Effect of vitamin D vaginal suppository on sexual functioning among postmenopausal women: A three-arm randomized controlled clinical trial
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ObjectiveVaginal atrophy, the second most common complication of menopause, can lead to sexual dysfunction. This study evaluated the effect of a vitamin D vaginal suppository on sexual functioning in postmenopausal women. MethodsThis three-arm randomized controlled trial was conducted between August 2019 and August 2020. The sample comprised 105 postmenopausal women who were referred to comprehensive health service centers to receive postmenopausal care. The inclusion criteria were as follows: (i) being menopausal for at least 1 year, (ii) being married, (iii) being sexually active, and (iv) having sexual desire. Participants were randomly assigned to three groups for 8 weeks of treatment: intervention (vaginal suppository containing 1,000 units of vitamin D3), placebo (vaginal suppository placebo), or control (no treatment). The main outcome measure was sexual functioning, which was assessed using the Female Sexual Function Scale (FSFI) 4 times during the study (i.e., 1 month before the intervention, immediately after the intervention, 1 month after the intervention, and 2 months after the intervention). ResultsImmediately and 1 month after the trial, the intervention group had the highest FSFI score, followed by the placebo group, both of which were significantly higher than those of the control group (P<0.05). At the 2-month follow-up, the intervention and placebo groups had similar FSFI scores (P=0.08), both of which were significantly higher than those in the control group (P=0.001 and P=0.03, respectively). ConclusionVitamin D vaginal suppositories were more effective at improving sexual functioning among postmenopausal women in the short-term and appeared to prevent aging-related sexual functioning decline in the long term.
Abstract
ObjectiveVaginal atrophy, the second most common complication of menopause, can lead to sexual dysfunction. This study evaluated the effect of a vitamin D vaginal suppository on sexual functioning in postmenopausal women. MethodsThis three-arm randomized controlled trial was conducted between August 2019 and August 2020. The sample comprised 105 postmenopausal women who were referred to comprehensive health service centers to receive postmenopausal care. The inclusion criteria were as follows: (i) being menopausal for at least 1 year, (ii) being married, (iii) being sexually active, and (iv) having sexual desire. Participants were randomly assigned to three groups for 8 weeks of treatment: intervention (vaginal suppository containing 1,000 units of vitamin D3), placebo (vaginal suppository placebo), or control (no treatment). The main outcome measure was sexual functioning, which was assessed using the Female Sexual Function Scale (FSFI) 4 times during the study (i.e., 1 month before the intervention, immediately after the intervention, 1 month after the intervention, and 2 months after the intervention). ResultsImmediately and 1 month after the trial, the intervention group had the highest FSFI score, followed by the placebo group, both of which were significantly higher than those of the control group (P<0.05). At the 2-month follow-up, the intervention and placebo groups had similar FSFI scores (P=0.08), both of which were significantly higher than those in the control group (P=0.001 and P=0.03, respectively). ConclusionVitamin D vaginal suppositories were more effective at improving sexual functioning among postmenopausal women in the short-term and appeared to prevent aging-related sexual functioning decline in the long term.
참고문헌 (39)
- Sturdee DW, "Recommendations for the management of postmenopausal vaginal atrophy", Climacteric, 13, pp.509~522 (2010)
- Mac Bride MB, "Vulvovaginal atrophy", Mayo Clin Proc, 85, pp.87~94 (2010)
- Casarotti GA, "Menopause : new frontiers in the treatment of urogenital atrophy", Eur Rev Med Pharmacol Sci, 22, pp.567~574 (2018)
- Cumming GP, "Women’s attitudes to hormone replacement therapy, alternative therapy and sexual health : a web-based survey", Menopause Int, 13, pp.79~83 (2007)
- Kiraly SJ, "Vitamin D as a neuroactive substance : review", ScientificWorldJournal, 6, pp.125~139 (2006)
- Kinuta K, "Vitamin D is an important factor in estrogen biosynthesis of both female and male gonads", Endocrinology, 141, pp.1317~1324 (2000)
- Costantino D, "Effectiveness and safety of vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women : an open, noncontrolled clinical trial", Eur Rev Med Pharmacol Sci, 12, pp.411~416 (2008)
- White JH, "Profiling 1,25-dihydroxyvitamin D3-regulated gene expression by microarray analysis", J Steroid Biochem Mol Biol, 89-90, pp.239~244 (2004)
