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Perceived Efficacy of Vaginal Dryness Relief: A Comparative Clinical Study between Sodium hyaluronate vaginal gel1 vs. Promestriene cream2

DOI: 10.4236/asm.2017.71003, PP. 34-43

Keywords: Vaginal Dryness, Menopause, Sodium Hyaluronate, Promestriene

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Abstract:

In the study, we report the comparative efficacy of the sodium hyaluronate gel vaginal application and promestriene cream which were tested to treat the gynecological symptoms of people who suffered from vaginal dryness. Method: 35 patients applied sodium hyaluronate vaginal gel one time a day for a period of two times a week during three weeks and other 33 patients using promestriene cream applied it every day for a period of three weeks also. Results: No significant difference was observed between vaginal application of sodium hyaluronate gel and promestriene cream, regarding both, as regarding the dryness of the intimate mucosa (p = 0.786), the attribute of moisturizing properties to the intimate mucosa (p = 0.142), the comfort sensation (p = 0.528), and no significant difference was observed regarding the fragrance of the product (p = 0.088). Conclusion: The similar results between vaginal application of both products support the use of sodium hyaluronate vaginal gel (Lubrinat®) in the initial approach of symptoms of vaginal dryness.

References

[1]  Soules, M.R., Sherman, S., Parrott, E., et al. (2001) Executive Summary: Stages of Reproductive Aging Workshop (STRAW). Fertility and Sterility, 76, 874-878.
https://doi.org/10.1016/S0015-0282(01)02909-0
[2]  Rees, M., Pérez-López, F.R., Ceasu, I., et al. (2012) EMAS Clinical Guide: Low-Dose Vaginal Estrogens for Post-Menopausal Vaginal Atrophy. Maturitas, 73, 171-174.
https://doi.org/10.1016/j.maturitas.2012.06.009
[3]  Levine, K.B., Williams, R.E. and Hartmann, K.E. (2008) Vulvovaginal Atrophy Is Strongly Associated with Female Sexual Dysfunction among Sexually Active Postmenopausal Women. Menopause, 15, 661-666.
https://doi.org/10.1097/gme.0b013e31815a5168
[4]  Conde, D.M., Pinto-Neto, A.M., Cabello, C., et al. (2005) Menopause Symptoms and Quality of Life in Women Aged 45 to 65 Years with and without Breast Cancer. Menopause, 12, 436-443.
https://doi.org/10.1097/01.GME.0000151655.10243.48
[5]  Mac Bride, M.B., Rhodes, D.J. and Shuster, L.T. (2010) Vulvovaginal Atrophy. Mayo Clinic Proceedings, 85, 87-94.
https://doi.org/10.4065/mcp.2009.0413
[6]  North American Menopause Society (2007) The Role of Local Vaginal Estrogen for Treatment of Vaginal Atrophy in Postmenopausal Women: 2007 Position Statement of the North American Menopause Society. Menopause, 14, 355-369.
[7]  Mehta, A. and Bachmann, G. (2008) Vulvovaginal Complaints. Clinical Obstetrics and Gynecology, 51, 549-555.
https://doi.org/10.1097/GRF.0b013e3181809a26
[8]  Kingsberg, S.A., Kellogg, S. and Krychman, M. (2009) Treating Dyspareunia Caused by Vaginal Atrophy: A Review of Treatment Options Using Vaginal Estrogen Therapy. International Journal of Women’s Health, 1, 105-111.
https://doi.org/10.2147/IJWH.S4872
[9]  Willhite, L.A. and O’Connell, M.B. (2001) Urogenital Atrophy: Prevention and Treatment. Pharmacotherapy, 21, 464-480.
https://doi.org/10.1592/phco.21.5.464.34486
[10]  Johnston, S.L., Farrell, S.A., Bouchard, C., et al. (2004) The Detection and Management of Vaginal Atrophy. Journal of Obstetrics and Gynaecology Canada, 26, 503-515.
