FIGO/IGCS Statement on the Efficacy of Topical Treatments for High-Risk Human Papillomavirus in Preventing CIN 3+ Lesions.

Cervical cancer is caused by persistent high-risk human papillomavirus (HR-HPV) infection and remains a major global health burden despite available preventive strategies. Most HR-HPV infections and associated low-grade squamous intraepithelial lesions (LSIL) regress spontaneously, yet increasing commercial promotion of topical therapies targeting HPV clearance has emerged in clinical practice. This FIGO/International Gynecologic Cancer Society (IGCS) Position Statement critically appraises the available evidence on topical treatments for HR-HPV infection and LSIL, and provides evidence-based recommendations for clinical practice and future research. No randomized controlled trial has been adequately designed or powered to evaluate the effect of topical therapies on the prevention of histologically confirmed high-grade squamous intraepithelial lesions (HSIL/CIN3+). Available studies are characterized by small sample sizes, short follow-up periods, heterogeneous populations, inadequate comparators, and reliance on surrogate endpoints of uncertain clinical relevance, including cytological regression, HPV nondetection, and immunohistochemical markers such as p16/Ki-67. Published meta-analyses reporting statistically significant improvements in virological and cytological surrogates are limited by substantial heterogeneity, publication bias, and follow-up periods under 1 year. Product-specific appraisal of Coriolus versicolor-based and silicon dioxide/selenite-based vaginal gels reveal additional methodological concerns, including retrospective trial registration, industry funding, and misinterpretation of findings consistent with the spin phenomenon. In the absence of high-quality evidence demonstrating clinically meaningful benefit, FIGO and IGCS do not endorse the routine clinical use of any currently available topical agent for HR-HPV infection or LSIL. Evidence-based surveillance remains the standard of care. Future research should prioritize rigorous trial design with histologically confirmed HSIL/CIN3+ as the primary endpoint, adequate follow-up of at least 3 years, and appropriate comparators. Clinical management should center on informed shared decision-making and evidence-based counseling, rather than on interventions lacking proven clinical benefit.