Clinical Articles
Post-menopausal women experiencing vulvovaginal symptoms will benefit just as much from using the cheapest over-the-counter lubricant or moisturiser as using topical oestrogen, a new study suggests. The 12-week randomised clinical trial, published in JAMA Internal Medicine, compared the efficacy of a low-dose vaginal oestradiol tablet and a vaginal moisturiser, each versus placebo among a group of over 300 post-menopausal women with moderate to severe vulvovaginal symptoms. To determine the effectiveness of the treatment women were asked to report on the severity of their ‘most bothersome symptom’ which included pain with vaginal penetration (60%), dryness (21%), itching (7%), irritation (6%) and pain (5%). Across the board, regardless of which treatment was used, most women had a decrease of at least 50% in symptom severity over the course of the study. This was significant in light of the fact that most women said they ‘frequently’ or ‘always’ distressed about their sex life at enrolment, whereas after the 12-week study nearly half said they were ‘rarely’ or ‘never’ distressed. “No treatment group differences in symptom reduction were observed for vaginal oestradiol tablet plus placebo gel vs dual placebo, or vaginal moisturiser plus placebo tablet vs dual placebo”, the US researchers reported. And it didn’t matter if the most bothersome symptom was dyspareunia or itching, it appeared the hormone treatment or the specific vaginal moisturiser (Replens) had no advantage over the placebo combination. According to the study authors, the placebo gel used in the study had a similar pH and viscosity as the vaginal moisturiser (Replens) but was less mucoadhesive. The fact that both formulations were equally effective in reducing symptoms suggests that the mucoadhesive properties are less important than previously thought. Similarly, markers of vaginal oestrogenisation such as the vaginal maturation index, did, naturally improve more with the topical oestrogen but this did not translate into a greater benefit in terms of symptoms over placebo. As an accompanying editorial points out, “ultimately, it is improvement in symptoms rather than surrogates such as tissue markers that should define the goal of care.” And while the study authors conclude that treatment choice for women with troublesome postmenopausal vulvovaginal symptoms should be ‘based on individual patient preferences regarding cost and formulation’ the editorial authors go in much stronger. “[P]ostmenopausal women experiencing vulvovaginal symptoms should choose the cheapest moisturiser or lubricant available over the counter – at least until new evidence arises to suggest there is any benefit to doing otherwise.” Ref: JAMA Intern Med. doi:10.1001/jamainternmed.2018.0116 JAMA Intern Med. doi:10.1001/jamainternmed.2018.0094
Expert/s: Dr Linda Calabresi