Introduction/Background High-risk strains of HPV are well established as the causative agents for cervical dysplasia and cervical cancer. It is also well known that pre-cancerous cervical lesions persist longer and progress quickly in women infected by high-risk HPV than in women with non-oncogenic HPV strains.
The aim of this study was to evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- in repairing HPV-dependent cervical lesions (ASCUS/LSIL) in three groups of patients according to the oncogenic potential of HPV strains.
Methodology Randomized, open-label, parallel-group, controlled clinical trial (Paloma Clinical Trial). HPV+ women aged between 30 and 65 with cytology of ASCUS or LSIL with concordant colposcopy image were randomized into 3 groups. Primary endpoint of the Paloma Clinical trial: percentage of patients with normal cytology and concordant colposcopy image at 6 months, evaluated in total population, high-risk subpopulation (16,18,31,33,35,39,45,51,52,56,58,59,68) subpopulation and the subpopulation infected by any combination of 16, 18 and 31, is presented. Pap smear evaluation was being centrally-conducted at the IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this per-protocol analysis.
Results A total of 84, 66 and 29 patients corresponding to total population, and high-risk and 16-18-31 subpopulations were evaluated, respectively.
At 6 months, normal cytology and concordant colposcopy image was observed in 85% (45/53), 88% (36/41) and 73% (11/15) of patients treated with Papilocare® vs 65% (20/31), 56% (14/25) and 43% (6/14) of patients in control group, in the total population, and high-risk and 16-18-31 subpopulations (p=0.0311; p=0.0034; p=0.0959, chi-square test; figure1) respectively.
Conclusion While the spontaneous normalizations of HPV-dependent cervical lesions clearly decreased according to the risk of HPV strains (Total population = 65%, HR-HPV=56%, and HPV-16-18-31=42%), the robust efficacy of Papilocare in normalizing cervical lesions was maintained in the 3 patients groups with statistically significant difference versus control.
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