Evaluation of the efficacy of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women: A pilot randomized controlled trial

Abstract

As estrogen level decreases with aging, the vaginal mucosa gets thinner, and collagen amount decreases. In addition, the population of Lactobacillus in the vagina declines, increasing the risk of atrophic vaginitis, bacterial vaginosis, and genitourinary symptoms in the postmenopausal women. In this study, we evaluated the effects of Lactobacillus-containing feminine hygiene products on vaginal microbiome and genitourinary symptoms in pre- and postmenopausal women. This was a pilot randomized controlled trial in 35 premenopausal and 35 postmenopausal healthy women. For 4 weeks, treatment 1 group (14 premenopausal and 16 postmenopausal women) used the Lactobacillus-containing feminine soap and cream, and treatment 2 group (15 premenopausal and 14 postmenopausal women) used Lactobacillus-containing feminine gel in addition to soap and cream. The remaining 6 premenopausal and 5 postmenopausal women served as controls without using any products. We then compared the changes in the vaginal microbiota, genitourinary symptoms, and other related biomarkers after completion of treatment. Vaginal pH and pathogenic flora were reduced in both treatment groups compared to control group, which was more significant in the treatment 2 group of postmenopausal women. Genitourinary symptoms significantly improved in 60% of premenopausal women in treatment 1 group and 81.3% of postmenopausal women in treatment 2 group, compared to control group (0%, p = 0.043 and p<0.01 respectively). Overactive bladder symptom scores were significantly improved after using the products in eleven out of twelve postmenopausal women suspected of having overactive bladder. The use of Lactobacillus-containing feminine products was associated with improved vaginal ecosystem and urogenital health compared to control group, especially in those women using feminine gel.

Menopausal Changes in the Microbiome—A Review Focused on the Genitourinary Microbiome

“…Lillemon et al [ 73 ] reported that treatment with 12 weeks of vaginal estrogen just changed the main symptoms of GSM from vulvovaginal dryness and urinary frequency to dyspareunia and urgency without significant improvement of GSM symptoms. There was a pilot RCT attempting to improve GSM using the microbiome [ 88 ]. The study placed 35 pre- and 35 postmenopausal women into treatment groups that either received Lactobacillus -containing feminine soap and cream and/or Lactobacillus-containing feminine gel (4 weeks), or a control group (no treatment).…”

“…GSM symptoms were improved in 81.3% of postmenopausal women—a significant improvement compared to the control group. The symptom of overactive bladder also improved in 91.7% of postmenopausal women in the treatment group [ 88 ]. Jaisamrarn et al [ 89 ] conducted a clinical trial investigating the effects of combined estrogen and Lactobacillus therapy.…”

Evaluating the Effects of Probiotics on Menopause-specific Health Outcomes: A Systematic Review & Meta-analysis

“…Eight studies evaluated the effects of probiotics on menopausal symptoms [21]; [22]; [23]; [24]; [25]; [26]; [27]; [28]. Fifteen studies explored probiotics and urogenital health including genitourinary syndrome of menopause [30]; [31]; [32]; ; [34]; [35], bacterial vaginosis [36], urinary tract infections [37]; [38], and vaginal atrophy [39]; [40]; [41]; [42]; [43]; [44]; [45].…”

“…Studies which examined the effects of probiotics on menopausal symptoms reported statistically significant reductions in menopausal symptoms (total score) [23]; [28]; [39]; [25]; [21]; [22], including specific symptoms such as hot flushes [27] and facial wrinkles [26]. For example, an RCT conducted by Sawada et al [23] demonstrated that L. gasseri provided significant relief for menopausal symptoms, with vasomotor, somatic, and psychological symptoms showing the greatest reductions in comparison to placebo.…”

“…Results favoured the effects of both vaginally and orally administered probiotics on improved vaginal health outcomes, including improvements in the vaginal microbiome, bacterial vaginosis, and vaginal atrophy [39]; [41]; [31]; [43]; [36]. In most studies, probiotics were also beneficial for reducing reoccurrences of urinary tract conditions ( [39]; [34]; [38]).…”