Experience in the clinical use of a non-hormonal vaginal cream for the treatment of genitourinary syndrome of menopause/vulvovaginal atrophy in patients with a history of estrogen-dependent oncological diseases
Objective: To evaluate the effectiveness of the treatment of genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA) with a non-hormonal vaginal cream containing hyaluronic acid and phytocomplex in patients with a history of hormone-dependent tumors of the reproductive organs.Ermakova E.I., Smetnik A.A.
Materials and methods: Thirty patients with symptoms of GSM/VVA aged 30 to 60 years with a history of breast cancer (n=13) and endometrial cancer (n=17) were included in an observational prospective study. At the screening visit, after the women’s condition was assessed, they received a non-hormonal cream with hyaluronic acid and phytocomplex using the following scheme: one dose at night in the vagina daily for 4 weeks, then one dose every other day for 8 weeks, then one dose twice a week for 12 weeks. The efficacy and safety of therapy was assessed after 3 and 6 months using a 4-point visual analog scale (VAS), the Bachmann Vaginal Health Index (VHI), pH-meters, the state of the vaginal microbiocenosis, and diaries of adverse events.
Results: The average age of the patients was 46±7 years, the average age of menopause was 4.0±2.7 years (from 1 to 14 years). There were 73.3% of sexually active women. Therapy with a non-hormonal vaginal cream for 6 months led to a statistically significant decrease in subjective symptoms (dryness, dyspareunia, burning, etc.) by more than 4 times compared with baseline data (VAS score at baseline – 11.7, after 6 months – 2.8,
p=1.23*10-24); a significant improvement in objective symptoms and an increase in the VHI by more than
2 times compared to the baseline values (VHI initially – 9.2, after 6 months – 20.1, p=5.81*10-20); a statistically significant decrease in vaginal pH: initially – 6.1, after 6 months – 5.1, p=4.46*10-12), an increase in the amount of lactoflora in the vaginal biotope by more than 2.5 times (initially, the average % of total bacterial mass (TBM) was 27.33, after 6 months of therapy it was 69.27) and a more than 2-fold decrease in optionally anaerobic (initial average % of TBM was 27.13%, after 6 months of therapy it was 13.73%) and obligate anaerobic microflora (initially average % of TBM was 46.14%, after 6 months of therapy it was 17.22%).
Conclusion: Our study showed that the combined cream Estrogial with hyaluronic acid and phytocomplex effectively reduces the symptoms of VVA, improves the condition of the vaginal mucosa, increases extravasation, significantly reduces the pH of the vagina and promotes the growth of normal microflora.
Authors’ contributions: Ermakova E.I. – collection and processing of material, data analysis, writing of an article; Smetnik A.A. – collection of material.
Conflicts of interest: The authors declare no possible conflicts of interest.
Funding: The study was conducted without sponsorship.
Ethical Approval: The study was approved by the Ethical Review Board of the Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia.
Patient Consent for Publication: All patients signed an informed consent for the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Ermakova E.I., Smetnik A.A. Experience in the clinical use of a non-hormonal vaginal cream for the treatment of genitourinary syndrome of menopause/vulvovaginal atrophy in patients with a history of estrogen-dependent oncological diseases.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (8): 167-176 (in Russian)
https://dx.doi.org/10.18565/aig.2023.192
Keywords
postmenopause
iatrogenic menopause
urogenital disorders
vulvovaginal atrophy
genitourinary syndrome of menopause
vaginal dryness
dyspareunia
estrogen-dependent oncological diseases of the reproductive system
lubricants
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Received 14.08.2023
Accepted 20.08.2023
About the Authors
Elena I. Ermakova, PhD, Senior Researcher, Academician V.I. Kulakov National Мedical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, Vice-president of Russian Society of Specialists in Gynecological Endocrinology and Menopause, +7(916)848-37-46, ermakova.health@mail.ru,https://orcid.org/0000-0002-6629-051X, 117997, Russia, Moscow, Oparin str., 4.
Antonina А. Smetnik, PhD, Head of the Department of Gynecological Endocrinology, Academician V.I. Kulakov National Мedical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, President of the Russian Society of Specialists in Gynecological Endocrinology and Menopause, +7(905)540-09-11,
asmetnik@mail.ru, https://orcid.org/0000-0002-6627-3902, 117997, Russia, Moscow, Oparin str., 4.
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