Local carboxymethyl-β-glucan and polycarbophil therapy is associated with regression of low-grade cervical cytological abnormalities: a prospective observational study.

AIM: To evaluate the association between intravaginal therapy with carboxymethyl-β-glucan (CMBG) and polycarbophil and cytological regression of atypical squamous cells of undetermined significance (ASCUS) and cervical intraepithelial neoplasia grade 1 (CIN 1), compared with standard follow-up. METHODS: This prospective observational controlled study included 80 women aged 23-49 years with ASCUS or CIN 1. Forty patients received intravaginal CMBG/polycarbophil spray, and 40 were managed with standard follow-up. Allocation was based on clinical assessment and therapy availability, without randomisation. The primary outcome was cytological normalisation after 12 months, based on Papanicolaou smear results. RESULTS: After 12 months, abnormal cytology was observed in 4 (10.0%) patients in the treatment group and 18 (45.0%) in the control group (RR 0.22; 95% CI 0.08-0.60; p < 0.001). Normal cytology was observed in 36 (90.0%) and 22 (55.0%) patients, respectively (p < 0.001). Human papillomavirus (HPV) persistence was detected in 2 (5.0%) patients in the treatment group and 5 (12.5%) in the control group (p = 0.432). CONCLUSION: Intravaginal CMBG/polycarbophil therapy was associated with a higher rate of cytological normalisation than standard follow-up in women with ASCUS and CIN 1.