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      A Prospective Study to Investigate the 12-week Efficacy of Soy Isoflavone Vaginal Gel (0.5%) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy

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          ABSTRACT

          Purpose

          To assess the feasibility and efficacy of a nonhormonal soy isoflavone vaginal gel in improving vulvovaginal estrogen-deprivation symptoms in postmenopausal women.

          Materials and Methods

          It was a single-center, prospective study. We identified postmenopausal women having at least one of the following self-assessed moderate to severe symptoms of vulvovaginal atrophy (VVA). Participants used soy isoflavone gel (0.5%) twice weekly for 12 weeks. Vulvovaginal symptoms and pH were assessed at three time points [baseline (T1), 4 weeks (T2) and 12 weeks (T3) with clinical evaluation, the Vaginal Health Index, Vaginal Assessment Scale, and the Vulvar Assessment Scale]. Efficacy and tolerability were assessed using the Patient Global Impression of Improvement (PGI-I) Scale and adverse effects were also recorded. In the results of 95 patients, the mean age was 55 years (range, 31–78), 68% ( n = 69) were partnered, and 60% ( n = 61) were sexually active. Vaginal Assessment Scale/Vulvar Assessment Scale scores significantly improved at all assessment points (all p = 6.5) and decreased from 26% at T1 to 19% at T3 ( p = 0.18).

          Conclusion

          Soy isoflavone vaginal gel (0.5%) use on a daily basis for 12 weeks leads to significant improvements in the symptoms of VVA in postmenopausal women. Topical isoflavones are a good treatment option for VVA, especially in women who either do not wish to use hormonal therapy or have contraindications to its use.

          How to cite this article

          Chaudhary D, Mishra V, Chaudhary S, et al. A Prospective Study to Investigate the 12-week Efficacy of Soy Isoflavone Vaginal Gel (0.5%) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy. J South Asian Feder Obst Gynae 2023;15(3):308–312.

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          Most cited references12

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          Recommendations for the management of postmenopausal vaginal atrophy.

          N. Panay, David Sturdee, (2010)
          Unlike hot flushes and night sweats which resolve spontaneously in time, atrophic symptoms affecting the vagina and lower urinary tract are often progressive and frequently require treatment. The prevalence of vaginal dryness increases as a woman advances through the postmenopausal years, causing itching, burning and dyspareunia, and sexual activity is often compromised. But, despite the various safe and effective options, only a minority (about 25% in the Western world and probably considerably less in other areas) will seek medical help. Some of this reluctance is due to the adverse publicity for hormone replacement therapy (HRT) over recent years that has suggested an increased risk of breast cancer, heart disease and stroke. But, regardless of whether these scares are justified, local treatment of vaginal atrophy is not associated with these possible risks of systemic HRT. Other reasons for the continued suffering in silence may be cultural and an understandable reluctance to discuss such matters, particularly with a male doctor, but the medical profession must also take much of the blame for failing to enquire of all postmenopausal women about the possibility of vaginal atrophic symptoms. Vaginal dryness can be helped by simple lubricants but the best and most logical treatment for urogenital atrophy is to use local estrogen. This is safe, effective and with few contraindications. It is hoped that these guidelines and recommendations, produced to coincide with World Menopause Day 2010, will help to highlight this major cause of distress and reduced quality of life and will encourage women and their medical advisers all over the world to seek and provide help.
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            Women's voices in the menopause: results from an international survey on vaginal atrophy.

            M Kokot, E. Nappi (2010)
            To consider issues relating to vaginal atrophy via an international survey. Using a structured questionnaire, interviews were performed on 4246 women aged 55-65 years living in Sweden, Finland, the United Kingdom, the United States and Canada. Overall, 98% of survey respondents were postmenopausal. Thirty-nine percent of the postmenopausal women had experienced vaginal atrophy, with the prevalence varying between countries, from 34% in Canada to 43% in Finland and the United States. Attitudes towards symptoms also varied between countries. Symptoms were described as moderate or severe by less than half of women from Finland and Sweden, compared with nearly two-thirds of women from the United States. However, vaginal atrophy was deemed to impact on quality of life by a higher proportion of women in Finland and Sweden (≥60%) than in the United Kingdom, the United States and Canada (≤50%). Overall, 77% of respondents believed women were uncomfortable discussing vaginal atrophy and 42% did not know that local treatment was available. The proportions of women unaware of the availability of local treatment were higher in the United States, the United Kingdom and Canada (51%, 50% and 48%, respectively), and very low in Finland (10%). Whilst 63% of women who had experienced vaginal atrophy had never been prescribed treatment for the condition, 67% of those who had been treated reported positive effects. The survey results illustrate differing needs of menopausal women in different countries. Country-specific approaches may be required to improve the uptake of treatment for vaginal atrophy. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
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              Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society.

