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      Efficacy and safety of hypoglycemic agents on gestational diabetes mellitus in women: A Bayesian network analysis of randomized controlled trials

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          Abstract

          Objective

          To compare the efficacy and safety of metformin, glyburide, and insulin for GDM, we conducted a subgroup analysis of outcomes for women with GDM according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criteria.

          Methods

          We searched the NCBI, Embase, and Web of Science databases from inception to March 2022. Randomized controlled trials (RCTs) that compared the outcomes of hypoglycemic agents in women with GDM were included. Bayesian network analysis was employed.

          Results

          A total of 29 RCTs were included. Metformin was estimated to lead to a slight improvement in total gestational weight gain (WMD – 1.24 kg, 95% CI −2.38, −0.09), a risk of unmet treatment target in the sensitivity analysis (OR 34.50, 95% CI 1.18–791.37) than insulin. The estimated effect of metformin showed improvements in birth weight than insulin (WMD – 102.58 g, 95% CI −180.45 to −25.49) and glyburide (WMD – 137.84 g, 95% CI −255.31 to −25.45), for hypoglycemia within 1 h of birth than insulin (OR 0.65, 95% CI 0.47 to 0.84). The improvement in the estimated effect of metformin for hypoglycemia within 1 h of birth still existed when compared with glyburide (OR 0.41, 95% CI 0.26 to 0.66), whether in the IADPSG group (OR 0.33, 95% CI 0.12 to 0.92) or not (OR 0.43, 95% CI 0.20 to 0.98).

          Conclusion

          Metformin is beneficial for GDM women to control total GWG compared with insulin, regulate fetal birth weight more than insulin and glyburide, and increase the risk of unmet treatment targets compared with insulin. Compared to metformin, glyburide is associated with neonatal hypoglycemia.

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          Most cited references39

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          Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range

          Background In systematic reviews and meta-analysis, researchers often pool the results of the sample mean and standard deviation from a set of similar clinical trials. A number of the trials, however, reported the study using the median, the minimum and maximum values, and/or the first and third quartiles. Hence, in order to combine results, one may have to estimate the sample mean and standard deviation for such trials. Methods In this paper, we propose to improve the existing literature in several directions. First, we show that the sample standard deviation estimation in Hozo et al.’s method (BMC Med Res Methodol 5:13, 2005) has some serious limitations and is always less satisfactory in practice. Inspired by this, we propose a new estimation method by incorporating the sample size. Second, we systematically study the sample mean and standard deviation estimation problem under several other interesting settings where the interquartile range is also available for the trials. Results We demonstrate the performance of the proposed methods through simulation studies for the three frequently encountered scenarios, respectively. For the first two scenarios, our method greatly improves existing methods and provides a nearly unbiased estimate of the true sample standard deviation for normal data and a slightly biased estimate for skewed data. For the third scenario, our method still performs very well for both normal data and skewed data. Furthermore, we compare the estimators of the sample mean and standard deviation under all three scenarios and present some suggestions on which scenario is preferred in real-world applications. Conclusions In this paper, we discuss different approximation methods in the estimation of the sample mean and standard deviation and propose some new estimation methods to improve the existing literature. We conclude our work with a summary table (an Excel spread sheet including all formulas) that serves as a comprehensive guidance for performing meta-analysis in different situations. Electronic supplementary material The online version of this article (doi:10.1186/1471-2288-14-135) contains supplementary material, which is available to authorized users.
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            Estimating the mean and variance from the median, range, and the size of a sample

            Background Usually the researchers performing meta-analysis of continuous outcomes from clinical trials need their mean value and the variance (or standard deviation) in order to pool data. However, sometimes the published reports of clinical trials only report the median, range and the size of the trial. Methods In this article we use simple and elementary inequalities and approximations in order to estimate the mean and the variance for such trials. Our estimation is distribution-free, i.e., it makes no assumption on the distribution of the underlying data. Results We found two simple formulas that estimate the mean using the values of the median (m), low and high end of the range (a and b, respectively), and n (the sample size). Using simulations, we show that median can be used to estimate mean when the sample size is larger than 25. For smaller samples our new formula, devised in this paper, should be used. We also estimated the variance of an unknown sample using the median, low and high end of the range, and the sample size. Our estimate is performing as the best estimate in our simulations for very small samples (n ≤ 15). For moderately sized samples (15 70), the formula range/6 gives the best estimator for the standard deviation (variance). We also include an illustrative example of the potential value of our method using reports from the Cochrane review on the role of erythropoietin in anemia due to malignancy. Conclusion Using these formulas, we hope to help meta-analysts use clinical trials in their analysis even when not all of the information is available and/or reported.
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              2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2020

              (2019)
              The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee (https://doi.org/10.2337/dc20-SPPC), a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc20-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
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                Author and article information

                Contributors
                Journal
                Front Public Health
                Front Public Health
                Front. Public Health
                Frontiers in Public Health
                Frontiers Media S.A.
                2296-2565
                02 December 2022
                2022
                : 10
                : 980578
                Affiliations
                [1] 1Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University , Xi'an, China
                [2] 2Department of Respiratory Medicine, Xi'an People's Hospital (Xi'an No. 4 Hospital) , Xi'an, China
                [3] 3Department of Endocrinology and Second Department of Geriatrics, The First Affiliated Hospital of Xi'an Jiaotong University , Xi'an, China
                [4] 4Department of Cardiovascular Medicine, Xi'an People's Hospital (Xi'an No. 4 Hospital) , Xi'an, China
                [5] 5Department of Medical Ultrasound, The Second Affiliated Hospital of Xi'an Jiaotong University , Xi'an, China
                [6] 6Department of Physiology and Pathophysiology, School of Basic Medical Sciences, Xi'an Jiaotong University Health Science Center , Xi'an, China
                [7] 7Chinese Journal of Woman and Child Health Research , Xi'an, China
                [8] 8Postdoctoral Research Station, School of Nursing, Health Science Center, Xi'an Jiaotong University , Xi'an, China
                Author notes

                Edited by: Elena Succurro, University of Magna Graecia, Italy

                Reviewed by: Amelia Caretto, Diabetes Research Institute, San Raffaele Hospital (IRCCS), Italy; Xi Chen, Zhejiang University, China

                *Correspondence: Bo Sun sunbo1217@ 123456mail.xjtu.edu.cn

                This article was submitted to Clinical Diabetes, a section of the journal Frontiers in Public Health

                †These authors have contributed equally to this work

                Article
                10.3389/fpubh.2022.980578
                9757606
                36530712
                0e019784-16e4-4761-846f-26de7c3678b1
                Copyright © 2022 Wang, Jing, Guo, Xu, Wang, Huang, Chen, Cui, Song, Liu, Sun and Wang.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 29 June 2022
                : 08 November 2022
                Page count
                Figures: 1, Tables: 4, Equations: 2, References: 39, Pages: 11, Words: 6835
                Funding
                Funded by: Natural Science Foundation of Shaanxi Province, doi 10.13039/501100007128;
                Award ID: 2019JM262
                Award ID: 2019JQ069
                Award ID: No. 2020GXLH-Y-029
                Funded by: National Natural Science Foundation of China, doi 10.13039/501100001809;
                Award ID: 81741079
                Award ID: 81801459
                Award ID: 82071732
                Categories
                Public Health
                Original Research

                gestational diabetes mellitus,metformin,glyburide,insulin,bayesian network analysis,randomized controlled trials

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