oesophageal cancer (OC), the role of antiepidermal growth factor receptor (anti-EGFR) agents in treating OC remains controversial. Herein, a systematic review and meta-analysis were conducted to elucidate the efficacy and safety of anti-EGFR agents in patients with OC.DesignMeta-analysis of randomised controlled trials (RCTs) identified by searching the PubMed, Embase, Web of Science, ClinicalTrials.gov, Cochrane Library, Chinese Biology Medicine, China National Knowledge Infrastructure and Wanfang Data Knowledge Service Platform databases from inception to December 2019. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.SettingRCTs from any country and healthcare setting.ParticipantsPatients with OC.InterventionsCombination therapy with anti-EGFR agents and conventional treatments versus conventional treatments alone in patients with OC.Primary and secondary outcome measuresOverall survival (OS) and progression-free survival (PFS) were primary outcome measures, and objective response rate (ORR), disease control rate (DCR) and treatment toxicities were secondary outcome measures.ResultsIn total, 25 RCTs comprising 3406 patients with OC were included. Overall, anti-EGFR treatment significantly improved the OS (HR: 0.81, 95% CI 0.74 to 0.89, p<0.00001), ORR (relative risk (RR): 1.33, 95% CI 1.16 to 1.52, p<0.0001) and DCR (RR: 1.22, 95% CI 1.11 to 1.34, p<0.0001) but not PFS (HR: 0.91, 95% CI 0.76 to 1.08, p=0.26). Anti-EGFR treatment was significantly associated with higher incidences of myelosuppression, diarrhoea, acne-like rash and hypomagnesaemia.ConclusionsOverall, anti-EGFR agents have positive effects on OS, the ORR and DCR in OC. However, considering the high incidence of adverse effects, such as myelosuppression, diarrhoea, acne-like rashes and hypomagnesaemia, careful monitoring of patients with OC is recommended during anti-EGFR treatment.Trial registration numberCRD42020169230.

scholarly journals Does propofol ameliorate occurrence of postoperative cognitive dysfunction after general anaesthesia? A protocol of systematic review

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Xi Zhao ◽  
Ze-qing Huang
Keyword(s):  
Systematic Review ◽  
Cognitive Dysfunction ◽  
Short Term Memory ◽  
Meta Analysis ◽  
Postoperative Cognitive Dysfunction ◽  
Biomedical Literature ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
China National Knowledge Infrastructure

Abstract Background Postoperative cognitive dysfunction (POCD) is a common condition after general anesthesia (GA). Previous studies have reported that propofol can ameliorate the occurrence of such disorder. However, its results are still inconsistent. Therefore, this systematic review will assess the efficacy and safety of propofol on POCD after GA. Methods Literature sources will be sought from inception to the present in Cochrane Library, MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure for randomized controlled trials (RCTs) assessing the administration of propofol on POCD after GA. All searches will be carried out without limitations to language and publication status. Outcomes comprise of cognitive impairments changes, impairments in short-term memory, concentration, language comprehension, social integration, quality of life, and adverse events. Cochrane risk of bias tool will be utilized to assess study quality. We will evaluate the quality of evidence for each outcome using Grading of Recommendations Assessment, Development and Evaluation approach. A narrative synthesis or a meta-analysis will be undertaken as appropriate. Discussion This study will systematically and comprehensively search literature and integrate evidence on the efficacy and safety of propofol on POCD after GA. Our findings will be of interest to clinicians and health-related policy makers. Systematic review registration PROSPERO CRD42020164096

scholarly journals Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Chronic Rhinosinusitis ◽  
Randomised Controlled Trials ◽  
Nasal Polyps ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomised Controlled

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.

scholarly journals Comparison of intravitreal dexamethasone implant and anti-VEGF drugs in the treatment of retinal vein occlusion-induced oedema: a meta-analysis and systematic review

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e032128
Author(s):  
Shuai Ming ◽  
Kunpeng Xie ◽  
Mingzhu Yang ◽  
Huijuan He ◽  
Ya Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Retinal Vein Occlusion ◽  
Real World ◽  
Meta Analysis ◽  
Real Life ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Vein Occlusion ◽  
Anti Vegf ◽  
Intravitreal Dexamethasone

