{"paper_id":"f871c585-86ce-4d5b-9037-37166af2d47f","body_text":"INTRODUCTION \nReview question / Objective The aim of this \nstudy is to comprehensively analyze \nevidence of elagolix in the treatment of \nmoderateto-severe endometriosis-associated pain. \nCondition being studied Endometriosis-related \npain, such as dysmenorrhea, non-menstrual pelvic \npain, and difficulties with sexual intercourse, \nseverely impairs the physical and mental health of \npatients and imposes a heavy economic burden. \nElagolix is an oral GnRH antagonist that has been \napproved by the FDA for the treatment of \nendometriosis. It inhibits the secretion of estrogen \nin a dose-dependent manner and allows for a rapid \nreversal of estrogen suppression shortly after \ndiscontinuation. Therefore, it can be conveniently \ndosed to balance effectiveness and safety. \nMETHODS \nSearch strategy Search: (((((Elagolix[Title/\nAbstract]) OR (R-(+)-4-(2-(5-(2- fluoro-3-\nmethoxyphenyl)-3-(2- fluoro-6-\n(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-3,6-\ndihydro-2H-pyrimidin-1-yl)-1-\nphenylethylamino)butyrate[Title/Abstract])) OR \n(elagolix sodium[Title/Abstract])) OR (Orilissa[Title/\nAbstract])) AND ((((Endometriosis[Title/Abstract]) \nOR (Endometrioses[Title/Abstract])) OR \n( E n d o m e t r i o m a [ T i t l e / A b s t r a c t ] ) ) O R \n( E n d o m e t r i o m a s [ T i t l e / A b s t r a c t ] ) ) ) A N D \n((randomized controlled trial[pt] OR controlled \nclinical trial[pt] OR randomized[tiab] OR \np l a c e b o [ t i a b ] O R c l i n i c a l t r i a l s a s \ntopic[mesh:noexp] OR randomly[tiab] OR trial[ti]) \nNOT (animals [mh] NOT (humans [mh] AND \nanimals[mh]))). \nINPLASY 1\nInternational Platform of Registered Systematic Review and Meta-analysis Protocols\nINPLASYEfcacy and safety of elagolix in moderate to severe \nendometriosis associated pain: a systematic review \nand meta analysis\nLiu, JF1; Wei, W2; Zhang, Y3; Chang, E4; Hou, Y5; Wei, X6; Yue, X7; \nZhong, L8.\nADMINISTRATIVE INFORMATION  \nSupport -  Deyang Science and Technology Plan Project. \nReview Stage at time of this submission - Preliminary searches. \nConflicts of interest - None declared. \nINPLASY registration number: INPLASY202390029 \nAmendments - This protocol was registered with the International \nPlatform of Registered Systematic Review and Meta-Analysis Protocols \n(INPLASY) on 10 September 2023 and was last updated on 10 \nSeptember 2023.\nCorresponding author: \nWei Wei\n472606614@qq.com\nAuthor Affiliation:                   \nPeople's Hospital of Zhongjiang \nCounty.\nLiu et al. INPLASY protocol 202390029. doi:10.37766/inplasy2023.9.0029\nLiu et al. INPLASY protocol 202390029. doi:10.37766/inplasy2023.9.0029 Downloaded from https://inplasy.com/inplasy-2023-9-0029/\nINPLASY202390029\ndoi: 10.37766/inplasy2023.9.0029 \nReceived: 10 September 2023\nPublished: 10 September 2023\n\nParticipant or population Patients with \nendometriosis. \nIntervention Elagolix. \nComparator Placebo. \nStudy designs to be included Randomized \ncontrolled trials (RCTs) with unlimited languages. \nEligibility criteria Endometriosis is characterized \nby the presence and growth of endometrial tissue \nin locations other than the uterine cavity. While a \ndefinitive diagnosis should be made histologically, \nalternative diagnostic methods, such as \nlaparoscopy are performed. The American Society \nof Reproductive Medicine (ASRM) staging system \nhas become the most common and international \nsystem, and diagnosis based on laparoscopic \nfindings has been recognized as the standard. \nHowever, laparoscopic findings have various \nlimitations and flaws and therefore cannot \nnecessarily serve as a perfect alternative to \nhistological diagnoses. Ultrasonography and \nmagnetic resonance imaging (MRI) have later been \nincorporated into the diagnosis of endometriosis. \nAs diagnostic imaging has improved in quality, \ninvasive laparoscopic diagnosis has somewhat \ndiminished in relative value, and the exclusive use \nof laparoscopy for diagnosis has become much \nless common. Subjective and objective findings \nand biochemical tests are all useful only when \ncombined with the results of diagnostic imaging \nand laparoscopy; none are used separately for \ndiagnosis. \nInformation sources Pubmed, Embase, cochrane, \nweb of science, CBM, CNKI, wanfang, \nClinicalTrials.\nMain outcome(s) Change from baseline to month \n3 in mumber rating scale (NRS) scores; Change \nfrom baseline to month 3 in dyspareunia (DYSP); \nChange from baseline to month 3 in non-menstrual \npelvic pain (NMPP); Patient Global Impression of \nChange Scale. \nQuality assessment / Risk of bias analysis The \nquality assessment for randomized controlled trials \nwas conducted by the Cochrane Risk of Bias tool \n1. Two reviewers will independently assess the risk \nof bias based on the following five domains: \nrandom sequence generation; allocation \nconcealment; blinding of participants and \npersonnel; blinding of outcome assessment; \nblinding of outcome data; selective reporting; and \nother bias. \nStrategy of data synthesis For dichotomous data, \nthe results were expressed as RR with 95% \nconfidence intervals. For continuous data, the \nresults were pooled for meta-analysis as the mean \ndifference (MD) with 95% confidence intervals if all \nstudies reported the same scales. When data were \nreported on different methods or scales, the \nstandardized mean di fference (SMD) was \ncalculated. P < 0.05 represented statistical \nsignificance.\nSubgroup analysis The effectiveness and safety \nof Elagolix are analyzed in subgroups based on \ndosage, including 150mg once daily (qd), 250mg \nonce daily (qd), and 200mg twice daily (bid). \nSensitivity analysis Stata software is used to \nperform sensitivity analysis, re flecting the \nsensitivity of the article by examining how the \neffect size changes after removing a particular \nstudy. \nCountry(ies) involved China. \nKeywords elagolix; Endometriosis. \nContributions of each author \nAuthor 1 - Jinfeng Liu.\nEmail: 472606614@qq.com\nAuthor 2 - Wei Wei.\nEmail: weiweieric0405@163.com\nAuthor 3 - Yue Zhang.\nAuthor 4 - En Chang.\nAuthor 5 - Yi Hou.\nAuthor 6 - Xi Wei.\nAuthor 7 - Xin Yue.\nAuthor 8 - Li Zhong.\nINPLASY 2Liu et al. INPLASY protocol 202390029. doi:10.37766/inplasy2023.9.0029\nLiu et al. INPLASY protocol 202390029. doi:10.37766/inplasy2023.9.0029 Downloaded from https://inplasy.com/inplasy-2023-9-0029/","source_license":"CC0","license_restricted":false}