Comparing active immunotherapy efficacy of PD-L1 ≥ 50% NSCLC patients: A systematic review and meta-analysis.

e21139 Background: Several therapies based on immune checkpoint inhibitors (ICIs) have been approved as the 1L standard of care for PD-L1≥ 50% advanced non-small cell lung cancer (NSCLC). However, little is known about the difference in efficacy between different strategies. We conducted a systematic review and meta-analysis to help clinicians choose more reasonable treatment options. Methods: We searched PubMed, Cochrane library, Embase and major conference proceedings from January 2010 to December 2020 for randomized controlled trials that had available subgroup hazard ratios (HRs) for overall survival according to PD-L1≥ 50%. Only drugs met primary outcome or approved by FDA were included for analysis. The primary outcome was the difference in overall survival (OS). HRs and 95% CI were calculated for the pooled OS using a random-effects model. p<0.05 was considered as statistical difference. Results: A total of 10 randomized controlled trials were included for this meta-analysis. The pooled HR and 95% CI for monotherapy, ICI plus chemotherapy and ICI plus ICI were 0.64 (0.55, 0.74), 0.64 (0.51, 0.79) and 0.70 (0.55, 0.90), respectively. There was no statistical differences between ICI monotherapy and ICI plus chemotherapy (HR 1.00, 95% CI 0.77- 1.30), between ICI monotherapy and ICI plus ICI (HR 0.91, 95% CI 0.69- 1.22) or between ICI plus chemotherapy and ICI plus ICI (HR 0.91, 95% CI 0.66- 1.27). Conclusions: For PD-L1≥ 50% NSCLC patients, active ICI monotherapies showed no different efficacy when compared with ICI combination therapies.

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Adjuvant Transarterial Chemoembolization Following Curative-Intent Hepatectomy Versus Hepatectomy Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Cancers ◽

10.3390/cancers13122984 ◽

2021 ◽

Vol 13 (12) ◽

pp. 2984

Author(s):

Stepan M. Esagian ◽

Christos D. Kakos ◽

Emmanouil Giorgakis ◽

Lyle Burdine ◽

J. Camilo Barreto ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Systematic Review ◽

Randomized Controlled Trials ◽

Transarterial Chemoembolization ◽

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Library ◽

Controlled Trials ◽

Curative Intent ◽

Randomized Controlled

The role of adjuvant transarterial chemoembolization (TACE) for patients with resectable hepatocellular carcinoma (HCC) undergoing hepatectomy is currently unclear. We performed a systematic review of the literature using the MEDLINE, Embase, and Cochrane Library databases. Random-effects meta-analysis was carried out to compare the overall survival (OS) and recurrence-free survival (RFS) of patients with resectable HCC undergoing hepatectomy followed by adjuvant TACE vs. hepatectomy alone in randomized controlled trials (RCTs). The risk of bias was assessed using the Risk of Bias 2.0 tool. Meta-regression analyses were performed to explore the effect of hepatitis B viral status, microvascular invasion, type of resection (anatomic vs. parenchymal-sparing), and tumor size on the outcomes. Ten eligible RCTs, reporting on 1216 patients in total, were identified. The combination of hepatectomy and adjuvant TACE was associated with superior OS (hazard ratio (HR): 0.66, 95% confidence interval (CI): 0.52 to 0.85; p < 0.001) and RFS (HR: 0.70, 95% CI: 0.56 to 0.88; p < 0.001) compared to hepatectomy alone. There were significant concerns regarding the risk of bias in most of the included studies. Overall, adjuvant TACE may be associated with an oncologic benefit in select HCC patients. However, the applicability of these findings may be limited to Eastern Asian populations, due to the geographically restricted sample. High-quality multinational RCTs, as well as predictive tools to optimize patient selection, are necessary before adjuvant TACE can be routinely implemented into standard practice. PROSPERO Registration ID: CRD42021245758.

