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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2018-027489 on 22 May 2019. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 27, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-027489 on 22 May 2019. Downloaded from ANTIFUNGAL (ORAL AND VAGINAL) THERAPY FOR RECURRENT VULVOVAGINAL CANDIDIASIS: A SYSTEMATIC REVIEW PROTOCOL ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-027489 Article Type: Protocol Date Submitted by the 24-Oct-2018 Author: Complete List of Authors: Lírio, Juliana; Universidade Estadual de Campinas, Obstetrics and Gynecology Giraldo, Paulo; Universidade Estadual de Campinas Amaral, Rose ; Universidade Estadual de Campinas Sarmento, Ayane Cristine ; Universidade Federal do Rio Grande do Norte Costa, Ana Paula; Universidade Federeal do Rio Grande do Norte Gonçalves, Ana ; Universidade Federal do Rio Grande do Norte, Keywords: Vulvovaginal candidiasis, TREATMENT, vaginitis, prophylaxis http://bmjopen.bmj.com/ on September 27, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-027489 on 22 May 2019. Downloaded from 1 2 3 1 ANTIFUNGAL (ORAL AND VAGINAL) THERAPY FOR RECURRENT 4 5 2 VULVOVAGINAL CANDIDIASIS: A SYSTEMATIC REVIEW PROTOCOL 6 7 8 3 9 10 4 Juliana Lírio1, Paulo Cesar Giraldo2, Ana Katherine Gonçalves3, Rose Luce do 11 2, 4 4 12 5 Amaral Ayane Cristine Alves Sarmento , Ana Paula Ferreira Costa 13 14 6 1 – Doctor, master's degree in Obstetrics and Gynecology, State University of 15 16 7 Campinas, Campinas,For Brazil. peer review only 17 18 8 2 - Teacher. Department of Obstetrics and Gynecology, State University of 19 Campinas, Campinas, Brazil. 20 9 21 10 3 - Teacher. Department of Obstetrics and Gynecology, Federal University of Rio 22 23 11 Grande do Norte, Natal, Brazil. 24 25 12 4 – Post-Graduate Program in Health Sciences, Federal University of Rio Grande 26 13 do Norte, Natal, Brazil. 27 28 14 29 30 15 *Corresponding author: 31 32 16 Ana Katherine Gonçalves http://bmjopen.bmj.com/ 33 34 17 E-mail address: [email protected] 35 36 18 Phone: 55 84 32154371 37 38 19 39 20 40 on September 27, 2021 by guest. Protected copyright. 41 21 42 43 22 44 45 23 46 47 24 48 25 49 50 26 51 52 27 53 28 54 55 29 56 57 58 1 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 21 BMJ Open: first published as 10.1136/bmjopen-2018-027489 on 22 May 2019. Downloaded from 1 2 3 30 4 5 31 6 7 32 8 33 ABSTRACT 9 10 34 Introduction: Vulvovaginal candidiasis affects up to 75% of women during their 11 12 35 reproductive years. Predisposing factors have been identified and include the use of 13 14 36 antibiotics, pregnancy, diabetes mellitus, genetic factors and behavioral factors. 15 37 However, almost 5% of women suffer from recurrent vulvovaginal candidiasis 16 For peer review only 17 38 (RVVC), which is commonly defined as four or more episodes of VVC during a period 18 19 39 of a year. The effective treatment of RVVC, with adequate control of the symptoms 20 40 and eradication of the fungus, represents a challenge in daily clinical practice. 21 22 41 Recently, a wide variety of drugs and formulations have been made available and 23 24 42 many different antifungal regimens are used for treatment, some of them with 25 26 43 adverse effects that end up reducing women's adherence to treatment. The lack of 27 44 specific clear criteria for the indication of available antifungal treatment and its 28 29 45 abusive use has contributed to an increase in the antifungal resistance verified in 30 31 46 certain clinical trials. This review aims to assess the efficacy of antifungal agents 32 http://bmjopen.bmj.com/ 33 47 administered orally or intravaginally for the treatment of RVVC, in order to define 34 48 clinical practices that will impact on the reduction of the morbidity of this pathology 35 36 49 and on the decrease of resistance to the drugs used. 37 38 50 Methods and analysis: A comprehensive search of the following databases will be 39 51 carried out: PubMed, Embase, Scopus, Web of Science, SciELO, the Cochrane 40 on September 27, 2021 by guest. Protected copyright. 