Zeng Genping, Lu Xijing, Li Peiyin, Zeng Tan, Lin Zitong, Miao Yuxi, Yuan Shuo, Liu Xiaojing, Zeng Lei
Guangzhou University of Chinese Medicine First Clinical School of Medicine, Guangzhou, Guangdong, China.
Yichun University Medical College, Yichun, Jiangxi, China.
BMJ Open. 2024 Dec 22;14(12):e088484. doi: 10.1136/bmjopen-2024-088484.
A variety of hypoglycaemic drugs are used to treat polycystic ovarian syndrome (PCOS), but their efficacy remains insufficient. Glucokinase activators (GKAs) are a unique class of hypoglycaemic medications with emerging potential, notably in significantly reducing insulin resistance (IR). Nevertheless, the efficacy of GKAs in treating PCOS, particularly in the absence or presence of IR, remains uncertain. The meta-analysis protocol aims to address this knowledge gap, furnish evidence-based data to support potential revisions in PCOS treatment guidelines and promote the utilisation of GKAs in clinical settings.
A comprehensive search will be conducted across the Cochrane Central Register of Controlled Trials, PubMed, Web of Science, Embase, Medline, Scopus, CNKI, Wanfang and VIP databases to identify randomised controlled trials investigating the use of GKAs in the treatment of PCOS, irrespective of the presence of IR. The search will encompass all available studies without language restrictions and cover the period from the inception of each database to 10 April 2024. Disputes will be resolved by talking with a third expert following the screening of articles and data extraction by two reviewers. The primary outcomes of interest encompass changes in anthropometric parameters, menstrual frequency, sex hormone levels, and glucose metabolism, while secondary objectives include lipid metabolism and adverse events. The methodological quality of each study will be assessed using Version 2 of the Cochrane Collaboration tool for assessing Risk of Bias (RoB 2.0), and the Grade of Recommendations, Assessment, Development and Evaluation (GRADE) technique will be used to assess the quality of evidence and degree of recommendation. The study duration of this study will be from 5 April 2024 to 10 April 2025.
Since this study just analyses data that are readily available to the public and does not directly involve patient participation, ethical approval is not necessary. The findings will be made public by being published in a medical journal that is subject to peer review.
CRD42024535633.
多种降糖药物用于治疗多囊卵巢综合征（PCOS），但其疗效仍不充分。葡萄糖激酶激活剂（GKAs）是一类具有潜在应用前景的独特降糖药物，尤其在显著降低胰岛素抵抗（IR）方面。然而，GKAs治疗PCOS的疗效，特别是在有无IR的情况下，仍不明确。本荟萃分析方案旨在填补这一知识空白，提供循证数据以支持PCOS治疗指南的潜在修订，并促进GKAs在临床中的应用。
将全面检索Cochrane对照试验中央登记库、PubMed、科学网、Embase、Medline、Scopus、中国知网、万方和维普数据库，以确定研究GKAs治疗PCOS的随机对照试验，无论是否存在IR。检索将涵盖所有可用研究，无语言限制，涵盖每个数据库创建至2024年4月10日的时间段。在两名审阅者筛选文章和提取数据后，如有争议将与第三位专家协商解决。主要关注的结果包括人体测量参数、月经频率、性激素水平和葡萄糖代谢的变化，次要目标包括脂质代谢和不良事件。将使用Cochrane协作网偏倚风险评估工具第2版（RoB 2.0）评估每项研究的方法学质量，并使用推荐分级、评估、制定与评价（GRADE）技术评估证据质量和推荐程度。本研究的持续时间为2024年4月5日至2025年4月10日。
由于本研究仅分析公开可得的数据，不直接涉及患者参与，无需伦理批准。研究结果将通过在同行评审的医学期刊上发表予以公开。
PROSPERO注册号：CRD42024535633。