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Overall survival after perioperative chemotherapy in the management of pulmonary metastasis in osteosarcoma.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e23508 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e23508-e23508

Author(s):

Zeba Siddiqui ◽

Megan E Delisle ◽

Amirrtha Srikanthan ◽

Ying Wang

Keyword(s):

Overall Survival ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Pulmonary Metastasectomy ◽

Cochrane Library ◽

Controlled Trials ◽

Perioperative Chemotherapy ◽

Extrinsic Factors ◽

Term Survival ◽

Randomized Controlled

e23508 Background: Pulmonary metastasectomy is performed on a select cohort of patients with advanced osteosarcoma with the potential for long term survival. However, evidence on peri-operative chemotherapy at time of metastasectomy is not completely understood and difficult to summarize without a systematic examination of existing literature. The purpose of this project is to perform a meta-analysis of existing studies to determine overall survival (OS) and prognostic factors in adults and children with advanced and recurrent osteosarcoma receiving chemotherapy around time of metastasectomy. Methods: We reviewed survival studies conducted in children and adults with advanced and recurrent osteosarcoma who undergo pulmonary metastasectomy published in English with more than 5 patients. The primary outcome was overall survival. Literature searches were performed in multiple electronic databases including Ovid MEDLINE (1946 to present), Ovid EMBASE (1974 to present), Web of Science, and Cochrane Library. Two investigators independently screened all citations, abstracts, and full-text articles. Results: 24 out of 80 observational studies between 1977 to 2018 were included. 2146 patients were studied of which 987 underwent pulmonary metastasectomy for osteosarcoma. 822 patients received perioperative chemotherapy in this setting. No randomized controlled trials were identified. Studies included patients from Asia, Africa, Europe, and North America. The median OS ranged between 20 to 90 months. 5-year OS ranged between 15 to 63%. Factors associated with survival included: age, number of lesions, disease free interval, time of development of metastases, number of lesions and laterality of pulmonary disease. Conclusions: Overall survival in study has a significant range. Factors influencing survival included intrinsic factors such as patient age and disease characteristics, as well as extrinsic factors such as evolution of chemotherapy regimen over the past four decades. The main limitations are related to the inherently low-quality evidence as a result of lack of randomized controlled trials. More comprehensive data is needed to guide shared decision making in this area.

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Zinc Supplementation and Body Weight: A Systematic Review and Dose–Response Meta-analysis of Randomized Controlled Trials

Advances in Nutrition ◽

10.1093/advances/nmz084 ◽

2019 ◽

Cited By ~ 2

Author(s):

Shima Abdollahi ◽

Omid Toupchian ◽

Ahmad Jayedi ◽

David Meyre ◽

Vivian Tam ◽

...

Keyword(s):

Systematic Review ◽

Body Weight ◽

Randomized Controlled Trials ◽

Dose Response ◽

Zinc Supplementation ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

Anthropometric Measures ◽

Randomized Controlled

ABSTRACT The aim of this study was to determine the effect of zinc supplementation on anthropometric measures. In this systematic review and dose–response meta-analysis, we searched PubMed, Scopus, ISI Web of Science, and the Cochrane Library from database inception to August 2018 for relevant randomized controlled trials. Mean differences and SDs for each outcome were pooled using a random-effects model. Furthermore, a dose–response analysis for zinc dosage was performed using a fractional polynomial model. Quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Twenty-seven trials (n = 1438 participants) were included in the meta-analysis. There were no significant changes in anthropometric measures after zinc supplementation in the overall analysis. However, subgroup analyses revealed that zinc supplementation increased body weight in individuals undergoing hemodialysis (HD) [3 trials, n = 154 participants; weighted mean difference (WMD) = 1.02 kg; 95% CI: 0.38, 1.65 kg; P = 0.002; I2 = 11.4%] and decreased body weight in subjects who are overweight/obese but otherwise healthy (5 trials, n = 245 participants; WMD = −0.55 kg; 95% CI: −1.06, −0.04 kg; P = 0.03; I2 = 31.5%). Dose–response analyses revealed a significant nonlinear effect of supplementation dosage on BMI (P = 0.001). Our data suggest that zinc supplementation increases body weight in patients undergoing HD and decreases body weight in individuals who are overweight/obese but otherwise healthy, although after normalization for study duration, the association observed in subjects who are overweight/obese disappeared. Although more high-quality studies are needed to reach a definitive conclusion, our study supports the view that zinc may be associated with body weight.

