Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial

Masomeh Yaralizadeh, Parvin Abedi'Correspondence information about the author Parvin AbediEmail the author Parvin Abedi, Shahnaz Najar, Foroogh Namjoyan, Amal Saki DOI: http://dx.doi.org/10.1016/j.maturitas.2015.11.005 | Abstract Highlights •The age of menopause in Iranian women is lower than that in other countries. •The life-expectancy of Iranian women increased to 72 years during recent years. •Vaginal atrophy is one of the main concerns during menopause. •The Foeniculum vulgare (fennel) is a herb that can alleviate the symptoms of vaginal atrophy (itching, burning, dryness and dyspareunia). •Fennel vaginal cream can improve the pH and cytology of vagina. •Using this cream is recommended in women who have contraindication for hormone therapy or not willing to use hormone because of its risk factors. Abstract Objective Vaginal atrophy is one of the main concerns of postmenopausal women. The aim of the present study was to investigate the effect of fennel vaginal cream on vaginal atrophy in postmenopausal women in Ahvaz, Iran. Materials and methods This double-blind randomized controlled trial was conducted on 60 postmenopausal women (45–65 years of age) in Ahvaz, Iran. The study participants were randomly divided into one of two groups, receiving either a placebo (n = 30) or fennel 5% vaginal cream (n = 30) administered as one application per day (5 g/day) for 8 weeks. Main outcome The vaginal pH and maturation vaginal index (MVI) were measured at baseline and 8 weeks after the intervention, while the vaginal atrophy symptoms was measured at baseline and at 2, 4, and 8 weeks after the intervention. The data were analyzed using the independent t-test, chi-square test, paired sample t-test, and the generalized estimating equation. Results The number of superficial cells increased significantly in the fennel group after 8 weeks compared to the control group (76.1 ± 15.3 vs. 11.8 ± 8, p < 0.001). The number of intermediate and parabasal cells decreased significantly in the fennel group compared to the control group (p < 0.001). The vaginal pH decreased significantly at the 8-week follow-up in the fennel group compared to the control group (100% vs. 7.4%, p < 0.001). All women in the fennel group had an MVI of 65–100 at the 8-week follow-up, whereas almost half (40.7%) of the women in the control group had an MVI of 50–64 (p < 0.001). Conclusion According to results of this study, fennel is an effective means to manage the symptoms of vaginal atrophy in postmenopausal women and is devoid of side effects. Larger studies are necessary to confirm the positive impact of fennel for vaginal conditions occurring among postmenopausal women. Keywords: Fennel vaginal cream, Foeniculum vulgare, Vaginal atrophy, Menopausal women