ObjectiveTo compare the efficacy and safety of intravitreal dexamethasone (DEX) implant and anti-vascular endothelial growth factor (anti-VEGF) agents in the treatment of macular oedema secondary to retinal vein occlusion (RVO).DesignSystematic review and meta-analysis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE).Data sourcesPubMed, Cochrane Library and ClinicalTrials.gov registry were searched from inception to 10 December 2019, without language restrictions.Eligibility criteriaRandomised controlled trials (RCTs) and real-world observation studies comparing the efficacy of DEX implant and anti-VEGF agents for the treatment of patients with RVO, naïve or almost naïve to both arms, were included.Data extraction and synthesisTwo reviewers independently extracted data for mean changes in best-corrected visual acuity (BCVA), central subfield thickness (CST) and product safety. Review Manager V.5.3 and GRADE were used to synthesise the data and validate the evidence, respectively.ResultsFour RCTs and 12 real-world studies were included. An average lower letter gain in BCVA was determined for the DEX implant (mean difference (MD) = −6.59; 95% CI −8.87 to −4.22 letters) administered at a retreatment interval of 5–6 months. Results were similar (MD6 months=−12.68; 95% CI −21.98 to −3.37 letters; MD12 months=−9.69; 95% CI −12.01 to −7.37 letters) at 6 and 12 months. The DEX implant resulted in comparable or marginally less CST reduction at months 6 and 12 but introduced relatively higher risks of elevated intraocular pressure (RR=3.89; 95% CI 2.16 to 7.03) and cataract induction (RR=5.22; 95% CI 1.67 to 16.29). Most real-life studies reported an insignificant numerical gain in letters for anti-VEGF drugs relative to that for DEX implant. However, the latter achieved comparable efficacy with a 4-month dosage interval.ConclusionCompared with anti-VEGF agents, DEX implant required fewer injections but had inferior functional efficacy and safety. Real-life trials supplemented the efficacy data for DEX implant.

scholarly journals Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e020633 ◽  
Author(s):  
Jiang Pu ◽  
Zheng Jiang ◽  
Weihua Wu ◽  
Li Li ◽  
Liling Zhang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Short Form ◽  
Meta Analysis ◽  
The Body ◽  
Peak Oxygen Consumption ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Sf 36 ◽  
Intradialytic Exercise

ObjectiveTo assess the efficacy and safety of intradialytic exercise for haemodialysis patients.DesignSystematic review and meta-analysis.Data sourcesDatabases, including PubMed, Embase, the Cochrane Library, China Biology Medicine and China National Knowledge Infrastructure, were screened from inception to March 2017.Eligibility criteriaRandomised controlled trials (RCTs) aimed at comparing the efficacy and safety of intradialytic exercise versus no exercise in adult patients on haemodialysis for at least 3 months. A minimum exercise programme period of 8 weeks.Data extractionStudy characteristics and study quality domains were reviewed. Studies were selected, and data extracted by two reviewers.Data analysisThe pooled risk ratios and mean differences (MDs) with 95% CIs for dichotomous data and continuous data were calculated, respectively.ResultsA total of 27 RCTs involving 1215 subjects were analysed. Compared with no exercise, intradialytic exercise increased dialysis adequacy (Kt/V) (MD 0.07, 95% CI 0.01 to 0.12, p=0.02) and maximum volume of oxygen that the body can use during physical exertion peak oxygen consumption (MD 4.11, 95% CI 2.94 to 5.27, p<0.0001), alleviated depression standardised mean difference (−1.16, 95% CI −1.86 to –0.45, p=0.001) and improved physical component summary-short form-36 (SF-36) level (MD 7.72, 95% CI 1.93 to 13.51, p=0.009). Also, intradialytic exercise could significantly reduce systolic blood pressure (MD −4.87, 95% CI −9.20 to –0.55, p=0.03) as well as diastolic blood pressure (MD −4.11, 95% CI −6.50 to –1.72, p=0.0007). However, intradialytic exercise could not improve mental component summary-SF-36 level (MD 3.05, 95% CI −1.47 to 7.57, p=0.19). There was no difference in the incidence of adverse events between the intradialytic exercise and control groups.ConclusionsIntradialytic exercise resulted in benefits in terms of improving haemodialysis adequacy, exercise capacity, depression and quality of life for haemodialysis.

scholarly journals Systematic Review and Network Meta-Analysis: Comparative Efficacy and Safety of Biosimilars, Biologics and JAK1 Inhibitors for Active Crohn Disease

2021 ◽  
Vol 12 ◽  
Author(s):  
Guozhi Wu ◽  
Yuan Yang ◽  
Min Liu ◽  
Yuping Wang ◽  
Qinghong Guo
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Crohn Disease ◽  
Meta Analysis ◽  
Certolizumab Pegol ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Maintenance Of Remission

