Masomeh Yaralizadeh1, Parvin Abedi2, Shahnaz Najar1, Foroogh Namjoyan3, Amal Saki4. 1. Midwifery Department, Menopause Andropause Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. 2. Menopause Andropause Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: parvinabedi@ymail.com. 3. Department of Pharmacology, Marine Pharmaceutical Research Center, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. 4. Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
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 (5g/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.
RCT Entities:
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 (5g/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.