OBJECTIVE: To estimate the effects of vaginal pH-balanced gel 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 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 thepH-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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00607295. LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: To estimate the effects of vaginal pH-balanced gel 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 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00607295. LEVEL OF EVIDENCE: I.