Introduction/Background*To evaluate the consistency of the efficacy of a multi-ingredient Coriolus versicolor-based vaginal gel, Papilocare®, on high-risk HPV (HR-HPV) clearance in 7 different studies.
Methodology Results of the 6 month-treatment period of Papilocare ® from 5 independent observational (3 Spanish and 2 Italian hospitals) were compared to results from a randomized, open, parallel, controlled trial (Paloma: ClinicalTrials.gov NCT04002154) and an observational, multicenter, prospective, one-cohort study (PapilOBS: ClinicalTrial.gov NCT04199260). Two prospective one-cohort (Vigo and Bari), 2 retrospective one-cohort (Coruña and Hospitalet) and 1 retrospective controlled (Roma) studies have been performed.
Vigo study. Secondary endpoint (SE): HPV clearance in 25 patients infected by HPV 16 and/or 18.
Bari study. Primary endpoint (PE): HPV clearance in 98 HR-HPV patients.
Coruña study: PE; HPV clearance assessed in 57 medical patients’ records.
Hospitalet study. PE: composite efficacy variable (patients with normal cytology and/or HPV clearance) in 91 HR-HPV patients.
Roma study. PE: HPV clearance in 183 HR-HPV patients.
PapilOBS study. SE: HR-HPV clearance in 178 patients.
Paloma trial. SE: HR-HPV clearance in 66 patients.
Result(s)*After the 6-month treatment period, 48% and 57% of patients cleared HPV 16-18 and HR-HPV in Vigo and Bari studies, respectively. 58% of reduction was observed in the number of HR-HPV patients (Coruña) and 72.5% of patients negativized cytology and/or cleared HR-HPV (Hospitalet). 67% HR-HPV clearance was observed (treated group) vs 37.2% (control group), p<0,0001 in the Roma study. In the Paloma trial, HR-HPV clearance reached 63% (treated group) vs 40% (control group). Similar rate of 57.4% HR-HPV clearance was observed in the PapilOBS study.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.