Local carboxymethyl β-glucan and polycarbophil in women positive for human papillomavirus: a prospective observational study.

BACKGROUND: High-risk human papillomavirus (HR-HPV) infections with normal or low-grade cervical cytology are generally managed through observation because many infections clear spontaneously. However, persistent infection, particularly in women over 35 years of age, may increase the risk of progression and lead to prolonged surveillance, repeated examinations and patient anxiety. This study evaluates the effectiveness of local treatment with carboxymethyl β-glucan and polycarbophil (Colpofix®) in achieving negativization of high-risk (HR) human papillomavirus (HPV) in a Spanish population of women with HR-HPV positivity. METHODS: This prospective, non-randomized controlled, multi-centre study enrolled 533 women aged 25-65 with HR-HPV and normal cytology, atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesions. Conducted in real clinical settings, it involved a 3-month treatment or 'wait-and-see' approach, with final follow-up at 6 months. Statistical analysis included various tests such as the Mann-Whitney test, Fisher's exact test and Pearson's χ2 test. RESULTS: At 6 months, HR-HPV negativity was observed in 50.1% of treated patients compared with 24.0% in the observation group (p<0.0001). Higher clearance rates were recorded across all HR-HPV genotypes. For HPV16, negativization occurred in 50.7% of treated patients versus 9.2% of controls (p=0.0291). Resolution of cervical ectopy was more frequent in the treatment group (42.6% versus 11.5%, p<0.0001). No adverse events were reported. CONCLUSIONS: Local treatment with carboxymethyl β-glucan and polycarbophil was associated with higher rates of HR-HPV negativization and ectopy resolution compared with observation alone at 6-month follow-up, supporting its use as a management option, particularly in women over 35 years of age.