Comparação entre a betametasona associada ou não à hialuronidase no tratamento tópico da fimose – ensaio clínico randomizado e duplo cego

Abstract

Phimosis can be defined as the inability to retract the foreskin, preventing partial or complete exposure of the glans. The diagnosis is clinical, and the use of corticosteroids has been a treatment option. Different treatment regimens and different agents have been used. The association of hyaluronidase with betamethasone has been proposed to increase absorption and improve the expected results. However, prolonged use may be associated with corticosteroid absorption and impairment of the cortisol axis. Objectives: To compare the effectiveness of topical treatment with betamethasone alone to its association with hyaluronidase, evaluate systemic absorption of cortisol and identify factors that predispose the success of topical treatment of phimosis in children aged 3 to 10 years. Methods. This is a randomized clinical trial which involved 152 participants (3 to 10 years old) with phimosis. The children were divided into two groups: A group Betamethasone associated with Hyaluronidase (Betamethasone Valerate 2.5 mg + Hyaluronidase 150 UTR) and B group Betamethasone (Betamethasone Valerate 2.5 mg). Before starting treatment, they were examined to identify the type of phimosis using the classification proposed by Kayaba. Those responsible were instructed on how to use the ointment (twice a day, after hygiene, for 60 days) and on collecting salivary cortisol at 11pm and 9am, before and after treatment. Participants were evaluated after 30 and 60 days and all who were unsuccessful in the treatment had the ointment changed to start a new protocol. Fisher's Exact Test and Paired T Test were performed to process the data. Results: Ninety (69.77%) children had a successful with the proposed treatment, with the success rate for Group A being 75.38% versus 64.06% for Group B; p=0.18. The systemic absorption of salivary cortisol did not show statistically significant differences after intervention (p>0.05), showing that there is no systemic absorption when using ointments with or without the combination of hyaluronidase. The factors age (OR = 0.98 – CI: 0.97 - 1.00), adherence (OR = 1.49 – CI: 0.53 - 4.16), balanoposthitis (OR = 1.85 – CI: 0.47 - 7.19), previous use of corticosteroids (OR = 1.21 – CI: 0.53 - 2.72) also did not show differences. Conclusion. Topical therapy for true phimosis with Betamethasone 0.2% + Hyaluronidase, despite not having shown differences when compared to therapy performed only with Betamethasone 0.2%, for a period of up to 60 days, proved to be a safe method, effective, and with good results. The factors analyzed were not able to predict the expected clinical response.