The effect of intra-vaginal oxytocin on sexual function in breastfeeding mothers: a randomized triple-blind placebo-controlled trial.
Breastfeeding mothers
Intravaginal Oxytocin
Postpartum
Sexual dysfunction
Sexual function
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
22 Jan 2022
22 Jan 2022
Historique:
received:
31
05
2021
accepted:
06
01
2022
entrez:
23
1
2022
pubmed:
24
1
2022
medline:
9
2
2022
Statut:
epublish
Résumé
Considering the importance of sexual function, high prevalence of sexual dysfunction (especially dyspareunia caused by atrophic vaginitis) in breastfeeding women, and lack of effective interventions, the present research aimed to determine the effect of oxytocin (OXT) vaginal gel on sexual function (primary outcome), sexual satisfaction, and depression (secondary outcomes) in the breastfeeding women. This randomized triple-blind controlled trial was conducted on 64 breastfeeding women who referred to health centers in the city of Tabriz, Iran, in 2020-21. Participants were equally assigned to intervention/control groups using block randomization. 200 IU of OXT vaginal gel was given to the participants in the intervention group daily for eight week and the same protocol was carried out for the control group with placebo. Standard questionnaires of Female Sexual Function Index (FSFI), Edinburgh Postpartum Depression Scale (EPDS) and Sexual satisfaction scale for women (SSSW) were completed at baseline and 8 weeks after intervention. ANCOVA test was used to compare post-intervention mean score of the groups, adjusted for the baseline values. After intervention, there was no statistically significant difference between groups in terms of mean total score of FSFI (Adjusted Mean Difference (AMD): 1.14; 95% Confidence Interval (95% CI): -1.28 to 9.16; P= 0.349) and sexual satisfaction (AMD: 5.01; 95% CI: -0.53 to 10.56; P= 0.075). However, there was statistically significant difference between the groups in terms of mean scores of sexual contentment (AMD: 1.56; 95% CI: 0.29 to 2.83; P = 0.017) and depression (AMD: -1.90; 95% CI: -1.27 to -2.54; P < 0.001). One participant in the OXT group and one participant in the placebo group reported mild uterine contraction and one person in the placebo group reported vaginal burning sensations. No evidence was found for the effects of OXT gel in the improvement of FSFI, even though, OXT significantly improved sexual satisfaction in the domain of contentment, and improved the symptoms of depression in comparison to the placebo group. However, a definite conclusion requires more research in this regard. the Iranian Registry of Clinical Trials (IRCT), code: IRCT20120718010324N55 , Date of registration: 27/05/2020, URL: https://en.irct.ir/user/trial/44986/view .
Sections du résumé
BACKGROUND
BACKGROUND
Considering the importance of sexual function, high prevalence of sexual dysfunction (especially dyspareunia caused by atrophic vaginitis) in breastfeeding women, and lack of effective interventions, the present research aimed to determine the effect of oxytocin (OXT) vaginal gel on sexual function (primary outcome), sexual satisfaction, and depression (secondary outcomes) in the breastfeeding women.
METHODS
METHODS
This randomized triple-blind controlled trial was conducted on 64 breastfeeding women who referred to health centers in the city of Tabriz, Iran, in 2020-21. Participants were equally assigned to intervention/control groups using block randomization. 200 IU of OXT vaginal gel was given to the participants in the intervention group daily for eight week and the same protocol was carried out for the control group with placebo. Standard questionnaires of Female Sexual Function Index (FSFI), Edinburgh Postpartum Depression Scale (EPDS) and Sexual satisfaction scale for women (SSSW) were completed at baseline and 8 weeks after intervention. ANCOVA test was used to compare post-intervention mean score of the groups, adjusted for the baseline values.
RESULTS
RESULTS
After intervention, there was no statistically significant difference between groups in terms of mean total score of FSFI (Adjusted Mean Difference (AMD): 1.14; 95% Confidence Interval (95% CI): -1.28 to 9.16; P= 0.349) and sexual satisfaction (AMD: 5.01; 95% CI: -0.53 to 10.56; P= 0.075). However, there was statistically significant difference between the groups in terms of mean scores of sexual contentment (AMD: 1.56; 95% CI: 0.29 to 2.83; P = 0.017) and depression (AMD: -1.90; 95% CI: -1.27 to -2.54; P < 0.001). One participant in the OXT group and one participant in the placebo group reported mild uterine contraction and one person in the placebo group reported vaginal burning sensations.
CONCLUSIONS
CONCLUSIONS
No evidence was found for the effects of OXT gel in the improvement of FSFI, even though, OXT significantly improved sexual satisfaction in the domain of contentment, and improved the symptoms of depression in comparison to the placebo group. However, a definite conclusion requires more research in this regard.
