LAUSR

Genitourinary syndrome of menopause (GSM) results from involution of the vaginal epithelium and tissues of the vulva and vagina due to declining levels of systemic estrogen during menopause. The vagina may decrease in caliber and the vaginal opening may become more narrow and constricted. Other common changes include progressive loss of vaginal elasticity, decreased lubrication, vaginal dryness, dyspareunia, vaginal burning, itching, and dysuria. The prevalence of these distressing vulvovaginal symptoms has been consistently reported in approximately 50% of postmenopausal women. GSM can have a significant negative impact on a woman’s sexual health and quality of life. First-line treatments for symptomatic women with GSM include vaginal moisturizers and vaginal lubricants. If these therapies fail, vaginal estrogen treatment or oral ospemifene should be considered in women without contraindications. These treatments are designed to temporarily alleviate symptoms and reverse atrophic anatomical changes. Despite proven effectiveness with symptom relief, compliance rates for estrogen are variable, ranging between 52% and 74%. When successful, patients must remain on treatment in perpetuity to maintain symptom relief. Some women, however, fail to find relief with medical therapies, others choose not to use estrogen therapy, and still others (such as breast cancer patients) may have a specific contraindication to hormone therapy. Fractional CO2 lasers (FCL) have shown promising results and have become an increasingly popular option for some of these patients, though they have not yet received FDA approval for the specific indication of GSM. Although a full discussion of the mechanism of action, safety, and efficacy of FCL for the treatment of GSM is beyond the scope of this response, the authors of this letter rightly raise some important issues surrounding this emerging therapy. I agree that FCL is being heavily marketed and patients often do not have accurate information with which to base a decision regarding proceeding with treatment. Unfortunately, FCL is not covered by insurance, so patients have to pay out of pocket. I hope this changes in the future. I agree that many physicians and health practitioners are beginning to offer this treatment, with minimal experience regarding the technical aspects of the therapy as well as a lack of understanding of mechanism of action and scientific validity of effectiveness. We are indeed in the hype cycle and quickly approaching the ‘‘peak of inflated expectation’’ (https:// en.wikipedia.org/wiki/Hype_cycle), with numerous other energy sources now being marketed with minimal to no data. As the proverbial saying goes, the only way to go is down from here. So what is the best way forward? We will get to that. But first, a brief response to the three reported cases highlighting possible ‘‘severe’’ adverse side effects to FCL in this article: Case 1: A 53-year-old woman reported intense itching after a second FCL treatment for vaginal atrophy, but was found to have a vaginal infection, which was treated with antibiotics. She carries a diagnosis of interstitial cystitis and had undergone chemotherapy for breast cancer. Although it is very possible that her itching is related to the FCL treatment, she has some confounding factors that may have contributed to her symptomatology including progressive atrophy, possible adverse reaction to a medication she may have been taking, and a vaginal infection. This case highlights the importance of proper patient selection for FCL therapy. In our studies, we did not see any major adverse events (including itching), but patients were carefully screened to ensure they were appropriate candidates and did not have confounding health conditions. Specific exclusions for participation in our trials included chronic pain conditions (such as interstitial cystitis) and vaginal infections. Case 2: A 58-year-old woman with progressive dyspareunia after FCL treatment, which was completed 3 months prior. Although it is possible that her dyspareunia has been worsened by FCL therapy, it is also possible that she has progressive dyspareunia from her progressive GSM. Perhaps the FCL treatment did not work for her because the area that bothers her most has been left untreated. Although it sounds like she underwent FCL of the vaginal lumen, did she also receive treatment of the introitus and vulva? It is interesting that on examination all of her findings seem to be external. Is she mostly bothered by insertional dyspareunia? If she did not undergo external therapy, then it would not be surprising to see worsening of her external symptoms over time. There is emerging experience with the use of FCL externally, and I imagine this patient is now responding well to vaginal estradiol if she is placing some of the medication externally on the affected areas. Case 3: A 57-year-old woman who underwent successful FCL treatment 1-year prior, now with recurring dyspareunia and lichen sclerosis and severe atrophy on examination. As opposed to saying this woman had a severe complication from FCL, it sounds to me like the therapy worked well for her but now her symptoms are returning. It also sounds like she has had untreated lichen sclerosis for some time. Although evidence is limited regarding FCL for the treatment of lichen sclerosis (lichen sclerosis was an exclusion in our studies), our 1-year outcomes study showed overall positive outcomes of FCL treatment for the symptoms of GSM but with some diminution of efficacy compared with 3-month outcomes. Pieralli et al showed that patient satisfaction after FCL tapered off between 18 and 24 months, with only 25% remaining satisfied at 24 months if no maintenance therapy was used. This suggests that patients may need intermittent maintenance after initial therapy. In our practice, we often see patients who come back once per year to maintain symptom relief. In another trial, Cruz et al showed that a combination of FCL and estrogen showed better sexual health outcomes than either estrogen or FCL alone, though all patients who were treated with FCL, estrogen, or both showed improvement. So perhaps FCL followed by maintenance vaginal estrogen therapy would have LETTERS TO THE EDITOR