Astodrimer Gel for Treatment of Bacterial Vaginosis: A Systematic Review and Meta‐analysis of Randomized Controlled Trials

International Journal of Clinical PracticeVolume 75, Issue 7 e14165 META-ANALYSIS Astodrimer gel for treatment of bacterial vaginosis: A systematic review and meta-analysis of randomized controlled trials Ahmed Abu-Zaid, Corresponding Author Ahmed Abu-Zaid aabuzaid@live.com orcid.org/0000-0003-2286-2181 Department of Obstetrics and Gynecology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, USA Correspondence Ahmed Abu-Zaid, Department of Pharmacology, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, USA. Email: aabuzaid@live.comSearch for more papers by this authorMajed Saeed Alshahrani, Majed Saeed Alshahrani orcid.org/0000-0001-9718-6371 Department of Obstetrics and Gynecology, Faculty of Medicine, Najran University, Najran, Saudi ArabiaSearch for more papers by this authorHanadi Bakhsh, Hanadi Bakhsh Clinical Sciences Department, College of Medicine, Princess Nourah bint Abdulrahman University, Riyadh, Saudi ArabiaSearch for more papers by this authorNajlaa Talat Miski, Najlaa Talat Miski Department of Obstetrics and Gynecology, Faculty of Medicine, King Abdulaziz University, Rabigh, Saudi ArabiaSearch for more papers by this authorMohammed Abuzaid, Mohammed Abuzaid Department of Obstetrics and Gynecology, King Fahad Medical City, Riyadh, Saudi ArabiaSearch for more papers by this authorOsama Alomar, Osama Alomar Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorEmad Jabrah, Emad Jabrah Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorMohammed Ziad Jamjoom, Mohammed Ziad Jamjoom Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorHany Salem, Hany Salem Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorIsmail Abdulrahman Al-Badawi, Ismail Abdulrahman Al-Badawi Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorSaeed Baradwan, Saeed Baradwan orcid.org/0000-0003-0427-8758 Department of Obstetrics and Gynecology, Security Forces Hospital, Makkah, Saudi ArabiaSearch for more papers by this author Ahmed Abu-Zaid, Corresponding Author Ahmed Abu-Zaid aabuzaid@live.com orcid.org/0000-0003-2286-2181 Department of Obstetrics and Gynecology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, USA Correspondence Ahmed Abu-Zaid, Department of Pharmacology, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, USA. Email: aabuzaid@live.comSearch for more papers by this authorMajed Saeed Alshahrani, Majed Saeed Alshahrani orcid.org/0000-0001-9718-6371 Department of Obstetrics and Gynecology, Faculty of Medicine, Najran University, Najran, Saudi ArabiaSearch for more papers by this authorHanadi Bakhsh, Hanadi Bakhsh Clinical Sciences Department, College of Medicine, Princess Nourah bint Abdulrahman University, Riyadh, Saudi ArabiaSearch for more papers by this authorNajlaa Talat Miski, Najlaa Talat Miski Department of Obstetrics and Gynecology, Faculty of Medicine, King Abdulaziz University, Rabigh, Saudi ArabiaSearch for more papers by this authorMohammed Abuzaid, Mohammed Abuzaid Department of Obstetrics and Gynecology, King Fahad Medical City, Riyadh, Saudi ArabiaSearch for more papers by this authorOsama Alomar, Osama Alomar Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorEmad Jabrah, Emad Jabrah Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorMohammed Ziad Jamjoom, Mohammed Ziad Jamjoom Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorHany Salem, Hany Salem Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorIsmail Abdulrahman Al-Badawi, Ismail Abdulrahman Al-Badawi Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi ArabiaSearch for more papers by this authorSaeed Baradwan, Saeed Baradwan orcid.org/0000-0003-0427-8758 Department of Obstetrics and Gynecology, Security Forces Hospital, Makkah, Saudi ArabiaSearch for more papers by this author First published: 22 March 2021 https://doi.org/10.1111/ijcp.14165Citations: 2Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract Background Bacterial vaginosis is a frequent source of vaginal infection among reproductive-aged women. Astodrimer gel is a novel drug which demonstrated favourable outcomes for treatment of patients with bacterial vaginosis. Aim We attempted to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which examined the efficacy and safety of astodrimer gel in patients with bacterial vaginosis. Methods We searched four databases from inception to August 15, 2020, using relevant keywords. We identified all RCTs which surveyed the efficacy and safety of astodrimer gel in treating patients with bacterial vaginosis. We appraised the quality of the included RCTs using the Cochrane risk of bias assessment tool. We pooled dichotomous outcomes as numbers and totals and reported them as risk ratios (RR) with 95% confidence intervals (95% CI) under random- or fixed-effects meta-analysis models depending on heterogeneity. Results Three eligible studies comprising four independent RCTs and 1165 patients were identified (614 and 551 patients received astodrimer gel and placebo, respectively). For efficacy outcomes (n = 320 astodrimer gel versus n = 260 placebo), astodrimer gel was significantly superior to placebo for all pooled efficacy outcomes, including clinical cure rate (at 9-12 and 21-30 days), microbiological Nugent cure rate (at 9-12 and 21-30 days), patient self-reported absence of vaginal odor/discharge (at 9-12 and 21-30 days), resolution of Amsel criteria (at 9-12 days) and percentage of patients who did not receive rescue therapy during study. With respect to safety outcomes (n = 614 astodrimer gel versus n = 551 placebo), astodrimer gel demonstrated equal tolerability to placebo for all pooled safety endpoints, expect unfavourably for vulvovaginal candidiasis and treatment-related vulvovaginal candidiasis. Conclusions Astodrimer gel is effective in treating bacterial vaginosis and corroborated by clinical (Amsel criteria) and microbiological (Nugent score) measurements as well as patient-reported symptoms. Moreover, astodrimer gel is largely safe and associated with marginal rate of vulvovaginal candidiasis. Open Research DATA AVAILABILITY STATEMENT All data are available in the manuscript. Citing Literature Supporting Information Filename Description ijcp14165-sup-0001-FigS1-8.pdfPDF document, 236.6 KB Fig S1-8 Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article. Volume75, Issue7July 2021e14165 RelatedInformation