RESUMEN
Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a Coriolus-versicolor-based vaginal gel (Papilocare®) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women ≥ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study's duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild-moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare® vaginal gel than spontaneous regression rates reported in the literature.
RESUMEN
INTRODUCTION: An important inverse relation between IUD use and risk of cervical cancer has been proved. Women who used IUD had half the risk of developing cervical cancer. The mechanism how IUD is a protector factor is still unknown. Could be improving the clearance of HPV infection or stopping progression to cancer from preneoplasic lesion. The aim of the study is to check if IUD increases HPV clearance, that is, checking if after 1 year HPV infection disappears in more patients using IUD than those not using it. STUDY DESIGN: This is a cohort case-control prospective study, carried out in Universitary Hospital La Zarzuela in Madrid, Spain, performed between October 2015 and April 2018. No pregnant women between 25-50 years old, with HPV cervical infection were enrolled. We separated the participants into two groups: an IUD group, with women starting using IUD and non IUD group, with women using any other contraceptive method or none. HPV genotyping of cervical cytology samples were performed initially on enrolment day and one year after. RESULTS: 254 participants were enrolled at the beginning of the study, 85 in the IUD group and 169 in the control group (non IUD). 179 participants completed the study, 54 (31%) in IUD group and 120 participants in non IUD group (69%). 38 women from IUD group cleared HPV infection (69.5%) and 65 women from control group cleared it (54.2%) (p = 0.044). An association in logistic regression was observed in HPV clearance with different factors. Firstly, higher percentage of patients with IUD clear the HPV infection than those in control group significantly associated (OR = 0.698, CI 95%; 0.251-0.998, p = 0.046). Clearance was higher in patients with low-risk HPV infection comparing with high risk HPV (OR = 1.078, CI 95%; 1.126-4.6.281, p = 0.026) and in patients with only one HPV type than those with more than one (OR = 0.194, CI 95%; 0.084-0.403, p < 0.001). CONCLUSIONS: In Spanish women with HPV infection, the HPV clearance between IUD and non IUD groups show results with statistical significance, patients with IUD have higher clearance rates. There were differences also between suffering one HPV type or more than one, and having low-risk HPV or high-risk HPV infection.