By Rebecca H. Allen, MD, MPH, Editor
SYNOPSIS: In this double-blinded, randomized controlled trial, fractional carbon dioxide vaginal laser was no better than sham laser in improving Female Sexual Function Index scores among 72 breast cancer survivors on aromatase inhibitors over a six-month period.
SOURCE: Mension E, Alonso I, Angles-Acedo S, et al. Effect of fractional carbon dioxide vs sham laser on sexual function in survivors of breast cancer receiving aromatase inhibitors for genitourinary syndrome of menopause: The LIGHT randomized clinical trial. JAMA Netw Open 2023;6:e2255697.
Vaginal laser therapy for the genitourinary syndrome of menopause (GSM) has been controversial. This condition is common among postmenopausal individuals and can be treated well with systemic and vaginal estrogen therapies. However, in some patients (such as breast cancer patients taking tamoxifen or aromatase inhibitors), topical estrogen is relatively contraindicated, and laser may be an option. Nevertheless, the efficacy and safety of this therapy have not yet been proven. The authors of this study undertook a randomized controlled trial comparing the intervention to sham laser to answer this question.
This was a Spanish double-blinded, randomized controlled trial of 72 women who were survivors of breast cancer aged 30 years and older receiving aromatase inhibitors (for at least six months) that compared five monthly sessions of vaginal carbon dioxide laser treatment with sham laser treatment. Participants had to have symptoms of GSM and a willingness to be sexually active during the trial. Both groups also received nonhormonal moisturizers and a vaginal vibrator stimulation for baseline care.
The study was conducted from October 2020 and September 2021. The exclusion criteria included use of vaginal moisturizers or lubricants in the last 30 days; vaginal hormonal treatment in the last six months; use of radiofrequency, laser treatment, hyaluronic acid, or lipofilling in the vagina in the last two years; ospemifene treatment; intraepithelial neoplasm of the cervix, vagina, or vulva; active genital tract infection; prior treatment for genital cancer; organ prolapse stage II or greater; and positive test results for human papillomavirus. The primary outcome was sexual function measured by the Female Sexual Function Index (FSFI) questionnaire, which was assessed at baseline and again at six months (one month after the fifth session of therapy). The FSFI assesses six sexual dimensions (desire, arousal, lubrication, orgasm, satisfaction, and pain). Global sexual function results in a score ranging from 2 to 36 points, with a higher score indicating better sexual function and a score less than 26 indicating women at risk of female sexual dysfunction. The study had the power to detect a four-point difference on the FSFI. Other secondary outcomes, including but not limited to adverse events, dyspareunia, body image, quality of life, and vaginal health index, were measured.
A total of 84 patients were randomized and a subset, 72 participants with mean age of 52.3 years (standard deviation [SD], 8.3), were analyzed, including 35 patients randomized to active laser treatment and 37 patients randomized to sham laser treatment. All patients used the vaginal lubricants and vibrator. The mean frequency of sexual activity was 2.7 events per month. There was no significant difference in adherence between the two groups. For all patients, the FSFI score improved from 15.2 (SD, 7.2) at baseline to 21.8 (8.1) at six months (P < 0.001). The active laser treatment group improved from a baseline of 14.8 (5.2) to 20.0 (9.5) at six months and the sham laser treatment group improved from a baseline of 15.6 (7.0) to 23.5 (6.5) with no statistically significant difference between the two groups. Excluding the 20 women who were not sexually active did not change the results. There was no statistically significant difference between the two groups in measures of dyspareunia, body image, quality of life, vaginal health index, vaginal pH, vaginal maturation index, vaginal epithelial thickness, and vaginal epithelial elasticity. There also was no major difference between the two groups in adverse events.
COMMENTARY
GSM is the preferred nomenclature for the disorder resulting from the effect that the lack of estrogen has on the genitourinary tissues. Atrophic vulvovaginitis is associated with this entity but, as the name implies, it also refers to hypoestrogenic effects on the urinary system. Symptoms can include vaginal dryness, burning, and irritation, as well as urinary urgency and dysuria. This can lead to dyspareunia and recurrent urinary tract infections.1 Usually, this condition can be well treated with vaginal lubricants, moisturizers, and topical or systemic estrogen as per the patient’s wishes. Other therapy options include vaginal dehydroepiandrosterone and oral ospemifene. However, patients with hormone-sensitive cancers, such as breast cancer, traditionally have not been able to access even topical estrogen therapies because of the concern that it could affect their risk of recurrence. Additionally, they often are taking medications, such as tamoxifen and aromatase inhibitors, that lower estrogen levels, which can cause GSM in premenopausal patients and worsen it in postmenopausal patients.
Alternative therapies to topical estrogen are needed, and laser treatment has been explored as a possibility. The laser is thought to create microdamage to the vaginal epithelium that then heals, which leads to the stimulation of collagen growth and blood flow to the area.1
This well-conducted randomized controlled trial did not show any difference between the carbon dioxide vaginal laser and sham therapy among this population of patients. In fact, outcomes improved in both groups, which may have been the result of the use of vaginal lubricants/vibrators and/or the placebo effect of being in a research study. However, there were no severe adverse outcomes, demonstrating the safety of the intervention. Of course, the findings of this study are limited to breast cancer patients and may not be generalizable to other postmenopausal patients with GSM. Nevertheless, carbon dioxide laser for the treatment of GSM has been controversial, and this study, along with others, demonstrates its lack of efficacy.2
A 2021 systematic review of carbon dioxide vaginal laser for GSM revealed that there were contradictory findings among previously published randomized controlled trials and that most of the literature consisted of observational studies or before-and-after studies without control groups and with relatively small numbers, resulting in a poor evidence base for the therapy.3 There was some evidence that sexual function and vaginal health improved in the short term, but again, the types of studies made the data appear weak. The fractional carbon dioxide laser has never been Food and Drug Administration-approved but is on the market because the device was approved for the treatment of other disorders.4 The most recent American College of Obstetricians and Gynecologists (ACOG) statement on the matter opined that, although laser therapy has shown some promise, it still needs to be evaluated long-term.1 ACOG also pointed out that it was not covered by insurance and is costly to patients. Finally, there is emerging evidence, per ACOG, that breast cancer survivors with GSM could use low-dose vaginal estrogen when taking tamoxifen and aromatase inhibitors with a shared decision-making conversation with their oncologist and gynecologist. Therefore, the role of vaginal laser therapy for GSM remains unclear and unproven.
REFERENCES
- American College of Obstetricians and Gynecologists. Treatment of urogenital symptoms in individuals with a history of estrogen-dependent breast cancer. Clinical Consensus Number 2. Published December 2021. https://www.acog.org/clinical/clinical-guidance/clinical-consensus/articles/2021/12/treatment-of-urogenital-symptoms-in-individuals-with-a-history-of-estrogen-dependent-breast-cancer
- Li FG, Maheux-Lacroix S, Deans R, et al. Effect of fractional carbon dioxide laser vs sham treatment on symptom severity in women with postmenopausal vaginal symptoms: A randomized clinical trial. JAMA 2021;326:1381-1389.
- Mension E, Alonso I, Tortajada M, et al. Vaginal laser therapy for genitourinary syndrome of menopause – systematic review. Maturitas 2022;156:37-59.
- U.S. Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation.” Published July 30, 2018. www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-efforts-safeguard-womens-health-deceptive-health-claims
In this double-blinded, randomized controlled trial, fractional carbon dioxide vaginal laser was no better than sham laser in improving Female Sexual Function Index scores among 72 breast cancer survivors on aromatase inhibitors over a six-month period.
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