ABSTRACT
OBJECTIVE: The aim of the study was to evaluate the efficacy of Papilocare, a Coriolus versicolor-based vaginal gel, in repairing human papillomavirus (HPV)-related low-grade cervical lesions. METHODS: The study is a multicenter, open-label, randomized, parallel-group, watchful waiting approach-controlled trial involving 91 HPV-positive women with low-grade Pap smear alterations and consistent colposcopy. RESULTS: The percentage of patients with normal Pap smear and concordant colposcopy 3 and 6 months after receiving treatment (78.0% and 84.9%) was significantly higher than without treatment (54.8% and 64.5%), especially in high-risk HPV patients (79.5% and 87.8% vs 52.0% and 56.0%). At 6-month visit, overall HPV clearance was achieved by a greater number of patients receiving treatment (59.6%) compared with those without treatment (41.9%), especially high-risk HPV ones (62.5% vs 40.0%). The cervical re-epithelization score was significantly higher with treatment (mean = 4.5) than without (mean = 4.1). Compared with baseline, perceived stress decreased in the treatment group (from 21.1 to 19.0) and increased in the control group (from 17.7 to 20.7). A total of 7 possible or probable treatment-related adverse events were reported, most of them (n = 6) being mild or moderate in severity. CONCLUSIONS: Treatment with Papilocare has demonstrated a better clinical benefit than the conventional watchful waiting approach in clinical practice for total and high-risk HPV patients in terms of its efficacy to treat HPV-related cervical lesions and to clear all HPV strains after a single 6-month period. It has demonstrated an adequate safety and tolerability and confers additional benefits such as higher re-epithelization, stress reduction, and high treatment adherence.
Subject(s)
Papillomaviridae/drug effects , Papillomavirus Infections/drug therapy , Polyporaceae , Uterine Cervical Dysplasia/drug therapy , Uterine Cervical Dysplasia/virology , Uterine Cervical Neoplasms/drug therapy , Uterine Cervical Neoplasms/virology , Vaginal Creams, Foams, and Jellies/pharmacology , Adult , Female , Humans , Middle Aged , Spain , Treatment Outcome , Uterine Cervical Neoplasms/pathology , Young Adult , Uterine Cervical Dysplasia/pathologyABSTRACT
Están definidos dos escenarios para la aplicación de las estrategias preventivas de un cáncer, los que se desarrollan en el ámbito de las iniciativas de salud pública y aquellos que se circunscriben a la actividad asistencial personalizada. Saber dónde estamos trabajando y no mezclar estos ámbitos preventivos es imprescindible para alcanzar bien los objetivos, que son diferentes en su ambición, por lo que en su consecución, en pura lógica, deberán ser usadas metodologías también diferentes. A continuación detallamos las que en opinión de los firmantes podrían ser los modelos de conducta a seguir en la actividad asistencial personalizada enfocados a la prevención de los cánceres ginecológicos (AU)
Two scenarios are defined for the application of preventive strategies of cancer, those developed within the scope of public health initiatives and those that are confined to the personalized care activity. Knowing where we are working and not mixing these preventive areas is essential to achieve the objectives properly, which are different in their ambition, so that in their pursuit, in pure logic, there should be used different methodologies. Next are detailed, in the opinion of the signatories, which could be the models of conduct to be followed in the personalized care activity focused on the prevention of gynecological cancers (AU)
