{"paper_id":"0fe34728-33f4-45b2-b632-84d924f16324","body_text":"INTRODUCTION \nReview question / Objective: The aim of the \nsystematic review and meta-analysis is to \nevaluate the efficacy and safety of \ndienogest in the treatment of women with \nsymptoms ascribed to endometriosis or \nadenomyosis. \nCondition being studied: Endometriosis is a \ncommon gynecological disease, which is \nestimated to affect 10% to 15% of all \nINPLASY 1\nInternational Platform of Registered Systematic Review and Meta-analysis Protocols\nINPLASY\nPROTOCOL\nEfficacy and safety of dienogest \nfor the treatment of endometriosis \nand adenomyosis: a systematic \nreview and meta-analysis\nLin, S1; Wang, X2; Fu, X3; Yang, W4; Bai, Y5; Shi, Z6; Du, J7; \nWang, B8.\nTo cite: Lin et al. Efficacy and \nsafety of dienogest for the \ntreatment of endometriosis \nand adenomyosis: a \nsystematic review and meta-\nanalysis. Inplasy protocol \n202050107. doi: \n10.37766/inplasy2020.5.0107\nReceived: 28 May 2020\nPublished: 28 May 2020\nReview question / Objective: The aim of the systematic \nreview and meta-analysis is to evaluate the efficacy and \nsafety of dienogest in the treatment of women with symptoms \nascribed to endometriosis or adenomyosis. \nCondition being studied: Endometriosis is a common \ngynecological disease, which is estimated to affect 10% to \n15% of all women in reproductive age. It has a negative \nimpact on quality of life, sexual function, work productivity \nand personal relationships of patients. Medical treatment \nshould be the first-line therapeutic option for patients who do \nnot wish to have babies immediately. Dienogest, a 19-nor \ntestosterone and progesterone derivative, is a fourth-\ngeneration synthetic oral progestin. RCTs has proved the \ngood efficacy and favorable safety of dienogest. The meta-\nanalysis about dienogest is rare. So we will conduct the \nsystematic review and meta-analysis was to evaluate the \nefficacy and safety of dienogest in the treatment of patients \nwith endometriosis or adenomyosis. \nINPLASY registration number: This protocol was registered with \nthe International Platform of Registered Systematic Review and \nMeta-Analysis Protocols (INPLASY) on 28 May 2020 and was last \nu p d a t e d o n 28 May 2 0 2 0 ( r e g i s t r a t i o n n u m b e r \nINPLASY202050107). \nCorresponding author: \nBaojin Wang \n307797362@qq.com \nAuthor Affiliation:                  \nThe third affiliated hospital of \nzhengzhou univers \nSupport: Science and \nTechnology Departm. \nReview Stage at time of this \nsubmission: Data extraction. \nConflicts of interest:          \nNone.\nLin et al. Inplasy protocol 202050107. doi:10.37766/inplasy2020.5.0107\nLin et al. Inplasy protocol 202050107. doi:10.37766/inplasy2020.5.0107 Downloaded from https://inplasy.com/inplasy-2020-5-0107/\n\nwomen in reproductive age. It has a \nnegative impact on quality of life, sexual \nfunction, work productivity and personal \nrelationships of patients. Medical treatment \nshould be the first-line therapeutic option \nfor patients who do not wish to have babies \ni m m e d i a t e l y. D i e n o g e s t , a 1 9 - n o r \ntestosterone and progesterone derivative, \nis a fourth-generation synthetic oral \nprogestin. RCTs has proved the good \nefficacy and favorable safety of dienogest. \nThe meta-analysis about dienogest is rare. \nSo we will conduct the systematic review \nand meta-analysis was to evaluate the \nefficacy and safety of dienogest in the \ntreatment of patients with endometriosis or \nadenomyosis. \nMETHODS \nParticipant or population: Patients with \nendometriosis or adenomyosis. \nIntervention: Dienogest. \nComparator: Placebo，GnRH-a or other \ninterventions. \nStudy designs to be included: Randomized \ncontrolled trials (RCTs). \nEligibility criteria: (1) prospective \nrandomized controlled trials(RCTs); (2) \nEnglish language studies; (3) Patients in the \nexperimental group were treated with \ndienogest, while patients in the control \ngroup received other medications, such as \nGnRH analogue, placebo, Combination oral \ncontraceptives or non-steroidal anti-\ninflammatory drugs. (4) The primary \noutcome is the improvement in pain \nassociated with endometriosis, other \noutcomes include side effects and changes \nin the clinical laboratory parameters. Meta-\na n a l y s e s , r e v i e w s , c a s e r e p o r t s , \nconference abstracts, cohort studies ，\nretrospective studies and trails without \navailable data are excluded. Studies \ninvolving adolescent or menopausal \nwomen are excluded. \nInformation sources: A systematic search \nconducts in the Cochrane library, Embase, \nPubmed and Web of Science. \nMain outcome(s): The primary efficacy \noutcome is changes in VAS scores of \nendometriosis-related pain before and after \nthe trial, changes in the amount of \nanalgesics intake is the secondary \noutcome of efficacy. The outcomes that \nevaluated the safety included changes in \nbone mineral density, changes in estrogen \nconcentration, the incidence of hot flushes, \nheadaches and other adverse events. \nQuality assessment / Risk of bias analysis: \nTo assess study quality, the Cochrane risk \nof bias assessment tool will be used. Seven \ndomains related to risk of bias are \nassessed in each study: (1) random \nsequence generation; (2) allocation \nconcealment; (3) blinding of participants \nand personnel; (4) blinding of outcome \nassessment; (5) incomplete outcome data; \n(6) selective reporting; (7) other bias. \nStrategy of data synthesis: The Review \nManager 5.3 software are used to conduct \nthe meta-analysis. Continuous data will be \nc a l c u l a t e d b y m e a n d i ff e r e n c e , \ndichotomous data will be calculated by \nrelative risk. I2 statistics will be applied to \nevaluated the heterogeneity of results \namong studies. The fixed-effect model will \nbe used to analyze results, when there is \nno heterogeneity or the value of I2 < 50%, \notherwise, the random-effect will be \nperformed. \nSubgroup analysis: If a sufficient number of \nstudies are identified for inclusion, we will \nconduct subgroup analysis of the included \nstudies according to the types of drugs. \nSensibility analysis: If a sufficient number \nof studies are identified for inclusion, we \nwill conduct sensibility analysis by \neliminating studies one by one to find the \nsource of heterogeneity. \nLanguage: English. \nINPLASY 2Lin et al. Inplasy protocol 202050107. doi:10.37766/inplasy2020.5.0107\nLin et al. Inplasy protocol 202050107. doi:10.37766/inplasy2020.5.0107 Downloaded from https://inplasy.com/inplasy-2020-5-0107/\n\nCountry(ies) involved: China. \nKeywords: dienogest, meta-analysis, \nendometriosis-related pain, GnRH-a.  \nContributions of each author: \nAuthor 1 - Shaochong Lin. \nAuthor 2 - Xinyue Wang. \nAuthor 3 - Xiling Fu. \nAuthor 4 - Wenhui Yang. \nAuthor 5 - Yang Bai. \nAuthor 6 - Zhongna Shi. \nAuthor 7 - Junpeng Du. \nAuthor 8 - Baojin Wang. \nINPLASY 3Lin et al. Inplasy protocol 202050107. doi:10.37766/inplasy2020.5.0107\nLin et al. Inplasy protocol 202050107. doi:10.37766/inplasy2020.5.0107 Downloaded from https://inplasy.com/inplasy-2020-5-0107/","source_license":"CC0","license_restricted":false}