Clinical evidence on a Coriolus versicolor-based vaginal gel for HPV-related cervical disease: a narrative review.

Abstract

Background and objective: Human papillomavirus (HPV) infection is the most common sexually transmitted disease worldwide. Its persistence may lead to cervical dysplasia and, eventually, cervical cancer. Currently, there are no approved treatments specifically targeting HPV infection or low-grade squamous intraepithelial lesions (LSILs). A multicomponent vaginal gel containing Trametes versicolor extract, prebiotics, moisturizing agents, and anti-inflammatory coadjuvants has been developed to support natural HPV clearance and promote lesion healing or regression. The aim of this review is to summarize the available evidence regarding a multi-ingredient vaginal gel for HPV infection and cervical low-grade dysplasia treatment and to provide a critical review of the literature.

Methods: A structured literature search was performed in MEDLINE, Embase, and Scopus without language or date restrictions. Additional records were identified through ClinicalTrials.gov and Google Scholar. Both peer-reviewed publications and conference abstracts reporting clinical outcomes of Trametes versicolor-based vaginal gel (Papilocare® or Palomacare®) were included.

Key content and findings: Papilocare®/Palomacare® is available in over 65 countries across Europe, Africa, Asia, and Latin America. The clinical evidence includes two pilot studies, two prospective non-controlled interventional studies, one randomized clinical trial, and one retrospective observational study. This narrative review summarizes their design, results, strengths, and limitations. Ethical issues related to trial design, lack of biopsy confirmation, absence of blinding, and retrospective registration are discussed. Although some preliminary data suggest potential benefits in epithelial repair and HPV clearance, current evidence remains insufficient to support its routine clinical use.

Conclusions: Further independent, well-designed, and adequately powered randomized trials are required to confirm the safety and efficacy of this formulation. Strengthening methodological rigor will be essential to define its role in HPV-related cervical disease management.