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Bendamustine Is Not Associated With An Increase In Infections – Systematic Review and Meta-Analysis Of Randomized Controlled Trials

Blood ◽

10.1182/blood.v122.21.5125.5125 ◽

2013 ◽

Vol 122 (21) ◽

pp. 5125-5125 ◽

Cited By ~ 1

Author(s):

Anat Gafter-Gvili ◽

Ronit Gurion ◽

Pia Raanani ◽

Ofer Shpilberg ◽

Liat Vidal

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Alkylating Agent ◽

Meta Analysis ◽

Alkylating Agents ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Solid Malignancies ◽

Grade 3

Abstract Background Bendamustine is a chemotherapeutic drug with structural similarities to both alkylating agents (nitrogen mustard derivative) and purine analogues (benzimidazole ring). Theoretically, due to its nucleoside-like properties it might be associated with more infections. Data in the literature is lacking regarding the infection-related adverse events of bendamustine-containing regimens. Thus, we aimed to assess this risk. Methods Systematic review and meta-analysis of all randomized controlled trials comparing bendamustine containing regimens (alone or combined with other chemotherapeutic agents and/or rituximab) to any other regimens. Trials evaluating bendamustine for any indication (hematological as well as solid malignancies) were included. A comprehensive search of The Cochrane Library, MEDLINE, conference proceedings and references was conducted until July 2013. Two reviewers appraised the quality of trials and extracted data. Outcomes assessed were: any infections, grade 3-4 infections, fatal infections, grade 3-4 neutropenia and grade 3-4 lymphopenia. For dichotomous data, relative risks (RR) with 95% confidence intervals (CIs) were estimated and pooled. We used fixed effect model to pool data, unless there was significant heterogeneity, in which case we used the random effects model. Results Ten trials conducted between the years 1998 and 2013 and randomizing 2360 patients were included. We included 4 trials of patients with non-Hodgkin lymphoma (Rummel 2013, Rummel 2010, Herold 2006 and the Bright study 2013), 3 trials of CLL (Knauf 2009, Niederle 2013, LeBlond 2013), 1 trial of patients with multiple myeloma (Ponish 2006) and 2 trials of breast carcinoma patients. The bendamustine arm included: bendamustine alone (2 trials), bendamustine-rituximab (BR) (4 trials), bendamustine, vincristine, prednisone (BOP) (1 trial), bendamustine, MTX. 5FU (BMF) (2 trials) and bendamustine, prednisone (BP) (1 trial). The comparator arms in 8 of the trials included other alkylating agents: chlorambucil, R -CHOP, cyclophosphamide, MTX, 5-FU (CMF) and melphalan-prednisone (MP) – each regimen used in 2 trials and COP used in 1 trial. In 2 trials the comparator arm included fludarabine based regimens (alone or with rituximab). There was no statistically significant effect for bendamustine on the rate of any type of infection (RR 1.06 [95% CI 0.83, 1.34], 6 trials, figure). This analysis included only trials of hematological malignancies. There was no increase in the rate of grade 3-4 infections (RR 1.45 [95% CI 0.86, 2.45], 7 trials) or fatal infection (RR 0.69 [95% CI 0.30, 1.58], 3 trials). Data were too scarce to analyze by specific types of infections separately. There was no increase in the rate of grade 3-4 neutropenia in the bendamustine arm (RR 0.9 [95% CI 0.58, 1.42], 6 trials). This was true both when the comparator was alkylating agent containing regimens (RR 0.87 [95% CI 0.52, 1.48], 4 trials) or fludarabine containing regimens (RR 1.02 [95% CI 0.54, 1.91], 2 trials). There was a significant increase in grade 3-4 lymphopenia in the bendamustine arm compared to alkylating agent containing regimens (RR 1.95[95% CI 1.54, 2.47). Conclusions Our systematic review demonstrates no effect of bendamustine on the rate of infections when compared to either alkylating agents or fludarabine, in hematological as well as in solid malignancies, despite an increase in lymphopenia. Thus, bendamustine remains a safe therapeutic option. The main drawback of this meta-analysis is the heterogeneity between malignancies and treatments. Disclosures: No relevant conflicts of interest to declare.

