Doctor LEE You-Kyung of SNU Hospital attended the American Society of Breast Disease (ASBD) Annual Symposium and presented her results of the randomised, double-blind, placebo-controlled trial. The title of the presentation was"The Effect and Safety of Clino-San on Vaginal Symptoms in Breast Cancer Survivors: A Randomized, Controlled Study".

LEE said that a lactic acid topical solution (Clino-San) can relieve dryness and other vaginal symptoms in breast cancer survivors who experience menopause after treatment with chemotherapy and endocrine therapy.

LEE aimed to determine the effect of the solution on vaginal symptoms and atrophy in breast cancer survivors who had been treated with chemotherapy or endocrine therapy.

Patients were aged 19 years and older, and had a history of chemotherapy or hormonal therapy, menopause after breast cancer treatment, menopause for at least 12 months before the study, and vulvovaginal dryness with a pain score >5 on the visual analogue scale (VAS).

Exclusion criteria included natural menopause antecedent to diagnosis of breast cancer; the presence of other malignancies such as cervical, ovarian, and uterine cancers; an operative history of hysterectomy or oophorectomy; and unexplained vaginal bleeding.

A total of 81 women were randomly assigned to receive the lactic acid solution (n = 42) or placebo (n = 39) 3 times per week for 12 weeks. Vaginal dryness and dyspareunia were measured by VAS, vaginal health index, and vaginal pH; and the effect on endometrium or ovary were evaluated.

The mean age of the women in the lactic acid solution group was 45.86 years, and the women had been menopausal for a mean of 18.18 months. Mean age for the placebo group was 44.98 years, and patients in this group had been in menopause for a mean of 18.45 months.

Vaginal dryness and dyspareunia improved significantly in the lactic acid treatment group compared with the placebo group (P = .012), and vaginal pH decreased more in the lactic acid group than in the placebo group (P = .025). Lactic acid increased the vaginal health index, but the improvement was not statistically significant (P = .058).

Adverse effects were similar in both groups, with the exception of a mild irritation that occurred during early use of the lactic acid solution. The most common complaints included irritation, a burning sensation, itching, and vaginal discharge, most of which were relieved within the first 4 weeks of the study.

The researchers concluded that the lactic acid topical solution is effective in the relief of vaginal symptoms associated with menopause in breast cancer survivors who had received cancer treatment.

April 8, 2009
SNU PR Office