Randomized, Double-blind, Placebo-controlled Clinical Trial for Evaluating the Efficacy of Fractional CO2 Laser Compared With Topical Estriol in the Treatment of Vaginal Atrophy in Postmenopausal Women

Vera L. Cruz, MD; Marcelo L. Steiner, MD, PhD; Luciano M. Pompei, MD, PhD; Rodolfo Strufaldi, MD, PhD; Fernando L. Afonso Fonseca, PhD; Lucila H. Simardi Santiago, MD, PhD; Tali Wajsfeld, MD; Cesar E. Fernandes, MD, PhD

Disclosures

Menopause. 2018;25(1):21-28. 

In This Article

Abstract and Introduction

Abstract

Objective: The aim of the study was to evaluate efficacy of fractional CO2 vaginal laser treatment (Laser, L) and compare it to local estrogen therapy (Estriol, E) and the combination of both treatments (Laser + Estriol, LE) in the treatment of vulvovaginal atrophy (VVA).

Methods: A total of 45 postmenopausal women meeting inclusion criteria were randomized in L, E, or LE groups. Assessments at baseline, 8 and 20 weeks, were conducted using Vaginal Health Index (VHI), Visual Analog Scale for VVA symptoms (dyspareunia, dryness, and burning), Female Sexual Function Index, and maturation value (MV) of Meisels.

Results: Forty-five women were included and 3 women were lost to follow-up. VHI average score was significantly higher at weeks 8 and 20 in all study arms. At week 20, the LE arm also showed incremental improvement of VHI score (P = 0.01). L and LE groups showed a significant improvement of dyspareunia, burning, and dryness, and the E arm only of dryness (P < 0.001). LE group presented significant improvement of total Female Sex Function Index (FSFI) score (P = 0.02) and individual domains of pain, desire, and lubrication. In contrast, the L group showed significant worsening of pain domain in FSFI (P = 0.04), but FSFI total scores were comparable in all treatment arms at week 20.

Conclusions: CO2 vaginal laser alone or in combination with topical estriol is a good treatment option for VVA symptoms. Sexual-related pain with vaginal laser treatment might be of concern.

Introduction

Vulvovaginal atrophy (VVA) is a common disorder among postmenopausal women as a result of declining estrogen levels with menopause. It affects up to 50% of postmenopausal women, causing great impact in both quality of life and sexual function.[1–5]

Postmenopausal estrogen deficiency promotes morphological and secretory changes in the vulva and vagina. Reduced vascularization and blood flow leading to altered lubrication, loss of tissue elasticity, thinning of the vaginal epithelium, and tissue friability are some of the local changes that contribute to sexual-related symptoms.[6] A substantial decline in glycogen production due to thinning of the vaginal epithelium promotes changes in the vaginal pH and flora with decreased lactobacilli (which normally dominates the vaginal flora), high bacterial diversity, and increase susceptibility to inflammation.[7]

Signs and symptoms of VVA including dyspareunia, dryness, mucosal irritation, itching, and dysuria tend to worsen within 4 to 5 years after menopause.[8] An online survey investigated 56,000 women's perception of VVA symptoms, and found dryness (55% of participants), dyspareunia (44%), and irritation (37%) to be the most commonly reported symptoms.[6,9,10]

Topical hormonal treatment is considered the gold standard therapy for postmenopausal vaginal symptoms, promoting restoration of epithelial integrity, vaginal flora, and improving VVA symptoms.[5] Low-dose vaginal estrogen has also been shown to be superior to systemic therapy for vulvovaginal symptomatic improvement.[11,12] This treatment is, however, associated with poor compliance due to multiple and inconvenient self-applications and increased vaginal discharge. The prescription of topical estrogens should also be avoided in women with history of breast cancer, estrogen-sensitive tumors, and thromboembolism, emphasizing the necessity for treatment alternatives.[6,13] Lubricants and moisturizers are available options to help improve dryness, but not enough data addressing efficacy have been published.[13] Ospemifene is another alternative and has been shown to decrease symptoms related to hypoestrogenism.[14]

In the context of individualizing management of VVA symptoms, fractional CO2 laser treatment has emerged as an alternative treatment option for the management of vulvovaginal symptoms.[6,15,16,17] Fractional CO2 laser collagen remodeling and increased vascularization effects have been described ex vivo.[17] Microablative fractional CO2 laser therapy has also improved vaginal health by restoring vaginal flora to premenopause status with predominant lactobacilli.[18]

A significant improvement of VVA symptoms has been described after laser treatment in observational case series.[3,16,19] Sokol and Karram also described lasting effects of microablative fractional CO2 laser at a 1-year follow-up.[20]

Currently, there are no clinical trials demonstrating the efficiency and safety of fractional CO2 laser or comparing it to other well-established therapies. This study focused on the evaluation of fractional CO2 laser treatment safety in comparison to topical estriol and the combination of both treatments in postmenopausal women presenting with VVA symptoms.

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