Efficacy of a Coriolus versicolor-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study

Authors: Santiago Palacios Gil-Antuñano, Luis Serrano Cogollor, Andrés C. López Díaz, Silvia P. González Rodríguez, Damián Dexeus Carter, Cristina Centeno Mediavilla, Pluvio Coronado Martín, Jesús de la Fuente Valero, José A. López Fernández, Cristina Vanrell Barbat, and Javier Cortés Bordoy

Journal: Journal of Personalized Medicine

Study Design: Multicenter, randomized, open-label, parallel-group, controlled clinical trial (sub-analysis of the PALOMA trial)

Participants: 41 women over 40 years old with low-grade HPV-dependent cervical lesions

Trial Length: 6 months

Intervention:

• Treatment group: Papilocare® vaginal gel (containing Coriolus versicolor) once daily for 21 days, followed by 7 days rest, for 1 or 3 months. Then, alternate-day therapy for 5 or 3 months.
• Control group: Watchful waiting approach

Primary Outcomes:

• Repair of cervical-vaginal lesions (normalized cytology and concordant colposcopy)
• HPV clearance (total or partial)

Summary: The study evaluated the efficacy of a Coriolus versicolor-based vaginal gel (Papilocare®) in repairing low-grade cervical lesions and clearing HPV in women over 40. The results showed that the gel significantly improved the repair of lesions compared to watchful waiting, particularly in women with high-risk HPV subtypes. Although not statistically significant, there was also a positive trend towards increased HPV clearance in the treatment group. The study concludes that Papilocare® is effective in repairing HPV-related cervical lesions and may contribute to HPV clearance in women over 40, a population at higher risk of persistent HPV infection and cervical cancer development.