To the Editor:

Umberto Leone Roberti Maggiore; Simone Ferrero

doi:10.1097/GME.0000000000001044

To the Editor:

Leone Roberti Maggiore, Umberto; Ferrero, Simone

2018-03-01 00:00:00

Menopause: The Journal of The North American Menopause Society Vol. 25, No. 3, pp. 357-358 DOI: 10.1097/GME.0000000000001044 2017 by The North American Menopause Society LETTERS TO THE EDITOR We read with interest the recently published article by Cruz Simone Ferrero, PhD, et al entitled ‘‘Randomized, double-blind, placebo-con- Academic Unit of Obstetrics and Gynaecology IRCCS Ospedale Policlinico San Martino trolled clinical trial for evaluating the efficacy of fractional Genoa, Italy CO laser compared with topical estriol in the treatment of Department of Neurosciences, Rehabilitation vaginal atrophy in postmenopausal women’’. Ophthalmology, Genetics, Maternal and Child Health This study aimed to evaluate the efficacy of fractional CO (DiNOGMI) vaginal laser treatment and compare it with local estrogen University of Genoa therapy, and the combination of both treatments for vulvovaginal Genoa, Italy atrophy (VVA). The regenerative effects of intravaginal frac- tional CO laser on the vaginal epithelium and lamina propria in REFERENCES postmenopausal women with VVA were previously reported. Microablative fractional CO laser has been demonstrated to be 1. Cruz VL, Steiner ML, Pompei LM, et al. Randomized, double-blind, feasible, efficacious, and safe in improving VVA-related symp- placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy toms in postmenopausal women at 12 weeks of follow-up. In in postmenopausal women. Menopause 2018;25:21-28. addition, this technique caused a significant decrease of dyspar- 2. Salvatore S, Leone Roberti Maggiore U, Athanasiou S, et al. Histological eunia related to the vaginal dryness, and it was consequently study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause 2015;22:845-849. associated with a consistent improvement in sexual function and 3. Salvatore S, Nappi RE, Zerbinati N, et al. A 12-week treatment with satisfaction of menopausal women with VVA. fractional CO laser for vulvovaginal atrophy: a pilot study. Climacteric The current study is to be commended for being the first 2014;17:363-369. 4. Salvatore S, Nappi RE, Parma M, et al. Sexual function after fractional randomized controlled trial. However, we deem that some microablative CO(2) laser in women with vulvovaginal atrophy. Climac- methodological flaws are present and some details should be teric 2015;18:219-225. more extensively explained to allow a more thorough interpretation of the findings. Firstly, no sample size calculation has been reported in the statistical analysis, and this is hardly acceptable when perform- ing a RCT. Ideally, a study should be large enough to have a high In Reply: chance (power) to identify as statistically significant a clinically We thank Professors Maggiore and Ferrero for showing important difference and especially if such a difference exists. interest and reading our article entitled ‘‘Randomized, Thus, it would be helpful to understand why the authors con- double blind, placebo-controlled clinical trial for evaluating sidered 15 patients per arm enough to draw their conclusions on the efficacy of fractional CO compared with topical estriol the outcomes achieved with the different treatments. in the treatment of vaginal atrophy in postmenopausal Secondly, we deem that clarification about blinding is women.’’ We are also willing to clarify all methodological also needed. In our experience, the CO laser procedure details to allow a more thorough interpretation of our is always associated with the presence of some smoke findings. and burning odor, and with the feeling of heat by the patient. In our view, the statement that our article did not report Therefore, it seems difficult to comprehend that both the the sample size calculation is incorrect. In the methods patient and the physician who performed the laser treatment section, there is an item called ‘‘Sample Size’’ where are actually blinded. We believe that the presence of an calculation is described. Our goal was to compare efficacy assessor-blinded physician would be a better choice to reduce between local estrogen therapy (gold standard for vulvova- this bias. ginal atrophy [VVA]) and vaginal laser for VVA symptoms. As there are no previous studies comparing these two treat- Financial disclosure/conflicts of interest: None reported. ments, the ideal sample size calculation was not possible. We assumed that CO laser treatment would be inferior to Umberto Leone Roberti Maggiore, PhD, local estriol for vaginal atrophy symptoms and then we have Academic Unit of Obstetrics and Gynaecology calculated our sample size based on CO laser therapy to IRCCS Ospedale Policlinico San Martino 2 Genoa, Italy detect a three-point difference in the Vaginal Health Index Menopause, Vol. 25, No. 3, 2018 357 Copyright @ 2017 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.