https://doi.org/10.1016/S1701-2163(16)30662-4
[11]  Pandit, L. and Ouslander, J.G. (1997) Postmenopausal Vaginal Atrophy and Atrophic Vaginitis. The American Journal of the Medical Sciences, 314, 228-231.
[12]  Castelo-Branco, C., Cancelo, M.J., Villero, J., Nohales, F. and Julia, M.D. (2005) Management of Post-Menopausal Vaginal Atrophy and Atrophic Vaginitis. Maturitas, 52, 46-52.
https://doi.org/10.1016/j.maturitas.2005.06.014
[13]  Beral, V. (2003) Million Women Study Collaborators. Breast Cancer and Hormone Replacement Therapy in the Million Women Study. The Lancet, 362, 419-427.
https://doi.org/10.1016/S0140-6736(03)14596-5
[14]  American Society for Testing and Materials (2006) Standard Guide for Sensory Claim Substantiation. ASTM E 1958-06.
[15]  Soules, M.R. and Bremner, W.J. (1982) The Menopause and Climacteric: Endocrinologic Basis and Associated Symptomatology. Journal of the American Geriatrics Society, 30, 547-561.
https://doi.org/10.1111/j.1532-5415.1982.tb05661.x
[16]  Bachmann, G.A. and Leiblum, S.R. (2004) The Impact of Hormones on Menopausal Sexuality: A Literature Review. Menopause, 11, 120-130.
https://doi.org/10.1097/01.GME.0000075502.60230.28
[17]  Nappi, R.E., Albani, F., Santamaria, V., et al. (2010) Hormonal and Psycho-Relational Aspects of Sexual Function during Menopausal Transition and Early Menopause. Maturitas, 67, 78-83.
https://doi.org/10.1016/j.maturitas.2010.05.008
[18]  Lachowsky, M. and Nappi, R.E. (2009) The Effects of Oestrogen on Urogenital Health. Maturitas, 63, 149-151.
https://doi.org/10.1016/j.maturitas.2009.03.012
[19]  Johnston, S. and Farrell, S. (2004) The Detection and Management of Vaginal Atrophy. Journal of Obstetrics and Gynaecology Canada, 26, 503-508.
https://doi.org/10.1016/S1701-2163(16)30662-4
[20]  Cardozo, L., Bachmann, G., McClish, D., Fonda, D. and Birgerson, L. (1998) Meta-Analysis of Estrogen Therapy in the Management of Urogenital Atrophy in Postmenopausal Women: Second Report of the Hormones and Urogenital Therapy Committee. Obstetrics & Gynecology, 92, 722-727.
https://doi.org/10.1097/00006250-199810001-00045
[21]  Gelfand, M. (2000) Sexuality among Older Women. Journal of Women's Health and Gender-Based Medicine, 9, 15-20.
https://doi.org/10.1089/152460900318812
[22]  Pompei, L.M., Fernandes, C.E. and Melo, N.R. (2010) Promestriene no tratamento da atrofia vulvovaginal: Revisao sistemática. Femina, 38, 359-365.
[23]  Johnston, S. (2002) The Recognition and Management of Atrophic Vaginitis. Geriatrics/Aging, 5, 9-15.
[24]  Keil, K. (2002) Urogenital Atrophy: Diagnosis, Sequelae, and Management. Current Women’s Health Reports, 2, 305-311.
[25]  Grady, D. (2006) Management of Menopausal Symptoms. The New England Journal of Medicine, 355, 2338-2347.
https://doi.org/10.1056/NEJMcp054015
[26]  Barlow, D.H., Cardozo, L.D., Francis, R.M., et al. (1997) Urogenital Ageing and Its Effect on Sexual Health in Older British Women. British Journal of Obstetrics and Gynaecology, 104, 87-91.
https://doi.org/10.1111/j.1471-0528.1997.tb10655.x
[27]  FEBRASGO (2010) Climatério—Manual de orientacao. Sao Paulo, Brazil.
[28]  Nappi, R.E. and Lachowsky, M. (2009) Menopause and Sexuality: Prevalence of Symptoms and Impact on Quality of Life. Maturitas, 63, 138-141.
https://doi.org/10.1016/j.maturitas.2009.03.021
[29]  Bachmann, G.A., Leiblum, S.R. and Grill, J. (1989) Brief Sexual Inquiry in Gynecologic Practice. Obstetrics & Gynecology, 73, 425-427.