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Immunotherapy efficacy and safety of programmed cell death 1 (PD-1) versus programmed death ligand-1 (PD-L1) inhibitors in pan-cancer: A systematic review and meta-analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e14113 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e14113-e14113

Author(s):

Jianchun Duan ◽

Longgang Cui ◽

Guoqiang Wang ◽

Zhengyi Zhao ◽

Shiqing Chen ◽

...

Keyword(s):

Systematic Review ◽

Overall Survival ◽

Safety Profile ◽

Meta Analysis ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Programmed Cell Death 1 ◽

The Difference ◽

Pan Cancer

e14113 Background: Immune checkpoint inhibitors (ICIs) that target programmed cell death 1 (PD-1) and its ligand (PD-L1) have led to a paradigm shift in cancer treatment, while whether PD-1 and PD-L1 inhibitors deliver different clinical outcomes remains obscure. Here we carried out a systematic review and meta-analysis to compare the efficacy and safety profile of PD-1 and PD-L1 inhibitors in pan-cancer patients. Methods: We systematically searched PubMed, Cochrane library, and Embase from January 2000 to December 2018 for randomized controlled trials that compared PD-1/PD-L1 inhibitors with standard treatment in patients with solid tumors. We also reviewed abstracts and presentations from all major conference proceedings. Retrospective studies and trials that compared anti-PD-1/PD-L1 with other immunotherapies were excluded. The primary outcome was the difference in overall survival (OS). Studies were stratified into comparison groups upon studies mirrored with trial design and patient characteristics. Effect size in each comparison group was pooled first, the difference in overall survival was estimated, and the overall effect sizes was pooled using a random-effects model. Results: A total of 3864 publications were retrieved through initial literature search, 17 randomized controlled trials involving 9549 patients with solid tumors were included for this meta-analysis. PD-1 inhibitors exhibited significantly improved OS over PD-L1 inhibitors either in overall population (HR 0.75, 95% CI 0.64-0.87), as monotherapy (HR 0.79, 95% CI 0.65-0.96), or combination with chemotherapy (HR 0.66, 95% CI 0.53-0.82). PD-1 inhibitors also showed improved progression free survival (PFS) over PD-L1 inhibitors in overall population (HR 0.70, 95% CI 0.53-0.94). No significant difference was observed for safety profile between PD-1 inhibitors and PD-L1 inhibitors as monotherapy. PD-1 inhibitors plus chemotherapy have less Grade 3-5 adverse events than PD-L1 inhibitors plus chemotherapy (overall RR 0.84, 95% CI 0.75-0.93). Sensitivity analysis presented a satisfactory consistency of the overall estimates across these analyses. Conclusions: PD-1 inhibitors exhibited better clinical performance for survival outcome and safety profile over PD-L1 inhibitors. Future studies and explorations of the underlying mechanisms are needed for the further optimization of treatment strategies in clinical practice.

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

Frontiers in Pharmacology ◽

10.3389/fphar.2021.655865 ◽

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.

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The Efficacy and Tolerability of Ubrogepant for Acute Migraine: A Systematic Review and Meta-Analysis

10.21203/rs.2.20666/v1 ◽

2020 ◽

Author(s):

Yun Diao ◽

Hang Yang ◽

Yang Chun Zhou ◽

Biao Du

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Acute Attack ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

