Introduction: Polycystic ovary syndrome (PCOS) is a heterogeneous reproductive endocrine disorder. Several ongoing trials test sodium-glucose cotransporter-2 (SGLT-2) inhibitors for women with PCOS. However, their effectiveness has not been fully elucidated owing to the lack of high-confidence evidence. Our group agrees with the statement that SGLT-2 inhibition could treat PCOS as it is supported by reports demonstrating the benefits of SGLT-2 inhibition on metabolic status and weight control. Moreover, the functions of chronic inflammation amelioration and cardiovascular system protection make it a more attractive candidate for PCOS therapy. Therefore, to provide physicians with a reference, we intend to perform a meta-analysis on the efficacy and safety of SGLT-2 inhibitors on the endocrine and metabolic profiles of patients with PCOS.
Methods and analysis: We will search for randomised controlled trials performed until September 2022 using PubMed, Web of Science, EMBASE, the Cochrane Library, Google Scholar, the PhRMA Clinical Study Results Database (www.
Clinicaltrials: gov), the China National Knowledge Infrastructure, the Wanfang, the Weipu and the Chinese biomedical literature databases. The outcomes will include androgen-associated outcomes, body fat, glucose and lipid homoeostasis, inflammatory outcomes and adverse events. In addition, two investigators will independently assess methodological quality using the revised Cochrane risk-of-bias tool 2. The analysis will be performed using RevMan V.5.3 software, and subgroup and sensitivity analyses and a meta-regression will be used to determine the heterogeneity source.
Ethics and dissemination: Ethical approval is not required because this is a meta-analysis. We will disseminate these results by publishing them in a peer-reviewed journal.
Prospero registration number: CRD42021281176.
Keywords: Diabetes & endocrinology; Lipid disorders; Protocols & guidelines; Reproductive medicine.
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