We thank Professors Maggiore and Ferrero for showing interest and reading our article entitled “Randomized, double blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women.” We are also willing to clarify all methodological details to allow a more thorough interpretation of our findings.
In our view, the statement that our article did not report the sample size calculation is incorrect. In the methods section, there is an item called “Sample Size” where calculation is described. Our goal was to compare efficacy between local estrogen therapy (gold standard for vulvovaginal atrophy [VVA]) and vaginal laser for VVA symptoms. As there are no previous studies comparing these two treatments, the ideal sample size calculation was not possible. We assumed that CO2 laser treatment would be inferior to local estriol for vaginal atrophy symptoms and then we have calculated our sample size based on CO2 laser therapy to detect a three-point difference in the Vaginal Health Index with a SD of 2.5. Nevertheless, in the discussion we pointed out that sample size calculation was based on detecting differences on VHI and not on all the multiple comparisons performed and therefore the findings should be interpreted with caution.
Regarding doubts related to the blinding, we affirm that both participant and physician remained blinded throughout the study. In our experience, the application of intravaginal laser is not accompanied by pain or any kind of burning odor. Such effects occur at vulvar laser application, where laser parameters are increased and the region is more innervated and sensitive. In our study protocol, we limited CO2 laser application to the vaginal canal and preserved the vulvar wall. The vaginal introitus was used as a reference for the vaginal canal ending. In addition, the sound emitted by the laser unit is retained even when set to power 0.
Finally, we thank the editor for the opportunity to clarify our study methodological detail and would like to say that our group is interested in discussing all the aspects related to this promising new therapeutic modal for VVA symptoms.