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Menopause Wolters Kluwer Health

http://www.deepdyve.com/lp/wolters-kluwer-health/to-the-editor-010JeNqaj5

To the Editor:

$Menopause: The Journal of The North American Menopause Society Vol. 25, No. 3, pp. 357-358 DOI: 10.1097/GME.0000000000001044 2017 by The North American Menopause Society LETTERS TO THE EDITOR We read with interest the recently published article by Cruz Simone Ferrero, PhD, et al entitled ‘‘Randomized, double-blind, placebo-con- Academic Unit of Obstetrics and Gynaecology IRCCS Ospedale Policlinico San Martino trolled clinical trial for evaluating the efficacy of fractional Genoa, Italy CO laser compared with topical estriol in the treatment of Department of Neurosciences, Rehabilitation vaginal atrophy in postmenopausal women’’. Ophthalmology, Genetics, Maternal and Child Health This study aimed to evaluate the efficacy of fractional CO (DiNOGMI) vaginal laser treatment and compare it with local estrogen University of Genoa therapy, and the combination of both treatments for vulvovaginal Genoa, Italy atrophy (VVA). The regenerative effects of intravaginal frac- tional CO laser on the vaginal epithelium and lamina propria in REFERENCES postmenopausal women with VVA were previously reported. Microablative fractional CO laser has been demonstrated to be 1. Cruz VL, Steiner ML, Pompei LM, et al. Randomized, double-blind, feasible, efficacious, and safe in improving VVA-related symp- placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy toms in postmenopausal women at 12 weeks of follow-up. In in postmenopausal women. Menopause 2018;25:21-28. addition, this technique caused a significant decrease of dyspar- 2. Salvatore S, Leone Roberti Maggiore U, Athanasiou S, et al. Histological eunia related to the vaginal dryness, and it was consequently study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause 2015;22:845-849. associated with a consistent improvement in sexual function and 3. Salvatore S, Nappi RE, Zerbinati N, et al. A 12-week treatment with satisfaction of menopausal women with VVA. fractional CO laser for vulvovaginal atrophy: a pilot study. Climacteric The current study is to be commended for being the first 2014;17:363-369. 4. Salvatore S, Nappi RE, Parma M, et al. Sexual function after fractional randomized controlled trial. However, we deem that some microablative CO(2) laser in women with vulvovaginal atrophy. Climac- methodological flaws are present and some details should be teric 2015;18:219-225. more extensively explained to allow a more thorough interpretation of the findings. Firstly, no sample size calculation has been reported in the statistical analysis, and this is hardly acceptable when perform- ing a RCT. Ideally, a study should be large enough to have a high In Reply: chance (power) to identify as statistically significant a clinically We thank Professors Maggiore and Ferrero for showing important difference and especially if such a difference exists. interest and reading our article entitled ‘‘Randomized, Thus, it would be helpful to understand why the authors con- double blind, placebo-controlled clinical trial for evaluating sidered 15 patients per arm enough to draw their conclusions on the efficacy of fractional CO compared with topical estriol the outcomes achieved with the different treatments. in the treatment of vaginal atrophy in postmenopausal Secondly, we deem that clarification about blinding is women.’’ We are also willing to clarify all methodological also needed. In our experience, the CO laser procedure details to allow a more thorough interpretation of our is always associated with the presence of some smoke findings. and burning odor, and with the feeling of heat by the patient. In our view, the statement that our article did not report Therefore, it seems difficult to comprehend that both the the sample size calculation is incorrect. In the methods patient and the physician who performed the laser treatment section, there is an item called ‘‘Sample Size’’ where are actually blinded. We believe that the presence of an calculation is described. Our goal was to compare efficacy assessor-blinded physician would be a better choice to reduce between local estrogen therapy (gold standard for vulvova- this bias. ginal atrophy [VVA]) and vaginal laser for VVA symptoms. As there are no previous studies comparing these two treat- Financial disclosure/conflicts of interest: None reported. ments, the ideal sample size calculation was not possible. We assumed that CO laser treatment would be inferior to Umberto Leone Roberti Maggiore, PhD, local estriol for vaginal atrophy symptoms and then we have Academic Unit of Obstetrics and Gynaecology calculated our sample size based on CO laser therapy to IRCCS Ospedale Policlinico San Martino 2 Genoa, Italy detect a three-point difference in the Vaginal Health Index Menopause, Vol. 25, No. 3, 2018 357 Copyright @ 2017 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.$

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