NEW YORK (Reuters Health) – A pH-balanced vaginal gel can alleviate vulvovaginal symptoms after treatment for breast cancer, according to results of randomized controlled study published in the latest issue of Obstetrics and Gynecology.
“There are so many breast cancer survivors who complain of vaginal dryness after chemotherapy or endocrine therapy,” Dr. Jae Weon Kim from Seoul National University College of Medicine noted in an email to Reuters Health. “We found that vaginal pH-balanced gel could relieve vaginal symptoms and improve vaginal health in breast cancer survivors who have experienced menopause after cancer treatment.”
In the normal vaginal environment, low pH plays an important role in maintaining vaginal health. Elevated vaginal pH higher than 4.5 is associated with vaginitis, which causes several vaginal symptoms, seen commonly after menopause.
The pH-balanced gel used in the study called “clino-san” contains lactic acid to maintain the vaginal pH at about 4.0, according to the package insert from Han Kook Pharmed Co, Ltd, of Seoul, Korea. A placebo gel, without lactic acid, was provided in identical packages.
Participants in the study included 98 women, with a mean age of about 45 years, who experienced menopause after chemotherapy or hormonal therapy for breast cancer. All of them had complained of vulvovaginal dryness. Using a vaginal applicator, the women inserted the pH-balanced gel or placebo gel three times weekly at bedtime for 12 weeks.
Forty-four women in the pH-balanced gel arm and 42 in the placebo gel arm completed the study. After 12 weeks’ treatment, women using the pH-balanced gel reported significantly greater improvement in vaginal dryness and dyspareunia than those using the placebo gel (P = 0.001 and P = 0.040, respectively).
Compared with the placebo gel, the pH-balanced gel also significantly reduced the vaginal pH (P < 0.001) and enhanced vaginal maturation index (p < 0.001) and vaginal health index (P = 0.002), the researchers report. There were no serious adverse events and no significant between-group difference in adverse events. The most common side effect was mild or moderate vulvovaginal irritation or burning, usually just in the first 4 weeks of treatment. Dr. Kim told Reuters Health that vaginal pH-balanced gel should be the standard of care for the control of atrophic vaginitis among breast cancer survivors. “I do think it can help relieve vaginal symptoms,” the researcher said. Still, Dr. Kim and colleagues note in their report that the study only lasted for 3 months. They say further studies are needed with longer follow-up periods to confirm the results. Obstet Gynecol