Acute Migraine ◽

High Quality ◽

Randomized Controlled

Abstract Objective: The aim of this review was to evaluate the efficacy and tolerability of ubrogepant in patients with acute migraine. Methods: We systematically searched PubMed, Embase, MEDLINE, Cochrane Library, and clinicaltrials.gov from inception to JULY, 2019. Randomized controlled trials of the efficacy and/or tolerability of ubrogepant for migraine were included. Meta-analysis was conducted by RevMan 5.3 software. Results: A total of 4 RCTs involving 4 163 patients were included. The meta-analysis showed that:compared to the control group, the percentage of participants with PF, the percentage of participants with PR, the percentage of participants with SPF, the percentage of participants with SPR,the absence of phonophobia in sound，the absence of phonophobia in light and the absence of nausea (RR=1.31,95%CI:1.18~1.45，P<0.00001, RR=1.63,95%CI:1.46~1.82，P<0.00001, RR=1.22,95%CI:1.15~1.29，P<0.00001, RR=1.32,95%CI:1.22~1.42，P<0.00001, RR=1.16,95%CI:1.05~1.27，P=0.002), all the differences were statistically significant. Conclusions: For adult patients with acute migraine, ubrogepant could effectively abort the acute attack. High-quality, adequately powered RCTs are needed to fully evaluate the efficacy and tolerability of ubrogepant for acute migraine.

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Comparison of nephroscopy and cystoscopy used in the treatment of bladder stones: a systematic review and meta-analysis of randomized controlled trials

BMC Surgery ◽

10.1186/s12893-021-01461-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Liping Gou ◽

Zhenghao Wang ◽

Ye Zhou ◽

Xiaofeng Zheng

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Operative Time ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

Significant Heterogeneity ◽

Bladder Stones ◽

Randomized Controlled ◽

Significant Difference

Abstract Background A systematic review and meta-analysis was conducted to compare the safety and efficiency of nephroscopy and cystoscopy in transurethral cystolithotripsy (TUCL) for bladder stones (BS). Methods The PubMed, Web of Science, Embase, EBSCO, and Cochrane Library databases were searched up to January 2021 for studies assessing the effect of different types of endoscopes among patients who underwent TUCL. The search strategy and study selection process were in accordance with the PRISMA statement. Results Five randomized controlled trials were included in the meta-analysis. The results showed no difference in stone-free rate (RR = 1.00, CI = 0.98–1.02, p = 1.00) between the two groups and nonsignificant heterogeneity (I2 = 0%, p = 1.00), and all patients were rendered stone free. Use of the nephroscope significantly shortened the operative time compared with the cystoscope group (RR= − 26.26, CI = − 35.84 to − 16.68, p < 0.00001), and there was significant heterogeneity (I2= 87%, p < 0.00001). There was no significant difference in mean urethral entries (RR = 0.66, CI = − 0.71 to − 2.04, p = 0.35), hospitalization (MD = 0.08, 95% CI = − 0.07 to 0.23, p = 0.31) or total complication rate (RR=1.37, 95% CI = 0.47–4.00, p = 0.56) between the two groups. Conclusions In conclusion, this systematic review demonstrates that both nephroscopy and cystoscopy have high stone clearance efficiency, low rates of complications and short hospitalizations. The mean urethral entries depend on the treatment method for large stone fragments. However, the use of nephroscopy can significantly reduce the operative time.

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Efficacy of remdesivir versus placebo for the treatment of COVID-19: A protocol for systematic review and meta-analysis of randomized controlled trials

10.1101/2020.04.09.20059196 ◽

2020 ◽

Cited By ~ 1

Author(s):