Background: Crohn disease (CD) is a chronic inflammatory disease that affects quality of life. There are several drugs available for the treatment of CD, but their relative efficacy is unknown due to a lack of high-quality head-to-head randomized controlled trials.Aim: To perform a mixed comparison of the efficacy and safety of biosimilars, biologics and JAK1 inhibitors for CD.Methods: We searched PubMed, Web of Science, embase and the Cochrane Library for randomized controlled trials (RCTs) up to Dec. 28, 2020. Only RCTs that compared the efficacy or safety of biosimilars, biologics and JAK1 inhibitors with placebo or another active agent for CD were included in the comparative analysis. Efficacy outcomes were the induction of remission, maintenance of remission and steroid-free remission, and safety outcomes were serious adverse events (AEs) and infections. The Bayesian method was utilized to compare the treatments. The registration number is CRD42020187807.Results: Twenty-eight studies and 29 RCTs were identified in our systematic review. The network meta-analysis demonstrated that infliximab and adalimumab were superior to certolizumab pegol (OR 2.44, 95% CI 1.35–4.97; OR 2.96, 95% CI 1.57–5.40, respectively) and tofacitinib (OR 2.55, 95% CI 1.27–5.97; OR 3.10, 95% CI 1.47–6.52, respectively) and revealed the superiority of CT-P13 compared with placebo (OR 2.90, 95% CI 1.31–7.59) for the induction of remission. Infliximab (OR 7.49, 95% CI 1.85–34.77), adalimumab (OR 10.76, 95% CI 2.61–52.35), certolizumab pegol (OR 4.41, 95% CI 1.10–21.08), vedolizumab (OR 4.99, 95% CI 1.19–25.54) and CT-P13 (OR 10.93, 95% CI 2.10–64.37) were superior to filgotinib for the maintenance of remission. Moreover, infliximab (OR 3.80, 95% CI 1.49–10.23), adalimumab (OR 4.86, 95% CI 1.43–16.95), vedolizumab (OR 2.48, 95% CI 1.21–6.52) and CT-P13 (OR 5.15, 95% CI 1.05–27.58) were superior to placebo for steroid-free remission. Among all treatments, adalimumab ranked highest for the induction of remission, and CT-P13 ranked highest for the maintenance of remission and steroid-free remission.Conclusion: CT-P13 was more efficacious than numerous biological agents and JAK1 inhibitors and should be recommended for the treatment of CD. Further head-to-head RCTs are warranted to compare these drugs.

scholarly journals Efficacy and safety of Dabigatran vs. Rivaroxaban among Asians with non-valvular atrial fibrillation：Protocol for a systematic review and meta-analysis

2021 ◽  
Author(s):  
Li Jia ◽  
Mingming Zhou ◽  
Li Sun ◽  
Luhai Yu ◽  
Xiangyan He
Keyword(s):  
Systematic Review ◽  
Ischemic Stroke ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
China National Knowledge Infrastructure ◽  
Asian Patients ◽  
Meta Analyses

Abstract Atrial fibrillation(AF) increases the risk of ischemic stroke and systemic embolism in patients. Moreover, Asian patients with AF are more likely to have ischemic stroke than non-Asian patients. Oral anticoagulants could effectively prevent thrombotic events. Dabigatran and Rivaroxaban are two most commonly used novel oral anticoagulants (NOACs) in Asia, but those clinicial studies in relation with them are mostly in American and European countries. Therefore, whether there are differences between Dabigatran and Rivaroxaban among Asian patients with AF in terms of efficacy and safety is still unknown. This systematic review and meta-analysis will mainly assess clinical efficacy and safety of Dabigatran versus Rivaroxaban in Asian patients with AF by a pooled analysis. We will follow the PRISMA (preferred reporting items for systematic reviews and meta-analyses) and the reporting MOOSE (Meta-analyses of Observational Studies in Epidemiology) when performing this study. Then Cochrane Library,Web of Science, PubMed and China national knowledge infrastructure will be searched for eligible retrospective investigation that report the efficacy and safety outcomes of AF patients who utilised Dabigatran or Rivaroxaban for stroke prevention in Asian countries. The abovementioned database will be comprehensively searched from inception to September 30, 2019 to locate all potentially eligible studies. Outcome measures will include safety and efficacy indicators. Safety indicators include intracranial hemorrhage, major bleeding and gastrointestinal bleeding. Efficacy indicators include systemic embolism and stroke. New evidence for clinical profile of Dabigatran versus Rivaroxaban in AF patients will be provided for decision-making of Asian patients.PROSPERO registration number: CRD42020156197

scholarly journals Tuina for spasticity of poststroke: protocol of a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038705
Author(s):  
Qiongshuai Zhang ◽  
Guangcheng Ji ◽  
Fang Cao ◽  
Yihan Sun ◽  
Guanyu Hu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Short Form ◽  
Meta Analysis ◽  
Biomedical Literature ◽  
Primary Data ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Quality Of Life Scale

