A randomized controlled trial to evaluate a novel dual laser therapy for vulvar lichen sclerosus: exploratory study assessing the impact of menopausal status.

Abstract

Objective: A randomized controlled trial showed that Neodymium:YAG/Erbium:YAG laser therapy was safe and significantly improved clinical outcomes and subjective symptoms of vulvar lichen sclerosus (LS). Most improvements were similar to those after the recommended first-line therapy with topical steroid. In this exploratory study, we wanted to analyze the impact of menopausal status on perception and treatment outcome.

Methods: Sixty-six women with clinical lichen sclerosus were assigned to the laser or the steroid arm (2:1). Participants of the laser arm received four laser treatments with a follow-up of 6 months after treatment initiation. Clinical objective (LS score) and subjective outcomes (vulvovaginal symptoms questionnaire [VSQ], symptom visual analogue scale [VAS] score, patient satisfaction) were evaluated.

Results: Nineteen of the 66 study participants were premenopausal, 47 postmenopausal. At baseline, premenopausal women were significantly younger (39.4 vs 67.4 yr, P < 0.001), only a few applied local estrogen (16% vs 74%, P < 0.001), and their VSQ score was higher (9.58 vs 7.32, P = 0.015) indicating more severe vulvovaginal symptoms. Laser therapy objectively led to similar clinical improvements for pre- and postmenopausal women (-2.62 vs -2.23, P = 0.437), but subjectively to a significantly higher improvement of the VSQ score in postmenopausal women (-4.13 vs -1.08, P = 0.005). Postmenopausal women were more satisfied with laser therapy than premenopausal women (71% vs 46%, P = 0.002).

Conclusion: Compared to premenopausal women, postmenopausal women experienced a lower subjective burden of the disease and a better subjective improvement after laser therapy. Perceptions and expectations are age-dependent and should be considered when treating women with lichen sclerosus.