id,collection,dc.contributor.author,dc.date.accessioned,dc.date.available,dc.date.issued,dc.description.abstract[en],dc.identifier.uri,dc.language,dc.rights.uri,dc.subject.ddc,dc.subject[en],dc.title,dc.type,dcterms.accessRights.openaire,dcterms.bibliographicCitation.doi,dcterms.bibliographicCitation.journaltitle,dcterms.bibliographicCitation.number,dcterms.bibliographicCitation.originalpublishername,dcterms.bibliographicCitation.pageend,dcterms.bibliographicCitation.pagestart,dcterms.bibliographicCitation.pmid,dcterms.bibliographicCitation.volume,dcterms.isPartOf.eissn,dcterms.isPartOf.issn,refubium.affiliation,refubium.funding,refubium.resourceType.isindependentpub "7c973bcb-b7b0-4097-8137-4f053f700cba","fub188/15","Yang, Bing‐Yi||Gulinazi, Yierfulati||Du, Yan||Ning, Cheng‐Cheng||Cheng, Ya‐Li||Shan, Wei‐Wei||Luo, Xue‐Zhen||Zhang, Hong‐Wei||Zhu, Quin||Ma, Fenghua||Liu, Jia||Sun, Li||Yu, Min||Guan, Jun||Chen, Xiaojun","2022-01-20T08:49:57Z","2022-01-20T08:49:57Z","2020","Objective: To assess the efficacy of metformin in megestrol acetate (MA)-based fertility-sparing treatment for patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC). Design: A randomised, single-centre, open-label, controlled trial conducted between October 2013 and December 2017. Setting: Shanghai OBGYN Hospital of Fudan University, China. Population: A total of 150 patients (18-45 years old) with primary AEH or well-differentiated EEC were randomised into an MA group (n = 74) and an MA plus metformin group (n = 76). Methods: Patients with AEH or EEC were firstly stratified, then randomised to receive MA (160 mg orally, daily) or MA (160 mg orally, daily) plus metformin (500 mg orally, three times a day). Main outcomes and measures: The primary efficacy parameter was the cumulate complete response (CR) rate within 16 weeks of treatment (16w-CR rate); the secondary efficacy parameters were 30w-CR rate and adverse events. Results: The 16w-CR rate was higher in the metformin plus MA group than in the MA-only group (34.3 versus 20.7%, odds ratio [OR] 2.0, 95% confidence interval [CI] 0.89-4.51, P = 0.09) but the difference was more significant in 102 AEH patients (39.6 versus 20.4%, OR 2.56, 95% CI 1.06-6.21, P = 0.04). This effect of metformin was also significant in non-obese (51.4 versus 24.3%, OR 3.28, 95% CI 1.22-8.84, P = 0.02) and insulin-sensitive (54.8 versus 28.6%, OR 3.04, 95% CI 1.03-8.97, P = 0.04) subgroups of AEH women. No significant result was found in secondary endpoints. Conclusion: As a fertility-sparing treatment, metformin plus MA was associated with a higher early CR rate compared with MA alone in AEH patients. Tweetable abstract For AEH patients, metformin plus MA might be a better fertility-sparing treatment to achieve a higher early CR rate compared with MA alone.","https://refubium.fu-berlin.de/handle/fub188/33642||http://dx.doi.org/10.17169/refubium-33362","eng","https://creativecommons.org/licenses/by/4.0/","600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit","Atypical endometrial hyperplasia||endometrioid endometrial cancer||fertility-sparing||megestrol acetate||metformin","Metformin plus megestrol acetate compared with megestrol acetate alone as fertility‐sparing treatment in patients with atypical endometrial hyperplasia and well‐differentiated endometrial cancer: a randomised controlled trial","Wissenschaftlicher Artikel","open access","10.1111/1471-0528.16108","BJOG: An International Journal of Obstetrics & Gynaecology","7","Wiley","857","848","31961463","127","1471-0528","1470-0328","Charité - Universitätsmedizin Berlin","DEAL Wiley","no"