New vaginal moisturizer is well-accepted and reduces symptoms related to the genitourinary syndrome of menopause in Brazilian women
O novo hidratante vaginal é bem aceito e reduz os sintomas relacionados à síndrome geniturinária da menopausa nas mulheres brasileiras
DOI:
https://doi.org/10.34119/bjhrv5n5-211Keywords:
atrophic vaginitis, menopause, vaginal moisturizer, genitourinary syndrome of menopause, vulvovaginal atrophy, brazilian womenAbstract
Objectives: To evaluate the effectiveness and acceptability of a new vaginal moisturizer composed of a combination of humectants, moisturizers, bioadhesives, and viscosity polymers (sodium hyaluronate 0.1%, polycarbophil 1.5%, carbomer 1.5%, and glycerin 1%) for relief of vulvovaginal symptoms associated with genitourinary syndrome of menopause in Brazilian postmenopausal women. Methods: An open clinical trial was performed with 33 postmenopausal women between 47 and 68 years of age with genitourinary syndrome of menopause symptoms such as vaginal dryness accompanied by pain or discomfort during intercourse. Clinical efficacy in relieving symptoms of genitourinary syndrome of menopause and acceptability were assessed using a Likert scale questionnaire. Efficacy and safety were assessed through gynecological examination, which included visual inspection of the epithelium and vaginal contents, and determination of vaginal pH. Wilcoxon's non-parametric test and paired Student's t-test were used for statistical analyses.Results: After 3 weeks of treatment, most participants reported improvement in GSM symptoms like vaginal dryness (p<0.001), discomfort during or after sexual intercourse (p<0.001), pain during or after sexual intercourse (p<0.001), vaginal odor (p=0.047) and itching (p=0.032) and good acceptability of the moisturizer. There was no alteration in the vaginal health index; however, a reduction in vaginal inflammation (p=0.046) was observed. No clinically significant adverse events were reported by participants. Conclusions: Treatment with non-hormonal vaginal moisturizer for 3 consecutive weeks in postmenopausal women with symptoms of genitourinary syndrome of menopause promoted improvements in vaginal hydration, showing a clinically adequate profile of efficacy and safety, in addition to a satisfactory degree of acceptability.
References
Fakhari, A., & Berkland, C. (2013). Applications and emerging trends of hyaluronic acid in tissue engineering, as a dermal filler and in osteoarthritis treatment. Acta Biomater, 9(7), 7081-7092. https://doi.org/10.1016/j.actbio.2013.03.005
Fiorilli, A., Molteni, B., & Milani, M. (2005). Successful treatment of bacterial vaginosis with a policarbophil-carbopol acidic vaginal gel: results from a randomised double-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol, 120(2), 202-205. https://doi.org/10.1016/j.ejogrb.2004.10.011
Heinemann, L. A., Potthoff, P., & Schneider, H. P. (2003). International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes, 1, 28. https://doi.org/10.1186/1477-7525-1-28
Hunter, C. A., Jr., & Long, K. R. (1958). Vaginal and cervical pH in normal women and in patients with vaginitis. Am J Obstet Gynecol, 75(4), 872-874. https://doi.org/10.1016/0002-9378(58)90669-0
Karakoç, H., Uçtu, A. K., & Özerdoğan, N. (2019). Genitourinary syndrome of menopause: effects on related factors, quality of life, and self-care power. Prz Menopauzalny, 18(1), 15-22. https://doi.org/10.5114/pm.2019.84152
Kogan, G., Soltés, L., Stern, R., & Gemeiner, P. (2007). Hyaluronic acid: a natural biopolymer with a broad range of biomedical and industrial applications. Biotechnol Lett, 29(1), 17-25. https://doi.org/10.1007/s10529-006-9219-z
Litwiniuk, M., Krejner, A., Speyrer, M. S., Gauto, A. R., & Grzela, T. (2016). Hyaluronic Acid in Inflammation and Tissue Regeneration. Wounds, 28(3), 78-88.
Milani, M., & Molteni, B. (2000). Effects of miphil, a new polycarbophil vaginal gel, in suspected bacterial vaginosis: a randomized study versus vaginal douche. Obstetrics & Gynecology, 95(4, Supplement 1), S58. https://doi.org/10.1016/S0029-7844(00)00710-9
Nappi, R. E., & Kokot-Kierepa, M. (2010). Women's voices in the menopause: results from an international survey on vaginal atrophy. Maturitas, 67(3), 233-238. https://doi.org/10.1016/j.maturitas.2010.08.001
Paternoster, D. M., Tudor, L., Milani, M., Maggino, T., & Ambrosini, A. (2004). Efficacy of an acidic vaginal gel on vaginal pH and interleukin-6 levels in low-risk pregnant women: a double-blind, randomized placebo-controlled trial. J Matern Fetal Neonatal Med, 15(3), 198-201. https://doi.org/10.1080/14767050410001668310
Portman, D. J., & Gass, M. L. (2014). Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause, 21(10), 1063-1068. https://doi.org/10.1097/gme.0000000000000329
Ritthidej, G. C. (2011). Chapter 3 - Nasal Delivery of Peptides and Proteins with Chitosan and Related Mucoadhesive Polymers. In C. Van Der Walle (Ed.), Peptide and Protein Delivery (pp. 47-68). Academic Press. https://doi.org/https://doi.org/10.1016/B978-0-12-384935-9.10003-3
Sinha, A., & Ewies, A. A. (2013). Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview. Climacteric, 16(3), 305-312. https://doi.org/10.3109/13697137.2012.756466
The North American Menopause Society (2020). The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause, 27(9), 976-992. https://doi.org/10.1097/gme.0000000000001609
World Health Organization (2012). Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA/FHI360: advisory note. Retrieved from https://apps.who.int/iris/handle/10665/76580. Accessed April 1, 2022
Wu, J. P., Fielding, S. L., & Fiscella, K. (2007). The effect of polycarbophil gel (Replens) on bacterial vaginosis: a pilot study. Eur J Obstet Gynecol Reprod Biol, 130(1), 132-136. https://doi.org/10.1016/j.ejogrb.2006.01.007
