Comparison of effect of vitamin E vaginal cream with vaginal estradiole on atrophic vaginitis among menopausal women

Abstract

Abstract Background and objectives: Genitourinary syndrome of menopause is a new term, invovling genital symptoms, such as dryness, burning and irritation, and dyspareunia, and urinary symptoms, such as urgency, frequency and recurrent urinary tract infections, which are caused by the estrogen hormone drop following menopause and can affect the comfort and quality of life. About 40% of postmenopausal women experience symptoms of volvovaginal atrophy (VVA) and the overall prevalence of overactive bladder syndrome (OABS) in postmenopausal women is 30.9%. The gold standard treatment for atrophic vaginitis is estrogen, however due to the side effects of estrogen and the lack of acceptability, the first line treatment is non-hormonal treatment. As a result, the patient’s treatment process becomes difficult. The present study aimed to investigate the effect of vitamin E on VVA and OABS and compare it with estrogen. Materials and method: This triple-blind randomized controlled clinical trial was conducted on 72 postmenopausal women with VVA and OABS referring to health centers of Ahar city located in the northwest of Iran. Participants were randomly divided into the intervention (vitamin E, vaginal cream) and control (conjugated estrogen, vaginal cream) groups. The duration of the intervention was 8 weeks, in the first week they took medicine every day and then, twice a week. The primary outcome was to compare the symptoms of VVA in the intervention and control groups, and the secondary outcome was include the comparison of the mean score of OABS, pH, vaginal health index (VHI) 8-week after treatment. Statistical analysis was done using SPSS18 software. Normality distribution of data was assessed using by Shapiro- Wilk test. Demographic characteristics between the two groups were compared using chi-square test. The scores of VVA, VHI, and OABS were compared between the two groups before the intervention using the independent t-test and after the intervention by adjusting the baseline score using the ANCOVA test. For intra-group comparison, Wilcoxon test was used for VVA score and paired t-test was employed for VHI score.

Results There was no statistically significant difference between the social and demographic characteristics of the participants between the control and intervention groups. The VVA score in both groups improved significantly during eight-week, and the difference between the groups was not statistically significant [Adjusted mean difference (95% Confidence interval), 0.63 (-1.03 to 2.28), p=0.449]. The mean score of OABS decreased significantly in both groups, and the difference between the groups was not statistically significant [Adjusted mean difference (95% Confidence interval), 0.261 (-1.278 to 1.799), p=0.736]. The mean score of VHI increased significantly in both groups, and the difference between the groups was not significant [Adjusted mean difference (95% Confidence interval), 0.64 (-0.13 to 1.42), p=0.101].

Conclusion: The improved scores of VVA, OABS, and VHI after the eight week indicated that the treatment was effective in both groups. Therefore, vaginal vitamin E cream may be an alternative to vaginal estrogen in the relief of symptoms of vaginal atrophy and OABS in postmenopausal women, specially those who are unable to use hormone therapy or have poor compliance.