The first published randomised controlled trial of laser treatment for vaginal atrophy raises serious questions

Buttini, Melissa J; Maher, Christopher

doi:10.5694/mja18.00187

Topics

Anatomy and physiology

Surgical procedures, operative

Women's health

Ethics and law

We still await well conducted RCTs of CO₂ laser therapy for vaginal atrophy; in the meantime, topical oestrogen therapy remains the gold standard

Vaginal laser therapy has entered the global marketplace promising women relief from symptoms of genitourinary syndrome of menopause (GSM), formerly known as vulvovaginal atrophy.

1 The Wesley Hospital, Brisbane, QLD
2 University of Queensland, Brisbane, QLD

Correspondence: melissa.buttini0@gmail.com

Competing interests:

No relevant disclosures.

1. American College of Obstetricians and Gynecologists: Fractional laser treatment of vulvovaginal atrophy and US Food and Drug Administration clearance: position statement. Washington, DC: ACOG, approved May 2016, reaffirmed July 2018. https://www.acog.org/Clinical-Guidance-and-Publications/Position-Statements/Fractional-Laser-Treatment-of-Vulvovaginal-Atrophy-and-US-Food-and-Drug-Administration-Clearance (viewed Sept 2018).
2. Therapeutic Goods Administration. Public summary for ARTG entry: 106780 High Tech Laser Australia P/L. https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=B5C3E89B35339C9ECA2577DD0001F0EB&agid=(PrintDetailsPublic)&actionid=1 (viewed Feb 2018).
3. US Food and Drug Administration. Guidance for industry: estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms – recommendations for clinical evaluation. Rockville, MD: FDA, 2003. https://www.fda.gov/downloads/Drugs/DrugSafety/informationbyDrugClass/UCM135338.pdf (viewed Feb 2018).
4. Chollet JA. Efficacy and safety of ultra-low-dose Vagifem (10 mcg). Patient Prefer Adherence 2011; 5: 571-574.
5. Wurz GT, Kao CJ, DeGregorio MW. Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause. Clin Interv Aging 2014; 9: 1939-1950.
6. Salvatore S, Nappi RE, Zerbinati N, et al. A 12-week treatment with fractional CO₂ laser for vulvovaginal atrophy: a pilot study. Climacteric 2014; 17: 363-369.
7. Salvatore S, Nappi RE, Parma M, et al. Sexual function after fractional microablative CO₂ laser in women with vulvovaginal atrophy. Climacteric 2015; 18: 219-225.
8. Salvatore S, Leone Roberti Maggiore U, Athanasiou S, et al. Histological study on the effects of microablative fractional CO₂ laser on atrophic vaginal tissue: an ex vivo study. Menopause 2015; 22: 845-849.
9. Athanasiou S, Pitsouni E, Antonopoulou S, et al. The effect of microablative fractional CO₂ laser on vaginal flora of postmenopausal women. Climacteric 2016; 19: 512-518.
10. Pitsouni E, Grigoriadis T, Tsiveleka A, et al. Microablative fractional CO₂ laser therapy and the genitourinary syndrome of menopause: an observational study. Maturitas 2016; 94: 131-136.
11. Salvatore S, Pitsouni E, Del Deo F, et al. Sexual function in women suffering from genitourinary syndrome of menopause treated with fractionated CO₂ laser. Sex Med Rev 2017; 5: 486-494.
12. Athanasiou S, Pitsouni E, Falagas ME, et al. CO₂ laser for the genitourinary syndrome of menopause. How many laser sessions? Maturitas 2017; 104: 24-28.
13. Cruz VL, Steiner ML, Pompei LM, et al. 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. Menopause 2018; 25: 21-28.

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