Ensaio clínico randomizado com laser de CO2 fracionado e clobetasol no tratamento do líquen escleroso vulvar: um estudo clínico de viabilidade

Abstract

The vulva can be affected by multiple diseases. In this context, the vulvar lichen sclerosus stands out, a chronic inflammatory disease whose etiology is still unknown and which affects, especially, postmenopausal women. It is associated with important complications, becoming debilitating and with many negative repercussions on women's health. High-potency topical corticosteroid therapy has been reported as a first-line treatment for the disease, but there are still caveats about long-term safety and the occurrence of side effects. Thus, there is a need to search for new therapeutic options, such as fractional CO2 laser treatment. The randomized clinical trial developed had as main objective to describe the vulvar lesions previously and to compare changes after 3 months and 12 months of the adopted therapeutic approaches. The study was carried out with 20 women seen at the Vulva outpatient clinic of the Gynecology Service of the HU-UFJF, 9 of whom underwent standard treatment with Clobetasol and the other 11 underwent three sessions of fractional CO2 laser. Epidemiological data were obtained, referring to the quality of life by applying the WHOQOL-BREF questionnaire, referring to the vulvar anatomy and, finally, the assessment of the patient's perception of the treatment through an evaluation form developed by the researchers themselves. Assessments were made before the start of treatment, during its implementation, shortly after its end (3 months) and after 12 months. Data were entered into the SPSS 14.0 program and descriptive measures of frequency of categorical variables were obtained. Association between categorical and dependent independent variables was obtained using Pearson's Chi-Square Test or Fisher's Test. Quantitative variables were submitted to the Kolmogorov-Smirnov test with assumed normality. The t-Student test was performed for the quantitative variables of the current age and the diagnosis and domains of the WHOQOL-BREF and, still, Spearman's correlation was performed. The level of significance adopted was 5%. The entire sample consisted of elderly women. The clinical/anatomical characteristics of the vulva, in general, did not differ between treatment groups, both before and after its performance. Ulceration and hyperkeratosis were the characteristics that negatively influenced the patient's self-perception of the appearance of her vulva after treatment. Perianal impairment and synechia negatively influenced the quality of the patients' sexual life after treatment. Only 35% of the patients had an active sex life. Women with no sexual partner and with higher education had better scores in the Psychological domain and those with sexual partners, better performance in the Social domain. However, there was no statistically significant difference between the treatments performed with regard to the impact on the patients' quality of life. A higher degree of satisfaction with the treatment was obtained in patients in the Laser group, when self-perception was evaluated. The fractional CO2 laser proved to be well accepted and is a promising therapeutic option, especially in patients who respond poorly or partially to treatment with Clobetasol.