Effect of Focused Ultrasound With or Without Anti-HPV β-Glucan Therapy on Persistent Cervical HPV Infection: A Randomized Controlled Trial

Abstract

Persistent high-risk human papillomavirus (HPV) infection is a leading cause of cervical cancer worldwide. While prophylactic vaccines exist, many women remain at risk due to prior exposure or limited access to vaccination. Current treatments focus on ablating visible lesions but often fail to clear the virus completely. Adjunctive therapies that enhance immune clearance may improve outcomes. This study aimed to evaluate whether combining focused ultrasound with anti-HPV β-glucan therapy improves HPV clearance and vaginal microecology compared to focused ultrasound alone. A total of 44 women diagnosed with persistent HPV infection were enrolled at Shandong Provincial Third Hospital between October 2022 and December 2023. Participants were randomly assigned to either focused ultrasound alone (control group) or combination therapy (focused ultrasound plus β-glucan dressing). Outcomes included HPV negative conversion rate, vaginal pH, hydrogen peroxide levels, Nugent score, and cellular cleanliness. Assessments were made at baseline and 3 months' post-treatment. The HPV negative conversion rate was significantly higher in the combination group (90.9%) than in the control group (72.7%) (p < 0.05). Combination therapy better restored normal vaginal pH, increased hydrogen peroxide-producing lactobacilli, and reduced inflammation markers. Microbial balance was fully restored in all patients receiving combination therapy versus only 59.09% in the control group. Pathogen profiles, including Nugent and aerobic vaginitis scores, also showed greater improvement in the intervention group. Combining focused ultrasound with anti-HPV β-glucan therapy significantly enhances HPV clearance and restores vaginal homeostasis. This noninvasive dual approach offers a promising option for managing persistent HPV infections.