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.