41 52 Central Register of Controlled Trials (CENTRAL), BVS/BIREME, CINAHL, and in the 42 43 53 clinical trials databases (www.trialscentral.org; www.controlled-trials.com; 44 45 54 www.clinicaltrials.gov). Electronic searches will be performed without restriction of 46 55 dates or languages. Two reviewers will independently select trials and extract data 47 48 56 from the original publications. The risk of bias will be assessed according to the 49 50 57 Cochrane Risk of Bias tool. We will perform data synthesis using the Review 51 52 58 Manager (RevMan) software V.5.2.3. To assess heterogeneity, we will compute the 53 59 I2 statistic. 54 55 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-027489 on 22 May 2019. Downloaded from 1 2 3 60 Ethics and dissemination: This study will be a review of published data and it is 4 5 61 not necessary to obtain ethical approval. Findings of this systematic review will be 6 7 62 published in a peer-reviewed journal. 8 63 Trial registration number for International Prospective Register of Systematic 9 10 64 Reviews 2018: International Prospective Register of Systematic Reviews 2014: 11 12 65 CRD42018093817 13 14 66 Strengths and limitations of this study 15 16 For peer review only 17 67 - The results obtained in this systematic review will indicate which antifungal 18 19 68 therapeutic regimen is most effective for the treatment of recurrent vulvovaginal 20 69 candidiasis. 21 22 70 - Two independent reviewers will select the studies included in this review, extract 23 24 71 data without different variables and assess the risk of bias. 25 26 72 - There may be a limitation of outcome from treatment variation, routes of 27 73 administration, different doses and quality of the randomized trials used in the 28 29 74 systematic review. 30 31 75 - This review and meta-analysis aims to combine the results of different studies that 32 http://bmjopen.bmj.com/ 76 have comparable sizes of effect that can be computed. 33 34 77 - However, it may be that we have only a small sample size and a limited number of 35 36 78 studies, which may influence the validity and reliability of the findings 37 38 79 39 80 40 on September 27, 2021 by guest. Protected copyright. 41 81 42 43 82 44 45 83 46 84 47 48 85 49 50 86 51 87 52 53 88 54 55 89 56 57 58 3 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 21 BMJ Open: first published as 10.1136/bmjopen-2018-027489 on 22 May 2019. Downloaded from 1 2 3 90 4 5 91 6 7 92 8 93 9 10 94 11 12 95 13 14 96 15 97 16 For peer review only 17 98 18 19 99 INTRODUCTION 20 100 21 22 101 Description of the condition: 23 24 102 Most women will have life-long episodes of vaginal discharge. Many times, 25 26 103 this discharge is caused by vulvovaginitis. Vaginal candidiasis appears as the 2nd 27 104 most frequent cause of vulvovaginitis (25%), being behind bacterial vaginosis.[1] It 28 29 105 is characterized by a process of desquamation and transudation of the vaginal 30 31 106 epithelium, associated with local inflammation of variable intensity, due to vaginal 32 http://bmjopen.bmj.com/ 33 107 colonization by Candida sp., a prerequisite for the disease to occur. About 20 to 25% 34 108 of asymptomatic women have positive vaginal cultures for Candida sp. [2] Candida 35 36 109 species can be commensal organisms or it can transform colonization without 37 38 110 symptoms into an infection. 39 111 The mechanisms of transformation of colonization into infection are 40 on September 27, 2021 by guest. Protected copyright. 41 112 multifactorial and relate to age being over 45, type 1 diabetes mellitus, use of 42 43 113 antibiotics, immunodeficiencies, stress, hormonal changes, pregnancy, obesity, use 44 45 114 of oral contraceptives with high doses of estrogens, life habits, hygiene, clothing, diet 46 115 rich in sugar, and sexual life, among others.
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