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The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis

BACKGROUND: Genitourinary syndrome of menopause (GSM) is a common and disturbing issue in the postmenopausal period. Unlike vasomotor symptoms, it has a progressive trend. Our study aims to evaluate the efficacy and safety of oxytocin gel versus placebo gel in postmenopausal women with GSM. METHODS:...

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Autores principales: Farahat, Ramadan Abdelmoez, Salamah, Hazem Mohamed, Mahmoud, Abdelrahman, Hamouda, Esraa, Hashemy, Mahmoud, Hamouda, Heba, Samir, Ali, Chenfouh, Imane, Marey, Ahmed, Awad, Dina M., Farag, Elsayed, Abd-Elgawad, Mohamed, Eldesouky, Elsayed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10505316/
https://www.ncbi.nlm.nih.gov/pubmed/37716966
http://dx.doi.org/10.1186/s12905-023-02645-0
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author Farahat, Ramadan Abdelmoez
Salamah, Hazem Mohamed
Mahmoud, Abdelrahman
Hamouda, Esraa
Hashemy, Mahmoud
Hamouda, Heba
Samir, Ali
Chenfouh, Imane
Marey, Ahmed
Awad, Dina M.
Farag, Elsayed
Abd-Elgawad, Mohamed
Eldesouky, Elsayed
author_facet Farahat, Ramadan Abdelmoez
Salamah, Hazem Mohamed
Mahmoud, Abdelrahman
Hamouda, Esraa
Hashemy, Mahmoud
Hamouda, Heba
Samir, Ali
Chenfouh, Imane
Marey, Ahmed
Awad, Dina M.
Farag, Elsayed
Abd-Elgawad, Mohamed
Eldesouky, Elsayed
author_sort Farahat, Ramadan Abdelmoez
collection PubMed
description BACKGROUND: Genitourinary syndrome of menopause (GSM) is a common and disturbing issue in the postmenopausal period. Unlike vasomotor symptoms, it has a progressive trend. Our study aims to evaluate the efficacy and safety of oxytocin gel versus placebo gel in postmenopausal women with GSM. METHODS: A systematic review and meta-analysis synthesizing randomized controlled trials (RCTs) from Web of Science, SCOPUS, PubMed, and Cochrane Central Register of Controlled Trials databases on January 18, 2023. Keywords such as “oxytocin,“ “intravaginal,“ “vaginal,“ “atrophic,“ and “atrophy” were used. We used Review Manager (RevMan) version 5.4 in our analysis. We used the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes; both were presented with the corresponding 95% confidence interval (CI) and were calculated with the Mantel-Haenszel or inverse variance statistical method. Cochrane’s Q test and the I(2) statistic were used as measures of statistical inconsistency and heterogeneity. The Cochrane Risk of Bias Tool for RCTs was used for the quality assessment of the included studies. RESULTS: Seven studies with 631 patients were included. Regarding the maturation index, there was a statistically insignificant increase in the oxytocin arm (MD = 12.34, 95% CI (-12.52-37.19), P = 0.33). Clinically assessed vaginal atrophy showed a statistically significant reduction in the oxytocin group (RR = 0.32, 95% CI (0.23 − 0.10), P < 0.00001). For dyspareunia, vaginal pH, and histological evaluation of vaginal atrophy, there was a statistically insignificant difference between the two groups (RR = 1.02, 95% CI (0.82–1.27), P = 0.84), (MD = -0.74, 95% CI (-1.58-0.10), P = 0.08), and (MD = -0.38, 95% CI (-0.82-0.06), P = 0.09), respectively. There was no significant difference in the safety profile between the two groups as measured by endometrial thickness (MD = 0.00, 95% CI (-0.23-0.23), P = 0.99). CONCLUSIONS: Although oxytocin has been proposed as a viable alternative to estrogen in the treatment of GSM, our findings show the opposite. Larger, high-quality RCTs are needed to confirm or refute our results. TRIAL REGISTRATION: PROSPERO registration number CRD42022334357. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12905-023-02645-0.
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spelling pubmed-105053162023-09-18 The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis Farahat, Ramadan Abdelmoez Salamah, Hazem Mohamed Mahmoud, Abdelrahman Hamouda, Esraa Hashemy, Mahmoud Hamouda, Heba Samir, Ali Chenfouh, Imane Marey, Ahmed Awad, Dina M. Farag, Elsayed Abd-Elgawad, Mohamed Eldesouky, Elsayed BMC Womens Health Research BACKGROUND: Genitourinary syndrome of menopause (GSM) is a common and disturbing issue in the postmenopausal period. Unlike vasomotor symptoms, it has a progressive trend. Our study aims to evaluate the efficacy and safety of oxytocin gel versus placebo gel in postmenopausal women with GSM. METHODS: A systematic review and meta-analysis synthesizing randomized controlled trials (RCTs) from Web of Science, SCOPUS, PubMed, and Cochrane Central Register of Controlled Trials databases on January 18, 2023. Keywords such as “oxytocin,“ “intravaginal,“ “vaginal,“ “atrophic,“ and “atrophy” were used. We used Review Manager (RevMan) version 5.4 in our analysis. We used the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes; both were presented with the corresponding 95% confidence interval (CI) and were calculated with the Mantel-Haenszel or inverse variance statistical method. Cochrane’s Q test and the I(2) statistic were used as measures of statistical inconsistency and heterogeneity. The Cochrane Risk of Bias Tool for RCTs was used for the quality assessment of the included studies. RESULTS: Seven studies with 631 patients were included. Regarding the maturation index, there was a statistically insignificant increase in the oxytocin arm (MD = 12.34, 95% CI (-12.52-37.19), P = 0.33). Clinically assessed vaginal atrophy showed a statistically significant reduction in the oxytocin group (RR = 0.32, 95% CI (0.23 − 0.10), P < 0.00001). For dyspareunia, vaginal pH, and histological evaluation of vaginal atrophy, there was a statistically insignificant difference between the two groups (RR = 1.02, 95% CI (0.82–1.27), P = 0.84), (MD = -0.74, 95% CI (-1.58-0.10), P = 0.08), and (MD = -0.38, 95% CI (-0.82-0.06), P = 0.09), respectively. There was no significant difference in the safety profile between the two groups as measured by endometrial thickness (MD = 0.00, 95% CI (-0.23-0.23), P = 0.99). CONCLUSIONS: Although oxytocin has been proposed as a viable alternative to estrogen in the treatment of GSM, our findings show the opposite. Larger, high-quality RCTs are needed to confirm or refute our results. TRIAL REGISTRATION: PROSPERO registration number CRD42022334357. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12905-023-02645-0. BioMed Central 2023-09-16 /pmc/articles/PMC10505316/ /pubmed/37716966 http://dx.doi.org/10.1186/s12905-023-02645-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Farahat, Ramadan Abdelmoez
Salamah, Hazem Mohamed
Mahmoud, Abdelrahman
Hamouda, Esraa
Hashemy, Mahmoud
Hamouda, Heba
Samir, Ali
Chenfouh, Imane
Marey, Ahmed
Awad, Dina M.
Farag, Elsayed
Abd-Elgawad, Mohamed
Eldesouky, Elsayed
The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis
title The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis
title_full The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis
title_fullStr The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis
title_full_unstemmed The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis
title_short The efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis
title_sort efficacy of oxytocin gel in postmenopausal women with vaginal atrophy: an updated systematic review and meta-analysis
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10505316/
https://www.ncbi.nlm.nih.gov/pubmed/37716966
http://dx.doi.org/10.1186/s12905-023-02645-0
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