[30]  Nappi, R.E., Liekens, G. and Brandenburg, U. (2006) Attitudes, Perceptions and Knowledge about the Vagina: The International Vagina Dialogue Survey. Contraception, 73, 493-500.
https://doi.org/10.1016/j.contraception.2005.12.007
[31]  Avis, N.E., Zhao, X., Johannes, C.B., et al. (2005) Correlates of Sexual Function among Multi-Ethnic Middle-Aged Women: Results from the Study of Women’s Health across the Nation (SWAN). Menopause, 12, 385-398.
https://doi.org/10.1097/01.GME.0000151656.92317.A9
[32]  Bygdeman, M. and Swahn, M.L. (1996) Replens versus Dienestrol Cream in the Symptomatic Treatment of Vaginal Atrophy in Post-Menopausal Women. Maturitas, 23, 259-263.
https://doi.org/10.1016/0378-5122(95)00955-8
[33]  Morali, G., Polatti, F. and Metelitsa, E.N. (2006) Open, Non-Controlled Clinical Studies to Assess the Efficacy and Safety of a Medical Device in Form of Gel Topically and Intravaginally Used in Postmenopausal Women with Genital Atrophy. Drug Research, 56, 230-238.
[34]  Archer, D.F. (2010) Efficacy and Tolerability of Local Estrogen Therapy for Urogenital Atrophy. Menopause, 17, 194-203.
https://doi.org/10.1097/gme.0b013e3181a95581
[35]  Santos, I. and Clissold, S. (2010) Urogenital Disorders Associated with Oestrogen Deficiency: The Role of Promestriene as Topical Oestrogen Therapy. Gynecological Endocrinology, 26, 644-651.
https://doi.org/10.3109/09513591003767948
[36]  Wolff, J.P., Cachelou, R. and Gueritée, N. (1982) Absence of Systemic Hormonal Effects in an Oestradiol Diether Topically Active on the Vaginal Mucosa. Maturitas, 4, 239-246.
https://doi.org/10.1016/0378-5122(82)90054-8
[37]  Campana, G. and Di Francesco, G. (1976) Menopausal Syndrome: Clinical Experiences with Promestriene. Ann Ost Med Pren, 3, 1-9.
[38]  Del Pup, L., Postruznik, D. and Corona, G. (2012) Effect of One-Month Treatment with Vaginal Promestriene on Serum Estrone Sulfate Levels in Cancer Patients: A Pilot Study. Maturitas, 72, 93-94.
https://doi.org/10.1016/j.maturitas.2012.01.017
[39]  Costantino, D. and Guaraldi, C. (2008) Effectiveness and Safety of Vaginal Suppositories for the Treatment of the Vaginal Atrophy in Postmenopausal Women: An Open, Non-Controlled Clinical Trial. European Review for Medical and Pharmacological Sciences, 12, 411-416.
[40]  Ekin, M., Yasar, L., Savan, K., et al. (2010) The Comparison of Hyaluronic Acid Vaginal Tablets with Estradiol Vaginal Tablets in the Treatment of Atrophic Vaginitis: A Randomized Controlled Trial. Archives of Gynecology and Obstetrics, 283, 39-43.
[41]  Le Donne, M., Caruso, C., Mancuso, A., et al. (2011) The Effect of Vaginally Administered Genistein in Comparison with Hyaluronic Acid on Atrophic Epithelium in Post Menopause. Archives of Gynecology and Obstetrics, 283, 1319-1323.
https://doi.org/10.1007/s00404-010-1545-7
[42]  Grimaldi, E.F., Restaino, S., Inglese, S., et al. (2012) Role of High Molecular Weight Hyaluronic Acid in Postmenopausal Vaginal Discomfort. Minerva Ginecologica, 64, 321-329.
[43]  Chen, J., Geng, L., Song, X., et al. (2013) Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness: A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group, Clinical Trial. The Journal of Sexual Medicine, 10, 1575-1584.
https://doi.org/10.1111/jsm.12125
[44]  North American Menopause Society (2013) The Role of Local Vaginal Estrogen for Treatment of Vaginal Atrophy in Postmenopausal Women: 2013 Position Statement of the North American Menopause Society. Menopause, 9, 888-902.

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