Clinical Studies

Vaginal pH-Balanced Gel (Lactic Acid) for the Control of Atrophic Vaginitis Among Breast Cancer Survivors

Abstract

OBJECTIVE: To estimate the effects of vaginal pH-balanced gel (Lactic Acid) on vaginal symptoms and atrophy in breast cancer survivors treated with chemotherapy or endocrine therapy.

METHODS: This was a randomized, double-blind, placebo controlled study. Breast cancer survivors who experienced menopause after chemotherapy or endocrine therapy were voluntarily enrolled and randomly administered vaginal topical pH-balanced gel (Lactic Acid) or placebo three times per week for 12 weeks. Vaginal dryness and dyspareunia were measured by visual analog scale, vaginal health index, and vaginal pH. The endometrium and ovary were evaluated by transvaginal ultrasonography.

RESULTS: Among 98 enrolled women, 86 completed the treatment (n!44 and n!42 for the pH-balanced gel group and placebo group, respectively). Vaginal dryness and dyspareunia improved more in the pH-balanced gel group than in the placebo group (baseline mean 8.20 compared with end-point mean 4.23 [P!.001] and 8.23 compared with 5.48 [P!.040], respectively). Vaginal pH balanced gel reduced the vaginal pH (gel: baseline mean 6.49 compared with end-point mean 5.00; placebo: 6.22 compared with 5.69 [P<.001]), and enhanced vaginal maturation index (gel: 45.5 compared with 51.2; placebo: 46.4 compared with 47.9 [P<.001]) and vaginal health index (gel: 15.8 compared with 21.1; placebo 14.3 compared with 16.98 [P!.002]). There was no significant difference in adverse effects between the two groups except for mild irritation at the early time of pH-balanced gel administration.

 

CONCLUSION: Vaginal pH-balanced gel could relieve vaginal symptoms and improve vaginal health in breast cancer survivors who have experienced menopause after cancer treatment.

Results:

Chart: Changes of Parameters 12 Weeks After Treatment of Vulvovaginal Symptoms

VAS, visual analog scale. Data are mean #standard deviation unless otherwise specified. * Comparison of pH-balanced gel and placebo groups at baseline and end point, Student t test. † Comparison of changes from baseline to end point between pH-balanced gel and placebo groups, paired t test.

P is equal to 0.001, 0.040, 0.002. <0.001, <0.001 respectively.