TRIAL REGISTRATION
BACKGROUND
the Iranian Registry of Clinical Trials (IRCT), code: IRCT20120718010324N55 , Date of registration: 27/05/2020, URL: https://en.irct.ir/user/trial/44986/view .
Identifiants
pubmed: 35065634
doi: 10.1186/s12884-022-04384-w
pii: 10.1186/s12884-022-04384-w
pmc: PMC8783987
doi:
Substances chimiques
Vaginal Creams, Foams, and Jellies
0
Oxytocin
50-56-6
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
62Informations de copyright
© 2022. The Author(s).
Références
J Sex Med. 2012 Feb;9(2):514-23
pubmed: 22146084
Horm Behav. 2015 Mar;69:82-8
pubmed: 25562711
Neurogastroenterol Motil. 2004 Apr;16(2):233-40
pubmed: 15086877
Obstet Gynecol. 2018 Aug;132(2):453-458
pubmed: 29995725
Scand J Caring Sci. 2005 Dec;19(4):381-7
pubmed: 16324063
Post Reprod Health. 2017 Mar;23(1):6-12
pubmed: 28381099
Depress Anxiety. 2016 Apr;33(4):316-22
pubmed: 26756305
Post Reprod Health. 2016 Mar;22(1):25-33
pubmed: 26883689
Nat Rev Neurosci. 2006 Feb;7(2):126-36
pubmed: 16429122
Br J Psychiatry. 1987 Jun;150:782-6
pubmed: 3651732
Epilepsy Behav. 2016 Nov;64(Pt A):294
pubmed: 27567216
MCN Am J Matern Child Nurs. 2009 Jul-Aug;34(4):218-23
pubmed: 19587565
Neuropeptides. 2012 Oct;46(5):211-5
pubmed: 22884888
Psychoneuroendocrinology. 1998 Nov;23(8):819-35
pubmed: 9924739
J Pak Med Assoc. 2015 Mar;65(3):248-52
pubmed: 25933554
Fertil Steril. 2015 Sep;104(3):715-23.e4
pubmed: 26151620
Med J Aust. 2020 Apr;212(7):329-334
pubmed: 32172535
Horm Behav. 2014 Mar;65(3):308-18
pubmed: 24503174
Climacteric. 2018 Apr;21(2):174-178
pubmed: 29347848
J Sex Marital Ther. 2019;45(6):538-549
pubmed: 30836903
J Sex Med. 2012 Jun;9(6):1497-507
pubmed: 22462756
J Clin Psychopharmacol. 2018 Jun;38(3):239-242
pubmed: 29596150
Midwifery. 2010 Apr;26(2):e1-9
pubmed: 20172635
Breastfeed Med. 2020 Nov;15(11):731-738
pubmed: 32960073
Braz J Med Biol Res. 2014 Feb;47(3):206-14
pubmed: 24676493
Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1249-54
pubmed: 1659199
J Pediatr Adolesc Gynecol. 2016 Feb;29(1):11-7
pubmed: 26165914
J Sex Med. 2016 Feb;13(2):144-52
pubmed: 26953829
Br J Psychiatry. 1986 Jan;148:74-9
pubmed: 3955323
BJOG. 2006 Aug;113(8):914-8
pubmed: 16907937
Psychoneuroendocrinology. 2008 Jun;33(5):591-600
pubmed: 18375074
CNS Neurosci Ther. 2010 Oct;16(5):e138-56
pubmed: 20626426
Arch Womens Ment Health. 2019 Aug;22(4):485-491
pubmed: 30306269
Int Urogynecol J. 2019 Mar;30(3):377-383
pubmed: 30178126
BMC Psychiatry. 2007 Apr 04;7:11
pubmed: 17408479
J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208
pubmed: 10782451
Naunyn Schmiedebergs Arch Pharmacol. 1998 Jun;357(6):701-4
pubmed: 9686948
Med Clin North Am. 2019 Jul;103(4):681-698
pubmed: 31078200
Harv Rev Psychiatry. 2016 Jan-Feb;24(1):1-13
pubmed: 26735320
JAMA Intern Med. 2018 May 1;178(5):681-690
pubmed: 29554173
J Midwifery Womens Health. 2003 Jul-Aug;48(4):282-4
pubmed: 12867914
Tidsskr Nor Laegeforen. 2012 May 15;132(9):1089-93
pubmed: 22614307
Post Reprod Health. 2015 Sep;21(3):88-97
pubmed: 25995333
Int J Impot Res. 2015 May-Jun;27(3):118-20
pubmed: 25672800
Arch Womens Ment Health. 2016 Aug;19(4):561-70
pubmed: 27295067
Sex Med. 2020 Mar;8(1):8-13
pubmed: 31837965