Desye Gebrie ◽

Desalegn Getnet ◽

Tsegahun Manyazewal

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Antiviral Drug ◽

Risk Of Bias ◽

Cochrane Library ◽

Controlled Trials ◽

Significant Heterogeneity ◽

List Type ◽

Randomized Controlled

AbstractBackgroundIn spite of the global containment on prevention efforts, the spread of coronavirus disease 2019 (COVID-19) is continuing to rise, with 1.1 million confirmed cases and 60,124 deaths recorded worldwide since 04 April 2020. The outbreak has a significant threat to international health and economy. At present, there is no approved vaccine or treatment for the disease, while efforts are underway. Remdesivir, a nucleotide-analogue antiviral drug developed for Ebola, is determined to prevent and stop infections with COVID-19, while results are yet controversial. Here, we aim to conduct a systematic review and meta-analysis of randomized controlled trials to compare the effectiveness of remdesivir and placebo in patients with COVID-19.Method and analysisWe will search MEDLINE-PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and Google scholar databases without restriction in year of publication. We will include randomized controlled trials that assessed the effectiveness of remdesivir versus placebo for patients confirmed with COVID-19. We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA 2015) guidelines for the design and reporting of the results. The primary endpoint will be time to clinical recovery. The secondary endpoints will be all cause mortality, discharged date, frequency of respiratory progression, and treatment-emergent adverse events. Two independent authors will perform study selection, data extraction, and methodology quality assessment. RevMan 5.3 software will be used for statistical analysis. Random/fixed effect model will be carried out to calculate mean differences for continuous outcomes and risk ratio for dichotomous outcomes between remdesivir and placebo.Ethics and disseminationThis study does not require ethical approval, because no participant’s data will be involved in this systematic review and meta-analysis. The findings of this study will be published in reputable and peer-reviewed journal.RegistrationThis review protocol is submitted in PROSPERO database for registration and we will include the registration number in the revised version of the manuscript.Strengths and limitations of this study➣This systematic review and meta-analysis will be derived from only randomized controlled trials which will increase the quality of evidences.➣This systematic review and meta-analysis will be derived from only randomized controlled trials which will reduce between study heterogeneity.➣Subgroup and sensitivity analysis will be carried out to identify possible reasons that may cause significant heterogeneity between studies.➣The use of Cochrane risk of bias tool to assess risk of bias for each included studies to extract and synthesize evidence based conclusions.➣One of the limitation of this study might be the restriction of trials published in English language.

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Vitamin D Supplementation Ameliorates Metabolic Dysfunction in Patients with PCOS: A SystematicReview of RCTs and Insight into the Underlying Mechanism

International Journal of Endocrinology ◽

10.1155/2020/7850816 ◽

2020 ◽

Vol 2020 ◽

pp. 1-18

Author(s):

Shan Guo ◽

Reshef Tal ◽

Haoyu Jiang ◽

Tao Yuan ◽

Ying Liu

Keyword(s):

Systematic Review ◽

Vitamin D ◽

Randomized Controlled Trials ◽

Vitamin D Deficiency ◽

Meta Analysis ◽

Serum Triglyceride ◽

Vitamin D Supplementation ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled

Objective. Evidence suggests that vitamin D deficiency correlated with metabolic disorders in women with polycystic ovary syndrome (PCOS). We conducted this systematic review and meta-analysis to evaluate the impact of vitamin D supplementation alone on glucose, lipid, and androgen parameters and inflammation biomarkers in women with PCOS. Methods. Literature research was conducted in Pubmed, Embase, Web of Science, Clinical Trials, and Cochrane Library to identify relevant randomized controlled trials (RCTs) up to March 2020. The effect of vitamin D supplementation alone on women with PCOS was compared with administration of placebo. The systematic review and meta-analysis protocol was registered in the International Prospective Register of Systematic Reviews (Prospero) as number CRD42020157444. Results. Thirteen randomized controlled trials with 824 patients in total were included. Serum FPG, fasting insulin, HOMA-IR, and VLDL-C were significantly decreased in the vitamin D group versus placebo. Vitamin D supplementation group also showed a significantly elevated level of QUICKI. No significant impact was seen on serum triglyceride, total-C, LDL-C, HDL-C, total testosterone, DHEAS, SHBG, or hs-CRP. Subgroup analysis demonstrated that oral vitamin D intake had significantly decreased serum triglyceride and total-C level in women with PCOS who have vitamin D deficiency (serum vitamin D < 20 ng/ml). Conclusion. The findings of the present meta-analysis indicate that vitamin D supplementation exerted favorable effects among women with PCOS on glucose metabolism and lipid metabolism, especially in vitamin D deficient women, but had no significant effect on the androgenic profile or inflammation status.

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