Effects of oxytocin versus promestriene on genitourinary syndrome: a pilot, prospective, randomized, double-blind study

Santos, Liani Patricia Andrade; Bonduki, Claudio Emílio; Dardes, Rita de Cassia de Maio; Heinke, Thais; Patriarca, Marisa Teresinha

doi:10.1016/j.clinsp.2022.100116

Acessibilidade / Reportar erro

Brasil

Español English

sumário « anterior atual seguinte »

Sumário

Original articles • Clinics 77 • 2022 • https://doi.org/10.1016/j.clinsp.2022.100116 copy

Effects of oxytocin versus promestriene on genitourinary syndrome: a pilot, prospective, randomized, double-blind study

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Objectives:

In this pilot, prospective, randomized, double-blind study, the authors compared the efficacy of oxytocin with promestriene in improving vaginal atrophy of Genitourinary Syndrome of Menopause (GSM).

Methods:

A total of 51 postmenopausal women with symptoms of GSM were evaluated. They were randomized into two groups: oxytocin (25 patients) and promestriene (26 patients) and were evaluated before and after 90 days of treatment; the evaluation was based on the domains of the Female Sexual Function Index (FSFI) (lubrication, satisfaction, and pain during sexual intercourse), clinical visual examination, and vaginal wall thickness.

Results:

After the use of the medications, both groups showed significant improvement in the three evaluated FSFI domains (p < 0.05) and there was no significant difference between the groups (p > 0.05). On clinical examination, the medications improved all the evaluated parameters but without statistical significance (p > 0.05). The evaluation of the thickness of the vaginal epithelium showed that both treatments led to increase in the vaginal epithelium (p < 0.05); however, the efficacy of promestriene was higher than that of oxytocin (p < 0.05).

Conclusions:

Both medications were effective, however, studies with larger samples and longer follow-ups are needed to confirm the clinical applicability.

Keywords:
Genitourinary Syndrome; Promestriene; Oxytocin; Vulvovaginal Atrophy; Menopause

HIGHLIGHTS

Prospective, double-blind, randomized pilot study.

Compares efficacy of oxytocin and promestriene in Genitourinary Menopause Syndrome.

The two medications improved the three domains of the FSFI scales scores evaluated.

Both medications showed an increase in the thickness of the vaginal epithelium (p < 0.05).

Oxytocin and promestriene were both effective in Genitourinary Menopause Syndrome.

	Oxytocin (n = 25)	Promestriene (n = 26)	Total	p-value
Age: Median; IQR (Min–Max)	56; 8 (40–64)	53.5; 8 (45–69)	54; 8 (40–69)	0.515^a a Mann-Whitney test.
Number of pregnancies: Median; IQR (Min–Max)	3; 2 (0–8)	3; 2 (0–10)	3; 2 (0–10)	0.049^a a Mann-Whitney test.
Age at last menstruation: Median; IQR (Min–Max)	47; 13 (30–55)	48; 6 (30–55)	47; 9 (30–55)	0.491^a a Mann-Whitney test.
Marital Status, n (%)
Single	1 (4)	1 (3.8)	2 (3.9)	0.034^b b Pearson’s Chi-Square test.
Married	14 (56)	24 (92.3)	38 (74.5)
In a relationship	3 (12)	0 (0)	3 (5.9)
Widow	3 (12)	0 (0)	3 (5.9)
Divorced	4 (16)	1 (3.8)	5 (9.8)

Before	Oxytocin (n = 25)	Promestriene (n = 26)	p-value
	Median; IQR (min‒max)	Median; IQR (min‒max)
Lubrication	1.5; 2.6 (0–4.5)	1.8; 1.4 (0–3.9)	0.819^a a Mann-Whitney test (independent samples).
Satisfaction	1.6; 3 (0–4)	1.8; 1.6 (0–3.6)	0.894^a a Mann-Whitney test (independent samples).
Pain	1.6; 2 (0–4)	1.2; 1.9 (0–4)	0.985^a a Mann-Whitney test (independent samples).
After	Oxytocin (n = 16)	Promestriene (n = 20)	p-value
	Median; IQR (min-max)	Median; IQR (min-max)
Lubrication	3.9; 4.2 (0–4.5)	3.9; 2.9 (0–4.5)	0.422^a a Mann-Whitney test (independent samples).
Satisfaction	3.2; 3.6 (0–4)	3.2; 1.7 (0–4)	0.888^a a Mann-Whitney test (independent samples).
Pain	3; 4 (0–4)	4; 1.5 (0–4)	0.223^a a Mann-Whitney test (independent samples).
Before vs. After	Oxytocin (n = 16)	Promestriene (n = 20)
	p-value	p-value
Lubrication	0.018^b b Wilcoxon Test (matched samples).	0.005^b b Wilcoxon Test (matched samples).
Satisfaction	0.036^b b Wilcoxon Test (matched samples).	0.020^b b Wilcoxon Test (matched samples).
Pain	0.033^b b Wilcoxon Test (matched samples).	0.001^b b Wilcoxon Test (matched samples).

FSFI Domains	Oxytocin (n = 16)	Promestriene (n = 20)	p-value
Lubrication (Mean ± SD)	1.33 ± 1.89	1.46 ± 1.56	0.831^a a Student’s t-test for comparing means of independent samples.Shapiro-Wilk test not significant in both samples for all variables. SD, Standard Deviation.
Satisfaction (Mean ± SD)	1.10 ± 1.70	0.78 ± 1.24	0.518^a a Student’s t-test for comparing means of independent samples.Shapiro-Wilk test not significant in both samples for all variables. SD, Standard Deviation.
Pain (Mean ± SD)	0.98 ± 1.57	1.54 ± 1.28	0.242^a a Student’s t-test for comparing means of independent samples.Shapiro-Wilk test not significant in both samples for all variables. SD, Standard Deviation.

Thickness of the vaginal epithelium (mm)	Oxytocin mean (SD) Min–Max	Promestriene mean (SD) Min–Max	p-value
Before	(n = 25)	(n = 26)	0.348^a a Student’s t-test for comparing means of independent samples.
	0.21 (0.08)	0.19 (0.07)
	0.10–0.45	0.05–0.35
After	(n = 16)	(n = 20)	0.018 ^a a Student’s t-test for comparing means of independent samples.
	0.25 (0.09)	0.32 (0.07)
	0.10–0.50	0.20–0.45
Before vs. After	(n = 16)	(n = 20)	0.036 ^a a Student’s t-test for comparing means of independent samples.
Mean (SD)	0.05 (0.08)	0.12 (0.08)
p-value	0.017^b b Student’s t-test for comparing means of matched samples.Shapiro-Wilk test not significant in both samples for all variables. SD, Standard Deviation.	< 0.001^b b Student’s t-test for comparing means of matched samples.Shapiro-Wilk test not significant in both samples for all variables. SD, Standard Deviation.

Faculdade de Medicina / USP Rua Dr Ovídio Pires de Campos, 225 - 6 and., 05403-010 São Paulo SP - Brazil, Tel.: (55 11) 2661-6235 - São Paulo - SP - Brazil
E-mail: clinics@hc.fm.usp.br

Acompanhe os números deste periódico no seu leitor de RSS

[1] * Corresponding author. E-mail address: liani.paty@gmail.com (L.P.A. Santos).