- Abban G, "Regulation of the vitamin D receptor and cornifin beta expression in vaginal epithelium of the rats through vitamin D3", Eur J Histochem, 52, pp.107~114 (2008)
- 김경미, "Serum vitamin D levels and ovarian reserve markers in secondary amenorrhea patients: Is there a link?", Obstetrics & Gynecology Science, 63(4), pp.521~528 (2020), 대한산부인과학회[DOI]
- Fatemeh Abdi, "Role of vitamin D and calcium in the relief of primary dysmenorrhea: a systematic review", Obstetrics & Gynecology Science, 64(1), pp.13~26 (2021), 대한산부인과학회[DOI]
- Fatemeh Alsadat Rahnemaei, "Vitamin D supplementation for primary dysmenorrhea: a double-blind, randomized, placebo-controlled trial", Obstetrics & Gynecology Science, 64(4), pp.353~363 (2021), 대한산부인과학회[DOI]
- Schulte-Uebbing C, "Stage I and II stress incontinence(SIC) : high dosed vitamin D may improve effects of local estriol", Dermatoendocrinol, 8, pp.e1079359~ (2016)
- Lotfi B, "Evaluation of breast cancer in Iranian women in an ecological study based on latitude, sun exposure and vitamin D intake", Iran J Obstet Gynecol Infertil, 17, pp.17~25 (2014)
- Monastra G, "Vitamin D : a steroid hormone with progesterone-like activity", Eur Rev Med Pharmacol Sci, 22, pp.2502~2512 (2018)
- de Villiers TJ, "Updated 2013 International Menopause Society recommendations on menopausal hormone therapy and preventive strategies for midlife health", Climacteric, 16, pp.316~337 (2013)
- Johansen C, "1alpha, 25-dihydroxyvitamin D3 stimulates activator protein 1 DNA-binding activity by a phosphatidylinositol 3-kinase", Ras, extracellular signal regulated kinase 1, pp.2 and c-Jun N-terminal kinase 1-dependent increase in c-Fos, Fra1, and c-Jun expression in human keratinocytes, J Invest Dermatol[DOI]
- Jetten AM, "Control of squamous differentiation in tracheobronchial and epidermal epithelial cells : role of retinoids", J Natl Cancer Inst Monogr, (13), pp.93~100 (1992)
- Eckert RL, "Keratinocyte survival, differentiation, and death : many roads lead to mitogenactivated protein kinase", J Investig Dermatol Symp Proc, 7, pp.36~40 (2002)
- Yildirim B, "The effects of postmenopausal vitamin D treatment on vaginal atrophy", Maturitas, 49, pp.334~337 (2004)
- Rad P, "The effect of vitamin D on vaginal atrophy in postmenopausal women", Iran J Nurs Midwifery Res, 20, pp.211~215 (2015)
- Daan NM, "Menopause prediction and potential implications", Maturitas, 82, pp.257~265 (2015)
- Sarebani Z, "Investigating the effect of vitamin D vaginal suppository on sexual function among postmenopausal women : study protocol for a randomized controlled trial", BMC Womens Health, 20, pp.27~ (2020)
- Cayan F, "Comparison of the effects of hormone therapy regimens, oral and vaginal estradiol, estradiol + drospirenone and tibolone, on sexual function in healthy postmenopausal women", J Sex Med, 5, pp.132~138 (2008)
- Rosen R, "The female sexual function index(FSFI) : a multidimensional self-report instrument for the assessment of female sexual function", J Sex Marital Ther, 26, pp.191~208 (2000)
- Fakhri A, "The female sexual function index : translation and validation of an Iranian version", J Sex Med, 9, pp.514~523 (2012)
- Alshahrani F, "Vitamin D : deficiency, sufficiency and toxicity", Nutrients, 5, pp.3605~3616 (2013)
- Vieth R, "Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety", Am J Clin Nutr, 69, pp.842~856 (1999)
- Kimball S, "Self-prescribed high-dose vitamin D3 : effects on biochemical parameters in two men", Ann Clin Biochem, 45, pp.106~110 (2008)
- Taylor PN, "A review of the growing risk of vitamin D toxicity from inappropriate practice", Br J Clin Pharmacol, 84, pp.1121~1127 (2018)
- Imbens GW, "Causal inference in statistics, social, and biomedical sciences" (2015), Cambridge University Press
- Fritz CO, "Effect size estimates : current use, calculations, and interpretation", J Exp Psychol Gen, 141, pp.2~18 (2012)
- Copay AG, "Understanding the minimum clinically important difference : a review of concepts and methods", Spine J, 7, pp.541~546 (2007)
- Krychman M, "Effect of single-session, cryogen-cooled monopolar radiofrequency therapy on sexual function in women with vaginal laxity : the VIVEVE I trial", J Womens Health(Larchmt), 27, pp.297~304 (2018)
- Sedaghat AR, "Understanding the minimal clinically important difference(MCID)of patient-reported outcome measures", Otolaryngol Head Neck Surg, 161, pp.551~560 (2019)
- Jacobson NS, "Clinical significance : a statistical approach to defining meaningful change in psychotherapy research", J Consult Clin Psychol, 59, pp.12~19 (1991)
- Weber MA, "Assessment of vaginal atrophy : a review", Int Urogynecol J, 26, pp.15~28 (2015)
- Pearson T, "Atrophic vaginitis", J Nurse Pract, 7, pp.502~512 (2011)
- Zeyneloglu HB, "The effect of raloxifene in association with vitamin D on vaginal maturation index and urogenital symptoms in postmenopausal osteoporotic women", Fertil Steril, 88, pp.530~532 (2007)