              (2013)
              To update and expand the previous position statement of The North American Menopause Society (NAMS) on the management of symptomatic vulvovaginal atrophy (VVA) in postmenopausal women. NAMS searched PubMed for medical literature on VVA published since their 2007 position statement on the role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women. A panel of acknowledged experts in the field of genitourinary health reviewed the literature to evaluate new evidence on local estrogen as well as on other management options available or in development for symptomatic VVA. The panel's conclusions and recommendations were reviewed and approved by the NAMS Board of Trustees. Symptomatic VVA can significantly impair the quality of life (QOL) of postmenopausal women and may be underdiagnosed. In most cases, it can be managed successfully. A number of over-the-counter and government-approved prescription therapies available in the United States and Canada demonstrate effectiveness, depending on the severity of VVA symptoms. These include vaginal lubricants and moisturizers, vaginal estrogen, hormone therapy, and the selective estrogen-receptor modulator ospemifene (indicated for dyspareunia). Long-term studies on the endometrial safety of local estrogen and ospemifene are lacking. Changes in the vaginal microbiome have various effects on symptoms. Clinicians can improve the sexual health and QOL of postmenopausal women by educating women about, diagnosing, and appropriately managing symptomatic VVA. Choice of therapy depends on the severity of symptoms, the effectiveness and safety of therapy for the individual patient, and patient preference. Estrogen therapy is the most effective treatment for moderate to severe symptoms, although a direct comparison of estrogen and ospemifene is not available. Nonhormonal therapies available without a prescription provide sufficient relief for most women with mild symptoms. When low-dose estrogen is administered locally, a progestogen is not indicated for women without a uterus and generally is not indicated for women with an intact uterus. However, endometrial safety has not been studied in clinical trials beyond 1 year. There are insufficient data to confirm the safety of local estrogen in women with breast cancer; management of VVA should take the woman's needs and the recommendation of her oncologist into consideration. Research on the vaginal microbiome may lead to other therapies in the future.
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                Author and article information

                Journal
                Journal ID (publisher-id): JSAFOG
                Title: Journal of South Asian Federation of Obstetrics and Gynaecology
                Abbreviated Title: JSAFOG
                Publisher: Jaypee Brothers Medical Publishers
                ISSN (Print): 0974-8938
                ISSN (Electronic): 0975-1920
                Publication date (Print): May-June 2023
                Volume: 15
                Issue: 3
                Pages: 308-312
                Affiliations
                [1,3 ]Department of Obstetrics and Gynaecology, SMS Medical College, Jaipur, Rajasthan, India
                [2 ]Department of Obstetrics and Gynaecology, IKDRC, Ahmedabad, Gujarat, India
                [4 ]Department of Psychiatry, SMS Medical College, Jaipur, Rajasthan, India
                Author notes
                Deepa Chaudhary, Department of Obstetrics and Gynaecology, SMS Medical College, Jaipur, Rajasthan, India, Phone: +91 9413843022/+91 98290621111, e-mail: deepagaurav35@ 123456gmail.com
                Article
                DOI: 10.5005/jp-journals-10006-2237
                SO-VID: 2c98d0d4-cf05-42f0-a9c9-5fcff0c56beb
                Copyright © Copyright © 2023; The Author(s).
                License:

                © The Author(s). 2023 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and non-commercial reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 17 April 2022
                Date accepted : 01 October 2022
                Date: 31 July 2023
                Categories
                Subject: ORIGINAL ARTICLE
                Custom metadata
                file-pdf jsafog-15-308.pdf

                ScienceOpen disciplines: Obstetrics & Gynecology
                Keywords: Patient satisfaction,Year since menopause,Pruritus vulva,Postmenopausal women,Pelvic ultrasonography
                Data availability:
                ScienceOpen disciplines: Obstetrics & Gynecology
                Keywords: Patient satisfaction, Year since menopause, Pruritus vulva, Postmenopausal women, Pelvic ultrasonography

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