The Efficacy of Vaginal Laser and Other Energy-based Treatments on Genital Symptoms in Postmenopausal Women: A Systematic Review and Meta-analysis

Abstract

This systematic review examined energy-based treatments of the vagina for postmenopausal vaginal symptoms. Data Sources: We performed a systematic review from April 2017 (the end date of our previous review) to April 2020, searching Medline, Embase, and Scopus. Methods of Study Selection: The inclusion criteria were all randomized studies, prospective studies with >10 cases, and retrospective studies with >20 cases published in English or French that assessed change in postmenopausal vaginal symptoms and/or sexual function in women after energy-based vaginal treatments. Meta-analyses were performed on randomized data. Tabulation, Integration, and Results: Of the 989 results retrieved, 3 randomized studies, 16 prospective studies, and 7 retrospective studies were included in the review, representing data from 2678 participants. Pooled data from 3 randomized controlled trials show no difference between vaginal laser and topical hormonal treatments for change in vaginal symptoms (−0.14, 95% confidence interval −1.07 to 0.80) or sexual function scores (2.22, 95% confidence interval −0.56 to 5.00). Furthermore, no difference among vaginal laser, topical hormone, and lubricant was demonstrated in sexual function (p = .577). As in our previous review, non-randomized data support energy-based treatments in improving vaginal symptoms, sexual function, and clinician-reported outcomes. No severe adverse events were reported in the included studies. Significant heterogeneity of data arising from differing measures and reported outcomes continues to be an issue, with data remaining low quality, with high risk of bias, and no double-blind or placebo-controlled randomized trials yet reported, although 1 has now completed recruitment. Conclusion: There are 3 randomized trials comparing energy-based systems with hormonal treatment, with no clinical difference in these 2 approaches. Although prospective data continue to show promising outcomes, without strong evidence from well-powered, double-blind placebo-controlled trials to determine the efficacy of treatment compared with placebo, the use of energy-based treatments should continue to be undertaken in research studies only, with high-quality studies essentially free from bias (International Prospective Register of Systematic Review registration number: 178346).

Long-Term Follow-Up of Fractional CO2 Laser Therapy for Genitourinary Syndrome of Menopause in Breast Cancer Survivors

“…However, the study was likely underpowered due to its small sample size [49]. Another recently published sham-controlled randomized trial of 85 postmenopausal women, 50% of whom had a history of breast cancer, also showed no improvement in vaginal symptoms with laser treatment compared to sham treatment with 12 months follow-up [50]. However, a randomized double-blind, sham-controlled study of 58 postmenopausal women by Salvatore et al showed that vaginal symptoms and FSFI and UDI-6 scores were improved in the treatment group compared to the sham group [19].…”

“…Similar to vaginal estrogen treatment, vaginal laser treatment has been shown to increase the thickness of vaginal epithelium and improve the quality of the vaginal mucosa [14]. However, there is still limited prospective data with long-term follow-up and there are some studies which failed to show an improvement with laser treatment [49,50].…”

The evidence behind the use of LASER for genitourinary syndrome of menopause, vulvovaginal atrophy, urinary incontinence and lichen sclerosus: A state‐of‐the‐art review

“…Li et al carried out a review using the QUADAS‐2 tool and Cochrane REVIEW MANAGER version 5.4 to assess the risk of bias; they found that most of the studies on women with postmenopausal genital symptomswere at high risk of bias. The types of bias included reporting bias and industry involvement, as some of the studies are industry‐financed, and some of the authors are consultants for the LASER firms 145 . A cost‐effective analysis estimated an out‐of‐pocket cost at US$2733 for three sessions of LASER 146 .…”

“…24 In accordance with previous reviews on the field, we identified several weaknesses in the current literature. 10,[143][144][145] The relative shortness of follow-up is a challenge, as the majority of studies do not follow their participants more than 6 months post treatment, and in only one high-quality study a follow-up of 1 year after the first treatment. 24 A longer follow-up period after treatment is needed to establish the longterm effect of vaginal LASER.…”

Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology

“…They state, ".initial publications suggested that vaginal laser therapy was noninferior to treatments that were not better than placebo instead of addressing whether the laser technology had the desired effect on GSM symptoms." They cite a 2021 systematic review and meta-analysis, 1 which identified 16 prospective studies, 7 retrospective studies and only 3 randomized trials, none of which was double blinded or placebo controlled, which evaluated the efficacy of energy-based treatments on genital symptoms in postmenopausal patients. They point out that the nonrandomized data supported energybased treatments for patient-and clinician-reported outcomes, but pooled data from the 3 randomized controlled trials reported no difference in vaginal symptom outcomes, sexual function or vaginal health index between the vaginal laser and topical hormone treatment groups.…”