[Multicenter randomized clinical study of high-intensity focused ultrasound and cortical hormone in the treatment of non-neoplastic epithelial disorders of vulva].

ABSTRACT

OBJECTIVE: To evaluate the efficacy of high-intensity focused ultrasound (HIFU) and cortical hormone in the treatment of non-neoplastic epithelial disorders of vulva. METHODS: A total of 268 cases with pathologically diagnosed non-neoplastic epithelial disorders of vulva were randomly allocated into two groups of high-intensity focused ultrasound (HIFU) (n = 119) and cortical hormone (n = 124). And 25 cases became lost to follow-ups. Their signs, symptoms and quality-of-life were assessed before treatment, 1 month post-treatment and 3 months post-treatment. And the relationship was analyzed between pathologic type, age, course and efficacies. RESULTS: Their signs, symptoms and quality-of-life improved in both groups after 1 and 3 month. Compared with drug therapy, HIFU showed superior results in lesion amelioration at 1 month with significantly statistical difference and so did lesion amelioration and therapeutic effect at 3 month. And the efficacy of HIFU was better in those with >10-year disease course and pathologically diagnosed lichen sclerosus in 3 months. CONCLUSIONS: HIFU is both safe and effective in the treatment of non-neoplastic epithelial disorders of vulva.