IntroductionSpasticity is a common complication of poststroke, tuina is a widely used rehabilitation treatment, although there is a lack of supportive evidence on efficacy and safety for patients with poststroke spasticity. The aim of this systematic review is to assess and synthesis evidence of efficacy and safety of tuina for spasticity of poststroke.Methods and analysisA comprehensive electronic search of EMBASE, MEDLINE, Cochrane Library, Web of Science, Wiley, Springer, PEDro, Chinese Science Citation Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific and Journal Database (VIP), Wanfang Database (Wanfang), Japanese medical database (CiNii), Korean Robotics Institute Summer Scholars and Thailand Thai-Journal Citation Index Centre will be conducted to search literatures of randomised controlled trials of tuina for spasticity of poststroke survivors range from the establishment to 1 January 2020.There is no time of publication limitations. The primary outcome will be measured with the Modified Ashworth Scale, and the second outcome will include Fugl-Meyer Assessment Scale, surface electromyogram RMS value, the Modified Barthel Index, Stroke Specific Quality of Life Scale, quality of life 36-Item Short-Form Health Survey and Visual Analogue Scale. Cochrane Handbook for Systematic Reviews of Interventions will be used to assess the risk of bias, and GRADE will be used to access the confidence in cumulative evidence. The protocol will be conducted according to approach and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015.Ethics and disseminationEthical approval will not be required, for no primary data of individual patients were collected. We will publish the findings in a peer-reviewed journal.PROSPERO registration numberCRD42020163384.

Outcomes of allogeneic hematopoietic cell transplantation in patients with myelofibrosis: A systematic review and meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7045-7045
Author(s):  
Jan Philipp Bewersdorf ◽  
Amar Sheth ◽  
Shaurey Vetsa ◽  
Alyssa Grimshaw ◽  
Smith Giri ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
Controlled Vocabulary ◽  
Hematopoietic Cell ◽  
Cochrane Library ◽  
Free Text ◽  
Cell Transplant ◽  
Efficacy And Safety ◽  
Significant Difference

7045 Background: Allogeneic hematopoietic cell transplant (allo-HCT) remains the only potentially curative therapeutic modality for patients with primary or secondary myelofibrosis (MF). However, many patients (pts) are ineligible for allo-HCT and transplant-related mortality can be substantial. Data on the efficacy and safety of allo-HCT are mixed and largely derived from retrospective studies. Methods: To synthesize the available evidence, we conducted a systematic review and meta-analysis searching Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection from inception to October 11, 2020 for studies on allo-HCT in MF. Databases were searched using a combination of controlled vocabulary and free text terms for relevant studies on the efficacy and safety of allo-HCT in pts with primary and secondary MF. This study protocol has been registered on PROSPERO (CRD42020188706). Random-effects models were used to pool response rates for the co-primary outcomes of 1-year, 2-year and 5-year overall survival (OS). Results: We identified 4247 studies after duplicate removal. 393 studies were assessed as full-texts for eligibility and 43 studies (38 retrospective, 1 prospective study, 4 phase II clinical trials) with 8739 pts were included in this meta-analysis. Study quality was limited by the absence of randomized clinical trials and retrospective design of most studies. Rates of 1-year, 2-year, and 5-year OS were 66.7% (95% confidence interval: 63.5-69.8%), 64.4% (57.6-70.6%), and 55.0% (51.8-58.3%), respectively. Rates of 1-year, 2-year, and 5-year non-relapse mortality were 25.9% (23.3-28.7%), 29.7% (24.5-35.4%), and 30.5% (25.9-35.5%), respectively. Among evaluable studies, rates of 1-year, 2-year, and 5-year relapse-free survival were 65.3% (56.5-73.1%), 56.2% (41.6-69.8%), and 53.6% (39.9-66.9%), respectively. Adverse events related to all-HCT were manageable with rates of acute and chronic graft-versus-host disease in 44.0% (39.6-48.4%; grade III/IV: 15.2%) and 46.5% of patients (42.2-50.8%; extensive or moderate/severe: 26.1%), respectively. Subgroup analyses did not show any significant difference between conditioning regimen intensity (myeloablative vs reduced-intensity), median patient age, and proportion of DIPSS-intermediate-2/high pts. Conclusions: Given the poor prognosis of patients not receiving transplant and in the absence of curative non-transplant therapies, our results support consideration of allo-HCT for eligible pts with MF. However, additional studies in pre- and post-allo-HCT setting are necessary to enhance patient selection (e.g. by incorporation of molecular markers), to optimize transplant strategies (e.g. peri-transplant ruxolitinib, conditioning regimens, and donor selection), symptom management and decrease non-relapse mortality.

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