Therapy with Pegylated Interferon or Combined with Cryosurgery in Condyloma Acuminata. Phase iii Clinical Trial

Abstract

Background: The continuous recurrence of condyloma acuminata makes the constant search for necessary therapeutic alternatives. Patients and method: To evaluate the therapeutic efficacy and safety of pegylated interferon, alone or adjuvant for cryosurgery, in the condyloma acuminata an open clinical trial was carried out on 30 patients of the "Hermanos Ameijeiras" hospital, who were randomized to receive for 6 weeks (group A) only fortnightly cryosurgery, (group B) subcutaneous pegylated interferon, once a week, associated with fortnightly cryosurgery application or (group C) only subcutaneous pegylated interferon, once a week. The main variable was the percentage of recurrence at one year of follow-up, evaluated quarterly. There was also a rigorous control of adverse events. Results: At the end of the treatment 8/10 (80%) patients from group A, 10/10 (100%) from group B and 9/10 (90%) from group C were left without injuries. During the follow-up, none of the patients who received pegylated interferon, alone or adjuvant to cryosurgery, had recurrences; while 100% of patients who received cryosurgery as exclusive treatment relapsed (p <0.000). The most frequent events were local burning (100%) due to cryosurgery and fever (6.6%), headache (6.6%), myalgia (3.3%) and malaise (3.3%) due to interferon. Conclusion: Pegylated interferon alone or adjuvant to cryosurgery provides benefits for the quality of life of patients, with absolute and relative reduction of a 100% of the risk of recurrence.