Objective: To explore the feasibility and efficacy of focused ultrasound treatment of squamous hyperplasia and lichen sclerosus.
Methods: A simple randomized phase 2 study was conducted in which a total of 76 patients (45 with squamous hyperplasia and 31 with lichen sclerosus) were treated with focused ultrasound therapy from 1999 to 2002. Before and after the treatment, the therapeutic responses were evaluated based on changes in clinical symptoms and signs. Pre- and posttreatment biopsy specimens were also assessed through the light and electron microscopic examinations. The positive expressions of CD34 and myelin basic protein (MBP) tests with the strepavidin-peroxidase immunohistochemistry method were used to evaluate the therapeutic response. Statistical analysis was performed using chi2 (McNemar chi2) test and t test.
Results: After the ultrasound treatment, clinical symptoms were dramatically improved with a total response rate of 94.74%. Three to 6 months later the skin of treated areas returned to normal appearance. In the 2-year follow-up, 49 of 76 cases (32 squamous hyperplasia and 17 lichen sclerosus) were cured, 23 (11 squamous hyperplasia and 12 lichen sclerosus) improved and 4 (2 squamous hyperplasia and 2 lichen sclerosus) persisted. The positive expressions of CD34 and MBP after treatment increased significantly at the treated region (P < .05). No major complications occurred.
Conclusion: Vulvar dystrophy could be effectively treated with focused ultrasound therapy. This approach appears to be a new promising treatment method, although further studies are still needed. LEVEL OF EVIDENCE II-3.